Self-expandable CoreValve implantation without contrast media.

PubMed

Bruschi, Giuseppe; Colombo, Paola; De Marco, Federico; Barosi, Alberto; Mauri, Silvia; Klugmann, Silvio

2016-09-01

Transcatheter aortic valve implantation has been designed to treat high-risk surgical patients affected by severe aortic stenosis, many of whom are affected by chronic kidney disease. To perform transcatheter self-expandable valve implantation, multiple contrast injections are required to monitor the procedure, so these patients are at increased risk of acute kidney injury. We described self-expandable transcatheter aortic valve implantation without contrast media in an 80-year-old man affected by severe aortic stenosis and endstage chronic kidney disease. © The Author(s) 2015.

Concomitant transcatheter aortic valve and left ventricular assist device implantation.

PubMed

Baum, Christina; Seiffert, Moritz; Treede, Hendrik; Reichenspurner, Hermann; Deuse, Tobias

2013-01-01

Relevant aortic regurgitation (AR) requires surgical repair at the time of left ventricular assist device (LVAD) implantation to reduce recirculation and ensure adequate forward flow. We report here on a patient with moderate AR in a noncalcified aortic valve and extensive calcification of the ascending aorta. The latter precluded aortic-crossclamping and, thus, surgical intervention on the aortic valve. Although there were no valvular or annular calcifications, a JenaValve transcatheter heart valve was successfully placed transapically with subsequent LVAD implantation in one operation. We believe concomitant transcatheter aortic valve implantation (TAVI) and LVAD implantation is a promising hybrid procedure, even in patients with pure AR.

Trans-catheter aortic valve implantation after previous aortic homograft surgery.

PubMed

Drews, Thorsten; Pasic, Miralem; Buz, Semih; Unbehaun, Axel

2011-12-01

In patients with previous heart surgery, the operative risk is elevated during conventional aortic valve re-operations. Trans-catheter aortic valve implantation is a new method for the treatment of high-risk patients. Nevertheless, this new procedure carries potential risks in patients with previous homograft implantation in aortic position. Between April 2008 and February 2011, 345 consecutive patients (mean EuroSCORE (European System for Cardiac Operative Risk Evaluation): 38 ± 20%; mean Society of Thoracic Surgeons (STS) Mortality Score: 19 ± 16%; mean age: 80 ± 8 years; 111 men and 234 women) underwent trans-apical aortic valve implantation. In three patients, previous aortic homograft implantation had been performed. Homograft degeneration causing combined valve stenosis and incompetence made re-operation necessary. In all three patients, the aortic valve could be implanted using the trans-apical approach, and the procedure was successful. In two patients, there was slight paravalvular leakage of the aortic prosthesis and the other patient had slight central leakage. Neither ostium obstruction nor mitral valve damage was observed. Trans-catheter valve implantation can be performed successfully after previous homograft implantation. Particular care should be taken to achieve optimal valve positioning, not to obstruct the ostium of the coronary vessels due to the changed anatomic situation and not to cause annulus rupture. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

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.

Trans-apical aortic valve implantation in patients with severe calcification of the ascending aorta.

PubMed

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

2011-08-01

In patients with calcification of the ascending aorta, postoperative stroke and mortality rates remain high after conventional aortic valve replacement, but the results of trans-apical aortic valve implantation in these patients are not known. We evaluate the outcome of trans-apical aortic valve implantation in patients with severely calcified ascending aorta in a single center with expanded procedural experience. Between April 2008 and July 2010, 258 patients underwent trans-apical aortic valve implantation using Edwards Sapien valve. By computed tomography (CT) scan, we identified 46 (18%) patients with severe calcification of the ascending aorta (16 with porcelain aorta and 30 with severe, but not complete, calcification). Of 46 patients (mean age 77 ± 10 years, range 63-90 years; EuroSCORE (European System for Cardiac Operative Risk Evaluation) 45 ± 22%; STS (Society of Thoracic Surgeons) score 23 ± 13) with calcified aorta, 15 received 23-mm valves and 31 patients 26-mm valves. Primary valve implantation was successful in 44 patients and a second valve was implanted (valve-in-valve) in two. Six patients underwent concomitant interventions (three elective percutaneous coronary intervention (PCI), one off-pump coronary artery bypass (OPCAB), one tricuspid valve reconstruction, and one left-ventricular (LV) aneurysmectomy). The final procedural results showed valve incompetence (trace or grade 1) in 17 (37%) patients and paravalvular leak in 15 (32.6%) (trace in 10 and grade 1 in five). There was no 30-day mortality. Postoperatively, cranial CT showed new cerebral ischemia areas in three patients (6.2%), but only one patient (2.1%) experienced postoperative neurological deficit (temporary aphasia). Survival at 6 and 12 months was 88% and 85.2%, respectively. Trans-apical aortic valve implantation can be performed safely in patients with aortic valve stenosis and severe calcification of the ascending aorta. Copyright © 2010 European Association for Cardio

Long-Term Mortality Effect of Early Pacemaker Implantation After Surgical Aortic Valve Replacement.

PubMed

Greason, Kevin L; Lahr, Brian D; Stulak, John M; Cha, Yong-Mei; Rea, Robert F; Schaff, Hartzell V; Dearani, Joseph A

2017-10-01

The need for pacemaker implantation is a well-described complication of aortic valve replacement. Not so well described is the effect such an event has on long-term outcome. This study reviewed a 21-year experience at the Mayo Clinic (Rochester, Minnesota) with aortic valve replacement to understand the influence of early postoperative pacemaker implantation on long-term mortality rates more clearly. This study retrospectively reviewed the records of 5,842 patients without previous pacemaker implantation who underwent surgical aortic valve replacement from January 1993 through June 2014. The median age of these patients was 73 years (range, 65 to 79 years), the median ejection fraction was 62% (range, 53% to 68%), 3,853 patients were male (66%), and coronary artery bypass graft operation was performed in 2,553 (44%) of the patients studied. Early pacemaker implantation occurred in 146 patients (2.5%) within 30 days of surgical aortic valve replacement. The median follow-up of patients was 11.1 years (range, 5.8 to 16.5 years), and all-cause mortality rates were 2.4% at 30 days, 6.4% at 1 year, 23.1% at 5 years, 48.3% at 10 years, and 67.9% at 15 years postoperatively. Early pacemaker implantation was associated with an increased risk of death after multivariable adjustment for baseline patients' characteristics (hazard ratio, 1.49; 95% confidence interval, 1.20, 1.84; p < 0.001). Early pacemaker implantation as a complication of surgical aortic valve replacement is associated with an increased risk of long-term death. Valve replacement-related pacemaker implantation rates should be important considerations with respect to new valve replacement paradigms, especially in younger and lower-risk patients. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transapical implantation of a second-generation transcatheter heart valve in patients with noncalcified aortic regurgitation.

PubMed

Seiffert, Moritz; Diemert, Patrick; Koschyk, Dietmar; Schirmer, Johannes; Conradi, Lenard; Schnabel, Renate; Blankenberg, Stefan; Reichenspurner, Hermann; Baldus, Stephan; Treede, Hendrik

2013-06-01

This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Percutaneously implantable aortic valve: the JenaValve concept evolution].

PubMed

Figulla, Hans R; Ferrari, Markus

2006-10-01

Due to the increasing incidence of severe aortic stenosis in old and multimorbid patients, the percutaneous implantation of aortic valve-carrying stents has become an alternative to the surgical replacement of aortic valves. Starting in 1995, the authors developed a self-expanding stent which transferred the necessary forces for anchoring up to the aorta ascendens-a conception taken over from CoreValve. The further improvement of this idea over the past 11 years has led to a self-expanding, relatively short stent-valve system that is reliably positioned in the cusps of the old aortic valve and holds the old valve like a paper clip, thus transferring the holding forces physiologically. As compared to conventional systems, the sophisticated insertion catheter requires further chronic animal tests so as to represent a true alternative to the conventional surgical procedure.

When Not to Go SOLO? Contraindications Based on Implant Experience.

PubMed

Wollersheim, Laurens W; Li, Wilson W; Kaya, Abdullah; van Boven, Wim J; van der Meulen, Jan; de Mol, Bas A

2016-11-01

Because of the design and specific implantation technique of the stentless Freedom SOLO bioprosthesis, patient selection is crucial. The aim of the study was to discuss the contraindications to this prosthesis based on the authors' implant experience. Between April 2005 and February 2015, one surgeon at the authors' center performed 292 aortic valve replacements using a bioprosthesis, with the initial intention of implanting a SOLO valve in every patient. A search was conducted for all of these patients and data collected on whether a SOLO valve was used, or not. A SOLO valve was implanted in 238 patients (82%), and a stented bioprosthesis in 54 (18%). The predominant reasons not to implant a SOLO valve were asymmetric commissures (26%) and a large aortic annulus (24%). Only one patient had structural valve deterioration, and none of the patients had to undergo reoperation because of aortic valve insufficiency or paravalvular leakage. Asymmetric commissures, large aortic annulus (>27 mm), calcified aortic sinuses, dilated sinotubular junction, aberrant location of coronary ostia and whenever the stent of a stented bioprosthesis is useful, were contraindications to implant a SOLO valve. When these contraindications were taken into account, a very good durability could be achieved with the SOLO valve during mid-term follow up.

Delayed-onset streptococcus pyogenes endophthalmitis following Ahmed glaucoma valve implantation.

PubMed

Bayraktar, Zerrin; Kapran, Ziya; Bayraktar, Sükrü; Acar, Nur; Unver, Yaprak Banu; Gök, Kemran

2005-01-01

To report a case of delayed-onset Streptococcus pyogenes endophthalmitis following implantation of an Ahmed glaucoma valve. A 10-year-old patient presented with acute endophthalmitis 1 year after Ahmed glaucoma valve implantation. The conjunctiva and Tenon's capsule over the valve plate had been penetrated by one of the polypropylene fixation sutures. The valve was removed, and pars plana vitrectomy was performed. Vitreous specimens and removal of the discharge over the plate revealed Streptococcus pyogenes. This is the first documented case of Streptococcus pyogenes endophthalmitis following Ahmed glaucoma valve implantation. We think the conjunctival buttonhole caused by the polypropylene suture provided an entry site for the infection. (c) Japanese Ophthalmological Society 2005.

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

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.

Minimally Invasive Aortic Valve Replacement Following Root Enlargement on too Narrow Annulus to Perform Transcatheter Aortic Valve Implantation.

PubMed

Sakamoto, Kosuke; Totsugawa, Toshinori; Hiraoka, Arudo; Tamura, Kentaro; Yoshitaka, Hidenori; Sakaguchi, Taichi

2018-05-30

An 88-year-old woman was diagnosed with aortic stenosis and an aortic annulus that was too narrow to perform transcatheter aortic valve implantation. Surgery was performed through a 7-cm right mini-thoracotomy at the fourth intercostal space. A 19-mm aortic valve bioprosthesis was implanted after root enlargement. The fourth intercostal space was a suitable site for aortic root enlargement because of the shorter skin-to-root distance and the detailed exposure of the aortic valve after cutting the aortic wall. This study concluded that minimally-invasive aortic valve replacement following root enlargement can be an option for the treatment of elderly patients with aortic stenosis accompanied by an annulus that is too small to perform transcatheter aortic valve implantation.

Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial.

PubMed

McElhinney, Doff B; Cheatham, John P; Jones, Thomas K; Lock, James E; Vincent, Julie A; Zahn, Evan M; Hellenbrand, William E

2011-12-01

Among patients undergoing transcatheter pulmonary valve (TPV) replacement with the Melody valve, risk factors for Melody stent fracture (MSF) and right ventricular outflow tract (RVOT) reintervention have not been well defined. From January 2007 to January 2010, 150 patients (median age, 19 years) underwent TPV implantation in the Melody valve Investigational Device Exemption trial. Existing conduit stents from a prior catheterization were present in 37 patients (25%, fractured in 12); 1 or more new prestents were placed at the TPV implant catheterization in 51 patients. During follow-up (median, 30 months), MSF was diagnosed in 39 patients. Freedom from a diagnosis of MSF was 77±4% at 14 months (after the 1-year evaluation window) and 60±9% at 39 months (3-year window). On multivariable analysis, implant within an existing stent, new prestent, or bioprosthetic valve (combined variable) was associated with longer freedom from MSF (P<0.001), whereas TPV compression (P=0.01) and apposition to the anterior chest wall (P=0.02) were associated with shorter freedom from MSF. Freedom from RVOT reintervention was 86±4% at 27 months. Among patients with a MSF, freedom from RVOT reintervention after MSF diagnosis was 49±10% at 2 years. Factors associated with reintervention were similar to those for MSF. MSF was common after TPV implant in this multicenter experience and was more likely in patients with severely obstructed RVOT conduits and when the TPV was directly behind the anterior chest wall and/or clearly compressed. A TPV implant site protected by a prestent or bioprosthetic valve was associated with lower risk of MSF and reintervention.

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

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

PubMed

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

[LONG TERM FOLLOW-UP OF TRANSCATHETER SELF EXPANDABLE AORTIC VALVE IMPLANTATION].

PubMed

Chen, Shmuel; Zenios, Vicky; Gilon, Dan; Planer, David; Beeri, Ronen; Lotan, Chaim; Danenberg, Haim D

2018-03-01

Aortic stenosis is the most common significant valvular disease in the western world. These patients are treated operatively unless they are at high operative risk or inoperable. During the last decade an alternative approach has evolved - transcatheter aortic valve implantation (TAVI). This method was shown to be at least as effective and safe as the operative one. However, very little data exists on long term follow-up (5 years and above), especially regarding valve durability and patient survival. To present a long term follow-up on patients who underwent transcutaneous self-expandable aortic valve implantation in our department between the years 2008-2011. In September 2008 the first CoreValve implantation was performed in Israel at Hadassah Medical Center. All records of patients who were transplanted between 9.2008 and 10.2011 were reviewed. The function of the valve early after the procedure was compared to its function at the end of the follow-up period. A total of 38 patients (out of 71) survived at least 54 months, of them, 19 have an echocardiography examination at the end of the follow-up period. In all patients the implanted valve was found to function well at the end of the follow-up period, without significant stenosis or paravalvular leak. In fact, in approximately half of these patients, the degree of paravalvular leak decreased during the follow-up period. On long term (5 years) follow-up of patients who were implanted with the self-expandable aortic valve (CoreValve), no deterioration of the valve was observed. In fact, in approximately half of the patients, a decrease in the severity of the paravalvular leak was demonstrated.

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.

Transcatheter aortic valve implantation for failing surgical aortic bioprosthetic valve: from concept to clinical application and evaluation (part 2).

PubMed

Piazza, Nicolo; Bleiziffer, Sabine; Brockmann, Gernot; Hendrick, Ruge; Deutsch, Marcus-André; Opitz, Anke; Mazzitelli, Domenico; Tassani-Prell, Peter; Schreiber, Christian; Lange, Rüdiger

2011-07-01

This study sought to review the acute procedural outcomes of patients who underwent transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation at the German Heart Center, Munich, and to summarize the existing literature on TAV-in-SAV implantation (n = 47). There are several case reports and small case series describing transcatheter aortic valve implantation for a failing surgical aortic valve bioprosthesis (TAV-in-SAV implantation). From January 2007 to March 2011, 20 out of 556 patients underwent a TAV-in-SAV implantation at the German Heart Center Munich. Baseline characteristics and clinical outcome data were prospectively entered into a dedicated database. The mean patient age was 75 ± 13 years, and the mean logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons' Risk Model scores were 27 ± 13% and 7 ± 4%, respectively. Of the 20 patients, 14 had stented and 6 had stentless surgical bioprostheses. Most cases (12 of 20) were performed via the transapical route using a 23-mm Edwards Sapien prosthesis (Edwards Lifesciences, Irvine, California). Successful implantation of a TAV in a SAV with the patient leaving the catheterization laboratory alive was achieved in 18 of 20 patients. The mean transaortic valve gradient was 20.0 ± 7.5 mm Hg. None-to-trivial, mild, and mild-to-moderate paravalvular aortic regurgitation was observed in 10, 6, and 2 patients, respectively. We experienced 1 intraprocedural death following pre-implant balloon aortic valvuloplasty ("stone heart") and 2 further in-hospital deaths due to myocardial infarction. TAV-in-SAV implantation is a safe and feasible treatment for high-risk patients with failing aortic bioprosthetic valves and should be considered as part of the armamentarium in the treatment of aortic bioprosthetic valve failure. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

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.

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) versus redo-Surgical aortic valve replacement (redo-SAVR): A systematic review and meta-analysis.

PubMed

Nalluri, Nikhil; Atti, Varunsiri; Munir, Abdullah B; Karam, Boutros; Patel, Nileshkumar J; Kumar, Varun; Vemula, Praveen; Edla, Sushruth; Asti, Deepak; Paturu, Amrutha; Gayam, Sriramya; Spagnola, Jonathan; Barsoum, Emad; Maniatis, Gregory A; Tamburrino, Frank; Kandov, Ruben; Lafferty, James; Kliger, Chad

2018-05-20

Bioprosthetic (BP) valves have been increasingly used for aortic valve replacement over the last decade. Due to their limited durability, patients presenting with failed BP valves are rising. Valve in Valve - Transcatheter Aortic Valve Implantation (ViV-TAVI) emerged as an alternative to the gold standard redo-Surgical Aortic Valve Replacement (redo-SAVR). However, the utility of ViV-TAVI is poorly understood. A systematic electronic search of the scientific literature was done in PubMed, EMBASE, SCOPUS, Google Scholar, and ClinicalTrials.gov. Only studies which compared the safety and efficacy of ViV-TAVI and redo-SAVR head to head in failed BP valves were included. Six observational studies were eligible and included 594 patients, of whom 255 underwent ViV- TAVI and 339 underwent redo-SAVR. There was no significant difference between ViV-TAVI and redo- SAVR for procedural, 30 day and 1 year mortality rates. ViV-TAVI was associated with lower risk of permanent pacemaker implantation (PPI) (OR: 0.43, CI: 0.21-0.89; P = 0.02) and a trend toward increased risk of paravalvular leak (PVL) (OR: 5.45, CI: 0.94-31.58; P = 0.06). There was no significant difference for stroke, major bleeding, vascular complications and postprocedural aortic valvular gradients more than 20 mm-hg. Our results reiterate the safety and feasibility of ViV-TAVI for failed aortic BP valves in patients deemed to be at high risk for surgery. VIV-TAVI was associated with lower risk of permanent pacemaker implantation with a trend toward increased risk of paravalvular leak. © 2018, Wiley Periodicals, Inc.

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

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sochman, Jan; Peregrin, Jan H.; Rocek, Miloslav

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 andmore » 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.« less

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

Trabeculectomy With Mitomycin C or Ahmed Valve Implantation in Eyes With Uveitic Glaucoma.

PubMed

Bettis, Daniel I; Morshedi, Richard G; Chaya, Craig; Goldsmith, Jason; Crandall, Alan; Zabriskie, Norm

2015-01-01

To report and compare the results of trabeculectomy with mitomycin C (MMC) and Ahmed valve implantation in the management of uveitic glaucoma. The records of 41 eyes of 29 patients who underwent trabeculectomy with MMC or Ahmed valve implantation for uveitic glaucoma were retrospectively reviewed. Seventeen eyes underwent trabeculectomy with MMC, and 24 eyes underwent Ahmed valve implantation. Outcomes included postoperative intraocular pressure (IOP), percent reduction from preoperative IOP, postoperative number of medications, time to failure, and complications. Mean follow-up was 21.2 months in the trabeculectomy group and 23.8 months in the valve group (P=0.06). Mean IOP was reduced from 29.2 to 18.4 mm Hg in the trabeculectomy group (31.3%), compared with a reduction from 33.4 to 15.5 mm Hg in the Ahmed valve group (42.7%, P=0.53). Postoperatively, 1.76 medications were used in the trabeculectomy group, compared with 1.83 medications in the Ahmed valve group (P=0.89). Cumulative success at 1 year was 66.7% in the trabeculectomy group, compared with 100% in the Ahmed valve group (P=0.02). Mean time to failure was 8.36 months with trabeculectomy, and 21.8 months with Ahmed valve (P=0.02). Complications in both groups were typically rare and self-limited, with recurrent inflammation being most common. Although both trabeculectomy with MMC and Ahmed valve implantation are reasonable surgical options in the management of uncontrolled uveitic glaucoma, Ahmed valve implantation was associated with higher cumulative success rate at 1 year and a longer mean time to failure.

Initial Clinical Experience with Ahmed Valve Implantation in Refractory Pediatric Glaucoma

PubMed

Novak-Lauš, Katia; Škunca Herman, Jelena; Šimić Prskalo, Marija; Jurišić, Darija; Mandić, Zdravko

2016-12-01

The purpose is to report on the safety and efficacy of Ahmed Glaucoma Valve (AGV, New World Medical, Inc., Rancho Cucamonga, CA, USA) implantation for the management of refractory pediatric glaucoma observed during one-year follow up period. A retrospective chart review was conducted on 10 eyes, all younger than 11 years, with pediatric glaucoma that underwent AGV implantation for medicamentously uncontrolled intraocular pressure (IOP) between 2010 and 2014. Outcome measures were control of IOP below 23 mm Hg (with or without antiglaucoma medications) and changes in visual acuity. Complications were recorded. After AGV implantation, IOP values ranged from 18 mm Hg to 23 mm Hg (except for one eye with postoperative hypotonia due to suprachoroid hemorrhage, where the postoperative IOP value was 4 mm Hg). The number of antiglaucoma medications was reduced, i.e. four patients had two medications, one patient had one medication, and the others did not need antiglaucoma medication on the last follow-up visit. One eye had suprachoroid hemorrhage, one eye had long-term persistent uveitic membrane, and two eyes had tube-cornea touch. In conclusion, AGV implantation appears to be a viable option for the management of refractory pediatric glaucoma and shows success in IOP control. However, there was a relatively high complication rate limiting the overall success rate.

Intravalvular Implantation of Mitral Valve Prostheses

PubMed Central

Cooley, Denton A.; Ingram, Michael T.

1987-01-01

We describe a technique of intravalvular implantation of a low-profile prosthesis that has been used in nine patients with mitral valve lesions. This technique preserves the anterior and posterior chordae and papillary mechanisms, which may decrease the incidence of postoperative left ventricular dysfunction that has been noted following standard mitral valve replacement. The technique may also be useful in some patients with aortic and tricuspid regurgitation when the annulus and leaflets are relatively normal pathologically. (Texas Heart Institute Journal 1987;14:188-193) PMID:15229740

Successful treatment of pure aortic insufficiency with transapical implantation of the JenaValve.

PubMed

Bleiziffer, Sabine; Mazzitelli, Domenico; Nöbauer, Christian; Ried, Thomas; Lange, Rüdiger

2013-08-01

Transcatheter aortic valve implantation was predominantly developed for patients with severe calcified aortic stenosis, as most devices are designed to anchor within the native valve calcium. We report on a patient with pure insufficiency of a non-calcified aortic valve, in whom an anatomically oriented catheter valve was implanted successfully. The design of the prosthesis with position feelers engaging the native aortic valve leaflets proved to be suitable for the treatment of pure aortic insufficiency. Georg Thieme Verlag KG Stuttgart · New York.

Registry of transcatheter aortic-valve implantation in high-risk patients.

PubMed

Gilard, Martine; Eltchaninoff, Hélène; Iung, Bernard; Donzeau-Gouge, Patrick; Chevreul, Karine; Fajadet, Jean; Leprince, Pascal; Leguerrier, Alain; Lievre, Michel; Prat, Alain; Teiger, Emmanuel; Lefevre, Thierry; Himbert, Dominique; Tchetche, Didier; Carrié, Didier; Albat, Bernard; Cribier, Alain; Rioufol, Gilles; Sudre, Arnaud; Blanchard, Didier; Collet, Frederic; Dos Santos, Pierre; Meneveau, Nicolas; Tirouvanziam, Ashok; Caussin, Christophe; Guyon, Philippe; Boschat, Jacques; Le Breton, Herve; Collart, Frederic; Houel, Remi; Delpine, Stephane; Souteyrand, Geraud; Favereau, Xavier; Ohlmann, Patrick; Doisy, Vincent; Grollier, Gilles; Gommeaux, Antoine; Claudel, Jean-Philippe; Bourlon, Francois; Bertrand, Bernard; Van Belle, Eric; Laskar, Marc

2012-05-03

Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).

Transapical tricuspid valve-in-ring implantation: An alternative approach to a challenging clinical scenario.

PubMed

Girdauskas, Evaldas; Lauer, Bernward; Kuntze, Thomas

2018-04-01

We report on a transapical tricuspid valve-in-ring implantation performed via right ventricular apex using the Sapien-XT-prosthesis. A 57-year-old woman with recurrent episodes of right heart failure and three previous sternotomies, including tricuspid valve repair with a 32 mm Carpentier-Edwards-Classic annuloplasty ring was admitted due to recurrent severe tricuspid regurgitation. Given the excessive surgical risk, a 29 mm Sapien-XT-prosthesis was selected for valve-in-ring implantation. Transapical valve-in-ring implantation procedure was uneventful. Predischarge echocardiography showed only trace paravalvular tricuspid regurgitation in the septal region. Transapical approach via right ventricular apex is a viable alternative for tricuspid valve-in-ring implantation in selected high-risk patients. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Conduction Abnormalities and Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement Using the Repositionable LOTUS Device: The United Kingdom Experience.

PubMed

Rampat, Rajiv; Khawaja, M Zeeshan; Hilling-Smith, Roland; Byrne, Jonathan; MacCarthy, Philip; Blackman, Daniel J; Krishnamurthy, Arvindra; Gunarathne, Ashan; Kovac, Jan; Banning, Adrian; Kharbanda, Raj; Firoozi, Sami; Brecker, Stephen; Redwood, Simon; Bapat, Vinayak; Mullen, Michael; Aggarwal, Suneil; Manoharan, Ganesh; Spence, Mark S; Khogali, Saib; Dooley, Maureen; Cockburn, James; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-06-26

The authors report the incidence of pacemaker implantation up to hospital discharge and the factors influencing pacing rate following implantation of the LOTUS bioprosthesis (Boston Scientific, Natick, Massachusetts) in the United Kingdom. Transcatheter aortic valve replacement (TAVR) is associated with a significant need for permanent pacemaker implantation. Pacing rates vary according to the device used. The REPRISE II (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System) trial reported a pacing rate of 29% at 30 days after implantation of the LOTUS device. Data were collected retrospectively on 228 patients who had the LOTUS device implanted between March 2013 and February 2015 across 10 centers in the United Kingdom. Twenty-seven patients (12%) had pacemakers implanted pre-procedure and were excluded from the analysis. Patients were aged 81.2 ± 7.7 years; 50.7% were male. The mean pre-procedural QRS duration was 101.7 ± 20.4 ms. More than one-half of the cohort (n = 111, 55%) developed new left bundle branch block (LBBB) following the procedure. Permanent pacemakers were implanted in 64 patients (32%) with a median time to insertion of 3.0 ± 3.4 days. Chief indications for pacing were atrioventricular (AV) block (n = 46, 72%), or LBBB with 1st degree AV block (n = 11, 17%). Amongst those who received a pacemaker following TAVR the pre-procedural electrocardiogram findings included: No conduction disturbance (n = 41, 64%); 1st degree AV block (n = 10, 16%); right bundle branch block (n = 6, 9%) and LBBB (n = 5, 8%). LBBB (but not permanent pacemaker) occurred more frequently in patients who had balloon aortic valvuloplasty before TAVR (odds ratio [OR]: 1.25; p = 0.03). Pre-procedural conduction abnormality (composite of 1st degree AV block, hemiblock, right bundle branch block, LBBB) was independently associated with the need for permanent pacemaker (OR: 2.54; p = 0.048). The absence of

Complications and 2-year valve survival following Ahmed valve implantation during the first 2 years of life.

PubMed

Almobarak, F; Al-Mobarak, F; Khan, A O

2009-06-01

To report complications and 2-year valve survival following Ahmed valve implantation during the first 2 years of life. Retrospective institutional case series. Forty-two eyes of 36 patients with Ahmed valve implantation (without prior drainage device surgery) during the first 2 years of life and 2 years' postsurgical follow-up were identified. Most eyes had primary congenital glaucoma (28/42, 66.7%), aphakic glaucoma (5/42, 11.9%) or Peters anomaly (5/42, 11.9%). All but three eyes had prior ocular surgery. Surgery was at a mean age of 11.83 months (m) (SD 5.63). The most common significant postoperative complications were tube malpositioning requiring intervention (11/42, 26.2%), endophthalmitis (3/42, 7.1%; one with tube exposure) and retinal detachment (3/42, 7.1%). Thirty-six eyes (85.8%) required resumption of antiglaucoma medications to maintain intraocular pressure (IOP) < or =22 mm Hg a mean of 7.2 m (SD 6.8) postoperatively. Cumulative probabilities of valve survival (IOP< or =22 mm Hg with or without medication) by Kaplan-Meier analysis were 73.8% and 63.3% at 12 months and 24 months, respectively. Postoperative tube malpositioning that required surgical revision was common in this age group. Infectious endophthalmitis and retinal detachment are known potential complications following any incisional surgery for advanced buphthalmos; however, tube exposure is a unique potential problem following aqueous shunt implantation that can lead to intraocular infection. Cumulative valve survival 2 years following implantation was 63.3%.

Transapical aortic valve implantation and minimally invasive off-pump bypass surgery

PubMed Central

Ahad, Samir; Baumbach, Hardy; Hill, Stephan; Franke, Ulrich F. W.

2014-01-01

Transcatheter aortic valve implantation (TAVI) has gained increasing popularity for high-risk patients with symptomatic aortic valve stenosis. A concomitant coronary artery disease leads to a complicated management and an increased perioperative risk. This case report describes the successful total arterial coronary revascularization of the left anterior descending and the left marginal branch of the circumflex artery utilizing the left internal mammary artery (LIMA) and left radial artery in off-pump technique in combination with the transapical transcatheter aortic valve implantation via minimally invasive anterolateral access in the fifth intercostal space. PMID:24221960

Transcatheter aortic valve implantation and cerebrovascular accidents.

PubMed

Stortecky, Stefan; Wenaweser, Peter; Windecker, Stephan

2012-09-01

Transcatheter aortic valve implantation (TAVI) is an evidence-based treatment alternative for selected high-risk patients with symptomatic severe aortic stenosis as acknowledged in the most recent edition of the ESC Guidelines on Valvular Heart Disease 2012. However, periprocedural complications and in particular cerebrovascular accidents remain a matter of concern. While transcatheter heart valve technology continuously improves and the development of novel and even less invasive implantation techniques is on-going, cerebrovascular events complicating TAVI may abrogate the usual improvement in terms of prognosis and quality of life. This article describes the incidence of cerebrovascular events after cardiovascular procedures, provides an overview of the pathophysiological mechanisms as well as the impact on outcomes and provides some insights into preventive strategies as well as the acute management of these events.

Transapical aortic valve implantation without angiography: proof of concept.

PubMed

Ferrari, Enrico; Sulzer, Christopher; Marcucci, Carlo; Rizzo, Elena; Tozzi, Piergiorgio; von Segesser, Ludwig K

2010-06-01

Cardiac computed tomographic scans, coronary angiograms, and aortographies are routinely performed in transcatheter heart valve therapies. Consequently, all patients are exposed to multiple contrast injections with a following risk of nephrotoxicity and postoperative renal failure. The transapical aortic valve implantation without angiography can prevent contrast-related complications. Between November 2008 and November 2009, 30 consecutive high-risk patients (16 female, 53.3%) underwent transapical aortic valve implantation without angiography. The landmarks identification, the stent-valve positioning, and the postoperative control were routinely performed under transesophageal echocardiogram and fluoroscopic visualization without contrast injections. Mean age was 80.1 +/- 8.7 years. Mean valve gradient, aortic orifice area, and ejection fraction were 60.3 +/- 20.9 mm Hg, 0.7 +/- 0.16 cm(2), and 0.526 +/- 0.128, respectively. Risk factors were pulmonary hypertension (60%), peripheral vascular disease (70%), chronic pulmonary disease (50%), previous cardiac surgery (13.3%), and chronic renal insufficiency (40%) (mean blood creatinine and urea levels: 96.8 +/- 54 microg/dL and 8.45 +/- 5.15 mmol/L). Average European System for Cardiac Operative Risk Evaluation was 32.2 +/- 13.3%. Valve deployment in the ideal landing zone was 96.7% successful and valve embolization occurred once. Thirty-day mortality was 10% (3 patients). Causes of death were the following: intraoperative ventricular rupture (conversion to sternotomy), right ventricular failure, and bilateral pneumonia. Stroke occurred in one patient at postoperative day 9. Renal failure (postoperative mean blood creatinine and urea levels: 91.1 +/- 66.8 microg/dL and 7.27 +/- 3.45 mmol/L), myocardial infarction, and atrioventricular block were not detected. Transapical aortic valve implantation without angiography requires a short learning curve and can be performed routinely by experienced teams. Our report

Comparison of Outcomes of Resident-performed Ahmed Valve Implantation vs Trabeculectomy

PubMed Central

Kammerdiener, Leah L; Wannamaker, Kendall W; Fan, Jie; Sharpe, Elizabeth D

2016-01-01

ABSTRACT Aims: To compare outcomes of resident-performed Ahmed valve surgery vs trabeculectomy in a Veteran Affairs medical facility. Materials and methods: A retrospective cohort of 103 eyes in 91 patients receiving Ahmed valve (valve) or trabeculectomy (trab) performed at a Veterans Administration Medical Center by residents in their third year of training. The primary outcomes included intraocular pressure (IOP), treatment failure, and complications over 1 year. Results: Of 103 eyes, 44 received valve and 59 received trab. Primary open-angle glaucoma was primary diagnosis more often in trab, while neovascular glaucoma predominated in the valve group (p < 0.001). Preoperative mean IOP was 35.1 ± 11.8 and 24.5 ± 7.1 mm Hg for valve and trabeculectomy respectively (p < 0.001), but at 1 year the IOP difference between groups was not statistically significant (p = 0.064). Overall, 11 (25.0%) and 11 (18.6%) eyes met any criteria for failure for valve and trab respectively. At 1 year, 22.5% of valves had IOP > 21 mm Hg vs only 4.3% of trab (p = 0.02). Complications were infrequent. There were no intraoperative complications for valve, whereas five for trab. Most common immediate complication for valve was hyphema. Both groups had low rates of choroidal effusions and reoperation. Conclusion: Ahmed valve implantation and trabeculectomy produce significant reductions in IOP when performed by residents-in-training. Valves tend to be used more frequently in patients with secondary glaucoma. Although complication profiles differ between procedures, both are safe and well tolerated when performed by resident physicians. Clinical significance: This study provides support for evidence-based patient counseling that supervised, resident-performed Ahmed valve implantation and trabeculectomy are indeed safe and effective. How to cite this article: Sharpe RA, Kammerdiener LL, Wannamaker KW, Fan J, Sharpe ED. Comparison of Outcomes of Resident-performed Ahmed Valve Implantation vs

Redo aortic valve surgery versus transcatheter valve-in-valve implantation for failing surgical bioprosthetic valves: consecutive patients in a single-center setting

PubMed Central

Wottke, Michael; Deutsch, Marcus-André; Krane, Markus; Piazza, Nicolo; Lange, Ruediger; Bleiziffer, Sabine

2015-01-01

Background Due to a considerable rise in bioprosthetic as opposed to mechanical valve implantations, an increase of patients presenting with failing bioprosthetic surgical valves in need of a reoperation is to be expected. Redo surgery may pose a high-risk procedure. Transcatheter aortic valve-in-valve implantation is an innovative, less-invasive treatment alternative for these patients. However, a comprehensive evaluation of the outcome of consecutive patients after a valve-in-valve TAVI [transcatheter aortic valve-in-surgical aortic valve (TAV-in-SAV)] as compared to a standard reoperation [surgical aortic valve redo-operation (SAV-in-SAV)] has not yet been performed. The goal of this study was to compare postoperative outcomes after TAV-in-SAV and SAV-in-SAV in a single center setting. Methods All SAV-in-SAV and TAV-in-SAV patients from January 2001 to October 2014 were retrospectively reviewed. Patients with previous mechanical or transcatheter valves, active endocarditis and concomitant cardiac procedures were excluded. Patient characteristics, preoperative data, post-procedural complications, and 30-day mortality were collected from a designated database. Mean values ± SD were calculated for all continuous variables. Counts and percentages were calculated for categorical variables. The Chi-square and Fisher exact tests were used to compare categorical variables. Continuous variables were compared using the t-test for independent samples. A 2-sided P value <0.05 was considered statistically significant. Results A total of 102 patients fulfilled the inclusion criteria, 50 patients (49%) underwent a transcatheter valve-in-valve procedure, while 52 patients (51%) underwent redo-surgery. Patients in the TAV-in-SAV group were significantly older, had a higher mean logistic EuroSCORE and exhibited a lower mean left ventricular ejection fraction than patients in the SAV-in-SAV group (78.1±6.7 vs. 66.2±13.1, P<0.001; 27.4±18.7 vs. 14.4±10, P<0.001; and 49.8±13

Percutaneous transfemoral-transseptal implantation of a second-generation CardiAQ mitral valve bioprosthesis: first procedure description and 30-day follow-up.

PubMed

Ussia, Gian Paolo; Quadri, Arshad; Cammalleri, Valeria; De Vico, Pasquale; Muscoli, Saverio; Marchei, Massimo; Ruvolo, Giovanni; Sondergaard, Lars; Romeo, Francesco

2016-02-01

Transcatheter mitral valve implantation for mitral valve regurgitation is in the very early phase of development because of challenging anatomy and device dimensions. We describe the procedure of a transfemoral-transseptal implantation of the second-generation CardiAQ mitral valve bioprosthesis and 30-day follow-up. The procedure was performed percutaneously, without any left extracorporeal circulatory support. The patient had severe mitral regurgitation with severely depressed ventricular function and other comorbidities. The patient was deemed extreme high risk for conventional cardiac surgery by a multidisciplinary team. The main procedural steps were the creation of an arteriovenous loop with an exchange nitinol wire, and the use of a customised "steerable snare system" to facilitate the catheter delivery system into the mitral annulus. Transoesophageal echocardiography and fluoroscopy were utilised for device positioning and deployment. The mitral valve prosthesis was implanted with mild mitral regurgitation. The postoperative course was uneventful and at 30-day follow-up the patient is in NYHA Class I, with good function of the mitral valve bioprosthesis. This procedure shows that percutaneous transfemoral transcatheter mitral valve implantation is feasible, safe and successful. Further experience is needed to render this procedure clinically available.

Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Beyersdorf, Friedhelm; Schönburg, Markus; Schuler, Gerhard; Sorg, Stefan; Mohr, Friedrich-W; Walther, Thomas

2011-11-01

Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN™ prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated. The Symetis Acurate™ trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive implantation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27mm. Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8±4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5±10.9% and Society of Thoracic Surgeons (STS) Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN™ valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4±10.7mmHg and mean 14.3±6.8mmHg. The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis Acurate™ device. Copyright © 2011

[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.

Early outcome of patients undergoing transcatheter aortic valve implantation (TAVI): The Auckland City Hospital experience 2011-2015.

PubMed

Wu, Sylvia S Y; Wang, Tom Kai Ming; Nand, Parma; Ramanathan, Tharumenthiran; Webster, Mark; Stewart, Jim

2016-01-08

Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement (AVR) in high-risk patients. We report the initial TAVI experience at Auckland City Hospital. The records of patients undergoing TAVI between 2011 and 2015 at Auckland City Hospital were reviewed. We report the procedural success and outcome, including major adverse events (death, stroke, myocardial infarction, bleeding, vascular complications and rehospitalisations), degree of aortic regurgitation and symptom status up to 1-year follow-up. Mean age was 80.7 years and mean Euroscore II and Society of Thoracic Surgeons' scores were 8.2% and 6.3% respectively; 50% had undergone previous cardiac surgery. Successful deployment of the valve was achieved in all patients. The cumulative mortality rates at 30 days, 6 months and 1 year were 2.4%, 6.1% and 12.2% and cumulative stroke rates 1.2%, 3% and 8.2% respectively. Severe aortic regurgitation occurred in 2.3% TAVI is available in the New Zealand public hospital system for patients who are high-risk candidates for AVR. Early results are excellent and indicate that the technology is being used appropriately, according to current access criteria. If the early cost effectiveness data are confirmed, the indications for TAVI may widen.

Comparative study of encapsulated blebs following Ahmed glaucoma valve implantation and trabeculectomy with mitomycin-C.

PubMed

Bae, Kunho; Suh, Wool; Kee, Changwon

2012-08-01

To compare the histopathologic and morphologic findings of encapsulated blebs following Ahmed glaucoma valve implantation and primary standard trabeculectomy with mitomycin-C. We reviewed the records of patients with otherwise uncontrollable glaucoma who had undergone Ahmed glaucoma valve implantation or trabeculectomy with mitomycin-C. Five eyes that underwent Ahmed valve implantation and three eyes that underwent trabeculectomy needed surgical revision of the initial surgery due to encapsulated bleb development with total loss of function. The surgically removed encapsulated blebs were analyzed macroscopically and microscopically. Removal of the encapsulated bleb was performed at a mean follow-up time of 26.6 ± 19.4 weeks in the Ahmed valve implantation group and 12.0 ± 11.4 weeks in the trabeculectomy group. The fibrotic wall of the encapsulated blebs had an overall thickness of 2.48 ± 0.42 mm in the Ahmed valve implantation group and 1.62 ± 0.37 mm in the trabeculectomy group. Macroscopically, the coconut flesh-like smooth surface was split into two layers, and the wall of the capsule was thicker in the Ahmed valve implantation group than in the trabeculectomy group. Histopathologically, the fibrotic capsule was composed of an inner fibrodegenerative layer and an outer fibrovascular layer, and there were no histopathological differences between the two groups. The fibrotic capsule wall was thicker in the Ahmed valve group, but there were no differences in histological findings between the two groups.

The effect of an Ahmed glaucoma valve implant on corneal endothelial cell density in children with glaucoma secondary to uveitis.

PubMed

Kalinina Ayuso, Viera; Scheerlinck, Laura M; de Boer, Joke H

2013-03-01

To assess the effect of Ahmed glaucoma valve implants on corneal endothelial cell density (ECD) in children with uveitic glaucoma. Cross-sectional study. setting: Institutional. patientpopulation: Eighty eyes from 42 patients diagnosed with uveitis before the age of 16. Twenty-eight eyes had an Ahmed glaucoma valve implant because of secondary glaucoma. Fifty-two eyes without an implant served as controls. intervention orobservationprocedure(s): Corneal ECD was examined cross-sectionally using a noncontact specular microscope. Univariate and multivariate generalized estimating equations analyses with correction for paired eyes were performed. mainoutcomemeasure(s): Correlation of ECD with the presence of an Ahmed glaucoma valve implant and with the time following implantation. ECD was significantly lower in the Ahmed glaucoma valve group than in controls (2359 and 3088 cells/mm(2), respectively; P < .001) following an average of 3.5 years after Ahmed glaucoma valve implantation. Presence of an Ahmed glaucoma valve implant, previous intraocular surgery, age, duration of uveitis, and history of corneal touch by the implant tube were all significantly associated with decreased ECD. Following a multivariate analysis, presence of an Ahmed glaucoma valve implant (B = -340; adjusted P < .011) and older age (B = -58; adjusted P = .005) remained independently associated with decreased ECD. Within the implant group, the age-adjusted time interval following Ahmed glaucoma valve implantation was highly correlated with decreased ECD (B = -558, P < .001). Ahmed glaucoma valve implants in children with uveitic glaucoma are independently associated with decreased ECD, and this effect is associated with the time interval following Ahmed glaucoma valve implantation. Copyright © 2013 Elsevier Inc. All rights reserved.

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.

Initial experience with the Freedom Solo® stentless aortic valve in a low volume centre.

PubMed

Kolseth, Solveig Moss; Nordhaug, Dag; Stenseth, Roar; Wahba, Alexander

2010-10-01

Freedom Solo is a stentless biological aortic valve which is implanted supra-annularly with a single suture line. An increased risk of postoperative thrombocytopenia in the early postoperative period has been reported in recent studies. In our study we evaluated postoperative haemodynamic performance and thrombocyte-levels. Thirty seven patients who underwent valve implantation of the Sorin Freedom Solo stentless valve were included. The haemodynamic performance of the valve was evaluated by transthoracic echocardiography postoperatively at the fourth day (mean) and after a median of 4.2 months. The mean gradient (mmHg) of Freedom Solo was 7.5 at four days and 8.6 at 4.2 months. Postoperatively no patient had more than grade 1 leakage. Seven percent of the patients had a reduction of thrombocytes to less than 20% of the preoperative level. Seventy six percent had a minimum postoperative thrombocyte level less than 100*10(9)/L. The 30 days mortality in our patient material was zero. Implantation of the Freedom Solo valve was uncomplicated in our experience. Favourable transvalvular gradients and no significant leaks were found. In accordance with the literature, we found a high percentage of patients having a postoperative level of thrombocytes less than 100*10(9)/L after implantation of Freedom Solo.

Follow-up of the original cohort with the Ahmed glaucoma valve implant.

PubMed

Topouzis, F; Coleman, A L; Choplin, N; Bethlem, M M; Hill, R; Yu, F; Panek, W C; Wilson, M R

1999-08-01

To study the long-term results of the Ahmed glaucoma valve implant in patients with complicated glaucoma in whom short-term results have been reported. In this multicenter study, we analyzed the long-term outcome of a cohort of 60 eyes from 60 patients in whom the Ahmed glaucoma valve was implanted. Failure was characterized by at least one of the following: intraocular pressure greater than 21 mm Hg at both of the last two visits less than 6 mm Hg at both of the last two visits, loss of light perception, additional glaucoma surgery, devastating complications, and removal or replacement of the Ahmed glaucoma valve implant. Devastating complications included chronic hypotony, retinal detachment, malignant glaucoma, endophthalmitis, and phthisis bulbi; we also report results that add corneal complications (corneal decompensation or edema, corneal graft failure) as defining a devastating complication. The mean follow-up time for the 60 eyes was 30.5 months (range, 2.1 to 63.5). When corneal complications were included in the definition of failure, 26 eyes (43%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 76%, 68%, 54%, and 45%, respectively. When corneal complications were excluded from the definition of failure, 13 eyes (21.5%) were considered failures. Cumulative probabilities of success at 1, 2, 3, and 4 years were 87%, 82%, 76%, and 76%, respectively. Most of the failures after 12 months of postoperative follow-up were because of corneal complications. The long-term performance of the Ahmed glaucoma valve implant is comparable to other drainage devices. More than 12 months after the implantation of the Ahmed glaucoma valve implant, the most frequent adverse outcome was corneal decompensation or corneal graft failure. These corneal problems may be secondary to the type of eyes that have drainage devices or to the drainage device itself. Further investigation is needed to identify the reasons that corneal problems

Transapical Transcatheter Aortic Valve Implantation Using the JenaValve: A One-Year Follow-up.

PubMed

Reuthebuch, Oliver; Koechlin, Luca; Kaufmann, Beat A; Kessel-Schaefer, Arnheid; Gahl, Brigitta; Eckstein, Friedrich S

2015-09-01

Since the first transcatheter aortic valve implantation (TAVI) in 2002, TAVI technique has gained an increasing popularity especially in high-risk patients. In this study, we present the first echocardiographic midterm outcome with the second-generation transapical JenaValve TAVI system (JenaValve Technology GmbH, Munich, Germany) in patients with aortic stenosis (AS). Between November 2011 and November 2012, a total of 28 patients received transapical TAVI using the JenaValve. Primary endpoint was a combined efficacy endpoint after 1 year, which included all-cause mortality after more than 30 days, failure of current therapy for AS requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Moreover, we analyzed secondary endpoints after 3 and 12 months including cardiovascular mortality; major stroke; and life-threatening, disabling, or major bleeding. Mean echocardiographic follow-up was 471.35 ± 102.72 days. Mean age was 80.43 ± 6.03 years and EuroSCORE II was 8.80 ± 7.21%. Successful implantation was accomplished in 100% (n = 28). Median transvalvular aortic mean pressure gradient was 44.5 mm Hg (interquartile range [IQR]: 34.5; 55.5) preoperatively, 12 mm Hg (IQR: 9; 16) postoperatively, and 11 mm Hg (IQR: 8; 16) after 1 year. After 12 months, no paravalvular leakage was seen in 52.38% of the patients and grade 1 paravalvular leakage was seen in 47.62% of the patients. There was no grade 2 or 3 leakage detected. Stroke, valve thrombosis or dislocation, myocardial infarction, or bleeding was also not observed. However, criteria for the combined efficacy endpoint after 1 year were met in five patients (17.86%). Thirty-day mortality was 14.29% (n = 4) and all-cause mortality after 1 year was 21.43% (n = 6). The JenaValve transapical TAVI system is a safe and feasible procedure with low peri- and postoperative complications and convincing midterm performance of the

Transcatheter aortic valve implantation in patients with bicuspid aortic valve stenosis.

PubMed

Wijesinghe, Namal; Ye, Jian; Rodés-Cabau, Josep; Cheung, Anson; Velianou, James L; Natarajan, Madhu K; Dumont, Eric; Nietlispach, Fabian; Gurvitch, Ronen; Wood, David A; Tay, Edgar; Webb, John G

2010-11-01

We evaluated transcatheter aortic valve implantation (TAVI) in high-risk patients with bicuspid aortic valve (BAV) stenosis. TAVI shows promise in the treatment of severe stenosis of triscupid aortic valves, especially in high-risk patients. However, BAV stenosis has been considered a contraindication to TAVI. Eleven patients (age 52 to 90 years) with symptomatic severe BAV stenosis underwent TAVI at 3 Canadian tertiary hospitals between May 2006 and April 2010. All patients were considered high risk for surgical aortic valve replacement. Edwards-SAPIEN transcatheter heart valves (Edwards Lifesciences, Inc., Irvine, California) were used. Transfemoral or transapical access was selected, depending on the adequacy of femoral access. Access was transfemoral in 7 patients and transapical in 4 patients. There were no intraprocedural complications. Significant symptomatic and hemodynamic improvement was observed in 10 of 11 patients. Baseline aortic valve area of 0.65 ± 0.17 cm(2) and mean transaortic pressure gradient of 41 ± 22.4 mm Hg were improved to 1.45 ± 0.3 cm(2) and 13.4 ± 5.7 mm Hg, respectively. Two patients had moderate perivalvular leaks. At the 30-day follow-up there were 2 deaths due to multisystem failure in 2 transapical patients. In 1 patient an undersized, suboptimally positioned, unstable valve required late conversion to open surgery. TAVI in selected high-risk patients with severe BAV stenosis can be successfully performed with acceptable clinical outcomes but will require further evaluation. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Patient-specific simulation of guidewire deformation during transcatheter aortic valve implantation.

PubMed

Vy, Phuoc; Auffret, Vincent; Castro, Miguel; Badel, Pierre; Rochette, Michel; Haigron, Pascal; Avril, Stéphane

2018-06-01

Transcatheter aortic valve implantation is a recent mini-invasive procedure to implant an aortic valve prosthesis. Prosthesis positioning in transcatheter aortic valve implantation appears as an important aspect for the success of the intervention. Accordingly, we developed a patient-specific finite element framework to predict the insertion of the stiff guidewire, used to position the aortic valve. We simulated the guidewire insertion for 2 patients based on their pre-operative CT scans. The model was designed to primarily predict the position and the angle of the guidewires in the aortic valve, and the results were successfully compared with intraoperative images. The present paper describes extensively the numerical model, which was solved by using the ANSYS software with an implicit resolution scheme, as well as the stabilization techniques which were used to overcome numerical instabilities. We performed sensitivity analysis on the properties of the guidewire (curvature angle, curvature radius, and stiffness) and the conditions of insertion (insertion force and orientation). We also explored the influence of the model parameters. The accuracy of the model was quantitatively evaluated as the distance and the angle difference between the simulated guidewires and the intraoperative ones. A good agreement was obtained between the model predictions and intraoperative views available for 2 patient cases. In conclusion, we showed that the shape of the guidewire in the aortic valve was mainly determined by the geometry of the patient's aorta and by the conditions of insertion (insertion force and orientation). Copyright © 2018 John Wiley & Sons, Ltd.

Surgical results of trabeculectomy and Ahmed valve implantation following a previous failed trabeculectomy in primary congenital glaucoma patients.

PubMed

Lee, Naeun; Ma, Kyoung Tak; Bae, Hyoung Won; Hong, Samin; Seong, Gong Je; Hong, Young Jae; Kim, Chan Yun

2015-04-01

To compare the surgical results of trabeculectomy and Ahmed glaucoma valve implantation after a previous failed trabeculectomy. A retrospective comparative case series review was performed on 31 eye surgeries in 20 patients with primary congenital glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation after a previous failed trabeculectomy with mitomycin C. The preoperative mean intraocular pressure was 25.5 mmHg in the trabeculectomy group and 26.9 mmHg in the Ahmed glaucoma valve implantation group (p = 0.73). The 48-month postoperative mean intraocular pressure was 19.6 mmHg in the trabeculectomy group and 20.2 mmHg in the Ahmed glaucoma valve implantation group (p = 0.95). The 12-month trabeculectomy success rate was 69%, compared with 64% for Ahmed glaucoma valve implantation, and the 48-month success rates were 42% and 36% for trabeculectomy and valve implantation, respectively. The success rates following the entire follow-up period were not significantly different between the two groups (p > 0.05 by log rank test). Postoperative complications occurred in 25% of the trabeculectomy-operated eyes and 9% of the Ahmed-implanted eyes (p = 0.38). There was no significant difference in surgical outcome between the trabeculectomy and Ahmed glaucoma valve implantation groups, neither of which had favorable results. However, the trabeculectomy group demonstrated a higher prevalence of adverse complications such as post-operative endophthalmitis.

New-generation devices for transcatheter aortic valve implantation.

PubMed

Gatto, Laura; Biondi-Zoccai, Giuseppe; Romagnoli, Enrico; Frati, Giacomo; Prati, Francesco; Giordano, Arturo

2018-04-20

Transcatheter aortic valve implantation (TAVI) has overcome the pioneering phase and thanks to accrued clinical evidence has become a mainstay alternative to surgical aortic valve replacement (SAVR) in patients at high risk for post-operative complications. Despite these successes, TAVI remains a junior technology facing momentous developments in techniques and devices. Indeed, several new-generation devices for TAVI have become available in the last few years, including Acurate, Allegra, Evolut, Lotus, JenaValve, Portico, and SAPIEN3. Despite the inevitable setbacks, such as the one represented by DirectFlow, these new devices appear associated with comparative benefits, especially for minimal invasiveness, rates of permanent pacemaker implantation, and risk of residual aortic regurgitation. Indeed, no single device appears clearly better than the others, and a tailored and individualized approach should be sought in using these prostheses, taking into account operator and institutional expertise, on top of patient features. Few comparative effectiveness studies are available to date to guide decision making, and thus careful scrutiny is needed even in everyday clinical practice, especially if seeking to expand the current indications of TAVI. Further guidance will however come from long-term follow-up of completed studies and from results of ongoing trials.

Tissue-Engineered Heart Valve with a Tubular Leaflet Design for Minimally Invasive Transcatheter Implantation

PubMed Central

Moreira, Ricardo; Velz, Thaddaeus; Alves, Nuno; Gesche, Valentine N.; Malischewski, Axel; Schmitz-Rode, Thomas; Frese, Julia

2015-01-01

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

Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort.

PubMed

Gurvitch, R; Wood, D A; Tay, E L; Leipsic, J; Ye, J; Lichtenstein, S V; Thompson, C R; Carere, R G; Wijesinghe, N; Nietlispach, F; Boone, R H; Lauck, S; Cheung, A; Webb, J G

2010-09-28

Although short- and medium-term outcomes after transcatheter aortic valve implantation are encouraging, long-term data on valve function and clinical outcomes are limited. Consecutive high-risk patients who had been declined as surgical candidates because of comorbidities but who underwent successful transcatheter aortic valve implantation with a balloon-expandable valve between January 2005 and December 2006 and survived past 30 days were assessed. Clinical, echocardiographic, and computed tomographic follow-up examinations were performed. Seventy patients who underwent successful procedures and survived longer than 30 days were evaluated at a minimum follow-up of 3 years. At a median follow-up of 3.7 years (interquartile range 3.4 to 4.3 years), survival was 57%. Survival at 1, 2, and 3 years was 81%, 74%, and 61%, respectively. Freedom from reoperation was 98.5% (1 patient with endocarditis). During this early procedural experience, 11 patients died within 30 days, and 8 procedures were unsuccessful. When these patients were included, overall survival was 51%. Transaortic pressure gradients increased from 10.0 mm Hg (interquartile range 8.0 to 12.0 mm Hg) immediately after the procedure to 12.1 mm Hg (interquartile range 8.6 to 16.0 mm Hg) after 3 years (P=0.03). Bioprosthetic valve area decreased from a mean of 1.7±0.4 cm(2) after the procedure to 1.4±0.3 cm(2) after 3 years (P<0.01). Aortic incompetence after implantation was trivial or mild in 84% of cases and remained unchanged or improved over time. There were no cases of structural valvular deterioration, stent fracture, deformation, or valve migration. Transcatheter aortic valve implantation demonstrates good medium- to long-term durability and preserved hemodynamic function, with no evidence of structural failure. The procedure appears to offer an adequate and lasting resolution of aortic stenosis in selected patients.

Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.

PubMed

Fiorina, Claudia; Maffeo, Diego; Curello, Salvatore; Lipartiti, Felicia; Chizzola, Giuliano; D'Aloia, Antonio; Adamo, Marianna; Mastropierro, Rosy; Gavazzi, Emanuele; Ciccarese, Camilla; Chiari, Ermanna; Ettori, Federica

2014-06-01

Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve. Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI. High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups. Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups. Copyright © 2014 Elsevier Inc. All rights reserved.

The effect of intravitreal bevacizumab injection before Ahmed valve implantation in patients with neovascular glaucoma.

PubMed

Kang, Jung Youb; Nam, Ki Yup; Lee, Sang Joon; Lee, Seung Uk

2014-08-01

To evaluate the effect of intravitreal bevacizumab (IVB) before Ahmed valve implantation for treatment of neovascular glaucoma (NVG). This study is a retrospective, comparative, consecutive case series. The study group consisted of 27 eyes of 26 patients with NVG who underwent an Ahmed valve implantation. Thirteen eyes were treated with Ahmed valve implantation alone (control group), and 14 eyes were treated with a combination of preoperative IVB injection and Ahmed valve implantation (IVB group). Visual acuity, intraocular pressure (IOP), number of anti-glaucoma medications, surgical complications, and success rate were compared between the two groups. There were no significant differences in preoperative characteristics between the two groups. Visual acuity at 1, 2 weeks, and 1 month after surgery were significantly better in the IVB group (p = 0.038, 0.034, and 0.032, respectively). Hyphema associated with Ahmed valve implantation occurred significantly less in the IVB group (p = 0.016). On the other hand, the mean IOP and number of anti-glaucoma medications at all follow-up periods were similar between the two groups. Kaplan-Meier survival analysis showed the probability of success 6 months after surgery as 71.4 % in the IVB group and 84.6 % in the control group. No significant difference in success rate was found between the groups (p = 0.422). IVB before Ahmed valve implantation for treatment of NVG reduced the incidence of hyphema. In this retrospective study, IVB provided better visual outcome in the early postoperative periods but did not significantly improve mean IOP, number of anti-glaucoma medications, or success rate.

Surgical Results of Trabeculectomy and Ahmed Valve Implantation Following a Previous Failed Trabeculectomy in Primary Congenital Glaucoma Patients

PubMed Central

Lee, Naeun; Ma, Kyoung Tak; Bae, Hyoung Won; Hong, Samin; Seong, Gong Je; Hong, Young Jae

2015-01-01

Purpose To compare the surgical results of trabeculectomy and Ahmed glaucoma valve implantation after a previous failed trabeculectomy. Methods A retrospective comparative case series review was performed on 31 eye surgeries in 20 patients with primary congenital glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation after a previous failed trabeculectomy with mitomycin C. Results The preoperative mean intraocular pressure was 25.5 mmHg in the trabeculectomy group and 26.9 mmHg in the Ahmed glaucoma valve implantation group (p = 0.73). The 48-month postoperative mean intraocular pressure was 19.6 mmHg in the trabeculectomy group and 20.2 mmHg in the Ahmed glaucoma valve implantation group (p = 0.95). The 12-month trabeculectomy success rate was 69%, compared with 64% for Ahmed glaucoma valve implantation, and the 48-month success rates were 42% and 36% for trabeculectomy and valve implantation, respectively. The success rates following the entire follow-up period were not significantly different between the two groups (p > 0.05 by log rank test). Postoperative complications occurred in 25% of the trabeculectomy-operated eyes and 9% of the Ahmed-implanted eyes (p = 0.38). Conclusions There was no significant difference in surgical outcome between the trabeculectomy and Ahmed glaucoma valve implantation groups, neither of which had favorable results. However, the trabeculectomy group demonstrated a higher prevalence of adverse complications such as post-operative endophthalmitis. PMID:25829827

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.

Tricuspid Valve Dysfunction Following Pacemaker or Cardioverter-Defibrillator Implantation.

PubMed

Chang, James D; Manning, Warren J; Ebrille, Elisa; Zimetbaum, Peter J

2017-05-09

The potential for cardiac implantable electronic device leads to interfere with tricuspid valve (TV) function has gained increasing recognition as having hemodynamic and clinical consequences associated with incremental morbidity and death. The diagnosis and treatment of lead-related (as distinct from functional) tricuspid regurgitation pose unique challenges. Because of pitfalls in routine diagnostic imaging, a high level of clinical suspicion must be maintained to avoid overlooking the possibility that worsening heart failure is a consequence of mechanical interference with TV leaflet mobility or coaptation and is amenable to lead extraction or valve repair or replacement. The future of cardiac implantable electronic devices includes pacing and perhaps defibrillation without a lead traversing the TV. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Trabeculectomy versus Ahmed Glaucoma Valve implantation in neovascular glaucoma

PubMed Central

Shen, Christopher C; Salim, Sarwat; Du, Haiming; Netland, Peter A

2011-01-01

Purpose: To compare surgical outcomes in neovascular glaucoma patients who underwent trabeculectomy with mitomycin C versus Ahmed Glaucoma Valve implantation. Patients and methods: This was a retrospective comparative case series. We reviewed 40 eyes of 39 patients with underlying diagnosis of neovascular glaucoma, divided into two groups: Ahmed Glaucoma Valve (N = 20) and trabeculectomy with mitomycin C (N = 20). Surgical success was defined as 6 mm Hg ≤ intraocular pressure ≤21 mm Hg, with or without the use of glaucoma medications, with no further glaucoma surgery, and light perception or better vision. Early postoperative hypotony was defined as intraocular pressure <5 mm Hg during the first postoperative week. Results: The average follow-up was 31 months (range 6–87 months) for the Ahmed Glaucoma Valve group and 25 months (6–77 months) for the trabeculectomy group. Although the mean number of postoperative intraocular pressure-lowering medications was significantly higher in the trabeculectomy group compared with the Ahmed Glaucoma Valve group at 3 and 6 month time points, there was no statistically significant difference at any other time point. There was no statistically significant difference between both groups in postoperative visual acuity and intraocular pressure. Success was 70% and 65% at 1 year and 60% and 55% at 2 years after Ahmed Glaucoma Valve and trabeculectomy, respectively. Kaplan–Meier survival curve analysis showed no significant difference in success between the two groups (P = 0.815). Hyphema was the most common complication in both groups. Conclusion: We found similar results after trabeculectomy with mitomycin C and Ahmed Glaucoma Valve implantation in eyes with neovascular glaucoma. PMID:21468334

Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside

PubMed Central

Saxon, John T; Allen, Keith B; Cohen, David J

2018-01-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) has been established as a safe and effective means of treating failed surgical bioprosthetic valves (BPVs) in patients at high risk for complications related to reoperation. Patients who undergo VIV TAVR are at risk of patient–prosthesis mismatch, as the transcatheter heart valve (THV) is implanted within the ring of the existing BPV, limiting full expansion and reducing the maximum achievable effective orifice area of the THV. Importantly, patient–prosthesis mismatch and high residual transvalvular gradients are associated with reduced survival following VIV TAVR. Bioprosthetic valve fracture (BVF) is as a novel technique to address this problem. During BPV, a non-compliant valvuloplasty balloon is positioned within the BPV frame, and a highpressure balloon inflation is performed to fracture the surgical sewing ring of the BPV. This allows for further expansion of the BPV as well as the implanted THV, thus increasing the maximum effective orifice area that can be achieved after VIV TAVR. This review focuses on the current evidence base for BVF to facilitate VIV TAVR, including initial bench testing, procedural technique, clinical experience and future directions. PMID:29593832

Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside.

PubMed

Saxon, John T; Allen, Keith B; Cohen, David J; Chhatriwalla, Adnan K

2018-01-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) has been established as a safe and effective means of treating failed surgical bioprosthetic valves (BPVs) in patients at high risk for complications related to reoperation. Patients who undergo VIV TAVR are at risk of patient-prosthesis mismatch, as the transcatheter heart valve (THV) is implanted within the ring of the existing BPV, limiting full expansion and reducing the maximum achievable effective orifice area of the THV. Importantly, patient-prosthesis mismatch and high residual transvalvular gradients are associated with reduced survival following VIV TAVR. Bioprosthetic valve fracture (BVF) is as a novel technique to address this problem. During BPV, a non-compliant valvuloplasty balloon is positioned within the BPV frame, and a highpressure balloon inflation is performed to fracture the surgical sewing ring of the BPV. This allows for further expansion of the BPV as well as the implanted THV, thus increasing the maximum effective orifice area that can be achieved after VIV TAVR. This review focuses on the current evidence base for BVF to facilitate VIV TAVR, including initial bench testing, procedural technique, clinical experience and future directions.

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.

Development of a micro-mechanical valve in a novel glaucoma implant.

PubMed

Siewert, Stefan; Schultze, Christine; Schmidt, Wolfram; Hinze, Ulf; Chichkov, Boris; Wree, Andreas; Sternberg, Katrin; Allemann, Reto; Guthoff, Rudolf; Schmitz, Klaus-Peter

2012-10-01

This paper describes methods for design, manufacturing and characterization of a micro-mechanical valve for a novel glaucoma implant. The implant is designed to drain aqueous humour from the anterior chamber of the eye into the suprachoroidal space in case of an elevated intraocular pressure (IOP). In contrast to any existing glaucoma drainage device (GDD), the valve mechanism is located in the anterior chamber and there, surrounded by aqueous humour, immune to fibrosis induced failure. For the prevention of hypotony the micro-mechanical valve is designed to open if the physiological pressure difference between the anterior chamber and the suprachoroidal space in the range of 0.8 mmHg to 3.7 mmHg is exceeded. In particular the work includes: (i) manufacturing and morphological characterization of polymer tubing, (ii) mechanical material testing as basis for (iii) the design of micro-mechanical valves using finite element analysis (FEA), (iv) manufacturing of microstent prototypes including micro-mechanical valves by femtosecond laser micromachining and (v) the experimental fluid-mechanical characterization of the manufactured microstent prototypes with regard to valve opening pressure. The considered materials polyurethane (PUR) and silicone (SIL) exhibit low elastic modulus and high extensibility. The unique valve design enables a low opening pressure of micro-mechanical valves. An ideal valve design for PUR and SIL with an experimentally determined opening pressure of 2 mmHg and 3.7 mmHg is identified. The presented valve approach is suitable for the inhibition of hypotony as a major limitation of today's GDD and will potentially improve the minimally invasive treatment of glaucoma.

Aortic annulus eccentricity before and after transcatheter aortic valve implantation: Comparison of balloon-expandable and self-expanding prostheses.

PubMed

Schuhbaeck, Annika; Weingartner, Christina; Arnold, Martin; Schmid, Jasmin; Pflederer, Tobias; Marwan, Mohamed; Rixe, Johannes; Nef, Holger; Schneider, Christian; Lell, Michael; Uder, Michael; Ensminger, Stephan; Feyrer, Richard; Weyand, Michael; Achenbach, Stephan

2015-07-01

The geometry of the aortic annulus and implanted transcatheter aortic valve prosthesis might influence valve function. We investigated the influence of valve type and aortic valve calcification on post-implant geometry of catheter-based aortic valve prostheses. Eighty consecutive patients with severe aortic valve stenosis (mean age 82 ± 6 years) underwent computed tomography before and after TAVI. Aortic annulus diameters were determined. Influence of prosthesis type and degree of aortic valve calcification on post-implant eccentricity were analysed. Aortic annulus eccentricity was reduced in patients after TAVI (0.21 ± 0.06 vs. 0.08 ± 0.06, p<0.0001). Post-TAVI eccentricity was significantly lower in 65 patients following implantation of a balloon-expandable prosthesis as compared to 15 patients who received a self-expanding prosthesis (0.06 ± 0.05 vs. 0.15 ± 0.07, p<0.0001), even though the extent of aortic valve calcification was not different. After TAVI, patients with a higher calcium amount retained a significantly higher eccentricity compared to patients with lower amounts of calcium. Patients undergoing TAVI with a balloon-expandable prosthesis show a more circular shape of the implanted prosthesis as compared to patients with a self-expanding prosthesis. Eccentricity of the deployed prosthesis is affected by the extent of aortic valve calcification. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Early outcomes of transcatheter aortic valve replacement in patients with severe aortic stenosis: single center experience

PubMed Central

Bozkurt, Engin; Keleş, Telat; Durmaz, Tahir; Akçay, Murat; Ayhan, Hüseyin; Bayram, Nihal Akar; Aslan, Abdullah Nabi; Baştuğ, Serdal; Bilen, Emine

2014-01-01

Introduction Transcatheter aortic valve implantation is a promising alternative to high risk surgical aortic valve replacement. The procedure is mainly indicated in patients with severe symptomatic aortic stenosis who cannot undergo surgery or who are at very high surgical risk. Aim Description early results of our single-center experience with balloon expandable aortic valve implantation. Material and methods Between July 2011 and August 2012, we screened in total 75 consecutive patients with severe aortic stenosis and high risk for surgery. Twenty-one of them were found ineligible for transcatheter aortic valve implantation (TAVI) because of various reasons, and finally we treated a total of 54 patients with symptomatic severe aortic stenosis (AS) who could not be treated by open heart surgery (inoperable) because of high-risk criteria. The average age of the patients was 77.4 ±7.1; 27.8% were male and 72.2% were female. The number of patients in NYHA class II was 7 while the number of patients in class III and class IV was 47. Results The average mortality score of patients according to the STS scoring system was 8.5%. Pre-implantation mean and maximal aortic valve gradients were measured as 53.2 ±14.1 mm Hg and 85.5 ±18.9 mm Hg, respectively. Post-implantation mean and maximal aortic valve gradients were 9.0 ±3.0 and 18.2 ±5.6, respectively (p < 0.0001). The left ventricular ejection fraction was calculated as 54.7 ±14.4% before the operation and 58.0 ±11.1% after the operation (p < 0.0001). The duration of discharge after the operation was 5.29 days, and a statistically significant correlation between the duration of discharge after the operation and STS was found (r = 0385, p = 0.004). Conclusions We consider that with decreasing cost and increasing treatment experience, TAVI will be used more frequently in broader indications. Our experience with TAVI using the Edwards-Sapien XT (Edwards Lifesciences, Irvine, CA) devices suggests that this is an

[Long-term outcomes of Ahmed glaucoma valve implantation for treating refractory glaucoma].

PubMed

Xu, Yumei; Hong, Tao; Li, Wanming

2015-02-10

To explore the efficacies and complications of Ahmed glaucoma valve implantation for treating refractory glaucoma. A retrospective study of case series was conducted for 24 patients (26 eyes) with refractory glaucoma from February 2001 to July 2008 at our hospital. Ahmed glaucoma valve implantation was performed. Pre- and post-operative best spectacle-corrected visual acuity (BSCVA), intraocular pressure (IOP), number of medications and complications were recorded and analyzed. The follow-up period was 58-159 months. The post-operative values of IOP were 13.02+/-6.79, 11.43+/-5.24 and 18.56+/-6.43 mmHg at 1 day, 1 month and the last follow-up respectively. There were significant difference when compared with pre-operative IOP (37.59+/-10.76 mmHg, P < 0.01). And 65.38% of eyes maintained or gained ≥ 1 line of BSCVA. But there was no significant difference with pre-operative BSCVA (P = 0.110). Twenty eyes required anti-glaucoma drugs after glaucoma valve implantation and the average number of medication was 1.72+/-0.98. There was significant difference with the pre-operative medication number 2.7 ± 0.7 (P = 0.001). The surgical success rate was 73.1%. And the causes of failure were endophthalmitis, corneal endothelial decompensation, persistent conjunctival wound non-healing, glaucoma valve exposure and loss of light perception.Early postoperative complications were ocular hypotony, shallow anterior chamber, hyphema, transient high IOP and tube occlusion. And long-term complications included encapsulated cyst formation, tube exposure, corneal endothelial decompensation and endophthalmitis. Ahmed glaucoma valve implantation is efficacious for refractory glaucoma.However, clinicians should pay attention to the prevention and treatment of complications.

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.

Pros and cons of transcatheter aortic valve implantation (TAVI).

PubMed

Terré, Juan A; George, Isaac; Smith, Craig R

2017-09-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement.

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

[Percutaneous stented pulmonary valve implantation].

PubMed

Ersbøll, Mads; Søndergaard, Lars

2010-03-29

A number of congenital cardiac malformations involve the right ventricular outflow tract and are often treated with a biological valved conduit. The longevity of these valves is limited due to graft degeneration, which causes progressive valvular dysfunction and subsequently right ventricular failure. Due to the young age of these patients, repeat surgery can be expected and this has motivated the invention of the percutaneous stented valve implantation (PPVR). We retrospectively examined 13 patients (mean age 26 +/- 10 years) treated with PPVR between 2006 and 2008 at our institution. Indications for PPVR were conduit dysfunction with severe stenosis and/or regurgitation, reduced exercise capacity and right ventricular dilatation. In all patients, immediate haemodynamic improvement occurred with full valvular competence after PPVR. The pressure gradient was reduced from 43 (+/- 15) mmHg to 12 (+/- 7) mmHg (p = 0,05) in patients with combined regurgitation and stenosis and 47 (+/- 14) mmHg to 12 (+/- 2) mmHg (p = 0,05) in patients with isolated stenosis. At mean follow-up after 141 (+/- 140) days, no reintervention had been required. Significant haemodynamic and clinical improvement occurred after PPVR in all patients and no major complications occurred. PPVR remains a safe and minimally invasive treatment modality, and our study demonstrates that PPVR can be safely performed in a low volume setting.

Apical-access-related complications associated with trans-catheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Piazza, Nicolo; Mazzitelli, Domenico; Opitz, Anke; Bauernschmitt, Robert; Lange, Rüdiger

2011-08-01

The left-ventricular trans-apical access has become well established for trans-catheter aortic valve implantation, especially for patients in whom a retrograde trans-arterial implantation is contraindicated. We report on the short- and long-term implications of the apical-access-site-specific complications. Between June 2007 and August 2010, 143 patients were scheduled for trans-apical aortic valve implantation (mean age 80 ± 6 years, n=116 females, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 21 ± 13%). The patients are followed up at 30 days, 6 months, and then annually. Severe apical bleeding complications occurred in 10 patients (7%). In three of these patients, the procedure was terminated, and no valve was implanted. In the remaining, the bleeding was controlled with cardiopulmonary bypass support (n=3), via median sternotomy (n=1), or both (n=1) ± later re-exploration. Two additional patients required postprocedural re-exploration for apical bleeding. An apical pseudo-aneurysm developed in two patients (2%), one of whom was treated by surgical revision. Survival was significantly impaired when either apical bleeding, aneurysm, or re-exploration occurred (75% ± 0.082 survival at 30 days and 59% ± 0.122 at 1 year vs 94% ± 0.023 and 80% ± 0.043 in patients without apical complications, p=0.012). Twelve patients (8%) experienced secondary wound healing. An apical hypo- or akinesia was detected in 18/54 (33%) patients at 6 months' echocardiographic investigation, and in 11/30 (37%) 1 year after the procedure. The trans-apical access for trans-catheter aortic valve implantation might be challenging in elderly patients with fragile tissue. Severe bleeding complications or aneurysm formation significantly impairs survival. The clinical impact of subsequent apical hypo- or akinesia has to be further followed up. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Transcatheter aortic valve implantation using anatomically oriented, marrow stromal cell-based, stented, tissue-engineered heart valves: technical considerations and implications for translational cell-based heart valve concepts.

PubMed

Emmert, Maximilian Y; Weber, Benedikt; Behr, Luc; Sammut, Sebastien; Frauenfelder, Thomas; Wolint, Petra; Scherman, Jacques; Bettex, Dominique; Grünenfelder, Jürg; Falk, Volkmar; Hoerstrup, Simon P

2014-01-01

While transcatheter aortic valve implantation (TAVI) has rapidly evolved for the treatment of aortic valve disease, the currently used bioprostheses are prone to continuous calcific degeneration. Thus, autologous, cell-based, living, tissue-engineered heart valves (TEHVs) with regeneration potential have been suggested to overcome these limitations. We investigate the technical feasibility of combining the concept of TEHV with transapical implantation technology using a state-of-the-art transcatheter delivery system facilitating the exact anatomical position in the systemic circulation. Trileaflet TEHVs fabricated from biodegradable synthetic scaffolds were sewn onto self-expanding Nitinol stents seeded with autologous marrow stromal cells, crimped and transapically delivered into the orthotopic aortic valve position of adult sheep (n = 4) using the JenaValve transapical TAVI System (JenaValve, Munich, Germany). Delivery, positioning and functionality were assessed by angiography and echocardiography before the TEHV underwent post-mortem gross examination. For three-dimensional reconstruction of the stent position of the anatomically oriented system, a computed tomography analysis was performed post-mortem. Anatomically oriented, transapical delivery of marrow stromal cell-based TEHV into the orthotopic aortic valve position was successful in all animals (n = 4), with a duration from cell harvest to TEHV implantation of 101 ± 6 min. Fluoroscopy and echocardiography displayed sufficient positioning, thereby entirely excluding the native leaflets. There were no signs of coronary obstruction. All TEHV tolerated the loading pressure of the systemic circulation and no acute ruptures occurred. Animals displayed intact and mobile leaflets with an adequate functionality. The mean transvalvular gradient was 7.8 ± 0.9 mmHg, and the mean effective orifice area was 1.73 ± 0.02 cm(2). Paravalvular leakage was present in two animals, and central aortic regurgitation due to a

[Pannus Formation Two Years after Bioprosthetic Aortic Valve Implantation;Report of a Case].

PubMed

Ono, Kimiyo; Kuroda, Hiroaki

2015-08-01

We report a case of early deterioration of the bioprosthetic aortic valve 23 months postoperatively. A 77-year-old man who had undergone aortic valve replacement with a 23-mm Epic valve( St. Jude Medical [SJM])presented to us after a syncopal episode. Echocardiography revealed severe aortic stenosis, and redo aortic valve replacement with a 21-mm SJM mechanical valve was performed. All 3 cusps of the tissue valve were thickened by fibrous pannus overgrowth. Neither calcification nor invasion of inflammatory cells was observed. The cause of pannus formation at such an early stage after implantation remains unknown.

Pros and cons of transcatheter aortic valve implantation (TAVI)

PubMed Central

Terré, Juan A.; George, Isaac

2017-01-01

Transcatheter aortic valve implantation (TAVI) or replacement (TAVR) was recently approved by the FDA for intermediate risk patients with severe aortic stenosis (AS). This technique was already worldwide adopted for inoperable and high-risk patients. Improved device technology, imaging analysis and operator expertise has reduced the initial worrisome higher complications rate associated with TAVR, making it comparable to surgical aortic valve replacement (SAVR). However, many answers need to be addressed before adoption in lower risk patients. This paper highlights the pros and cons of TAVI based mostly on randomized clinical trials involving the two device platforms approved in the United States. We focused our analysis on metrics that will play a key role in expanding TAVR indication in healthier individuals. We review the significance and gave a perspective on paravalvular leak (PVL), valve performance, valve durability, leaflet thrombosis, stroke and pacemaker requirement. PMID:29062739

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk

PubMed Central

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E.

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient. PMID:26346128

Transapical Implantation of a 2nd-Generation JenaValve Device in Patient with Extremely High Surgical Risk.

PubMed

Mieres, Juan; Menéndez, Marcelo; Fernández-Pereira, Carlos; Rubio, Miguel; Rodríguez, Alfredo E

2015-01-01

Transcatheter Aortic Valve Replacement (TAVR) is performed in patients who are poor surgical candidates. Many patients have inadequate femoral access, and alternative access sites have been used such as the transapical approach discussed in this paper. We present an elderly and fragile patient not suitable for surgery for unacceptable high risk, including poor ventricular function, previous myocardial infarction with percutaneous coronary intervention, pericardial effusion, and previous cardiac surgery with replacement of mechanical mitral valve. Transapical aortic valve replacement with a second-generation self-expanding JenaValve is performed. The JenaValve is a second-generation transapical TAVR valve consisting of a porcine root valve mounted on a low-profile nitinol stent. The valve is fully retrievable and repositionable. We discuss transapical access, implantation technique, and feasibility of valve implantation in this extremely high surgical risk patient.

Structural valve deterioration in a starr-edwards mitral caged-disk valve prosthesis.

PubMed

Aoyagi, Shigeaki; Tayama, Kei-Ichiro; Okazaki, Teiji; Shintani, Yusuke; Kono, Michitaka; Wada, Kumiko; Kosuga, Ken-Ichi; Mori, Ryusuke; Tanaka, Hiroyuki

2013-01-01

The durability of the Starr-Edwards (SE) mitral caged-disk valve, model 6520, is not clearly known, and structural valve deterioration in the SE disk valve is very rare. Replacement of the SE mitral disk valve was performed in 7 patients 23-40 years after implantation. Macroscopic examination of the removed disk valves showed no structural abnormalities in 3 patients, in whom the disk valves were removed at <26 years after implantation. Localized disk wear was found at the sites where the disk abutted the struts of the cage, in disk valves excised >36 years after implantation in 4 patients. Disk fracture, a longitudinal split in the disk along its circumference at the site of incorporation of the titanium ring, was detected in the valves removed 36 and 40 years after implantation, respectively, and many cracks were also observed on the outflow aspect of the disk removed 40 years after implantation. Disk fracture and localized disk wear were found in the SE mitral disk valves implanted >36 years previously. The present results suggest that SE mitral caged-disk valves implanted >20 years previously should be carefully followed up, and that those implanted >30 years previously should be electively replaced with modern prosthetic valves

Ten years of clinical experience in the use of fixed-pressure versus programmable valves: a retrospective study of 159 patients.

PubMed

Mpakopoulou, Maria; Brotis, Alexandros G; Gatos, Haralampos; Paterakis, Konstantinos; Fountas, Kostas N

2012-01-01

The aim of this study was to present our 10-year experience with the use of fixed-pressure and programmable valves in the treatment of adult patients requiring cerebrospinal fluid (CSF) diversion. Patients (n = 159; 89 male and 70 female) suffering from hydrocephalus of various causes underwent CSF shunt implantation. Forty fixed-pressure and 119 programmable valves were initially implanted. The observed revision rate was 40% in patients with fixed-pressure valves. In 20% of these patients, a revision due to valve mechanism malfunction was undertaken, and the initial valve was replaced with a programmable one. The revision rate in the adjustable-pressure valve subgroup was 20%. The infection rate for the fixed-pressure and programmable valve subgroups were 3%, and 1.7%, respectively. Similarly, subdural fluid collections were noticed in 17% and 4% of patients with fixed-pressure valves and programmable valves, respectively. The revision and over-drainage rates were significantly lower when using programmable valves, and thus, this type of valve is preferred whenever CSF has to be diverted.

[Long-term effects of permanent pacemaker implantation on tricuspid valve regurgitation].

PubMed

Ren, Chong-lei; Wang, Yao; Wang, Rong; Li, Bo-jun; Geng, Ren-yi; Gao, Chang-qing

2012-08-14

To explore the long-term effects of permanent pacemaker implantation (PPI) on tricuspid valve regurgitation (TR) in Chinese patients so as to determine the incidence and related factors, evaluate its effects on heart structure and function and ascertain the exact mechanism of TR after PPI. A total of 430 patients undergoing permanent pacemaker replacement at our hospital between January 2000 and June 2011 were recruited. The patients with isolated atrial lead implantation procedures, significant heart valve disease or chronic obstructive pulmonary disease were excluded. The data of 108 patients who had Doppler echocardiograms performed before the first pacemaker implantation procedure and this pacemaker replacement procedure were obtained and retrospectively analyzed. According to the post-implant grade of TR, the patients were divided into two groups: normal tricuspid (n = 79) and abnormal tricuspid (n = 29). Their clinical characteristics and echocardiographic data between two groups were analyzed and compared. The mean follow-up time (from the first pacemaker implantation) was (13 ± 6) years (range: 4 - 34). Among 108 patients with initially normal tricuspid post-implant, 29 patients (26.9%) developed significant TR during the follow-up. In comparison to those in normal tricuspid group, the patients in abnormal tricuspid group had a longer time from the first pacemaker implantation ((16 ± 7) vs (12 ± 5) years, P = 0.003), more transtricuspid leads (1.31 ± 0.66 vs 1.10 ± 0.30, P = 0.026), larger right atrial size ((38 ± 7) vs (35 ± 4) mm, P = 0.028) and higher prevalence of mild TR and mitral valve regurgitation (MR) pre-implantation (TR: 21% vs 4%, P = 0.015, MR: 28% vs 5%, P = 0.003). The size of right atrium, right ventricle and left atrium in abnormal tricuspid group were more than those in normal tricuspid group. The prevalence of significant MR post-implantation in abnormal tricuspid group was higher than that in normal tricuspid group. The ejection

Prevalence and Prognostic Significance of Right Ventricular Systolic Dysfunction in Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lindsay, Alistair C; Harron, Katie; Jabbour, Richard J; Kanyal, Ritesh; Snow, Thomas M; Sawhney, Paramvir; Alpendurada, Francisco; Roughton, Michael; Pennell, Dudley J; Duncan, Alison; Di Mario, Carlo; Davies, Simon W; Mohiaddin, Raad H; Moat, Neil E

2016-07-01

Cardiovascular magnetic resonance (CMR) can provide important structural information in patients undergoing transcatheter aortic valve implantation. Although CMR is considered the standard of reference for measuring ventricular volumes and mass, the relationship between CMR findings of right ventricular (RV) function and outcomes after transcatheter aortic valve implantation has not previously been reported. A total of 190 patients underwent 1.5 Tesla CMR before transcatheter aortic valve implantation. Steady-state free precession sequences were used for aortic valve planimetry and to assess ventricular volumes and mass. Semiautomated image analysis was performed by 2 specialist reviewers blinded to patient treatment. Patient follow-up was obtained from the Office of National Statistics mortality database. The median age was 81.0 (interquartile range, 74.9-85.5) years; 50.0% were women. Impaired RV function (RV ejection fraction ≤50%) was present in 45 (23.7%) patients. Patients with RV dysfunction had poorer left ventricular ejection fractions (42% versus 69%), higher indexed left ventricular end-systolic volumes (96 versus 40 mL), and greater indexed left ventricular mass (101 versus 85 g/m(2); P<0.01 for all) than those with normal RV function. Median follow-up was 850 days; 21 of 45 (46.7%) patients with RV dysfunction died, compared with 43 of 145 (29.7%) patients with normal RV function (P=0.035). After adjustment for significant baseline variables, both RV ejection fraction ≤50% (hazard ratio, 2.12; P=0.017) and indexed aortic valve area (hazard ratio, 4.16; P=0.025) were independently associated with survival. RV function, measured on preprocedural CMR, is an independent predictor of mortality after transcatheter aortic valve implantation. CMR assessment of RV function may be important in the risk stratification of patients undergoing transcatheter aortic valve implantation. © 2016 American Heart Association, Inc.

Association of CKD with Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation

PubMed Central

Kaier, Klaus; Kaleschke, Gerrit; Gebauer, Katrin; Meyborg, Matthias; Malyar, Nasser M.; Freisinger, Eva; Baumgartner, Helmut; Reinecke, Holger; Reinöhl, Jochen

2017-01-01

Background and objectives Despitethe multiple depicted associations of CKD with reduced cardiovascular and overall prognoses, the association of CKD with outcome of patients undergoing transcatheter aortic valve implantation has still not been well described. Design, setting, participants, & measurements Data from all hospitalized patients who underwent transcatheter aortic valve implantation procedures between January 1, 2010 and December 31, 2013 in Germany were evaluated regarding influence of CKD, even in the earlier stages, on morbidity, in-hospital outcomes, and costs. Results A total of 28,716 patients were treated with transcatheter aortic valve implantation. A total of 11,189 (39.0%) suffered from CKD. Patients with CKD were predominantly women; had higher rates of comorbidities, such as coronary artery disease, heart failure at New York Heart Association 3/4, peripheral artery disease, and diabetes; and had a 1.3-fold higher estimated logistic European System for Cardiac Operative Risk Evaluation value. In-hospital mortality was independently associated with CKD stage ≥3 (up to odds ratio, 1.71; 95% confidence interval, 1.35 to 2.17; P<0.05), bleeding was independently associated with CKD stage ≥4 (up to odds ratio, 1.82; 95% confidence interval, 1.47 to 2.24; P<0.001), and AKI was independently associated with CKD stages 3 (odds ratio, 1.83; 95% confidence interval, 1.62 to 2.06) and 4 (odds ratio, 2.33; 95% confidence interval, 1.92 to 2.83 both P<0.001). The stroke risk, in contrast, was lower for patients with CKD stages 4 (odds ratio, 0.23; 95% confidence interval, 0.16 to 0.33) and 5 (odds ratio, 0.24; 95% confidence interval, 0.15 to 0.39; both P<0.001). Lengths of hospital stay were, on average, 1.2-fold longer, whereas reimbursements were, on average, only 1.03-fold higher in patients who suffered from CKD. Conclusions This analysis illustrates for the first time on a nationwide basis the association of CKD with adverse outcomes in patients

Association of CKD with Outcomes Among Patients Undergoing Transcatheter Aortic Valve Implantation.

PubMed

Lüders, Florian; Kaier, Klaus; Kaleschke, Gerrit; Gebauer, Katrin; Meyborg, Matthias; Malyar, Nasser M; Freisinger, Eva; Baumgartner, Helmut; Reinecke, Holger; Reinöhl, Jochen

2017-05-08

Despitethe multiple depicted associations of CKD with reduced cardiovascular and overall prognoses, the association of CKD with outcome of patients undergoing transcatheter aortic valve implantation has still not been well described. Data from all hospitalized patients who underwent transcatheter aortic valve implantation procedures between January 1, 2010 and December 31, 2013 in Germany were evaluated regarding influence of CKD, even in the earlier stages, on morbidity, in-hospital outcomes, and costs. A total of 28,716 patients were treated with transcatheter aortic valve implantation. A total of 11,189 (39.0%) suffered from CKD. Patients with CKD were predominantly women; had higher rates of comorbidities, such as coronary artery disease, heart failure at New York Heart Association 3/4, peripheral artery disease, and diabetes; and had a 1.3-fold higher estimated logistic European System for Cardiac Operative Risk Evaluation value. In-hospital mortality was independently associated with CKD stage ≥3 (up to odds ratio, 1.71; 95% confidence interval, 1.35 to 2.17; P <0.05), bleeding was independently associated with CKD stage ≥4 (up to odds ratio, 1.82; 95% confidence interval, 1.47 to 2.24; P <0.001), and AKI was independently associated with CKD stages 3 (odds ratio, 1.83; 95% confidence interval, 1.62 to 2.06) and 4 (odds ratio, 2.33; 95% confidence interval, 1.92 to 2.83 both P <0.001). The stroke risk, in contrast, was lower for patients with CKD stages 4 (odds ratio, 0.23; 95% confidence interval, 0.16 to 0.33) and 5 (odds ratio, 0.24; 95% confidence interval, 0.15 to 0.39; both P <0.001). Lengths of hospital stay were, on average, 1.2-fold longer, whereas reimbursements were, on average, only 1.03-fold higher in patients who suffered from CKD. This analysis illustrates for the first time on a nationwide basis the association of CKD with adverse outcomes in patients who underwent transcatheter aortic valve implantation. Thus, classification of CKD stages

Minimally Invasive Implantation of HeartWare Assist Device and Simultaneous Tricuspid Valve Reconstruction Through Partial Upper Sternotomy.

PubMed

Hillebrand, Julia; Hoffmeier, Andreas; Djie Tiong Tjan, Tonny; Sindermann, Juergen R; Schmidt, Christoph; Martens, Sven; Scherer, Mirela

2017-05-01

Left ventricular assist device (LVAD) implantation is a well-established therapy to support patients with end-stage heart failure. However, the operative procedure is associated with severe trauma. Third generation LVADs like the HeartWare assist device (HeartWare, Inc., Framingham, MA, USA) are characterized by enhanced technology despite smaller size. These devices offer new minimally invasive surgical options. Tricuspid regurgitation requiring valve repair is frequent in patients with the need for mechanical circulatory support as it is strongly associated with ischemic and nonischemic cardiomyopathy. We report on HeartWare LVAD implantation and simultaneous tricuspid valve reconstruction through minimally invasive access by partial upper sternotomy to the fifth left intercostal space. Four male patients (mean age 51.72 ± 11.95 years) suffering from chronic heart failure due to dilative (three patients) and ischemic (one patient) cardiomyopathy and also exhibiting concomitant tricuspid valve insufficiency due to annular dilation underwent VAD implantation and tricuspid valve annuloplasty. Extracorporeal circulation was established via the ascending aorta, superior vena cava, and right atrium. In all four cases the LVAD implantation and tricuspid valve repair via partial median sternotomy was successful. During the operative procedure, no conversion to full sternotomy was necessary. One patient needed postoperative re-exploration because of pericardial effusion. No postoperative focal neurologic injury was observed. New generation VADs are advantageous because of the possibility of minimally invasive implantation procedure which can therefore minimize surgical trauma. Concomitant tricuspid valve reconstruction can also be performed simultaneously through partial upper sternotomy. Nevertheless, minimally invasive LVAD implantation is a challenging operative technique. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals

Evolution of Cognitive Function After Transcatheter Aortic Valve Implantation.

PubMed

Schoenenberger, Andreas W; Zuber, Chantal; Moser, André; Zwahlen, Marcel; Wenaweser, Peter; Windecker, Stephan; Carrel, Thierry; Stuck, Andreas E; Stortecky, Stefan

2016-10-01

This study aimed to assess the evolution of cognitive function after transcatheter aortic valve implantation (TAVI). Previous smaller studies reported conflicting results on the evolution of cognitive function after TAVI. In this prospective cohort, cognitive function was measured in 229 patients ≥70 years using the Mini Mental State Examination before and 6 months after TAVI. Cognitive deterioration or improvement was defined as change of ≥3 points decrease or increase in the Mini Mental State Examination score between baseline and follow-up. Cognitive deterioration was found in 29 patients (12.7%). Predictive analysis using logistic regression did not identify any statistically significant predictor of cognitive deterioration. A review of individual medical records in 8 patients with a major Mini Mental State Examination score decrease of ≥5 points revealed specific causes in 6 cases (postinterventional delirium in 2; postinterventional stroke, progressive renal failure, progressive heart failure, or combination of preexisting cerebrovascular disease and mild cognitive impairment in 1 each). Among 48 patients with impaired baseline cognition (Mini Mental State Examination score <26 points), 18 patients (37.5%) cognitively improved. The preinterventional aortic valve area was lower in patients who cognitively improved (median aortic valve area 0.60 cm 2 ) as compared with patients who did not improve (median aortic valve area 0.70 cm 2 ; P=0.01). This is the first study providing evidence that TAVI results in cognitive improvement among patients who had impaired preprocedural cognitive function, possibly related to hemodynamic improvement in patients with severe aortic stenosis. Our results confirm that some patients experience cognitive deterioration after TAVI. © 2016 American Heart Association, Inc.

A second prosthesis as a procedural rescue option in trans-apical aortic valve implantation.

PubMed

Kempfert, Jörg; Rastan, Ardawan J; Schuler, Gerhard; Linke, Axel; Holzhey, David; van Linden, Arnaud; Mohr, Friedrich-W; Walther, Thomas

2011-07-01

Trans-apical aortic valve implantation (TA-AVI) using the Edwards SAPIEN™ prosthesis has evolved to a routine procedure for selected high-risk elderly patients. In rare cases, misplacement of the SAPIEN™ valve (too low a position), dysfunction of the leaflets or perforation of the interventricular septum (ventricular septal defect, VSD) occurs and requires immediate implantation of a second prosthesis within the first one. Results of this 'bailout' maneuver have not been reported yet. Of 305 TA-AVI procedures, 15 patients required a second prosthesis due to dysfunctional leaflets (n = 6), low position (n = 7), or VSD (n = 2). Mean age was 82.5 ± 1.3 years, mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 45.5 ± 5.4, and Society of Thoracic Surgeons (STS) Score was 13.5 ± 1.5. All second SAPIEN™ valves could be implanted successfully within the first one. The second prosthesis solved leaflet dysfunction, sealed the VSD (lower position of the second prosthesis), or corrected the initial misplacement (higher position of the second prosthesis) in all patients. Within 30 days, four patients died (low cardiac output n = 3, all with preoperative ejection fraction (EF) <35%; intestinal ischemia n = 1). Intra-operative echocardiogram and angiogram revealed mild paravalvular leak in three and none/trace in 12 patients. Transvalvular gradients were low despite the implantation of the second valve (P(max)/mean 13.7 ± 4.3/6.4 ± 2.0). Placement of a second SAPIEN™ valve is a valuable 'bailout' technique in case of VSD, dysfunctional leaflets, or too low placement of the first prosthesis. The technique leads to an excellent functional result with low transvalvular gradients. The simple, straight, tubular stent design of the SAPIEN™ prosthesis may be the ideal design for such valve-in-valve procedures. Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

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.

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.

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

2017-11-01

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.

Transcatheter aortic valve implantation transapical: step by step.

PubMed

Walther, Thomas; Möllmann, Helge; van Linden, Arnaud; Kempfert, Jörg

2011-01-01

Transcatheter aortic valve implantation (T-AVI) has been introduced into clinical practice to treat high-risk elderly patients with aortic stenosis. T-AVI can be performed by using a retrograde transfemoral (TF), transsubclavian, transaortic, and/or antegrade transapical (TA) approach. For TA-AVI, CE mark approval was granted in 2008 for the Edwards SAPIEN (Edwards Lifesciences, Irvine, CA) prosthesis with the Ascendra delivery system and in 2010 for the second-generation Edwards SAPIEN XT prosthesis and the Ascendra II delivery system, with 23-mm and 26-mm valves. In 2011, CE mark approval has been granted for TA-AVI by using the SAPIEN XT 29-mm prosthesis. Several other devices from different companies (Jenavalve, Jena Valve Inc, Munich, Germany; Embracer, Medtronic Inc, Guilford, CT; Accurate, Symetis Inc, Geneva, Switzerland) have passed "first in man trials" successfully and are being evaluated within multicenter pivotal studies. In this article we will focus on specific aspects of the TA technique for AVI. Copyright © 2011 Elsevier Inc. All rights reserved.

Advanced transcatheter aortic valve implantation (TAVI) planning from CT with ShapeForest.

PubMed

Swee, Joshua K Y; Grbić, Saša

2014-01-01

Transcatheter aortic valve implantation (TAVI) is becoming a standard treatment for non-operable and high-risk patients with symptomatic severe aortic valve stenosis. As there is no direct view or access to the affected anatomy, comprehensive preoperative planning is crucial for a successful outcome, with the most important decisions made during planning being the selection of the proper implant size, and determining the correct C-arm angulations. While geometric models extracted from 3D images are often used to derive these measurements, the complex shape variation of the AV anatomy found in these patients causes many of the shape representations used to estimate such geometric models to fail in capturing morphological characteristics in sufficient detail. In addition, most current approaches only model the aortic valve (AV), omitting modeling the left ventricle outflow tract (LVOT) entirely despite its high correlation with severe complications such as annulus ruptures, paravalvular leaks and myocardial infarction. We propose a fully automated method to extract patient specific models of the AV and the LVOT, and derive comprehensive biomarkers for accurate TAVI planning. We utilize a novel shape representation--the ShapeForest--which is able to model complex shape variation, preserves local shape information, and incorporates prior knowledge during shape space inference. Extensive quantitative and qualitative experiments performed on 630 volumetric data sets demonstrate an accuracy of 0.69 mm for the AV and 0.83 mm for the LVOT, an improvement of over 16% and 18% respectively when compared against state of the art methods.

Surgical Outcome of Ahmed Valve Implantation in Mexican Patients with Neovascular Glaucoma.

PubMed

Hernandez-Oteyza, Alejandra; Lazcano-Gomez, Gabriel; Jimenez-Roman, Jesus; Hernandez-Garciadiego, Carlos

2014-01-01

To describe clinical results of Ahmed glaucoma valve implantation in Mexican patients with neovascular glaucoma (NVG). We reviewed records of 60 eyes of 60 patients with NVG who underwent Ahmed valve implantation, with a follow-up period of 1 year. We identified successful and failed cases and compared baseline and follow-up characteristics to identify possible differences between both groups. We classified 36 eyes (60%) as successful and 24 (40%) as failed cases. We found a significant difference in success rate in patients who had a hypertensive phase at any time during the follow-up period (OR = 5.15, CI = 1.49-20.15, p = 0.004). Patients in the success group showed a statistically significant decrease in the number of glaucoma medications 1 year after surgery (p <0.0001). We found a statistically significant difference in success rate in patients who had preoperative best corrected visual acuity (BCVA) better than logmar 0.70 (odds ratio 4.31, CI = 1.1-19.3, p = 0.03086). A hypertensive postoperative phase and a preoperative BCVA worse or equal to 20/100 seem to be risk factors for Ahmed valve surgical failure in patients with NVG. How to cite this article: Hernandez-Oteyza A, Lazcano-Gomez G, Jimenez-Roman J, Hernandez-Garciadiego C. Surgical Outcome of Ahmed Valve Implantation in Mexican Patients with Neovascular Glaucoma. J Curr Glaucoma Pract 2014;8(3):86-90.

Transcatheter Aortic Valve-in-Valve Procedure in Patients with Bioprosthetic Structural Valve Deterioration

PubMed Central

Reul, Ross M.; Ramchandani, Mahesh K.; Reardon, Michael J.

2017-01-01

Surgical aortic valve replacement is the gold standard procedure to treat patients with severe, symptomatic aortic valve stenosis or insufficiency. Bioprosthetic valves are used for surgical aortic valve replacement with a much greater prevalence than mechanical valves. However, bioprosthetic valves may fail over time because of structural valve deterioration; this often requires intervention due to severe bioprosthetic valve stenosis or regurgitation or a combination of both. In select patients, transcatheter aortic valve replacement is an alternative to surgical aortic valve replacement. Transcatheter valve-in-valve (ViV) replacement is performed by implanting a transcatheter heart valve within a failing bioprosthetic valve. The transcatheter ViV operation is a less invasive procedure compared with reoperative surgical aortic valve replacement, but it has been associated with specific complications and requires extensive preoperative work-up and planning by the heart team. Data from experimental studies and analyses of results from clinical procedures have led to strategies to improve outcomes of these procedures. The type, size, and implant position of the transcatheter valve can be optimized for individual patients with knowledge of detailed dimensions of the surgical valve and radiographic and echocardiographic measurements of the patient's anatomy. Understanding the complexities of the ViV procedure can lead surgeons to make choices during the original surgical valve implantation that can make a future ViV operation more technically feasible years before it is required. PMID:29743998

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.

Clinical outcomes of Ahmed glaucoma valve implantation in pediatric glaucoma.

PubMed

Pakravan, Mohammad; Esfandiari, Hamed; Yazdani, Shahin; Doozandeh, Azadeh; Dastborhan, Zahra; Gerami, Ebrahim; Kheiri, Bahareh; Pakravan, Parastou; Yaseri, Mehdi; Hassanpour, Kiana

2018-03-01

To evaluate the outcomes of Ahmed glaucoma valve implantation in refractory primary congenital glaucoma as well as primary procedure in aphakic glaucoma. In this retrospective study, medical records of patients who underwent Ahmed glaucoma valve implantation for refractory glaucoma and aphakic glaucoma were reviewed. Primary outcome measures were the surgical success defined as intraocular pressure ≤21 mm Hg and decreased ≥20% and no secondary glaucoma surgery. Secondary outcome measures were the number of glaucoma medications, complications, best corrected visual acuity, and intraocular pressure. A total of 62 eyes of refractory primary congenital glaucoma patients (group 1) and 33 eyes of aphakic glaucoma patients (group 2) were included in our study. Mean follow-up was 51 ± 33 months in group 1 and 49 ± 41 months in group 2 (p = 0.82). The cumulative probability of success was 90% in both groups at the first year; however, the success rate was 52.5% in group 1 and 71.5% in group 2 at 5 years' follow-up visit. In group 1, the mean intraocular pressure ± standard deviation was 33.1 ± 8.6 mm Hg at the baseline and decreased to 17.1 ± 5.3 mm Hg at 1 year and 18.5 ± 6.4 at 3 years postoperatively (all p's < 0.001). Corresponding values for group 2 were 28.9 ± 6.1, 15.2 ± 4.6, and 16.0 ± 5.9 mm Hg, respectively (all p's < 0.001). The baseline number of glaucoma medications was 3 ± 0.7 that decreased to 2 ± 0.8 at final follow-up (p = 0.02). Ahmed glaucoma valve implantation has a moderate success rate in the management of refractory primary congenital glaucoma with an increased chance of tube-related complications. The surgical success rate is higher in case of primary Ahmed glaucoma valve implant for aphakic glaucoma with acceptable safety profile.

Transfemoral implantation of an Edwards SAPIEN valve in a tricuspid bioprosthesis without fluoroscopic landmarks.

PubMed

Calvert, Patrick A; Himbert, Dominique; Brochet, Eric; Radu, Costin; Iung, Bernard; Hvass, Ulrik; Darondel, Jean-Marc; Depoix, Jean-Pol; Nataf, Patrick; Vahanian, Alec

2012-03-01

We describe the first report of an Edwards SAPIEN valve implanted in a tricuspid bioprosthesis from the femoral vein. We highlight the feasibility of this previously avoided approach and the techniques involved. A 61-year-old woman with multiple valve replacements for rheumatic heart disease presented with NHYA IV dyspnoea secondary to a severely stenosed tricuspid bioprosthesis. After failed aggressive medical therapy and surgical turn down, an Edwards SAPIEN XT valve was deployed in the tricuspid bioprosthesis via the right femoral vein. Adaptations to the standard transfemoral transcatheter aortic valve implantation (TAVI) technique included: (1) crossing the tricuspid bioprosthesis with a balloon floatation catheter; (2) temporary pacing wire in the coronary sinus rather than the right ventricle; (3) mounting of the SAPIEN XT valve in the reverse orientation to transfemoral TAVI; and (4) fine positioning of the final valve position pre-deployment by 3D transoesophageal echocardiography (3D TOE) alone due to complete radiolucency of the tricuspid bioprosthesis. The procedure was completed without complication and resulted in significant symptomatic improvement. Deployment of an Edwards SAPIEN valve in a tricuspid bioprosthesis via the femoral vein is feasible and, with careful adaptations to established TAVI techniques, can be performed without complications and with good clinical response.

Percutaneous implantation of the CoreValve® self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.

PubMed

Pascual, Isaac; Avanzas, Pablo; Muñoz-García, Antonio J; López-Otero, Diego; Jimenez-Navarro, Manuel F; Cid-Alvarez, Belén; del Valle, Raquel; Alonso-Briales, Juan H; Ocaranza-Sanchez, Raimundo; Alfonso, Fernando; Hernández, José M; Trillo-Nouche, Ramiro; Morís, César

2013-10-01

There is little information on the use of transcatheter aortic valve implantation in patients with severe aortic stenosis and porcelain aorta. The primary aim of this study was to analyze death from any cause after CoreValve(®) implantation in patients with severe aortic stenosis, with and without porcelain aorta. In this multicenter, observational prospective study, carried out in 3 hospitals, percutaneous aortic valves were implanted in 449 patients with severely calcified aortic stenosis. Of these, 36 (8%) met the criteria for porcelain aorta. The primary end-point was death from any cause at 2 years. Patients with porcelain aorta more frequently had extracardiac vascular disease (11 [30.6%] vs 49 [11.9%]; P=.002), prior coronary revascularization (15 [41.7%] vs 98 [23.7%]; P=.017), and dyslipidemia (26 [72.2%] vs 186 [45%]; P=.02). In these patients, there was greater use of general anesthesia (15 [41.7%] vs 111 [16.9%]; P=.058) and axillary access (9 [25%] vs 34 [8.2%]; P=.004). The success rate of the procedure (94.4 vs 97.3%; P=.28) and the incidence of complications (7 [19.4%] vs 48 [11.6%]; P=.20) were similar in both groups. There were no statistically significant differences in the primary end point at 24 months of follow-up (8 [22.2%] vs 66 [16%]; P=.33). The only predictive variable for the primary end point was the presence of complications during implantation (hazard ratio=2.6; 95% confidence interval, 1.5-4.5; P=.001). In patients with aortic stenosis and porcelain aorta unsuitable for surgery, percutaneous implantation of the CoreValve(®) self-expanding valve prosthesis is safe and feasible. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

The challenge of valve-in-valve procedures in degenerated Mitroflow bioprostheses and the advantage of using the JenaValve transcatheter heart valve.

PubMed

Conradi, Lenard; Kloth, Benjamin; Seiffert, Moritz; Schirmer, Johannes; Koschyk, Dietmar; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-12-01

Recently, the feasibility of valve-in-valve procedures using current first-generation transcatheter heart valves (THV) in cases of structural valve degeneration has been reported as an alternative to conventional open repeat valve replacement. By design, certain biological valve xenografts carry a high risk of coronary ostia occlusion due to lateral displacement of leaflets after valve-in-valve procedures. In the present report we aimed to prove feasibility and safety of transapical valve-in-valve implantation of the JenaValve THV in two cases of degenerated Mitroflow bioprostheses. We herein report two cases of successful transapical valve-in-valve procedures using a JenaValve THV implanted in Sorin Mitroflow bioprostheses for structural valve degeneration. Both patients were alive and in good clinical condition at 30 days from the procedure. However, increased transvalvular gradients were noted in both cases. Transcatheter valve-in-valve implantation of a JenaValve THV is a valid alternative for patients with degenerated Mitroflow bioprostheses of sufficient size and in the presence of short distances to the coronary ostia who are too ill for conventional repeat open heart surgery. Increased pressure gradients have to be expected and weighed against the disadvantages of other treatment options when planning such a procedure.

"Ring pledget": a new concept for secure apex closure during transapical aortic valve implantation.

PubMed

Astarci, Parla; Glineur, David; Kefer, Joelle; Renkin, Jean; Vanoverschelde, Jean-Louis; El Khoury, Gebrine

2010-03-01

Transapical aortic valve implantation requires puncture of the left ventricle apex and insertion of a 32-French delivery sheath. A critical step in the procedure consists of secure closure of the ventricular apex. We describe 2 cases of apical rupture of 42 transapical aortic valve implantations. Furthermore, we describe the use of a newly designed single circular Teflon pledget that can help to avoid this complication. This pledget provides a more secure and uniform shrinkage of the entire apex to close the defect left by the delivery sheath.

[Selection of patients for transcatheter aortic valve implantation].

PubMed

Tron, Christophe; Godin, Matthieu; Litzler, Pierre-Yves; Bauer, Fabrice; Caudron, Jérome; Dacher, Jean-Nicolas; Borz, Bogdan; Canville, Alexandre; Kurtz, Baptiste; Bessou, Jean-Paul; Cribier, Alain; Eltchaninoff, Hélène

2012-06-01

A good selection of patients is a crucial step before transcatheter aortic valve implantation (TAVI) in order to select the good indications and choose the access route. TAVI should be considered only in patients with symptomatic severe aortic stenosis and either contraindication or high surgical risk. Indication for TAVI should be discussed in a multidisciplinary team meeting. Echocardiography and/or CT scan are mandatory to evaluate the aortic annulus size and select the good prosthesis size. The possibility of transfemoral implantation is evaluated by angiography and CT scan, and based on the arterial diameters, but also on the presence of tortuosities and arterial calcifications. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

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

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. © 2014 Wiley Periodicals, Inc.

Thrombogenic potential of transcatheter aortic valve implantation with trivial paravalvular leakage

PubMed Central

Siegel, Rolland

2014-01-01

Background Significant paravalvular leakage after transcatheter aortic valve implantation (TAVI) correlates with increased morbidity and mortality, but adverse consequences of trivial paravalvular leakage have stimulated few investigations. Using a unique method distinctly different from other diagnostic approaches, we previously reported elevated backflow velocities of short duration (transients) in mechanical valve closure. In this study, similar transients were found in a transcatheter valve paravalvular leakage avatar. Methods Paravalvular leakage rate (zero to 58 mL/second) and aortic valve incompetence (volumetric back flow/forward flow; zero to 32%) were made adjustable using a mock transcatheter aortic valve device and tested in quasi-steady and pulsatile flow test systems. Projected dynamic valve area (PDVA) from the back illuminated mock transcatheter aortic valve device was measured and regional backflow velocities were derived by dividing volumetric flow rate by the PDVA over the open and closing valve phase and the total closed valve area derived from backflow leakage. Results Aortic incompetence from 1-32% generated negative backflow transients from 8 to 267 meters/second, a range not dissimilar to that measured in mechanical valves with zero paravalvular leakage. Optimal paravalvular leakage was identified; not too small generating high backflow transients, not too large considering volume overload and cardiac energy loss caused by defective valve behavior and fluid motion. Conclusions Thrombogenic potential of transcatheter aortic valves with trivial aortic incompetence and high magnitude regional backflow velocity transients was comparable to mechanical valves. This may have relevance to stroke rate, asymptomatic microembolic episodes and indications for anticoagulation therapy after transcatheter valve insertion. PMID:25333018

Evaluation of the safety and efficacy of transcatheter aortic valve implantation in patients with a severe stenotic bicuspid aortic valve in a Chinese population*

PubMed Central

Liu, Xian-bao; Jiang, Ju-bo; Zhou, Qi-jing; Pu, Zhao-xia; He, Wei; Dong, Ai-qiang; Feng, Yan; Jiang, Jun; Sun, Yong; Xiang, Mei-xiang; He, Yu-xin; Fan, You-qi; Dong, Liang; Wang, Jian-an

2015-01-01

Objective: The purpose of this study is to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with a severe stenotic bicuspid aortic valve (BAV) in a Chinese population. While several groups have reported the feasibility, efficacy, and safety of TAVI for patients with a BAV, worldwide experience of the technique is still limited, especially in China. Methods: From March 2013 to November 2014, high surgical risk or inoperable patients with symptomatic severe aortic stenosis (AS) who had undergone TAVI at our institution were selected for inclusion in our study. Results were compared between a BAV group and a tricuspid aortic valve (TAV) group. Results: Forty patients were included in this study, 15 (37.5%) of whom were identified as having a BAV. In the BAV group, the aortic valve area was smaller ((0.47±0.13) vs. (0.59±0.14) cm2), the ascending aortic diameter was larger ((40.4±4.4) vs. (36.4±4.3) mm), and the concomitant aortic regurgitation was lower. No significant differences were found between the groups in the other baseline characteristics. No differences were observed either in the choice of access or valve size. The procedural success achieved in this study was 100%. There were no differences between groups in device success (86.7% vs. 88.0%), 30-d mortality (6.7% vs. 8.0%), or 30-d combined end point (13.3% vs. 12.0%). The incidences of new pacemaker implantation, paravalvular regurgitation and other complications, recovery of left ventricle ejection fraction and heart function were similar in both groups. Conclusions: Patients with a severely stenotic BAV can be treated with TAVI, and their condition after treatment should be similar to that of people with a TAV. PMID:25743122

Successful non-surgical treatment of endocarditis caused by Staphylococcus haemolyticus following transcatheter aortic valve implantation (TAVI).

PubMed

Loverix, L; Timmermans, P; Benit, E

2013-01-01

We describe a case of a 79-year-old male patient with severe aortic stenosis who underwent transcatheter aortic valve implantation (TAVI) at our institution. He presented at the emergency department with dyspnea and fatigue 7 months after implantation. The diagnosis of early prosthetic valve endocarditis (PVE) caused by Staphylococcus haemolyticus was made by transesophageal echocardiography (TEE) and multiple positive blood cultures. Since our patient was considered inoperable due to a history of coronary artery bypass graft (CABG) surgery with patent bypasses, high peri-operative mortality including renal failure and a poor general prognosis, surgical removal of the valve was not an option. The patient was successfully treated with antibiotic therapy.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement.

PubMed

Huenges, Katharina; Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed.

Relationship of aortic annular eccentricity and paravalvular regurgitation post transcatheter aortic valve implantation with CoreValve.

PubMed

Wong, Dennis T L; Bertaso, Angela G; Liew, Gary Y H; Thomson, Viji S; Cunnington, Michael S; Richardson, James D; Gooley, Robert; Lockwood, Siobhan; Meredith, Ian T; Worthley, Matthew I; Worthley, Stephen G

2013-04-01

Significant paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is associated with negative clinical consequences. We hypothesize that increased eccentricity of the aortic annulus is associated with greater PAR. Patients with severe aortic stenosis underwent multidetector computed tomography (MDCT) before successful TAVI with the Medtronic CoreValve bioprosthesis. The smallest (D(min)) and largest (D(max)) orthogonal diameters in the basal ring of the aortic annulus were determined. We defined circularity of aortic annulus using the eccentricity index (1 - D(min)/D(max)). The primary endpoint was early occurrence of significant PAR, defined as > grade II PAR by postprocedural aortography. Eighty-four patients, mean age 83 ± 4 years with a mean aortic valve area of 0.7 ± 0.2 cm² were included. Twenty patients had postprocedural PAR > grade II. Using a receiver operating characteristic (ROC) analysis, eccentricity index correlated with significant PAR (AUC = 0.834; P=.034). A retrospectively determined eccentricity index cut-off of >0.25 was related to significant PAR with a sensitivity of 80%, specificity of 86%, and negative predictive value of 95% (P<.001). On univariate logistic regression, eccentricity index of >0.25 (P<.001) and device implantation depth (P=.015) correlated with significant PAR, while other parameters such as annular calcification and cover index did not. On multivariate analysis including only parameters with P<.1 on univariate analysis, eccentricity index >0.25 was the sole independent predictor of significant PAR. Eccentricity index is related to significant PAR after TAVI with Medtronic CoreValve. Further larger studies are required to determine the utility of this novel index in screening suitable patients for this procedure.

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.

Percutaneous valved stent implantation in the ascending aorta for the treatment of very high-risk aortic regurgitation: an animal study.

PubMed

Zong, Gang-Jun; Jiang, Hai-Bin; Bai, Yuan; Wu, Gang-Yong; Ye, Guang-Ming; Chen, Jing-Kai; Qin, Yong-Wen; Zhao, Xian-xian

2013-12-01

We investigated the effects of percutaneous valved stent implantation in the ascending aorta as an alternative treatment for aortic regurgitation in a canine model. A total of 16 healthy dogs weighing an average of 18.3 ± 2.1 kg were used for the establishment of animal models of chronic aortic regurgitation by percutaneous aortic valve perforation and balloon dilation. At 2 mo after successful model establishment, all experimental animals underwent valved stent implantation in the ascending aorta and then were followed up for 3 mo. Experimental models of chronic aortic regurgitation were successfully established in 10 dogs. Surviving dogs underwent successful valved stent implantation in the ascending aorta and were subsequently followed up for 3 mo. The level of instantaneous aortic regurgitation at 3-mo follow-up was significantly reduced compared with that before valved stent implantation (2.4 ± 0.9 versus 10.6 ± 2.1 mL/s, P < 0.05). The left ventricular ejection fraction was significantly increased (53.8 ± 4.2% versus 37.8 ± 3.7%, P < 0.05), and the left ventricular end-diastolic volume was also significantly reduced (30.3 ± 2.2 versus 40.1 ± 3.6 mL, P < 0.05). No paravalvular leak, stroke, atrioventricular block, or other complications occurred in dogs undergoing valved stent implantation. Percutaneous valved stent implantation in the ascending aorta is feasible, effective, and safe as an alternative treatment for very high-risk aortic regurgitation in a canine model. Copyright © 2013 Elsevier Inc. All rights reserved.

Complete Transversal Disc Fracture in a Björk-Shiley Delrin Mitral Valve Prosthesis 43 Years After Implantation.

PubMed

González-Santos, Jose María; Arnáiz-García, María Elena; Dalmau-Sorlí, María José; Sastre-Rincón, Jose Alfonso; Hernández-Hernández, Jesús; Pérez-Losada, María Elena; Sagredo-Meneses, Víctor; López-Rodríguez, Javier

2016-10-01

A patient who underwent previous implantation of a mitral valve replacement with a Björk-Shiley Delrin (BSD) mitral valve prosthesis during infancy was admitted to our institution 43 years later after an episode of syncope and cardiac arrest. Under extreme hemodynamic instability, a mitral valve prosthetic dysfunction causing massive mitral regurgitation was identified. The patient underwent an emergent cardiac operation, and a complete disc fracture with partial disc migration was found. Exceptional cases of mechanical prosthetic heart valve fracture exist. We report the first case of complete transversal disc rupture of a BSD mitral valve prosthesis after the longest period of implantation ever reported in that position. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Transcatheter aortic-valve implantation with one single minimal contrast media injection.

PubMed

Arrigo, Mattia; Maisano, Francesco; Haueis, Sabine; Binder, Ronald K; Taramasso, Maurizio; Nietlispach, Fabian

2015-06-01

Performing transcatheter aortic valve implantation (TAVI) with the use of minimal contrast in patients at high-risk for acute kidney injury (AKI). Contrast-induced nephropathy (CIN) is a major cause of AKI following TAVI and is associated with increased morbidity and mortality. The amount of contrast media used increases the risk for CIN. Computed tomography was omitted during the screening process. For the procedure transfemoral access was default. The self-expanding CoreValve prosthesis was chosen in all patients to minimize the risk of annular rupture in case of oversizing. Valve sizing was based on echocardiography, aortography, calcification on fluoroscopy, as well as weight and height of the patient. A single contrast injection was performed to confirm correct position of the pigtail catheter at the level of the annulus. The pigtail then served as the marker for the device landing zone. Intraprocedural assessment of the implantation result relied on echocardiography and hemodynamics. Five patients with severe aortic stenosis and at high risk for developing CIN were included. Device success was achieved in all patients and no major complications occurred. The median dose of injected contrast media was 8 ml (4-9). All but one patient had improved renal function after the intervention compared to baseline. Our study shows feasibility of performing TAVI with a single minimal contrast media injection, using a self-expandable valve. This technique has the potential to reduce the incidence of CIN. © 2015 Wiley Periodicals, Inc.

Left Ventricular Assist Device Implantation with Concomitant Aortic Valve and Ascending Aortic Replacement

PubMed Central

Panholzer, Bernd; Cremer, Jochen; Haneya, Assad

2018-01-01

Left ventricular assist device (LVAD) is nowadays a routine therapy for patients with advanced heart failure. We present the case of a 74-year-old male patient who was admitted to our center with terminal heart failure in dilated cardiomyopathy and ascending aortic aneurysm with aortic valve regurgitation. The LVAD implantation with simultaneous aortic valve and supracoronary ascending aortic replacement was successfully performed. PMID:29552039

The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation.

PubMed

Silaschi, Miriam; Conradi, Lenard; Wendler, Olaf; Schlingloff, Friederike; Kappert, Utz; Rastan, Ardawan J; Baumbach, Hardy; Holzhey, David; Eichinger, Walter; Bader, Ralf; Treede, Hendrik

2018-06-01

We present 1-year outcomes of the post-market registry of a next-generation transcatheter heart valve used for aortic regurgitation (AR). Transcatheter aortic valve replacement (TAVR) is routine in high-risk patients with aortic stenosis but is not recommended for AR. The JenaValve™ (JenaValve Technology GmbH, Munich, Germany) overcomes technical challenges in AR patients through a leaflet clipping mechanism. The JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere Aortic Stenosis oR Aortic Insufficiency (JUPITER) Registry is a European study to evaluate safety and effectiveness of this THV. From 2012-2015, 30 patients with AR were enrolled. Mean age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery. No annular rupture or coronary ostia obstruction occurred. Mortality at 30 days was 10.0% (3/30). Combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). Rate of permanent pacemaker implantation was 3.8% (1/26). One-year Kaplan-Meier survival was 79.9%, one-year combined efficacy was 73.1% (19/30). No further strokes were observed during 1 year of follow-up. The JenaValve overcomes technical challenges of TAVR in AR through a clipping mechanism. We report satisfactory outcomes of a multicenter registry using the JenaValve for predominant AR, as rate of THV embolization, residual AR and permanent pacemaker implantation was low. One-year results using the JenaValve for AR encourage its use for this indication. © 2017 Wiley Periodicals, Inc.

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.

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.

Post-introduction observation of transcatheter aortic valve implantation in Galicia (Spain).

PubMed

Varela-Lema, Leonor; Queiro-Verdes, Teresa; Baz-Alonso, José A; Cuenca-Castillo, José J; Durán-Muñoz, Darío; Gónzalez-Juanatey, José R; Herrera Noreña, José M; Iñiguez-Romo, Andrés; López-Otero, Diego; Pradas-Montilla, Gonzalo; Rubio-Álvarez, José; Salgado-Fernández, Jorge; Trillo Nouche, Ramiro; Vázquez-González, Nicolás; López-García, Marisa

2015-02-01

Transcatheter aortic valve implantation constitutes an example of a technology introduced into the Galician Health Care System basket and subjected to a post-introduction observational study after coverage. This paper aims to describe the process and results of this experience, illustrating the main challenges and opportunities in using these studies for supporting decision making. The study protocol was developed by a multidisciplinary team consisting of experts from the Galician HTA Agency (avalia-t), interventional cardiologists and cardiac surgeons. Together they agreed on the information that was relevant and feasible for collection, and planned the study design, data collection and analysis of results. During the 1-year recruitment period, 94 patients underwent percutaneous aortic valve replacement in the three authorized centres. Implantation rate and prosthesis models differed substantially across the centres. Overall, procedural success rate was 96.8% and hospital mortality was 7.4%. Complications during post-surgical admission were recorded in 40.4% of patients. Moderate residual aortic regurgitation was observed in 10% of patients, and the procedure was associated with a stroke rate of 3.3% at 30 days and 5.3% at 1 year. Post-introduction observation has made it feasible to determine the use of this procedure within the SERGAS context and has enabled the assessment of performance in real-life conditions. The proposed strategic actions and interventions have been drawn up based upon the collective judgement of a group of experienced professionals, and have served to establish recommendations on further research that would be required to optimize health benefits. © 2014 John Wiley & Sons, Ltd.

Percutaneous transcatheter aortic valve implantation for degenerated surgical bioprostheses: the first case series in Asia with one-year follow-up.

PubMed

Chiam, Paul Toon-Lim; Ewe, See-Hooi; Soon, Jia-Lin; Ho, Kay-Woon; Sin, Yong-Koong; Tan, Swee-Yaw; Lim, Soo-Teik; Koh, Tian-Hai; Chua, Yeow-Leng

2016-07-01

Percutaneous transcatheter aortic valve implantation (TAVI) has become an established therapy for inoperable and high-surgical-risk patients with severe aortic stenosis. Although TAVI in patients with degenerated surgical aortic bioprostheses (i.e. valve-in-valve TAVI) is increasingly reported in Western studies, such data is lacking in Asian patients. We describe the initial experience of valve-in-valve TAVI in Asia. Eight patients who underwent valve-in-valve TAVI due to degenerated aortic bioprostheses were enrolled. The mechanism of bioprosthetic valve failure was stenotic, regurgitation or mixed. All procedures were performed via transfemoral arterial access, using the self-expanding CoreValve prosthesis or balloon-expandable SAPIEN XT prosthesis. The mean age of the patients was 71.6 ± 13.2 years and five were male. Mean duration to surgical bioprosthesis degeneration was 10.2 ± 4.1 years. Valve-in-valve TAVI was successfully performed in all patients. CoreValve and SAPIEN XT prostheses were used in six and two patients, respectively. There were no deaths, strokes or permanent pacemaker requirement at 30 days, with one noncardiac mortality at one year. All patients experienced New York Heart Association functional class improvement. Post-procedure mean pressure gradients were 20 ± 11 mmHg and 22 ± 8 mmHg at 30 days and one year, respectively. Residual aortic regurgitation (AR) of more than mild severity occurred in one patient at 30 days. At one year, only one patient had mild residual AR. In our experience of valve-in-valve TAVI, procedural success was achieved in all patients without adverse events at 30 days. Good clinical and haemodynamic outcomes were sustained at one year. Copyright © Singapore Medical Association.

Medium-term outcome of Toronto aortic valve replacement: single center experience.

PubMed

Li, Wei; Price, Susanna; O'Sullivan, Christine A; Kumar, Pankaj; Jin, Xu Y; Henein, Michael Y; Pepper, John R

2008-09-26

Long-term competence of any aortic prosthesis is critical to its clinical durability. Bioprosthetic valves, and in particular the stentless type have been proposed to offer superior haemodynamic profiles with consequent potential for superior left-ventricular mass regression. These benefits however are balanced by the potential longevity of the implanted valve. The aims of this study were to assess medium-term Toronto aortic valve function and its effect on left-ventricular function. Between 1992 and 1996 86 patients underwent Toronto aortic valve replacement for aortic valve disease and were followed up annually. Prospectively collected data was analyzed for all patients where detailed echocardiographic follow-up was available. Echocardiographic studies were analyzed at 2+/-0.6 and 6+/-1.4 years after valve replacement. Data collected included left-ventricular systolic and diastolic dimensions, fractional shortening and left-ventricular mass. In addition, data on aortic valve and root morphology, peak aortic velocities, time velocity integral, stroke volume and the mechanism of valve failure where relevant, were also collected. Complete echocardiographic data were available for eighty-four patients, age 69+/-9 years, 62 male. Additional coronary artery bypass grafting was performed in 38% of patients. Twelve (14%) valves had failed during follow-up, 7 (8%) requiring re-operation. Valve failure was associated with morphologically bicuspid native aortic valve (9/12), and progressive dilatation of the aortic sinuses, sino-tubular junction and ascending aorta (11/12). Left-ventricular mass index remained high (184+/-75 g/m(2)) and did not continue to regress between early and medium-term follow-up (175.8+/-77 g/m(2)). Although more than 90% of implanted Toronto aortic valves remained haemodynamically stable with low gradient at medium-term follow-up, young age and larger aortic dimensions in patients with valve failure suggest better outcome if used in the elderly

Outcome after transvascular transcatheter aortic valve implantation in 2016.

PubMed

Gaede, Luise; Blumenstein, Johannes; Liebetrau, Christoph; Dörr, Oliver; Kim, Won-Keun; Nef, Holger; Husser, Oliver; Elsässer, Albrecht; Hamm, Christian W; Möllmann, Helge

2018-02-21

We analysed the number of procedures, complications, and in-hospital mortality rates of all patients undergoing transvascular transcatheter aortic valve implantation (TV-TAVI) in comparison to isolated surgical aortic valve replacement (iSAVR) from 2014 to 2016 in Germany. All aortic valve procedures performed in Germany are mandatorily registered in a quality control program. More than 15 000 TV-TAVI procedures were performed in 2016 in Germany. Especially the number of post-procedural complications declined within the last few years, including new pacemaker implantations (2015: 12.6% vs. 2016: 11.4%, P = 0.002) and vascular complications (2015: 8.5% vs. 2016: 7.1%; P < 0.001). Thus, in 2016 the overall in-hospital mortality rate after TV-TAVI was 2.6%, which is for the first time numerically below that of iSAVR, which was 2.9% (P = 0.19). A stratified analysis according to the German aortic valve score shows a lower observed than expected in-hospital mortality rate for TV-TAVI (O/E 0.68). Additionally, the in-hospital mortality was significantly lower after TV-TAVI than after iSAVR in the very high- (11.3% vs. 23.6%; P < 0.001), in the high- (4.1% vs. 9.2%; P < 0.001), and in the intermediate-risk group (3.0% vs. 4.6%; P = 0.016) and was similar to that of iSAVR in low-risk patients (1.6% vs. 1.4%; P = 0.4). The overall in-hospital mortality after TV-TAVI was numerically lower than after iSAVR in 2016 for the first time. In the low risk group in-hospital mortality was similar, whereas in all other risk groups in-hospital mortality after TV-TAVI was significantly lower than after SAVR. This is likely to contribute to a redefinition of the standard of care in the future. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Cardiology

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.

JenaValve.

PubMed

Treede, Hendrik; Rastan, Ardawan; Ferrari, Markus; Ensminger, Stephan; Figulla, Hans-Reiner; Mohr, Friedrich-Wilhelm

2012-09-01

The JenaValve is a next-generation TAVI device which consists of a well-proven porcine root valve mounted on a low-profile nitinol stent. Feeler guided positioning and clip fixation on the diseased leaflets allow for anatomically correct implantation of the device without rapid pacing. Safety and efficacy of transapical aortic valve implantation using the JenaValve were evaluated in a multicentre prospective study that showed good short and midterm results. The valve was CE-mark released in Europe in September 2011. A post-market registry ensures on-going and prospective data collection in "real-world" patients. The transfemoral JenaValve delivery system will be evaluated in a first-in-man study in the near future.

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.

Cardiac Valve Noise Reduction by Non-Drug Interventions Improves the Sleep Quality of Patients after Mechanical Cardiac Valve Implantation.

PubMed

Lin, Yanjuan; Xu, Le; Huang, Xizhen; Jiang, Fei; Lin, Fen; Ye, Qingyang; Lin, Jianling

2016-01-01

To investigate the effects of non-drug interventions on the sleep quality of patients after mechanical cardiac valve implantation. In this prospective, randomized, controlled trial, 64 patients scheduled for mechanical mitral valve replacement were recruited. Patients underwent cognitive behavioral therapy and wore noise cancelling earplugs and eye mask. Sleep quality was evaluated on the 4th after admission and the 5th days after operation. The primary outcome was the total sleep quality score differences between the 4th day after admission and the 5th day after operation. All patients had been suffering from poor sleep quality for a month before admission. There was no difference between both groups on the 4th day after admission. Overall sleep quality in the intervention group was better than in the control group on the 5th day after operation. The subjective sleep quality of the patients in each group was significantly lower on the 5th day after the operation than on the 4th day after admission (P <0.05). Non-drug intervention could improve the sleep quality of patients after mechanical cardiac valve implantation and help the postoperative recovery of the patients. ( ChiCTR-TRC-14004405, 21 March 2014.).

Incidence and treatment of procedural cardiovascular complications associated with trans-arterial and trans-apical interventional aortic valve implantation in 412 consecutive patients.

PubMed

Lange, Rüdiger; Bleiziffer, Sabine; Piazza, Nicolo; Mazzitelli, Domenico; Hutter, Andrea; Tassani-Prell, Peter; Laborde, Jean-Claude; Bauernschmitt, Robert

2011-11-01

Trans-catheter aortic valve implantation (TAVI) technology is rapidly evolving, with 412 procedures having been performed at our institution. Herein, we report a complete, prospective analysis of complications occurring during transvascular and trans-apical implantations with two different prostheses. Between June 2007 and June 2010, 412 patients (258 female, mean age 80.3±7.2 years, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) 20.2%±13.0%) underwent TAVI through either a retrograde (n=252 transfemoral, n=28 transaxillary, and n=5 transaortic) or antegrade (n=127 trans-apical) approach at our institution. The trans-apical access was chosen only in cases where transvascular implantation was not possible. As many as 283 CoreValve and 129 Edwards Sapien prostheses were implanted. Thirty-day survival was 90.9%. Vascular complications occurred in 42 patients (10.2%). In four patients, lethal aortic root (n=3) or abdominal (n=1) aortic rupture occurred. Pericardial effusion developed in 53 patients (12.8%), which resulted in cardiac tamponade in 12 patients (2.9%). Twenty-three patients (5.6%) with valve malplacement were treated interventionally. In five patients (1.2%), emergency institution of cardiopulmonary bypass was required during the procedure for temporary support; all patients survived. Seventeen patients underwent re-intervention on the catheter valve (4.1%). With growing experience, complications with TAVI may be avoided by proper patient selection and skillful management. Other complications, when they occur, require a specific treatment algorithm to avoid delay in decision making. A considerable number of complications after TAVI require surgical treatment. Therefore, the ideal environment for TAVI procedures is a hybrid operating room, where a multidisciplinary team of surgeons, cardiologists, and anesthesiologists is best fitted to meet the current needs associated with TAVI technology. A reduction in complications was

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

Prognostic Impact of Calcium Score after Transcatheter Aortic Valve Implantation Performed With New Generation Prosthesis.

PubMed

Akodad, Mariama; Lattuca, Benoit; Agullo, Audrey; Macia, Jean-Christophe; Gandet, Thomas; Marin, Grégory; Iemmi, Anaïs; Vernhet, Hélène; Schmutz, Laurent; Nagot, Nicolas; Albat, Bernard; Cayla, Guillaume; Leclercq, Florence

2018-05-15

Calcium score (CS) is a well-known prognostic factor after transcatheter aortic valve implantation (TAVI) performed with first generation prosthesis but few data are available concerning new generation valves. The aim of this study was to evaluate if CS remains a prognostic factor after Sapien 3 and Evolut R valves implantation. Agatston CS was evaluated on multislice computed tomography before TAVI in 346 patients implanted with Sapien XT (n = 61), CoreValve (n = 57) devices, (group 1, n = 118), and with new generation Sapien 3 (n = 147), Evolut R (n = 81) prosthesis, (group 2, n = 228). Major adverse cardiovascular events and aortic regurgitation (AR) were evaluated at 1 month. The 2 groups were similar at baseline except for logistic Euroscore (20.1% in group 1 vs 15.0 % in group 2; p = 0.001), chronic renal failure (44.1% vs 37.2% respectively, p = 0.007) and preprocedural CS (4,092 ± 2,176 vs 3,682 ± 2,109 respectively, p = 0.022). In group 1, 28 patients (23.7%) had adverse clinical events vs 21 (9.2%) in group 2 (p <0.01). In multivariate analysis, a higher CS was predictive of adverse events in group 1 (5,785 ± 3,285 vs 3,565 ± 1,331 p <0.0001) but not in group 2 (p = 0.28). A higher CS was associated with AR in group 1 (6,234 ± 2711 vs 3,429 ± 1,505; p <0.001) and in patients implanted with an Evolut R device from group 2 (4,085 ± 3,645 vs 2,551 ± 1,356; p = 0.01). In conclusion, CS appears as an important prognostic factor of major events after TAVI with first generation valves but not with new generation devices. CS remains associated with AR only with new generation self-expandable Evolut R devices. Copyright © 2018 Elsevier Inc. All rights reserved.

Complications of the access during aortic valve implantation through transfemoral access.

PubMed

Alsac, Jean-Marc; Zegdi, Rachid; Blanchard, Didier; Achouh, Paul; Cholley, Bernard; Berrebi, Alain; Julia, Pierre; Fabiani, Jean-Noël

2011-08-01

Aortic valve implantation (AVI) is a booming therapeutic option in high-risk patients with calcific aortic stenosis. Retrograde femoral approach drawbacks include vascular complications owing to the size of the introduction system (22- and 24-F).The aim of this study was to retrospectively analyze the incidence and the treatment of vascular complications in the first 2 years of transfemoral AVI experience with the first generation of Edwards SAPIEN transcatheter heart valves. Since December 2007, AVI has been performed in 71 patients, 21 times by the transapical route and 50 times by the transfemoral route through an inguinal approach with the first generation of Edwards SAPIEN transcatheter heart valves (23 and 26 mm). The incidence and the treatment of vascular complications were evaluated as main criteria for transfemoral AVI. All the procedures could be successfully performed by a femoral route, except for three cases when the introducing device could not be fixed on the thoracic aorta because of vascular access problems. Vascular access-related complications occurred in nine patients (18%), including three iliac dissections, two aortic dissections, three femoral lesions, and one thoracic aorta rupture. These complications were treated either in a conservative way (n = 2), or in an endovascular way using a contralateral approach (n = 3), or surgically through an inguinal approach (n = 3). A traumatic rupture of the thoracic aorta resulted in the death of a female patient. In our experience, transfemoral AVI gives a satisfying technical success rate in the selected patients. The incidence of complications involving the vascular access remains an important limitation of this new technique. Although a conservative or endovascular treatment can be applied in most cases, improving the introduction devices is highly expected because it would reduce the complications rate of vascular access. Copyright © 2011 Annals of Vascular Surgery Inc. Published by Elsevier Inc

Introduction of an interdisciplinary heart team-based transcatheter aortic valve implantation programme: short and mid-term outcomes.

PubMed

Martínez, G J; Seco, M; Jaijee, S K; Adams, M R; Cartwright, B L; Forrest, P; Celermajer, D S; Vallely, M P; Wilson, M K; Ng, M K C

2014-09-01

Transcatheter aortic valve implantation (TAVI) has been developed to treat symptomatic aortic stenosis in patients deemed too high risk for open-heart surgery. To address this complex population, an interdisciplinary heart team approach was proposed. Present the short- and mid-term outcomes of the first 100 patients in the Royal Prince Alfred Hospital multidisciplinary TAVI programme. Single-centre registry. Baseline and procedural data were prospectively recorded. Outcomes were recorded according to Valve Academic Research Consortium - version 2 guidelines. All patients underwent a comprehensive interdisciplinary pre-procedural evaluation. Sixty-eight transfemoral and 32 transapical implantations were performed. Mean age was 82 (±8.9) years old with an average logistic EuroSCORE of 33. Although 13 procedures had major complications, there was no intraprocedural mortality. During the first month, 9% of patients were re-admitted due to heart failure and 13% had a permanent pacemaker implanted. A 3% 30-day and 8% follow-up (mean 17 months) mortalities were recorded. While no significant differences in the rate of complications were found between the first and second half of the experience, all cases of mortality within 30 days (n = 3) occurred in the initial half. Sustained haemodynamic results were obtained with TAVI (immediate mean aortic valve gradient reduction from 47 to 9 mmHg; 1-year echocardiographic gradient 9.9 mmHg, with no moderate or severe aortic regurgitation). Excellent results can be achieved with TAVI in very high-risk patients at an Australian institution. A comprehensive evaluation based on a heart team can overcome most of the difficulties imposed by this challenging population. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

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

Percutaneous pulmonary valve implantation in patients with dysfunction of a "native" right ventricular outflow tract - Mid-term results.

PubMed

Georgiev, Stanimir; Tanase, Daniel; Ewert, Peter; Meierhofer, Christian; Hager, Alfred; von Ohain, Jelena Pabst; Eicken, Andreas

2018-05-01

To investigate the feasibility and mid-term results of percutaneous pulmonary valve implantation (PPVI) in patients with conduit free or "native" right ventricular outflow tracts (RVOT). We identified all 18 patients with conduit free or "native" right ventricular outflow tract, who were treated with percutaneous pulmonary valve implantation (PPVI) in our institution. They were divided into two groups - these in whom the central pulmonary artery was used as an anchoring point for the preparation of the landing zone (n=10) for PPVI and these, in whom a pulmonary artery branch was used for this purpose (n=8). PPVI was performed successfully in all patients with significant immediate RVOT gradient and pulmonary regurgitation grade reduction. Four patients had insignificant paravalvular regurgitation. In one patient the valve was explanted after 4months because of bacterial endocarditis. A follow-up of 19 (4-60) months showed sustained good function of the other implanted valves. The MRI indexed right ventricular end diastolic volume significantly decreased from 108(54-174) ml/m 2 before the procedure to 76(60-126) ml/m 2 six months after PPVI, p=0.01. PPVI is feasible with good mid-term results in selected patients with a "native" RVOT without a previously implanted conduit. Creating a stable landing zone with a diameter less than the largest available valve (currently 29mm) is crucial for the technical success of the procedure. Further studies and the development of new devices could widen the indications for this novel treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

Four-year durability of clinical and haemodynamic outcomes of transcatheter aortic valve implantation with the self-expanding CoreValve.

PubMed

Gulino, Simona; Barbanti, Marco; Deste, Wanda; Immè, Sebastiano; Aruta, Patrizia; Bottari, Vera; Benvenuto, Emanuele; Tamburino, Claudia; Di Landro, Alessio; Liberto, Daria; Santonoceto, Letizia; Sicuso, Rita; Di Stefano, Daniele; Todaro, Denise; Di Simone, Emanuela; Indelicato, Antonino; Giannazzo, Daniela; Sgroi, Carmelo; Tamburino, Corrado

2016-10-10

Long-term data on the durability of currently available transcatheter heart valves are limited. We sought to assess four-year clinical and echocardiographic outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. Between June 2007 and February 2014, 450 consecutive patients with symptomatic severe aortic stenosis underwent TAVI in our institution. For the purposes of this study, we included only those patients undergoing successful TAVI with the CoreValve prosthesis who had a minimum follow-up of four years (n=125). Survival rates at one, two, three and four years were 83.2, 76.8, 73.6 and 66.3%, respectively. Aortic regurgitation was a common finding after the procedure, especially due to paravalvular regurgitation (PVR), which was observed in the majority of patients (71.5%), mostly mild (52.0%). Progression from mild acute PVR to moderate PVR at four-year follow-up was reported in three patients. No cases of severe PVR were observed. Prosthetic valve failure was reported in four patients (3.2%). Our study demonstrates that favourable outcomes after successful TAVI are associated with sustained clinical and functional cardiovascular benefits up to four-year follow-up. Signs of moderate prosthetic valve failure are present only in a small percentage of patients.

Latest evidence on transcatheter aortic valve implantation vs. surgical aortic valve replacement for the treatment of aortic stenosis in high and intermediate-risk patients.

PubMed

Praz, Fabien; Siontis, George C M; Verma, Subodh; Windecker, Stephan; Jüni, Peter

2017-03-01

The goal of this review is to summarize the current evidence supporting the use of transcatheter aortic valve implantation (TAVI) in high and intermediate-risk patients. The focus is on the five randomized controlled trials comparing TAVI with surgical aortic valve replacement (SAVR) published to date, as well as two recent meta-analyses. TAVI has profoundly transformed the treatment of elderly patients presenting with symptomatic severe aortic stenosis. In experienced hands, the procedure has become well tolerated and the results more predictable. So far, two trials using two different devices [Placement of Aortic Transcatheter Valve (PARTNER) 1A and US CoreValve High Risk] have shown that TAVI is able to compete in terms of mortality with SAVR in high-risk patients. These findings have been extended to the intermediate-risk population in two recently published randomized controlled trials [PARTNER 2 and Nordic Aortic Valve Intervention (NOTION)]. The two meta-analyses suggested improved survival in both high and intermediate-risk patients during the first 2 years following the intervention. The survival benefit was only found in patients treated via the transfemoral access, and appeared more pronounced in women. Individual randomized trials enrolling high and intermediate-risk patients have established the noninferiority of TAVI in comparison with SAVR, whereas subsequent meta-analyses suggest superiority of transfemoral TAVI in terms of a sustained survival benefit 2 years after valve implantation irrespective of the surgical risk category. The benefit of TAVI appears more pronounced in women than in men.

Salvaging catastrophe in transcatheter aortic valve implantation: rehearsal, preassigned roles, and emergency preparedness.

PubMed

Tam, Derrick Y; Jones, Philip M; Kiaii, Bob; Diamantouros, Pantelis; Teefy, Patrick; Bainbridge, Daniel; Cleland, Andrew; Fernandes, Philip; Chu, Michael W A

2015-08-01

Emergency rescue plans for acute complications during transcatheter aortic valve implantation (TAVI) commonly include cardiopulmonary resuscitation, femoro-femoral cardiopulmonary bypass (CPB), and hemodynamic stabilization before definitive intervention is achieved. Nevertheless, most cases of emergency resuscitation remain chaotic and disorganized and often take longer than necessary, even in experienced centres. We sought to determine which factors and procedures may be associated with improved patient outcomes when emergencies arise during TAVI. MEDLINE(®) and EMBASE™ were searched with the following key words: "TAVI" or "TAVR" or "transcatheter valve implantation" or "transcatheter valve replacement" and "emergency cardiac surgery" or "conversion". Two hundred seventeen articles met the criteria and were reviewed. Utilization of a formal emergency checklist by a multidisciplinary TAVI team may reduce procedural errors, smooth the transition to CPB, and ultimately speed the delivery of corrective measures including emergency cardiac surgery. A well-organized regularly-rehearsed emergency rescue plan that preassigns resuscitative roles may shorten the duration of patient instability and resuscitation and improve patient outcomes when catastrophe occurs in TAVI. The anesthesia team plays a central role in preventing, detecting, and treating intraprocedural complications during TAVI.

Twenty-five-year experience with the Björk-Shiley convexoconcave heart valve: a continuing clinical concern.

PubMed

Blot, William J; Ibrahim, Michel A; Ivey, Tom D; Acheson, Donald E; Brookmeyer, Ron; Weyman, Arthur; Defauw, Joseph; Smith, J Kermit; Harrison, Donald

2005-05-31

The first Björk-Shiley convexoconcave (BSCC) prosthetic heart valves were implanted in 1978. The 25th anniversary provided a stimulus to summarize the research data relevant to BSCC valve fracture, patient management, and current clinical options. Published and unpublished data on the risks of BSCC valve fracture and replacement were compiled, and strategies for identifying candidates for prophylactic valve reoperation were summarized. By December 2003, outlet strut fractures (OSFs), often with fatal outcomes, had been reported in 633 BSCC valves (0.7% of 86,000 valves implanted). Fractures still continue to occur, but average rates of OSFs in 60 degrees valves are now <0.1% per year. OSF risk varies markedly by valve characteristics, especially valve angle and size, with weaker effects associated with other manufacturing variables. OSF risks are mildly lower among women than men but decline sharply with advancing age. The risks of valve replacement typically greatly exceed those of OSF. By comparing individualized estimated risks of OSF versus valve replacement, guidelines have been developed to identify the small percentage of BSCC patients (mostly younger men) who would be expected to have a gain in life expectancy should reoperative surgery be performed. Twenty-five years after the initial BSCC valve implants, fractures continue to occur. Continued monitoring of BSCC patients is needed to track and quantify risks and enable periodic updating of guidelines for patients and their physicians.

Emergency extracorporeal membrane oxygenation in transcatheter aortic valve implantation: A two-center experience of incidence, outcome and temporal trends from 2010 to 2015.

PubMed

Trenkwalder, Teresa; Pellegrini, Costanza; Holzamer, Andreas; Philipp, Alois; Rheude, Tobias; Michel, Jonathan; Reinhard, Wibke; Joner, Michael; Kasel, Albert M; Kastrati, Adnan; Schunkert, Heribert; Endemann, Dierk; Debl, Kurt; Mayr, N Patrick; Hilker, Michael; Hengstenberg, Christian; Husser, Oliver

2017-11-11

Although the incidence of periprocedural complications has decreased in transcatheter aortic valve implantation (TAVI), life-threatening complications occur and emergency veno-arterial extracorporeal membrane oxygenation (vaECMO) can provide immediate circulatory stabilization. We report our two-center experience of vaECMO during life-threatening complications in TAVI. From January 2010 to December 2015, 1,810 consecutive patients underwent TAVI at two centers. Clinical characteristics, type of complication, outcome and temporal trends in the requirement of emergency vaECMO were evaluated. Life-threatening complications requiring vaECMO occurred in 1.8% of cases (33 patients; 22 transfemoral, 11 transapical). Indications for vaECMO were ventricular rupture (30%, 10/33), low output (15%, 5/33), bleeding (12%, 4/33), coronary artery impairment (9%, 3/33), ventricular arrhythmias (6%, 2/33), severe aortic regurgitation (6%, 2/33), aortic annular rupture (6%, 2/33), and aortic dissection (3%, 1/33). In 4 cases, no definite cause for hemodynamic instability was identified. Conversion to open heart surgery was necessary in 42% of patients (14/33). Percutaneous coronary intervention was performed in all cases with coronary artery impairment (9%, 3/33). Patients with severe aortic regurgitation (6%, 2/33) underwent emergency valve-in-valve implantation. Other patients received, in addition to vaECMO support conservative treatment (42%, 14/33). In-hospital mortality and 30-day mortality were 46% (15/33). Of patients discharged, 67% (12/18) had no neurological impairment, whereas mild and severe neurological impairment was found in 11% (2/18) and 22% (4/18), respectively. From 2010 to 2015, with increasing procedures (from n = 43 to n = 553) requirement of vaECMO decreased from 9.3% to 0.9% (P for the trend <0.001). Over a 6-year period, need for emergency vaECMO during TAVI significantly decreased over time. Despite high in-hospital mortality, vaECMO represents a

A thin film nitinol heart valve.

PubMed

Stepan, Lenka L; Levi, Daniel S; Carman, Gregory P

2005-11-01

In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A "butterfly" valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Bio-corrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material's in vivo biocompatibility, thin film nitinol was implanted in pigs using stents covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on thin film nitinol samples after immersion in Hank's solution for one month. Finally, organ and tissue samples explanted from four pigs at 2, 3, 4, and 6 weeks after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation. Although long term testing is still necessary, thin film NiTi may be very well suited for use in artificial heart valves.

The third hand--a simple but useful tool for holding the sheath during transapical transcatheter aortic valve implantation.

PubMed

Wisser, Wilfried

2010-11-01

Transapical aortic valve implantation is an evolving technology for treating high-risk patients with symptomatic aortic stenosis. The transition to a catheter based implantation technique inherits one fundamental change: the native valve stays in place and is no longer removed. The selection of the correct plane of the aortic annulus, therefore, is mandatory. In addition, exact alignment of the sheath and catheters according to axis of the ascending aorta is imperative for correct implantation. That is why any additional movements have to be avoided. To aid in better workflow, we developed an easy-to-use cheap holder for the introduction sheath. By using a rigid table mount instrument holder the sheath can easily be fixed in the desired orientation, abolishing any movement and reducing the X-ray load to the implanting surgeon.

Proof-of-Concept Evaluation of the SailValve Self-Expanding Deep Venous Valve System in a Porcine Model.

PubMed

Boersma, Doeke; Vink, Aryan; Moll, Frans L; de Borst, Gert J

2017-06-01

To evaluate the SailValve, a new self-expanding deep venous valve concept based on a single polytetrafluoroethylene cusp floating up and down in the bloodstream like a sail, acting as a flow regulator and allowing minimal reflux to reduce thrombogenicity. Both iliac veins of 5 pigs were implanted with SailValve devices; the first animal was an acute pilot experiment to show the feasibility of accurately positioning the SailValve via a femoral access. The other 4 animals were followed for 2 weeks (n=2) or 4 weeks (n=2) under a chronic implantation protocol. Patency and valve function were evaluated directly in all animals using ascending and descending phlebography after device placement and at termination in the chronic implant animals. For reasons of clinical relevance, a regimen of clopidogrel and calcium carbasalate was administered. Histological analysis was performed according to a predefined protocol by an independent pathologist. Deployment was technically feasible in all 10 iliac veins, and all were patent directly after placement. No perioperative or postoperative complications occurred. Ascending phlebograms in the follow-up animals confirmed the patency of all valves after 2 or 4 weeks. Descending phlebograms showed full function in 5 of 8 valves. Limited reflux was seen in 1 valve (4-week group), and the function in the remaining 2 valves (2-week group) was insufficient because of malpositioning. No macroscopic thrombosis was noted on histology. Histology in the follow-up groups revealed a progressive inflammatory reaction to the valves. This animal study shows the potential of the SailValve concept with sufficient valve function after adequate positioning and no (thrombogenic) occlusions after short-term follow-up. Future research is essential to optimize valve material and long-term patency.

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

An augmented magnetic navigation system for Transcatheter Aortic Valve Implantation.

PubMed

Luo, Zhe; Cai, Junfeng; Nie, Yuanyuan; Wang, Guotai; Gu, Lixu

2013-01-01

This research proposes an augmented magnetic navigation system for Transcatheter Aortic Valve Implantation (TAVI) employing a magnetic tracking system (MTS) combined with a dynamic aortic model and intra-operative ultrasound (US) images. The dynamic 3D aortic model is constructed based on the preoperative 4D computed tomography (CT), which is animated according to the real time electrocardiograph (ECG) input of patient. And a preoperative planning is performed to determine the target position of the aortic valve prosthesis. The temporal alignment is performed to synchronize the ECG signals, intra-operative US image and tracking information. Afterwards, with the assistance of synchronized ECG signals, the contour of aortic root automatic extracted from short axis US image is registered to the dynamic aortic model by a feature based registration intra-operatively. Then the augmented MTS guides the interventionist to confidently position and deploy the aortic valve prosthesis to target. The system was validated by animal studies on three porcine subjects, the deployment and tilting errors of which are 3.17 ± 0.91 mm and 7.40 ± 2.89° respectively.

Transcatheter JenaValve Implantation in a Stentless Prosthesis: A Challenging Case After 4 Previous Aortic Procedures.

PubMed

Sponga, Sandro; Mazzaro, Enzo; Bagur, Rodrigo; Livi, Ugolino

2017-04-01

A 40-year-old man underwent 4 aortic surgeries because of endocarditis and subsequent prosthesis dehiscence. At the last recurrence he presented with acute severe aortic regurgitation of a Pericarbon Freedom (LivaNova plc, London, UK) stentless bioprosthesis and a morphologically disarranged aortic root. He also presented with left ventricular dysfunction and a very low origin of the left coronary artery. Therefore, a fifth redo aortic valve replacement was considered at high surgical risk. Accordingly, before listing the patient for a heart transplantation, a transcatheter valve-in-valve implantation with the JenaValve (JenaValve Technology, GmbH, Munich, Germany) prosthesis was performed. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

PubMed

Schofer, Joachim; Nietlispach, Fabian; Bijuklic, Klaudija; Colombo, Antonio; Gatto, Fernando; De Marco, Federico; Mangieri, Antonio; Hansen, Lorenz; Bruschi, Giuseppe; Ruparelia, Neil; Rieß, Friedrich-Christian; Maisano, Franscesco; Latib, Azeem

2015-12-21

This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

Superior versus inferior Ahmed glaucoma valve implantation.

PubMed

Pakravan, Mohammad; Yazdani, Shahin; Shahabi, Camelia; Yaseri, Mehdi

2009-02-01

To compare the efficacy and safety of Ahmed glaucoma valve (AGV) (New World Medical Inc., Rancho Cucamonga, CA) implantation in the superior versus inferior quadrants. Prospective parallel cohort study. A total of 106 eyes of 106 patients with refractory glaucoma. Consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included intraocular pressure (IOP) and rate of complications. Other outcome measures included best corrected visual acuity (BCVA), number of glaucoma medications, and success rate (defined as at least 30% IOP reduction and 5implant removal, additional glaucoma surgery, phthisis bulbi, or loss of light perception. Of a total of 106 eyes, 58 and 48 eyes underwent AGV implantation in the superior and inferior quadrants, respectively. Baseline characteristics were comparable in the study groups, except for preoperative IOP, which was higher in the superior group (P = 0.01). Patients were followed for a mean period of 10.6+/-8.49 months and 10.58+/-6.75 months in the superior and inferior groups, respectively (P = 0.477). BCVA was comparable between the groups at all postoperative visits (P>0.122). After 1 year, statistically significant but comparable IOP reduction from baseline (P<0.001) was achieved in both groups (47.0%+/-27.2% and 43.0%+/-24.5% reduction for superior and inferior groups, respectively, P = 0.725). The mean number of glaucoma medications was comparable after 1 year (1.3+/-1.2 vs. 1.9+/-0.8 for superior and inferior implants, respectively, P = 0.256). Success rates were also similar at 1 year: 27 eyes (81.8%) versus 20 eyes (95.2%) for superior and inferior implants, respectively (P = 0.227). However, the overall rate of complications, such as implant exposure necessitating removal, cosmetically unappealing appearance, and endophthalmitis, was higher in the inferior group: 12 eyes (25

Clinical Experience with the M4 Ahmed Glaucoma Drainage Implant.

PubMed

Sluch, Ilya; Gudgel, Brett; Dvorak, Justin; Anne Ahluwalia, Mary; Ding, Kai; Vold, Steve; Sarkisian, Steven

2017-01-01

To evaluate the safety and efficacy of the M4 (porous polyethylene plate) Ahmed Glaucoma Valve (AGV) drainage implant in a multicenter retrospective study. A retrospective chart review of medical records of patients who had undergone the M4 Ahmed valve was performed from January 2013 to April 2015. The primary outcome measure was surgical failure defined as: Less than a 20% reduction in baseline intraocular pressure (IOP) to last follow-up visit, final IOP less than 5 mm Hg or greater than 18 mm Hg, reoperation for glaucoma, or loss of light perception vision. All eyes not meeting the above criteria were defined as success. A total of 291 eyes met all study inclusion criteria. The average follow-up in the study was 6 months (±7.6 months) with 112 patients achieving 12-month follow-up (38.5%). 208 eyes (71.5%) met the study success criteria at final follow-up. No statistically significant spikes in postoperative IOP at 1 and 4 months were detected. The average preoperative IOP was 26.0 on an average of 2.8 medications. At 6 months, the average IOP dropped to 16.7 on 0.9 medications and stayed relatively stable at 15.8 on 1.2 medications at 12-month follow-up. The M4 valve appears to have less of a hypertensive phase compared with the other Ahmed class valves with a similar safety profile. While 71.5% success rate was achieved at final follow-up, the failure rate steadily increased over time. While the M4 production has been discontinued, the porous design of the M4 may avoid a pressure spike in the Ahmed valve class and warrants future investigation for valve design. How to cite this article: Sluch I, Gudgel B, Dvorak J, Ahluwalia MA, Ding K, Vold S, Sarkisian S. Clinical Experience with the M4 Ahmed Glaucoma Drainage Implant. J Curr Glaucoma Pract 2017;11(3):92-96.

Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium†

PubMed Central

Leon, Martin B.; Piazza, Nicolo; Nikolsky, Eugenia; Blackstone, Eugene H.; Cutlip, Donald E.; Kappetein, Arie Pieter; Krucoff, Mitchell W.; Mack, Michael; Mehran, Roxana; Miller, Craig; Morel, Marie-angèle; Petersen, John; Popma, Jeffrey J.; Takkenberg, Johanna J.M.; Vahanian, Alec; van Es, Gerrit-Anne; Vranckx, Pascal; Webb, John G.; Windecker, Stephan; Serruys, Patrick W.

2011-01-01

Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations in an effort to improve the quality of clinical research and to enable meaningful comparisons between clinical trials. To make these consensus definitions accessible to all stakeholders in TAVI clinical research through a peer reviewed publication, on behalf of the public health. Background Transcatheter aortic valve implantation may provide a worthwhile less invasive treatment in many patients with severe aortic stenosis and since its introduction to the medical community in 2002, there has been an explosive growth in procedures. The integration of TAVI into daily clinical practice should be guided by academic activities, which requires a harmonized and structured process for data collection, interpretation, and reporting during well-conducted clinical trials. Methods and results The Valve Academic Research Consortium established an independent collaboration between Academic Research organizations and specialty societies (cardiology and cardiac surgery) in the USA and Europe. Two meetings, in San Francisco, California (September 2009) and in Amsterdam, the Netherlands (December 2009), including key physician experts, and representatives from the US Food and Drug Administration (FDA) and device manufacturers, were focused on creating consistent endpoint definitions and consensus recommendations for implementation in TAVI clinical research programs. Important considerations in developing endpoint definitions included (i) respect for the historical legacy of surgical valve guidelines; (ii) identification of pathophysiological mechanisms associated with clinical events; (iii) emphasis on clinical relevance. Consensus criteria were developed for the following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, and prosthetic valve performance. Composite

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes.

PubMed

Erçalık, Nimet Yeşim; İmamoğlu, Serhat

2018-01-01

To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. The mean follow-up duration was 11.7 ± 5.5 (range, 6-23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg ( p =0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 ( p =0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation.

Ahmed Glaucoma Valve Implantation in Vitrectomized Eyes

PubMed Central

İmamoğlu, Serhat

2018-01-01

Purpose To evaluate the outcomes of Ahmed glaucoma valve (AGV) implantation in vitrectomized eyes. Materials and Methods The medical records of 13 eyes that developed glaucoma due to emulsified silicon oil or neovascularization following pars plana vitrectomy and underwent AGV implantation were retrospectively reviewed. The main outcome measures were intraocular pressure (IOP), best-corrected visual acuity (BCVA), number of antiglaucoma medications, and postoperative complications. Surgical success was defined as last IOP ≤21 mmHg or ≥6 mmHg and without loss of light perception. Results The mean follow-up duration was 11.7 ± 5.5 (range, 6–23) months. The mean IOP before the AGV implantation was 37.9 ± 6.7 mmHg with an average of 3.5 ± 1.2 drugs. At the final visit, the mean IOP was 15.9 ± 4.6 mmHg (p=0.001) and the mean number of glaucoma medications decreased to 2.3 ± 1.3 (p=0.021). At the last visit, 11 eyes (84.4%) had stable or improved VA and one eye (7.7%) had a final VA of no light perception. Surgical success was achieved in 11 of the 13 eyes (84.4%). Postoperative complications were bleb encapsulation (69.2%), early hypotony (38.5%), hyphema (23.1%), decompression retinopathy (23.1%), choroidal detachment (15.4%), intraocular hemorrhage (7.7%), and late endophthalmitis (7.7%). One eye (7.7%) was enucleated because of late endophthalmitis. Conclusions Despite complications necessitating medical and surgical interventions, vitrectomized eyes were effectively managed with AGV implantation. PMID:29862068

Efficacy of intravitreal ranibizumab combined with Ahmed glaucoma valve implantation for the treatment of neovascular glaucoma.

PubMed

Tang, Min; Fu, Yang; Wang, Ying; Zheng, Zhi; Fan, Ying; Sun, Xiaodong; Xu, Xun

2016-01-09

Neovascular glaucoma is a refractive glaucoma. Recently, anti-VEGF factors have been used alone or in combination for the treatment of neovascular glaucoma. However, the medium- and long-term efficacy of such drugs remains to be evaluated. This study was to determine the efficacy of intravitreal ranibizumab combined with Ahmed glaucoma valve implantation for the treatment of neovascular glaucoma. In this prospective non-randomized study, 43 neovascular glaucoma patients (43 eyes) were assigned to receive either 0.5 mg intravitreal ranibizumab for three to 14 days before Ahmed glaucoma valve implantation (injection group, n = 21) or Ahmed glaucoma valve implantation alone (control group, n = 22). The patients were followed up for six to 12 months. Differences in surgical success rate, intraocular pressure, best corrected visual acuity, anti-glaucoma medications and postoperative complications were compared between the two groups. Surgical success was defined as IOP > = 6 mm Hg and < = 21 mm Hg, with or without the use of anti-glaucoma medications, and without severe complications or reoperation. Of the 43 patients, 40 completed the 6-month follow-up and 37 completed the 1-year follow-up. Success rate was 73.7% vs. 71.4% at six months and 72.2% vs. 68.4% at 12 months in the injection group and the control group respectively. No significant difference was noted between the two groups (six months: P = 0.87, 12 months: P = 1.00). There were no significant differences in the two groups with respect to intraocular pressure, best corrected visual acuity, anti-glaucoma medications or postoperative complications at six months or 12 months. Single intravitreal ranibizumab (0.5 mg) before surgery has no significant effect on the medium- or long-term outcomes of neovascular glaucoma treated with Ahmed glaucoma valve implantation. Chinese Clinical Trial Registry ( ChiCTR-OOC-14005709, Trial registration date: 2014-12-01).

Successful Feasibility Human Trial of a New Self-Expandable Percutaneous Pulmonary Valve (Pulsta Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet α-Gal-Free Porcine Pericardial Valve in the Native Right Ventricular Outflow Tract.

PubMed

Kim, Gi Beom; Song, Mi Kyoung; Bae, Eun Jung; Park, Eun-Ah; Lee, Whal; Lim, Hong-Gook; Kim, Yong Jin

2018-06-01

Self-expandable percutaneous pulmonary valve implantation (PPVI) for native right ventricular outflow tract lesions is still in the clinical trial phase. The aim of this study is to present the result of feasibility study of a novel self-expandable knitted nitinol wire stent mounted with a treated trileaflet α-Gal-free porcine pericardial valve for PPVI. A feasibility study using Pulsta valve (TaeWoong Medical Co, Gyeonggi-do, South Korea) was designed for patients with severe pulmonary regurgitation in the native right ventricular outflow tract, and 6-month follow-up outcomes were reviewed. Ten tetralogy of Fallot patients were enrolled. Before PPVI, severe pulmonary regurgitation (mean pulmonary regurgitation fraction, 45.5%±7.2%; range, 34.9%-56%) and enlarged right ventricular volume (mean indexed right ventricular end-diastolic volume, 176.7±14.3 mL/m 2 ; range, 158.9-205.9 mL/m 2 ) were present. The median age at PPVI was 21.7±6.5 years (range, 13-36 years). Five patients were successfully implanted with 28 mm and the other 5 with 26 mm valves loaded on the 18F delivery cable. No significant periprocedural complications were noted in any patient. At the 6-month follow-up, indexed right ventricular end-diastolic volume was dramatically decreased to 126.3±20.3 mL/m 2 (range, 99-164.2 mL/m 2 ), and the mean value of peak instantaneous pressure gradient between the right ventricle and the pulmonary artery decreased from 6.8±3.5 mm Hg (range, 2-12 mm Hg) before PPVI to 5.7±6.7 mm Hg (range, 2-12 mm Hg) without significant pulmonary regurgitation. There was no adverse event associated with the valve. A feasibility study of the Pulsta valve for native right ventricular outflow tract lesions was completed successfully with planned Pulsta valve implantation and demonstrated good short-term effectiveness without serious adverse events. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02555319. © 2018 American Heart Association, Inc.

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

PubMed

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

2016-01-01

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. 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.

Is valve choice a significant determinant of paravalular leak post-transcatheter aortic valve implantation? A systematic review and meta-analysis.

PubMed

O'Sullivan, Katie E; Gough, Aideen; Segurado, Ricardo; Barry, Mitchel; Sugrue, Declan; Hurley, John

2014-05-01

Paravalvular regurgitation (PVR) following transcatheter aortic valve implantation (TAVI) is associated with poor survival. The two main valve delivery systems used to date differ significantly in both structure and deployment technique. The primary objective of this study was to perform a systematic review and meta-analysis of studies identifying PVR in patients post-TAVI using Medtronic CoreValve (MCV) and Edward Sapien (ES) valves in order to identify whether a significant difference exists between valve types. The secondary objective was to identify additional factors predisposing to PVR to provide an overview of the other associated considerations. A systematic review and meta-analysis of the current literature to identify PVR rate in patients with MCV and ES valves was performed. We also sought to examine other factors predisposing to PVR. A total of 5910 patients were identified from 9 studies. PVR rates for MCV and ES were analysed. MCV was associated with a higher PVR rate of 15.75% [95% confidence interval (CI) 12.48-19.32] compared with ES 3.93% [95% CI 1.05-8.38]. We separately reviewed predisposing factors associated with PVR. A formal comparison of the MCV and ES valve leakage rates by mixed-effects meta-regression with a fixed-effect moderator variable for valve type (MCV or ES) suggested a statistically significant difference in leakage rate between the two valve types (P = 0.0002). Unfavourable anatomical and pathological factors as well as valve choice have an impact on rates of PVR. Additionally, certain anatomical features dictate valve choice. A direct comparison of all the predisposing factors at this time is not possible and will require prospective multivariate analysis. There is, however, a significant difference in the PVR rates between valves based on the published observational data available to date. The ES valve associated with a lower incidence of PVR overall; therefore, we conclude that valve choice is indeed a significant

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

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

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.

Dysfunction of mechanical heart valve prosthesis: experience with surgical management in 48 patients

PubMed Central

Ma, Wei-Guo; Hou, Bin; Abdurusul, Adiljan; Gong, Ding-Xu; Tang, Yue; Chang, Qian; Xu, Jian-Ping

2015-01-01

Background Dysfunction of mechanical heart valve prostheses is an unusual but potentially lethal complication after mechanical prosthetic valve replacement. We seek to report our experience with mechanical valve dysfunction regarding etiology, surgical techniques and early outcomes. Methods Clinical data of 48 patients with mechanical valve dysfunction surgically treated between October 1996 and June 2011 were analyzed. Results Mean age was 43.7±10.9 years and 34 were female (70.8%). The median interval from primary valve implantation to dysfunction was 44.5 months (range, 1 hour to 20 years). There were 21 emergent and 27 elective reoperations. The etiology was thrombosis in 19 cases (39.6%), pannus in 12 (25%), thrombosis and pannus in 11 (22.9%), improper disc orientation in 2 (4.1%), missing leaflet in 1 (2.1%), excessively long knot end in 1 (2.1%), endogenous factor in 1 (2.1%) and unidentified in 1 (2.1%). Surgical procedure was mechanical valve replacement in 37 cases (77.1%), bioprosthetic valve replacement in 7 (14.9%), disc rotation in 2 (4.2%) and excision of excessive knot end in 1 (2.1%). Early deaths occurred in 7 patients (14.6%), due to low cardiac output in 3 (6.3%), multi-organ failure in 2 (4.2%) and refractory ventricular fibrillation in 2 (4.2%). Complications occurred in 10 patients (20.8%). Conclusions Surgical management of mechanical valve dysfunction is associated with significant mortality and morbidity. Earlier identification and prompt reoperation are vital to achieving better clinical outcomes. The high incidence of thrombosis in this series highlights the need for adequate anticoagulation and regular follow-up after mechanical valve replacement. PMID:26793354

"Bail out" procedures for malpositioning of aortic valve prosthesis (CoreValve).

PubMed

Vavouranakis, Manolis; Vrachatis, Dimitrios A; Toutouzas, Konstantinos P; Chrysohoou, Christina; Stefanadis, Christodoulos

2010-11-05

Two techniques for correcting malpositioning occurring during percutaneous aortic valve replacement (PAVR) with the CoreValve ReValving™ System are described in this article. The "Removing and Reinserting Technique" was used in 2 patients, in whom the prosthesis was positioned too high. The "Snare Technique" was used in 1 patient, in whom the prosthesis was implanted too low. In all patients the aortic valve prosthesis was successfully re-implanted. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

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.

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

Incidence and impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

PubMed

Bleiziffer, Sabine; Hettich, Ina; Hutter, Andrea; Wagner, Anke; Deutsch, Marcus-André; Piazza, Nicolo; Lange, Rüdiger

2013-05-01

The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI). The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%). The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM. PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

A Parylene MEMS Electrothermal Valve

PubMed Central

Li, Po-Ying; Givrad, Tina K.; Holschneider, Daniel P.; Maarek, Jean-Michel I.; Meng, Ellis

2011-01-01

The first microelectromechanical-system normally closed electrothermal valve constructed using Parylene C is described, which enables both low power (in milliwatts) and rapid operation (in milliseconds). This low-power valve is well suited for applications in wirelessly controlled implantable drug-delivery systems. The simple design was analyzed using both theory and modeling and then characterized in benchtop experiments. Operation in air (constant current) and water (current ramping) was demonstrated. Valve-opening powers of 22 mW in air and 33 mW in water were obtained. Following integration of the valve with catheters, our valve was applied in a wirelessly operated microbolus infusion pump, and the in vivo functionality for the appropriateness of use of this pump for future brain mapping applications in small animals was demonstrated. PMID:21350679

The Ahmed Glaucoma Valve in Refractory Glaucoma: Experiences in Southwest Ethiopia.

PubMed

Gessesse, Girum W

2015-07-01

The management of refractory glaucoma is a challenging task for any glaucoma surgeon. This study is aimed to evaluate the efficacy of Ahmed Glaucoma Valve implantation in refractory glaucomas in South-West Ethiopia. A retrospective review was conducted on the charts of consecutive patients treated with Ahmed glaucoma valve implantation at Jimma University Specialized Hospital between August 2012 and August 2014. Success was defined as Intraocular Pressure (IOP) less than 22 mm Hg and greater than 5mm Hg at 6 months, with at least 30% reduction from baseline, without medical therapy (complete success) or either with or without medication (qualified successes). A total of 12 eyes of 11 patients were included. The mean age of patients was 40.7 (SD= 19.0) years; 63.6% of them were males. The main types of glaucoma were pseudoexfoliative (3 eyes), uveitic (2 eyes), chronic angle closure (2 eyes) and Juvenile Open Angle (JOAG) (2 eyes). The mean IOP was reduced from preoperative level (32.75±7.14 mmHg) to (15.75 ±4.35 mmHg) at six postoperative months, (P<0.001); 66.7% eyes had complete successes while 83.3% had qualified success. Intra-operative complications were encountered in 2(16.7%) eyes, while 5/12 (41.7%) eyes had post-operative complications-hypotony (one with choroidal effusion) and progression of cataract in 2 eyes each. Hypertensive phase was diagnosed in 2(16.7%) eyes. The Ahmed glaucoma valve implant appears to be effective and relatively safe for treating complicated glaucomas with success rate comparable with those reported from other studies. Ahmed glaucoma valve, refractory glaucoma, complications, Ethiopia.

Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study).

PubMed

Barbanti, Marco; Schiltgen, Molly; Verdoliva, Sarah; Bosmans, Johan; Bleiziffer, Sabine; Gerckens, Ulrich; Wenaweser, Peter; Brecker, Stephen; Gulino, Simona; Tamburino, Corrado; Linke, Axel

2016-03-01

This study compared 3-year clinical outcomes of patients who underwent transcatheter aortic valve implantation with the Society of Thoracic Surgeons (STS) score ≤7% to those of patients with a score >7%. Data were drawn from the ADVANCE study, a multinational post-market clinical trial that enrolled real-world patients with severe aortic stenosis treated with the CoreValve bioprosthesis. Events were independently adjudicated using Valve Academic Research Consortium-1 definitions. A total of 996 patients were implanted: STS ≤7% (n = 697, median STS 4.3%, interquartile range 3.1% to 5.4%) and STS >7% (n = 298, median STS 9.7%, interquartile range 8.0% to 12.4%). At 3 years, the STS ≤7% group had lower rates of all-cause mortality (28.6 vs 45.9, p <0.01) and cardiovascular mortality (19.0 vs 30.2, p <0.01) than the STS >7% group. No differences were observed in cerebrovascular accidents, vascular complications, bleeding, or myocardial infarction. In patients with STS ≤7%, mortality at 3 years was higher in those with moderate or severe aortic regurgitation (AR) at discharge than in those with mild or less AR (39.9% vs 22.9%; hazard ratio 1.98; 95% confidence interval 1.37 to 2.86; p <0.01). Conversely, the severity of AR at discharge did not affect 3-year mortality in patients with STS >7% (42.9% vs 44.6%, moderate/severe vs mild/less; hazard ratio 1.04; 95% confidence interval, 0.62 to 1.75; p = 0.861; p for interaction = 0.047). In conclusion, patients with STS ≤7% had lower rates of all-cause and cardiovascular mortality at 3 years after transcatheter aortic valve implantation. Complication rates were low and stable in both groups, demonstrating the safety of this procedure for patients at various levels of surgical risk. Copyright © 2016 Elsevier Inc. All rights reserved.

Surgical Outcomes of Additional Ahmed Glaucoma Valve Implantation in Refractory Glaucoma.

PubMed

Ko, Sung Ju; Hwang, Young Hoon; Ahn, Sang Il; Kim, Hwang Ki

2016-06-01

To evaluate the surgical outcomes of the implantation of an additional Ahmed glaucoma valve (AGV) into the eyes of patients with refractory glaucoma following previous AGV implantation. This study is a retrospective review of the clinical histories of 23 patients who had undergone a second AGV implantation after a failed initial implantation. Age, sex, prior surgery, glaucoma type, number of medications, intraocular pressure (IOP), visual acuity, and surgical complications were analyzed. Surgical success was defined as IOP maintained below 21 mm Hg, with at least a 20% overall reduction in IOP, regardless of the use of IOP-lowering medications. Following the implantation of a second AGV, the mean IOP decreased from 39.3 to 18.5 mm Hg (52.9% reduction, P<0.001). The mean number of postoperative IOP-lowering medications administered decreased from 2.8 to 1.7 after the second AGV implantation (P<0.001). The cumulative probability of success for the procedure was 87% after 1 year and 52% after 3 years. Three patients (13.0%) experienced bullous keratopathy after the second AGV implantation. None of the patients showed any evidence of diplopia or ocular movement limitation as a result of the presence of 2 AGVs in the same eye. Prior trabeculectomy was found to be a significant risk factor for failure (P=0.027). A second AGV implantation can be a good choice of surgical treatment when the first AGV has failed to control IOP.

Impact of Mitral Regurgitation on Clinical Outcomes After Transcatheter Aortic Valve Implantation

PubMed Central

Tüller, David; Zbinden, Rainer; Eberli, Franz R

2016-01-01

Severe aortic stenosis (AS) and mitral regurgitation (MR) are the two most common valvular lesions referred for surgical intervention in Europe and frequently co-exist. In patients with both severe AS and significant MR referred for surgical aortic valve replacement (SAVR), a concomitant mitral valve intervention is typically performed if the MR is severe, despite the higher associated perioperative risk. The management of moderate MR among SAVR patients is controversial and depends on a number of factors including MR aetiology (i.e., organic versus functional MR), feasibility of repair and patient risk profile. Moderate or severe MR is present in up to one-third of patients undergoing transcatheter aortic valve implantation (TAVI), is mainly of functional aetiology and is typically left untreated. Although data are conflicting, a growing body of evidence suggests that significant MR exerts an adverse effect on both short- and long-term clinical outcomes after TAVI. Moderate or severe MR improves in just over half of patients following TAVI and recent data suggest MR is more likely to improve among patients receiving a balloon-expandable as compared with a self-expandable transcatheter heart valve. PMID:29588707

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

Successful use of a left ventricular apical access and closure device for second-generation transapical aortic valve implantation.

PubMed

Conradi, Lenard; Seiffert, Moritz; Shimamura, Kazuo; Schirmer, Johannes; Blankenberg, Stefan; Reichenspurner, Hermann; Diemert, Patrick; Treede, Hendrik

2014-09-01

Transcatheter aortic valve implantation (TAVI) has become routine for the treatment of high-risk patients with aortic stenosis. We assessed safety and feasibility of a left ventricular apical access and closure device combined with second-generation transapical (TA) TAVI transcatheter heart valves (THV). Three elderly, comorbid patients (logEuroSCORE I 13.0-31.1%) received transapical aortic valve implantation (TA-AVI) via the Apica ASC device (Apica Cardiovascular Ltd., Galway, Ireland) using second-generation THV (Medtronic Engager [Medtronic 3F Therapeutics, Santa Ana, California, United States], JenaValve [JenaValve Technology GmbH, Munich, Germany], Symetis Acurate [Symetis S.A., Ecublens, Switzerland]). Access was gained using a non-rib-spreading technique and a novel access and closure device. THV deployment was successful with excellent hemodynamic outcome (no PVL, n = 2; trace PVL, n = 1; mean transvalvular gradients, 5-19 mm Hg) and complete apical hemostasis. No periprocedural major adverse events occurred and Valve Academic Research Consortium-2-defined composite end point of device success was met in all cases. Safety and feasibility of TA-AVI using the ASC device with second-generation THV was demonstrated. Combining latest available technology is a major step toward improved functional outcome and decreased surgical trauma in TA-AVI. Potentially, technical enhancements may eventually pave the way toward a fully percutaneous TA-AVI procedure. Georg Thieme Verlag KG Stuttgart · New York.

Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system.

PubMed

Haas, Nikolaus A; Carere, Ronald Giacomo; Kretschmar, Oliver; Horlick, Eric; Rodés-Cabau, Josep; de Wolf, Daniël; Gewillig, Marc; Mullen, Michael; Lehner, Anja; Deutsch, Cornelia; Bramlage, Peter; Ewert, Peter

2018-01-01

Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking. We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years. The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS. NCT02302131. Copyright © 2017 Elsevier B.V. All rights reserved.

Percutaneous pulmonary valve implantation: an update.

PubMed

Lurz, Philipp; Bonhoeffer, Philipp; Taylor, Andrew M

2009-07-01

The field of percutaneous valvular interventions is one of the most exciting and rapidly developing within interventional cardiology. Percutaneous pulmonary valve implantation (PPVI) represents the first in-human application of these techniques and is a nonsurgical option for treating right ventricular outflow tract/pulmonary trunk dysfunction. With the growing numbers of patients with right ventricle to pulmonary artery conduit dysfunction after repair of congenital heart disease, the importance of a technique with lower morbidity and mortality, good patient acceptance and efficacy, that is comparable to surgery, cannot be underestimated. Over the last 9 years, PPVI has become a feasible, safe and effective treatment for both conduit stenosis and regurgitation. Median follow-up data show good freedom from reoperation and recatheterization and demonstrate that PPVI can postpone open-heart surgery, thereby potentially reducing the number of operations that patients have to undergo within their lifetime. Complications seen after PPVI, in particular stent fractures, can require reintervention in some cases (second stent-in-stent PPVI); however, valve competency remains good, with significant regurgitation during follow-up only seen in the context of occasional endocarditis. Attempts are now being made to prolong the lifespan of the device by reducing the incidence of stent fractures. Further, meticulous patient selection must be maintained to ensure that hemodynamic results are optimized and the safety of the procedure remains high. Finally, new devices have to be developed that will allow for PPVI in dilated, distensible outflow tracts, to offer this nonsurgical treatment option to a larger patient population with congenital heart disease.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

PubMed

Salizzoni, Stefano; D'Onofrio, Augusto; Agrifoglio, Marco; Colombo, Antonio; Chieffo, Alaide; Cioni, Micaela; Besola, Laura; Regesta, Tommaso; Rapetto, Filippo; Tarantini, Giuseppe; Napodano, Massimo; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, Marco; Sanna, Francesco; Iadanza, Alessandro; Pompei, Esmeralda; Stefàno, Pierluigi; Cappai, Antioco; Minati, Alessandro; Cassese, Mauro; Martinelli, Gian Luca; Agostinelli, Andrea; Fiorilli, Rosario; Casilli, Francesco; Reale, Maurizio; Bedogni, Francesco; Petronio, Anna Sonia; Mozzillo, Rosa Alba; Bonmassari, Roberto; Briguori, Carlo; Liso, Armando; Sardella, Gennaro; Bruschi, Giuseppe; Fiorina, Claudia; Filippini, Claudia; Moretti, Claudio; D'Amico, Maurizio; La Torre, Michele; Conrotto, Federico; Di Bartolomeo, Roberto; Gerosa, Gino; Rinaldi, Mauro

2016-12-01

The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m 2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR

Evaluation of the tightness of contact between 
limbal sclera tunnel and tube following Ahmed 
glaucoma valve implantation.

PubMed

Holló, Gábor; Naghizadeh, Farzaneh

2013-01-01

To investigate whether the tightness of contact between the tube and the limbal sclera tunnel can be evaluated with high-magnification anterior segment optical coherence tomography (OCT) imaging following Ahmed glaucoma valve implantation. Tightness between the tube and the limbal sclera tunnel was investigated with the CAM-L cornea lens adapter of the Optovue Fourier-domain OCT (RTVue-OCT) for 21 uncomplicated Ahmed glaucoma valves implanted in 20 eyes of 19 patients with glaucoma. Nineteen valves were implanted 4 to 124 months earlier (late postoperative cases) and 2 valves 1 day prior to the imaging (early postoperative cases). All valves were introduced into the anterior chamber via a limbal sclera tunnel. The limbal intratunnel part of the tube was successfully imaged in all but 2 cases where an additional full-thickness sclera patch was used. In 14 cases, the contact was tight without tube compression. In 
5 cases, the tube was partially compressed but remained open in the limbal sclera tunnel, and redilated behind the limbus. No case with loose contact or peritubular filtration was seen. The posterior run of the tube was successfully imaged in all 19 cases without a full-thickness sclera patch. High-magnification imaging with the CAM- L anterior segment adapter of the RTVue-OCT allows detailed examination of the limbal insertion area of tubes in both the early and late postoperative periods. Therefore this method may potentially be applied for detection of complications related to tube insertion after glaucoma drainage device surgery.

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.

Transapical JenaValve in a patient with mechanical mitral valve prosthesis.

PubMed

O' Sullivan, Katie E; Casserly, Ivan; Hurley, John

2015-04-01

We report the first case of transcatheter aortic valve replacement implantation using JenaValve™ in a patient with mechanical mitral valve prosthesis. We believe that the design features of this valve may be particularly suited for use in this setting. © 2014 Wiley Periodicals, Inc.

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

PubMed

van Rosendael, Philippe J; Delgado, Victoria; Bax, Jeroen J

2018-06-01

The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (<12.1%) quintile of PPI rate, patients within the highest quintile were more frequently women when compared with the lowest quintile group (50.9% vs. 46.3%, P < 0.001). Pre-existent conduction abnormalities (electrical factor), calcification of the left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated

Three dimensional rotational angiography for assessment of coronary arteries during melody valve implantation: introducing a technique that may improve outcomes.

PubMed

Pockett, C R; Moore, J W; El-Said, H G

2017-02-01

Adverse events from Melody valve implantation may be catastrophic. To date a role for three dimensional rotational angiography of the aortic root (3DRAA) during Melody valve implantation has not been established. To describe the role of 3DRAA in the assessment of Melody valve candidacy and to demonstrate that it may improve outcomes. All patients who underwent cardiac catheterisation for Melody valve implantation and 3DRAA between August 2013 and February 2015 were reviewed. 31 patients had 3DRAA with balloon sizing. Ten were deemed not Melody candidates (5 coronary compression, 2 aortic root distortion with cusp flattening, 2 RVOT was too large, and 1 had complex branch stenosis and a short landing zone). Of the 21 patients who were Melody candidates, 12 had conduits, 6 prosthetic valves and 3 native RVOTs. In patients with conduits, the technique of stenting the conduit prior to dilation was used after measuring the distance between the conduit and the coronary arteries on 3DRAA. In the Melody patients, we had 100% procedural success and no serious adverse events (coronary compression, tears, stent fracture or endocarditis). As a tool for case selection, 3DRAA may facilitate higher procedural success and decreased risk of serious adverse events. Furthermore, 3D rotational angiography allows stenting of the conduit prior to dilation, which may prevent tears and possibly endocarditis.

Totally biological composite aortic stentless valved conduit for aortic root replacement: 10-year experience

PubMed Central

2011-01-01

Objectives To retrospectively analyze the clinical outcome of a totally biological composite stentless aortic valved conduit (No-React® BioConduit) implanted using the Bentall procedure over ten years in a single centre. Methods Between 27/10/99 and 19/01/08, the No-React® BioConduit composite graft was implanted in 67 patients. Data on these patients were collected from the in-hospital database, from patient notes and from questionnaires. A cohort of patients had 2D-echocardiogram with an average of 4.3 ± 0.45 years post-operatively to evaluate valve function, calcification, and the diameter of the conduit. Results Implantation in 67 patients represented a follow-up of 371.3 patient-year. Males were 60% of the operated population, with a mean age of 67.9 ± 1.3 years (range 34.1-83.8 years), 21 of them below the age of 65. After a mean follow-up of 7.1 ± 0.3 years (range of 2.2-10.5 years), more than 50% of the survivors were in NYHA I/II and more than 60% of the survivors were angina-free (CCS 0). The overall 10-year survival following replacement of the aortic valve and root was 51%. During this period, 88% of patients were free from valved-conduit related complications leading to mortality. Post-operative echocardiography studies showed no evidence of stenosis, dilatation, calcification or thrombosis. Importantly, during the 10-year follow-up period no failures of the valved conduit were reported, suggesting that the tissue of the conduit does not structurally change (histology of one explant showed normal cusp and conduit). Conclusions The No-React® BioConduit composite stentless aortic valved conduit provides excellent long-term clinical results for aortic root replacement with few prosthesis-related complications in the first post-operative decade. PMID:21699696

Update of transcatheter valve treatment

PubMed Central

Liu, Xian-bao; Wang, Jian-an

2013-01-01

Transcatheter valve implantation or repair has been a very promising approach for the treatment of valvular heart diseases since transcatheter aortic valve implantation (TAVI) was successfully performed in 2002. Great achievements have been made in this field (especially TAVI and transcatheter mitral valve repair—MitraClip system) in recent years. Evidence from clinical trials or registry studies has proved that transcatheter valve treatment for valvular heart diseases is safe and effective in surgical high-risk or inoperable patients. As the evidence accumulates, transcatheter valve treatment might be an alterative surgery for younger patients with surgically low or intermediate risk valvular heart diseases in the near future. In this paper, the updates on transcatheter valve treatment are reviewed. PMID:23897785

A Systematic Review of Infective Endocarditis in Patients With Bovine Jugular Vein Valves Compared With Other Valve Types.

PubMed

Sharma, Ashutosh; Cote, Anita T; Hosking, Martin C K; Harris, Kevin C

2017-07-24

The aim of this study was to systematically evaluate the incidence of infective endocarditis (IE) in right ventricle-to-pulmonary artery conduits and valves, comparing bovine jugular vein (BJV) valves with all others. Recent evidence suggests that the incidence of IE is higher in patients with congenital heart disease who have undergone implantation of BJV valves in the pulmonary position compared with other valves. Systematic searches of published research were conducted using electronic databases (MEDLINE, Embase, and CINAHL) and citations cross-referenced current to April 2016. Included studies met the following criteria: patients had undergone right ventricle-to-pulmonary artery conduit or percutaneous pulmonary valve implantation, and investigators reported on the type of conduit or valve implanted, method of intervention (surgery or catheter based), IE incidence, and follow-up time. Fifty studies (Levels of Evidence: 2 to 4) were identified involving 7,063 patients. The median cumulative incidence of IE was higher for BJV compared with other valves (5.4% vs. 1.2%; p < 0.0001) during a median follow-up period of 24.0 and 35.5 months, respectively (p = 0.03). For patients with BJV valves, the incidence of IE was not different between surgical and catheter-based valve implantation (p = 0.83). There was a higher incidence of endocarditis with BJV valves than other types of right ventricle-to-pulmonary artery conduits. There was no difference in the incidence of endocarditis between catheter-based bovine valves and surgically implanted bovine valves, suggesting that the substrate for future infection is related to the tissue rather than the method of implantation. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up.

PubMed

Schlingloff, Friederike; Schäfer, Ulrich; Frerker, Christian; Schmoeckel, Michael; Bader, Ralf

2014-09-01

The second-generation Jenavalve prosthesis (Jenavalve Technology, Inc., Munich, Germany) is the first transcatheter valve Conformité Européene (CE) marked for treatment of both aortic stenosis (AS) and pure aortic regurgitation (AR). Although the feasibility of the Jenavalve transcatheter aortic valve implantation (TAVI) in patients with pure AR has been described, haemodynamic and follow-up data are lacking. We report on a series of 10 transapical Jenavalve implantations for pure AR between December 2012 and September 2013. The patients were determined for TAVI by heart team decision at high surgical risk [log EuroSCORE (European System for Cardiac Operative Risk Evaluation) >20%], frailty or Charlson Comorbidity Index (CCI). Transaortic gradients and right heart haemodynamics were measured invasively before and after TAVI. Ventriculography and transoesophageal echocardiography were used to determine paravalvular regurgitation. All-cause mortality, NYHA functional class and echocardiographic measurements were followed up at 30 days and at 3, 9 and 12 months postoperatively. Overall, mean age was 79 ± 9 years, mean left ventricular ejection fraction 50 ± 17% and mean log EuroSCORE 28.3 ± 17.1%. There were no perioperative complications. Paravalvular regurgitation immediately after implantation was graded none (n = 6), trace (n = 3) or mild (n = 1). Overall 30-day mortality was 30% (3/10). Three patients refused further treatment, such as haemodialysis or treatment of mitral regurgitation. Rate for pacemaker implantation was 2/10 (20%). Intraprocedural success and haemodynamic data in our cases were good. The mortality in our group highlighted the importance of careful patient selection, especially for this pathology. The Jenavalve prosthesis proved to be suitable for treatment of AR in surgical high-risk patients. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Prosepective Study to Evaluate Rate and Frequency of Perturbations of Implanted Programmable Hakim Codman Valve After 1.5-Tesla Magnetic Resonance Imaging.

PubMed

Capitanio, Jody Filippo; Venier, Alice; Mazzeo, Lucio Aniello; Barzaghi, Lina Raffaella; Acerno, Stefania; Mortini, Pietro

2016-04-01

Exposure to magnetic fields may alter the settings of programmable ventriculoperitoneal shunt valves or even cause permanent damages to these devices. There is little information about this topic, none on live patients. To investigate the effects of 1.5-tesla magnetic resonance imaging (MRI) on Hakim-Codman (HC) pressure programmable valves implanted in our hospital. A single-center prospective study to assess the rate of perturbations of HC programmable valve implanted. One hundred consecutive patients implanted for different clinical reasons between 2008 and 2012 were examined. A conventional skull x-ray before and after a standard MRI on 1.5 tesla. We evaluated before and after results, analyzed modification rate, and verified eventual damages to the implanted devices. Implanted HC valves are extremely handy and durable, even if they are likely to change often due to the exposure to magnetic fields. None of the patients complained of heating effects. Oscillations range from 10-30 mm H2O with a patient who reached 50 mm H2O and 1 who reached 60 mm H2O. Global alteration rate was 40%: 10 patients (10%) experienced a 10 mm H2O change; 14 patients (14%) had a 20 mm H2O change; 6 patients (6%) had a 30 mm H2O change; 8 patients (8%) had a 40 mm H2O change; 1 patient had a 50 mm H2O change; and 1 patient had a 60 mm H2O change. HC valves presented a variable perturbation rate, with an alteration rate of 40% with 1.5-telsa MRI. We have not observed malfunctioning hardware as a result of magnetic influence. We claim ​ a cranial x-ray immediately after the MRI because of a high risk (40%) of decalibration, especially in patients with low ventricles compliance. Copyright © 2016 Elsevier Inc. All rights reserved.

Transapical off-pump mitral valve repair. First experience with the NeoChord system in Poland (report of two cases).

PubMed

Wróbel, Krzysztof; Kurnicka, Katarzyna; Zygier, Marcin; Dyk, Wojciech; Wojdyga, Ryszard; Zieliński, Dariusz; Jarzębska, Małgorzata; Juraszyński, Zbigniew; Lichodziejewska, Barbara; Pruszczyk, Piotr; Biederman, Andrzej; Speziali, Giovanni; Kasten, Uwe

2017-01-01

Artificial chord implantation to repair a flail or prolapsing mitral valve leaflet requires open heart surgery and cardiopulmonary bypass. Transapical off-pump artificial chordae implantation is a new surgical technique proposed to treat degenerative mitral valve regurgitation. The procedure is performed using the NeoChord DS1000 system (NeoChord, Inc., St. Louis Park, MN, USA), which facilitates both implantation and lenght adjustment of the artificial chordae under two (2D)- and three (3D)-dimensional transoesophageal echocardiographic (TEE) guidance on a beating heart. Two male patients aged 60 and 55 years with severe mitral regurgitation due to posterior leaflet prolapse underwent transapical off-pump artificial chordae implantation on September 3, 2015. The procedure was performed by left minithoracotomy under general anaesthesia in a cardiac surgical theatre, using 2D and 3D TEE guidance. Early procedural success as confirmed by 3D TEE was achieved in both patients, with implantation of 6 artificial chordae in the first patient and 3 artificial chordae in the second patient. Both procedures were uneventful, and no postoperative complications were noted. The patients were discharged home on the 8th and 6th postoperative day, respectively. The NeoChord DS1000 system allows both implantation and lenght adjustment of artificial chordae under 2D and 3D TEE guidance on a beating heart. Our initial experience in 2 patients with posterior mitral leaflet prolapse indicates that the procedure is feasible and safe.

First-in-human implantation of a novel transfemoral selfexpanding transcatheter heart valve to treat pure aortic regurgitation.

PubMed

Schäfer, Ulrich; Schirmer, Johannes; Niklas, Schofer; Harmel, Eva; Deuschl, Florian; Conradi, Lenard

2017-12-20

Here we will describe the first case of a novel JenaValve design (JenaValve Technology, Irvine, CA, USA) using the transfemoral approach in a 78-year-old female patient with pure aortic regurgitation. The implantation was successfully performed with good haemodynamics and good clinical outcome at six-month follow- up. The technology is especially appealing in non-calcified anatomies due to the clipping mechanism which was previously utilised in the transapical design.

Device landing zone calcification and its impact on residual regurgitation after transcatheter aortic valve implantation with different devices.

PubMed

Seiffert, Moritz; Fujita, Buntaro; Avanesov, Maxim; Lunau, Clemens; Schön, Gerhard; Conradi, Lenard; Prashovikj, Emir; Scholtz, Smita; Börgermann, Jochen; Scholtz, Werner; Schäfer, Ulrich; Lund, Gunnar; Ensminger, Stephan; Treede, Hendrik

2016-05-01

Calcification of the device landing zone is linked to paravalvular regurgitation after transcatheter aortic valve implantation (TAVI). The mechanisms remain incompletely understood and the performance of next-generation transcatheter heart valves (THV) has not been investigated. We evaluated the impact of calcification patterns on residual aortic regurgitation (AR) after TAVI with different THV in patients with severe aortic stenosis. TAVI was performed in 537 patients at two centres. Devices implanted were the Edwards Sapien XT (n = 254), Medtronic CoreValve (n = 123), JenaValve (n = 62), Medtronic Engager (n = 56), and Symetis Acurate (n = 42) prostheses. Calcification of the device landing zone was retrospectively assessed from contrast-enhanced multidetector computed tomography data and correlated with echocardiographic and clinical data. Calcium volumes of the aortic valve and left-ventricular outflow tract were associated with residual AR: No AR, 604 mm(3) (inter-quartile range, IQR 349-916); trace AR, 639 mm(3) (IQR 368-948); mild AR, 710 mm(3) (IQR 412-2078); ≥moderate AR, 1041 mm(3) (IQR 791-1417, P = 0.001). Device landing zone calcium, particularly if located in the left-ventricular outflow tract, and a low cover index were predictive of AR. Differences in the incidence of AR were observed with regard to THV type. Higher calcium volume was associated with the need for post-dilation (n = 134, median 852 [IQR 342-945] vs. 604 [IQR 542-1207] mm(3), P < 0.001). Calcification of the device landing zone, particularly if located inferior to the annulus, was independently associated with residual AR after TAVI with all evaluated THV; however, the incidence of paravalvular leakage differed significantly between the devices implanted. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

'Caput medusae': tension reduction on a dehiscent native annulus in valve implantation in an endocarditis case.

PubMed

Albes, Johannes M

2017-12-01

Interrupted pledget-armed braided sutures are widely used for valve implantation. In a 74-year-old woman with aortic valve endocarditis and shallow annular abscess, annulus dehiscence resulted after resection. As resistance was too high for sufficient primary approximation, a snug fit of the valve by means of circumferential application of curbed tourniquets resembling Medusa's head after suture placement was achieved. Closest possible approximation of the upper and lower part of the annulus with the prosthesis prior to final fixation was thus possible, so that application of too much tension on a single suture could be avoided. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Apical closure device for full-percutaneous transapical valve implantation: stress-test in an animal model†.

PubMed

Ferrari, Enrico; Demertzis, Stefanos; Angelella, Jennifer; Berdajs, Denis; Tozzi, Piergiorgio; Moccetti, Tiziano; Maisano, Francesco; von Segesser, Ludwig K

2017-05-01

Transapical valve implantation is traditionally performed through a left antero-lateral mini-thoracotomy. A self-expandable apical closure device has recently been developed for full-percutaneous transapical valve implantation. We performed haemodynamics stress-tests on an animal model to evaluate the sealing properties. Under general anaesthesia 5 pigs (mean weight: 67 ± 6 Kg) received full heparinization (100 IU/Kg; activated clotting time >250 s and, through inferior mini-sternotomies, 21-Fr introducer sheaths for transapical aortic valve implantation (outer diameter: 25-Fr) were placed over-the-wire in the apexes. Delivery-catheters carrying folded occluders (SAFEX TM final design) were inserted in the introducer sheaths and plugs were then deployed under fluoroscopic guidance. Phase 1: after protamine injection, apical bleeding was monitored for 1 h with standard haemodynamics condition. Phase 2: we induced systemic hypertension with adrenaline infusion to test the sealing properties under stress. Animals were sacrificed after Phase 2 and hearts were removed and inspected. Five plugs were successfully introduced and deployed in 5 pig hearts. Plugs provided good apical sealing in each animal and a mean of 7 ± 4 ml of blood lost per animal was collected during Phase 1: haemodynamics remained stable and no plug dislodgement was detected (mean blood pressure: 52 ± 9 mmHg). During Phase 2, mean systolic and diastolic peak levels reached 268 ± 24 mmHg and 175 ± 17 mmHg, respectively, without plug dislodgment or bleeding. Post-mortem inspection showed good plug deployment and fixation without myocardial damage. The new apical occluder seals large-sized apical access sites in animal models also during induced systemic hypertension. This pilot study is a further step towards full-percutaneous transapical valve procedures in the clinical setting. © The Author 2017. Published by Oxford University Press on behalf of the European

Optimal prosthesis sizing in transcatheter aortic valve implantation by exclusive use of three-dimensional transoesophageal echocardiography.

PubMed

Kretzschmar, Daniel; Lauten, Alexander; Goebel, Bjoern; Doenst, Torsten; Poerner, Tudor C; Ferrari, Markus; Figulla, Hans R; Hamadanchi, Ali

2016-03-01

The assessment of aortic annular size is critical, and inappropriate sizing is thought to be a main reason of paravalvular aortic regurgitation. Multidetector computed tomograph is associated with the risk of contrast nephropathy. For optimal evaluation of the complex structure of the aortic annulus, three-dimensional (3D)-methods should be used. We therefore sought to determine the value of 3D-transoesophageal echocardiography (3D-TEE) for appropriate sizing. Hundred and one patients (mean age 81·4 years) with symptomatic aortic valve stenosis (AS) and high surgical risk profile (mean log. EuroScore 28·8%) being scheduled for transcatheter aortic valve implantation (TAVI) were included. 2D- and 3D-TEE were performed before the procedure to evaluate the aortic annulus diameter. Maximum, minimum and mean (max diameter + min diameter/2) annulus diameters were 24·7, 23·1 and 23. 9 mm in 3D-TEE and compared to 22·6 mm in 2D-TEE (P<0·001; 0·07; <0·001). The interobserver variability for 3D-TEE was low with a mean difference of 0·18 mm compared to 2D-TEE with 0·59 mm. The application of 3D-TEE caused a change of prosthesis size selection in 40% of patients compared to 2D-TEE. In this study, we implanted three different types of catheter-mounted valves (Edwards-SAPIEN(™) XT valve, CoreValve(™) and JenaValve(™) ). Final angiography confirmed valve competence (mild insufficiency) in 91%, and there was no aortic regurgitation greater than moderate in the follow-up echocardiographic evaluation. Assessment of aortic annulus dimensions for TAVI size selection can safely be performed with 3D-TEE only. Based on our results with significantly higher annulus diameter compared to 2D-TEE, we recommend 3D-TEE to reduce prosthesis undersizing. © 2014 Scandinavian Society of Clinical Physiology and Nuclear Medicine. Published by John Wiley & Sons Ltd.

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.

Determinants of image quality of rotational angiography for on-line assessment of frame geometry after transcatheter aortic valve implantation.

PubMed

Rodríguez-Olivares, Ramón; El Faquir, Nahid; Rahhab, Zouhair; Maugenest, Anne-Marie; Van Mieghem, Nicolas M; Schultz, Carl; Lauritsch, Guenter; de Jaegere, Peter P T

2016-07-01

To study the determinants of image quality of rotational angiography using dedicated research prototype software for motion compensation without rapid ventricular pacing after the implantation of four commercially available catheter-based valves. Prospective observational study including 179 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with either the Medtronic CoreValve (MCS), Edward-SAPIEN Valve (ESV), Boston Sadra Lotus (BSL) or Saint-Jude Portico Valve (SJP) in whom rotational angiography (R-angio) with motion compensation 3D image reconstruction was performed. Image quality was evaluated from grade 1 (excellent image quality) to grade 5 (strongly degraded). Distinction was made between good (grades 1, 2) and poor image quality (grades 3-5). Clinical (gender, body mass index, Agatston score, heart rate and rhythm, artifacts), procedural (valve type) and technical variables (isocentricity) were related with the image quality assessment. Image quality was good in 128 (72 %) and poor in 51 (28 %) patients. By univariable analysis only valve type (BSL) and the presence of an artefact negatively affected image quality. By multivariate analysis (in which BMI was forced into the model) BSL valve (Odds 3.5, 95 % CI [1.3-9.6], p = 0.02), presence of an artifact (Odds 2.5, 95 % CI [1.2-5.4], p = 0.02) and BMI (Odds 1.1, 95 % CI [1.0-1.2], p = 0.04) were independent predictors of poor image quality. Rotational angiography with motion compensation 3D image reconstruction using a dedicated research prototype software offers good image quality for the evaluation of frame geometry after TAVI in the majority of patients. Valve type, presence of artifacts and higher BMI negatively affect image quality.

Localized gene delivery using antibody tethered adenovirus from polyurethane heart valve cusps and intra-aortic implants.

PubMed

Stachelek, S J; Song, C; Alferiev, I; Defelice, S; Cui, X; Connolly, J M; Bianco, R W; Levy, R J

2004-01-01

The present study investigated a novel approach for gene therapy of heart valve disease and vascular disorders. We formulated and characterized implantable polyurethane films that could also function as gene delivery systems through the surface attachment of replication defective adenoviruses using an anti-adenovirus antibody tethering mechanism. Our hypothesis was that we could achieve site-specific gene delivery to cells interacting with these polyurethane implants, and thereby demonstrate the potential for intravascular devices that could also function as gene delivery platforms for therapeutic vectors. Previous research by our group has demonstrated that polyurethane elastomers can be derivatized post-polymerization through a series of chemical reactions activating the hard segment amide groups with alkyl bromine residues, which can enable a wide variety of subsequent chemical modifications. Furthermore, prior research by our group investigating gene delivery intravascular stents has shown that collagen-coated balloon expandable stents can be configured with anti-adenovirus antibodies via thiol-based chemistry, and can then tether adenoviral vectors at doses that lead to high levels of localized arterial neointima expression, but with virtually no distal spread of vector. Thus, we sought to create two-device configurations for our investigations building on this previous research. (1) Polyurethane films coated with Type I collagen were thiol activated to permit covalent attachment of anti-adenovirus antibodies to enable gene delivery via vector tethering. (2) We also formulated polyurethane films with direct covalent attachment of anti-adenovirus antibodies to polyurethane hard segments derivatized with alkyl-thiol groups, thereby also enabling tethering of replication-defective adenoviruses. Both formulations demonstrated highly localized and efficient transduction in cell culture studies with rat arterial smooth muscle cells. In vivo experiments with collagen

Right ventricular remodelling after transcatheter pulmonary valve implantation.

PubMed

Pagourelias, Efstathios D; Daraban, Ana M; Mada, Razvan O; Duchenne, Jürgen; Mirea, Oana; Cools, Bjorn; Heying, Ruth; Boshoff, Derize; Bogaert, Jan; Budts, Werner; Gewillig, Marc; Voigt, Jens-Uwe

2017-09-01

To define the optimal timing for percutaneous pulmonary valve implantation (PPVI) in patients with severe pulmonary regurgitation (PR) after Fallot's Tetralogy (ToF) correction. PPVI among the aforementioned patients is mainly driven by symptoms or by severe right ventricular (RV) dilatation/dysfunction. The optimal timing for PPVI is still disputed. Twenty patients [age 13.9 ± 9.2 years, (range 4.3-44.9), male 70%] with severe PR (≥3 grade) secondary to previous correction of ToF, underwent Melody valve (Medtronic, Minneapolis, MN) implantation, after a pre-stent placement. Full echocardiographic assessment (traditional and deformation analysis) and cardiovascular magnetic resonance evaluation were performed before and at 3 months after the intervention. 'Favorable remodelling' was considered the upper quartile of RV size decrease (>20% in 3 months). After PPVI, indexed RV effective stroke volume increased from 38.4 ± 9.5 to 51.4 ± 10.7 mL/m 2 , (P = 0.005), while RV end-diastolic volume and strain indices decreased (123.1 ± 24.1-101.5 ± 18.3 mL/m 2 , P = 0.005 and -23.5 ± 2.5 to -21 ± 2.5%, P = 0.002, respectively). After inserting pre-PPVI clinical, RV volumetric and deformation parameters in a multiple regression model, only time after last surgical correction causing PR remained as significant regressor of RV remodelling [R 2  = 0.60, beta = 0.387, 95%CI(0.07-0.7), P = 0.019]. Volume reduction and functional improvement were more pronounced in patients treated with PPVI earlier than 7 years after last RV outflow tract (RVOT) correction, reaching close-to-normal values. Early PPVI (<7 years after last RVOT operation) is associated with a more favorable RV reverse remodelling toward normal range and should be considered, before symptoms or RV damage become apparent. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Bacterial translocation and plasma cytokines during transcatheter and open-heart aortic valve implantation.

PubMed

Adrie, Christophe; Parlato, Marianna; Salmi, Lynda; Adib-Conquy, Minou; Bical, Olivier; Deleuze, Philippe; Fitting, Catherine; Cavaillon, Jean Marc; Monchi, Mehran

2015-01-01

To determine whether the good safety profile of transarterial aortic valve implantation (TAVI) is related to lower levels of systemic bacterial translocation and systemic inflammation compared with open-heart surgery. Transcatheter aortic valve implantation via the transfemoral approach is increasingly used in very high-risk patients with aortic stenosis. The outcomes seem similar to those after open-heart aortic valve replacement (OHAVR). Each of 26 consecutive high-risk patients (EuroSCORE >20% for risk of operative death) who underwent TAVI (cases) was matched to the first low-risk patient treated next in our department using elective OHAVR without coronary artery bypass (control subjects). We collected severity, outcome, and echocardiography indicators before and after surgery; complications; proinflammatory cytokine levels; and markers for microbial translocation. Despite greater illness severity, the TAVI patients had significantly lower vasopressor agent requirements, lower delirium rates, shorter hospital stays, and better hemodynamic findings compared with OHAVR patients. Vascular complications were more common after TAVI than after OHAVR (12, with seven requiring interventional therapy vs. 0, P = 0.006). Patients who underwent TAVI had lower blood transfusion requirements. Two TAVI patients died: one from iliac artery injury and the other from intracardiac prosthesis migration. Patients who underwent TAVI had lower plasma levels of endotoxin and bacterial peptidoglycan, as well as lower proinflammatory cytokine levels, suggesting less gastrointestinal bacterial translocation compared with OHAVR. Compared with OHAVR, TAVI was associated with decreases in bacterial translocation and inflammation. These differences may explain the lower delirium rate and better hemodynamic stability observed, despite the greater disease severity in TAVI patients.

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.

The importance of echocardiography in transcatheter aortic valve implantation.

PubMed

Bilen, Emine; Sari, Cenk; Durmaz, Tahir; Keleş, Telat; Bayram, Nihal A; Akçay, Murat; Ayhan, Hüseyin M; Bozkurt, Engin

2014-01-01

Valvular heart diseases cause serious health problems in Turkey as well as in Western countries. According to a study conducted in Turkey, aortic stenosis (AS) is second after mitral valve disease among all valvular heart diseases. AS is frequently observed in elderly patients who have several cardiovascular risk factors and comorbidities. In symptomatic severe AS, surgical aortic valve replacement (AVR) is a definitive treatment. However, in elderly patients with left ventricular dysfunction and comorbidities, the risk of operative morbidity and mortality increases and outweighs the gain obtained from AVR surgery. As a result, almost one-third of the patients with serious AS are considered ineligible for surgery. Transcatheter aortic valve implantation (TAVI) is an effective treatment in patients with symptomatic severe AS who have high risk for conventional surgery. Since being performed for the first time in 2002, with a procedure success rate reported as 95% and a mortality rate of 5%, TAVI has become a promising method. Assessment of vascular anatomy, aortic annular diameter, and left ventricular function may be useful for the appropriate selection of patients and may reduce the risk of complications. Cardiac imaging methods including 2D and 3D echocardiography and multidetector computed tomography are critical during the evaluation of suitable patients for TAVI as well as during and after the procedure. In this review, we describe the role of echocardiography methods in clinical practice for TAVI procedure in its entirety, i.e. from patient selection to guidance during the procedure, and subsequent monitoring. © 2013, Wiley Periodicals, Inc.

[Experience of Mitral Valve Replacement Using a Pulmonary Autograft (Ross II Operation) in an Infant;Report of a Case].

PubMed

Kawahito, Tomohisa; Egawa, Yoshiyasu; Yoshida, Homare; Shimoe, Yasushi; Onishi, Tatsuya; Miyagi, Yuhichi; Terada, Kazuya; Ohta, Akira

2015-07-01

A 24-day-old boy suddenly developed progressive heart failure and was transported to our hospital. Echocardiography showed massive mitral regurgitation due to chordal rupture. Mitral valve repair was performed at 28 days of life, but postoperative valvular function was not satisfactory. A mechanical valve was implanted in the supra-annular position at 37 days of life. Two months after valve replacement, the mechanical valve was suddenly stuck. Emergent redo valve replacement was performed, but the prosthetic valve became stuck again 2 months after the 3rd operation, despite sufficient anti-coagulation therapy. At the 4th operation (6 months after birth), we implanted a pulmonary autograft in the mitral position instead of another mechanical valve in an emergent operation. The right ventricular outflow tract was reconstructed with a valved conduit. A postoperative catheter examination, which was performed 1 year after the Ross II operation, showed mild mitral stenosis with no regurgitation. Previous reports of Ross II operations in infants are rare and long-term results are unknown. However, we advocate that this procedure should be a rescue operation for mitral valve dysfunction in the early period of infants.

Indication for percutaneous aortic valve implantation

PubMed Central

Akin, Ibrahim; Kische, Stephan; Rehders, Tim C.; Nienaber, Christoph A.; Rauchhaus, Mathias; Schneider, Henrik; Liebold, Andreas

2010-01-01

The incidence of valvular aortic stenosis has increased over the past decades due to improved life expectancy. Surgical aortic valve replacement is currently the only treatment option for severe symptomatic aortic stenosis that has been shown to improve survival. However, up to one third of patients who require lifesaving surgical aortic valve replacement are denied surgery due to high comorbidities resulting in a higher operative mortality rate. In the past such patients could only be treated with medical therapy or percutaneous aortic valvuloplasty, neither of which has been shown to improve mortality. With advances in interventional cardiology, transcatheter methods have been developed for aortic valve replacement with the goal of offering a therapeutic solution for patients who are unfit for surgical therapy. Currently there are two catheter-based treatment systems in clinical application (the Edwards SAPIEN aortic valve and the CoreValve ReValving System), utilizing either a balloon-expandable or a self-expanding stent platform, respectively. PMID:22371763

Double valve replacement in a patient with implantable cardioverter defibrillator with severe left ventricular dysfunction.

PubMed

Manjunath, Girish; Rao, Prakash; Prakash, Nagendra; Shivaram, B K

2016-01-01

Recent data from landmark trials suggest that the indications for cardiac pacing and implantable cardioverter defibrillators (ICDs) are set to expand to include heart failure, sleep-disordered breathing, and possibly routine implantation in patients with myocardial infarction and poor ventricular function.[1] This will inevitably result in more patients with cardiac devices undergoing surgeries. Perioperative electromagnetic interference and their potential effects on ICDs pose considerable challenges to the anesthesiologists.[2] We present a case of a patient with automatic ICD with severe left ventricular dysfunction posted for double valve replacement.

Short- and Medium-Term Outcomes After Transcatheter Pulmonary Valve Placement in the Expanded Multicenter US Melody Valve Trial

PubMed Central

McElhinney, Doff B.; Hellenbrand, William E.; Zahn, Evan M.; Jones, Thomas K.; Cheatham, John P.; Lock, James E.; Vincent, Julie A.

2014-01-01

Background Transcatheter pulmonary valve placement is an emerging therapy for pulmonary regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits. Methods and Results From January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at 5 centers. Implantation was attempted in 124 patients; in the other 12, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation. Before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (≥1 year in 65 patients). Freedom from diagnosis of stent fracture was 77.8±4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5±2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P=0.003) and younger age (P=0.01) were associated with shorter freedom from dysfunction. Conclusions In this updated report from the multicenter US Melody valve trial, we demonstrated an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870. PMID

Updated clinical indications for transcatheter aortic valve implantation in patients with severe aortic stenosis: expert opinion of the Italian Society of Cardiology and GISE.

PubMed

Indolfi, Ciro; Bartorelli, Antonio L; Berti, Sergio; Golino, Paolo; Esposito, Giovanni; Musumeci, Giuseppe; Petronio, Sonia; Tamburino, Corrado; Tarantini, Giuseppe; Ussia, Gianpaolo; Vassanelli, Corrado; Spaccarotella, Carmen; Violini, Roberto; Mercuro, Giuseppe; Romeo, Francesco

2018-05-01

: The introduction of percutaneous treatment of severe aortic stenosis with transcatheter aortic valve implantation (TAVI) remains one of the greatest achievements of interventional cardiology. In fact, TAVI emerged as a better option than either medical therapy or balloon aortic valvuloplasty for patients who cannot undergo surgical aortic valve replacement (SAVR) or are at high surgical risk. Recently, increased operator experience and improved device systems have led to a worldwide trend toward the extension of TAVI to low-risk or intermediate-risk patients. In this expert opinion paper, we first discuss the basic pathophysiology of aortic stenosis in different settings then the key results of recent clinical investigations on TAVI in intermediate-risk aortic stenosis patients are summarized. Particular emphasis is placed on the results of the nordic aortic valve intervention, placement of aortic transcatheter valves (PARTNER) 2 and Surgical Replacement and Transcatheter Aortic Valve Implantation Randomized trials. The PARTNER 2 was the first large randomized trial that evaluated the outcome of TAVI in patients at intermediate risk. The PARTNER 2 data demonstrated that TAVI is a feasible and reasonable alternative to surgery in intermediate-risk patients (Society of Thoracic Surgeons 4-8%), especially if they are elderly or frail. There was a significant interaction between TAVI approach and mortality, with transfemoral TAVI showing superiority over SAVR. Moreover, we examine the complementary results of the recently concluded Surgical Replacement and Transcatheter Aortic Valve Implantation trial. This prospective randomized trial demonstrated that TAVI is comparable with surgery (primary end point 12.6% in the TAVI group vs. 14.0% in the SAVR group) in severe aortic stenosis patients deemed to be at intermediate risk. We review the most relevant clinical evidence deriving from nonrandomized studies and meta-analyses. Altogether, clinical outcome available data

Endophthalmitis associated with the Ahmed glaucoma valve implant

PubMed Central

Al-Torbak, A A; Al-Shahwan, S; Al-Jadaan, I; Al-Hommadi, A; Edward, D P

2005-01-01

Aim: To investigate the rate, risk factors, clinical course, and treatment outcomes of endophthalmitis following glaucoma drainage implant (GDI) surgery. Methods: A computerised relational database search was conducted to identify all patients who were implanted with Ahmed glaucoma valve (AGV) and developed endophthalmitis following surgery at the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia, between 1 January 1994 and 30 November 2003. Only medical records of the patients who developed endophthalmitis were retrospectively reviewed. Results: 542 eyes of 505 patients who were on active follow up were included in the study. Endophthalmitis developed in nine (1.7%) eyes; the rate was five times higher in children than in adults. Delayed endophthalmitis (developed 6 weeks after surgery) occurred in eight of nine eyes. Conjunctival erosion overlying the AGV tube was present in six of nine eyes. Common organisms isolated in the vitreous included Haemophilus influenzae and Streptococcus species. Multiple regression analysis revealed that younger age and conjunctival erosion over the tube were significant risk factors associated with endophthalmitis. Conclusion: Endophthalmitis is a rare complication of GDI surgery that appears to be more common in children. Conjunctival dehiscence over the GDI tube seems to represent a major risk factor for endophthalmitis. Prompt surgical revision of an exposed GDI tube is highly recommended. PMID:15774923

Endophthalmitis associated with the Ahmed glaucoma valve implant.

PubMed

Al-Torbak, A A; Al-Shahwan, S; Al-Jadaan, I; Al-Hommadi, A; Edward, D P

2005-04-01

To investigate the rate, risk factors, clinical course, and treatment outcomes of endophthalmitis following glaucoma drainage implant (GDI) surgery. A computerised relational database search was conducted to identify all patients who were implanted with Ahmed glaucoma valve (AGV) and developed endophthalmitis following surgery at the King Khaled Eye Specialist Hospital in Riyadh, Saudi Arabia, between 1 January 1994 and 30 November 2003. Only medical records of the patients who developed endophthalmitis were retrospectively reviewed. 542 eyes of 505 patients who were on active follow up were included in the study. Endophthalmitis developed in nine (1.7%) eyes; the rate was five times higher in children than in adults. Delayed endophthalmitis (developed 6 weeks after surgery) occurred in eight of nine eyes. Conjunctival erosion overlying the AGV tube was present in six of nine eyes. Common organisms isolated in the vitreous included Haemophilus influenzae and Streptococcus species. Multiple regression analysis revealed that younger age and conjunctival erosion over the tube were significant risk factors associated with endophthalmitis. Endophthalmitis is a rare complication of GDI surgery that appears to be more common in children. Conjunctival dehiscence over the GDI tube seems to represent a major risk factor for endophthalmitis. Prompt surgical revision of an exposed GDI tube is highly recommended.

Contegra valved conduit in the paediatric population: an exciting prospect for right ventricle to pulmonary artery reconstruction; experience and outcomes at Aga Khan University.

PubMed

Siddiqui, Maria Tariq; Hasan, Asif; Mohsin, Shazia; Hamid, Mohammad; Amanullah, Muhammad Muneer

2012-10-01

The focus of this study is to share the experience and outcomes of Contegra graft implantation in the paediatric and adult population in Pakistan. Between May 2007 and July 2011, 16 patients, underwent implantation of a Contegra valved conduit. All operations were performed through a median sternotomy with cardiopulmonary bypass. Indications included: Pulmonary atresia with ventricular septal defect (n = 11), Tetralogy of Fallot with absent Pulmonary Valve (PV) syndrome (n = 2), double outlet right ventricle, transposition of great arteries and pulmonary stenosis (n = 1), isolated aortic valve disease (n = 1) and a pseudo-aneurysm with infective endocarditis (n = 1).Conduit sizes varied between 16-22 mm. The three in hospital deaths were unrelated to the Contegra valved conduit. One patient was lost to follow up. Of the 12 survivors, 10 are currently free from re-operation or complications related to the conduit while one needed distal pulmonary artery dilatation owing to critical stenosis and another had severe Valvular regurgitation. Echocardiographic evaluation of the Contegra valved conduit demonstrated no haemodynamically significant valve regurgitation in 10 patients. In this small review of 16 operations using the Contegra valved conduit for Right Venticular Outflow Tract (RVOT) reconstruction in the paediatric population, we observed good post operative results concerning conduit function. The Contegra conduit provides an excellent substitute to the homograft with satisfactory early and mid-term results though long-term results are awaited in Pakistan.

Meta-Analysis of Perioperative Stroke and Mortality in Transcatheter Aortic Valve Implantation.

PubMed

Muralidharan, Aditya; Thiagarajan, Karthy; Van Ham, Raymond; Gleason, Thomas G; Mulukutla, Suresh; Schindler, John T; Jeevanantham, Vinodh; Thirumala, Parthasarathy D

2016-10-01

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving safe method with decreasing incidence of perioperative stroke. There is a void in literature concerning the impact of stroke after TAVI in predicting 30-day stroke-related mortality. The primary aim of this meta-analysis was to determine whether perioperative stroke increases risk of stroke-related mortality after TAVI. Online databases, using relevant keywords, and additional related records were searched to retrieve articles involving TAVI and stroke after TAVI. Data were extracted from the finalized studies and analyzed to generate a summary odds ratio (OR) of stroke-related mortality after TAVI. The stroke rate and stroke-related mortality rate in the total patient population were 3.07% (893 of 29,043) and 12.27% (252 of 2,053), respectively. The all-cause mortality rate was 7.07% (2,053 of 29,043). Summary OR of stroke-related mortality after TAVI was estimated to be 6.45 (95% confidence interval 3.90 to 10.66, p <0.0001). Subgroup analyses were performed among age, approach, and valve type. Only 1 subgroup, transapical TAVI, was not significantly associated with stroke-related mortality (OR 1.97, 95% confidence interval, 0.43 to 7.43, p = 0.42). A metaregression was conducted among females, New York Heart Association class III/IV status, previous stroke, valve type, and implantation route. All failed to exhibit any significant associations with the OR. In conclusion, perioperative strokes after TAVI are associated with >6 times greater risk of 30-day stroke-related mortality. Transapical TAVI is not associated with increased stroke-related mortality in patients who suffer from perioperative stroke. Preventative measures need to be taken to alleviate the elevated rates of stroke after TAVI and subsequent direct mortality. Copyright © 2016 Elsevier Inc. All rights reserved.

Polymeric heart valves for surgical implantation, catheter-based technologies and heart assist devices.

PubMed

Bezuidenhout, Deon; Williams, David F; Zilla, Peter

2015-01-01

Efficient function and long-term durability without the need for anticoagulation, coupled with the ability to be accommodated in many different types of patient, are the principal requirements of replacement heart valves. Although the clinical use of valves appeared to have remained steady for several decades, the evolving demands for the elderly and frail patients typically encountered in the developed world, and the needs of much younger and poorer rheumatic heart disease patients in the developing world have now necessitated new paradigms for heart valve technologies and associated materials. This includes further consideration of durable elastomeric materials. The use of polymers to produce flexible leaflet valves that have the benefits of current commercial bioprosthetic and mechanical valves without any of their deficiencies has been held desirable since the mid 1950s. Much attention has been focused on thermoplastic polyurethanes in view of their generally good physico-chemical properties and versatility in processing, coupled with the improving biocompatibility and stability of recent formulations. Accelerated in vitro durability of between 600 and 1000 million cycles has been achieved using polycarbonate urethanes, and good resistance to degradation, calcification and thrombosis in vivo has been shown with some polysiloxane-based polyurethanes. Nevertheless, polymeric valves have remained relegated to use in temporary ventricular assist devices for bridging heart failure patients to transplantation. Some recent studies suggest that there is a greater degree of instability in thermoplastic materials than hitherto believed so that significant challenges remain in the search for the combination of durability and biocompatibility that would allow polymeric valves to become a clinical reality for surgical implantation. Perhaps more importantly, they could become candidates for use in situations where minimally invasive transcatheter procedures are used to

Saddle-shaped mitral valve annuloplasty rings experience lower forces compared with flat rings.

PubMed

Jensen, Morten O; Jensen, Henrik; Smerup, Morten; Levine, Robert A; Yoganathan, Ajit P; Nygaard, Hans; Hasenkam, J Michael; Nielsen, Sten L

2008-09-30

New insight into the 3D dynamic behavior of the mitral valve has prompted a reevaluation of annuloplasty ring designs. Force balance analysis indicates correlation between annulus forces and stresses in leaflets and chords. Improving this stress distribution can intuitively enhance the durability of mitral valve repair. We tested the hypothesis that saddle-shaped annuloplasty rings have superior uniform systolic force distribution compared with a nonuniform force distribution in flat annuloplasty rings. Sixteen 80-kg pigs had a flat (n=8) or saddle-shaped (n=8) mitral annuloplasty ring implanted. Mitral annulus 3D dynamic geometry was obtained with sonomicrometry before ring insertion. Strain gauges mounted on dedicated D-shaped rigid flat and saddle-shaped annuloplasty rings provided the intraoperative force distribution perpendicular to the annular plane. Average systolic annular height to commissural width ratio before ring implantation was 14.0%+/-1.6%. After flat and saddle shaped ring implantation, the annulus was fixed in the diastolic (9.0%+/-1.0%) and systolic (14.3%+/-1.3%) configuration, respectively (P<0.01). Force accumulation was seen from the anterior (0.72N+/-0.14N) and commissural annular segments (average 1.38N+/-0.27N) of the flat rings. In these segments, the difference between the 2 types of rings was statistically significant (P<0.05). The saddle-shaped annuloplasty rings did not experience forces statistically significantly larger than zero in any annular segments. Saddle-shaped annuloplasty rings provide superior uniform annular force distribution compared to flat rings and appear to represent a configuration that minimizes out-of-plane forces that could potentially be transmitted to leaflets and chords. This may have important implications for annuloplasty ring selections.

Efficacy and safety of intravitreal bevacizumab in eyes with neovascular glaucoma undergoing Ahmed glaucoma valve implantation: 2-year follow-up.

PubMed

Arcieri, Enyr S; Paula, Jayter S; Jorge, Rodrigo; Barella, Kleyton A; Arcieri, Rafael S; Secches, Danilo J; Costa, Vital P

2015-02-01

To evaluate the efficacy and safety of intravitreal bevacizumab (IVB) in eyes with neovascular glaucoma (NVG) undergoing Ahmed glaucoma valve (AGV) implantation. This was a multicentre, prospective, randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation. Patients were randomized to receive IVB (1.25 mg) or not during Ahmed valve implant surgery. Injections were administered intra-operatively, and 4 and 8 weeks after surgery. After a mean follow-up of 2.25 ± 0.67 years (range 1.5-3 years), both groups showed a significant decrease in IOP (p < 0.05). There was no difference in IOP between groups except at the 18-month interval, when IOP in IVB group was significantly lower (14.57 ± 1.72 mmHg vs. 18.37 ± 1.06 mmHg - p = 0.0002). There was no difference in survival success rates between groups. At 24 months, there was a trend to patients treated with IVB using less antiglaucoma medications than the control group (p = 0.0648). Complete regression of rubeosis iridis was significantly more frequent in the IVB group (80%) than in the control group (25%) (p = 0.0015). Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation. There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystems.

PubMed

Pan, Tingrui; Baldi, Antonio; Ziaie, Babak

2007-06-01

In this paper, we present two remotely adjustable check-valves with an electrochemical release mechanism for implantable biomedical microsystems. These valves allow one to vary the opening pressure set-point and flow resistance over a period of time. The first design consists of a micromachined check-valve array using a SU-8 polymer structural layer deposited on the top of a gold sacrificial layer. The second design is based on a variable length cantilever beam structure with a gold sacrificial layer. The adjustable cantilever-beam structure is fabricated by gold thermo-compression bond of a thin silicon wafer over a glass substrate. In both designs, the evaporated gold can be electrochemically dissolved using a constant DC current via a telemetry link. In the first design the dissolution simply opens up individual outlets, while in the second design, gold anchors are sequentially dissolved hence increasing the effective length of the cantilever beam (reducing the opening pressure). A current density of 35 mA/cm(2) is used to dissolve the gold sacrificial layers. Both gravity and syringe-pump driven flow are used to characterize the valve performance. A multi-stage fluidic performance (e.g. flow resistance and opening pressure) is clearly demonstrated.

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

Comparison between transcatheter and surgical aortic valve replacement: a single-center experience.

PubMed

Silberman, Shuli; Abu Akr, Firas; Bitran, Daniel; Almagor, Yaron; Balkin, Jonathan; Tauber, Rachel; Merin, Ofer

2013-07-01

A comparison was made of the outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR) in high-risk patients. All patients aged > 75 years that underwent a procedure for severe aortic stenosis with or without coronary revascularization at the authors' institution were included in the study; thus, 64 patients underwent TAVI and 188 underwent AVR. Patients in the TAVI group were older (mean age 84 +/- 5 versus 80 +/- 4 years; p < 0.0001) and had a higher logistic EuroSCORE (p = 0.004). Six patients (9%) died during the procedure in the TAVI group, and 23 (12%) died in the AVR group (p = 0.5). Predictors for mortality were: age (p < 0.0001), female gender (p = 0.02), and surgical valve replacement (p = 0.01). Gradients across the implanted valves at one to three months postoperatively were lower in the TAVI group (p < 0.0001). Actuarial survival at one, two and three years was 78%, 64% and 64%, respectively, for TAVI, and 83%, 78% and 75%, respectively, for AVR (p = 0.4). Age was the only predictor for late mortality (p < 0.0001). TAVI patients were older and posed a higher predicted surgical risk. Procedural mortality was lower in the TAVI group, but mid-term survival was similar to that in patients undergoing surgical AVR. Age was the only predictor for late survival. These data support the referral of high-risk patients for TAVI.

Transapical aortic valve implantation – a rescue procedure for patients with aortic stenosis and “porcelain aorta”

PubMed Central

Czerwinska, Katarzyna; Orłowska-Baranowska, Ewa; Witkowski, Adam; Demkow, Marcin; Abramczuk, Elżbieta; Michałek, Piotr; Greszata, Lidia; Stoklosa, Patrycjusz; Kuśmierski, Krzysztof; Kowal, Jaroslaw; Stepinska, Janina

2011-01-01

Surgical aortic valve replacement (AVR) still remains the treatment of choice in symptomatic significant aortic stenosis (AS). Due to technical problems, extensive calcification of the ascending aorta (“porcelain aorta”) is an additional risk factor for surgery and transapical aortic valve implantation (TAAVI) is likely to be the only rescue procedure for this group of patients. We describe the case of an 81-year-old woman with severe AS and “porcelain aorta”, in whom the only available life-saving intervention was TAAVI. PMID:22295040

Transcatheter Pulmonary Valve Replacement by Hybrid Approach Using a Novel Polymeric Prosthetic Heart Valve: Proof of Concept in Sheep

PubMed Central

Xu, Tong-yi; Zhang, Zhi-gang; Li, Xin; Han, Lin; Xu, Zhi-yun

2014-01-01

Background Since 2000, transcatheter pulmonary valve replacement has steadily advanced. However, the available prosthetic valves are restricted to bioprosthesis which have defects like poor durability. Polymeric heart valve is thought as a promising alternative to bioprosthesis. In this study, we introduced a novel polymeric transcatheter pulmonary valve and evaluated its feasibility and safety in sheep by a hybrid approach. Methods We designed a novel polymeric trileaflet transcatheter pulmonary valve with a balloon-expandable stent, and the valve leaflets were made of 0.1-mm expanded polytetrafluoroethylene (ePTFE) coated with phosphorylcholine. We chose glutaraldehyde-treated bovine pericardium valves as control. Pulmonary valve stents were implanted in situ by a hybrid transapical approach in 10 healthy sheep (8 for polymeric valve and 2 for bovine pericardium valve), weighing an average of 22.5±2.0 kg. Angiography and cardiac catheter examination were performed after implantation to assess immediate valvular functionality. After 4-week follow-up, angiography, echocardiography, computed tomography, and cardiac catheter examination were used to assess early valvular function. One randomly selected sheep with polymeric valve was euthanized and the explanted valved stent was analyzed macroscopically and microscopically. Findings Implantation was successful in 9 sheep. Angiography at implantation showed all 9 prosthetic valves demonstrated orthotopic position and normal functionality. All 9 sheep survived at 4-week follow-up. Four-week follow-up revealed no evidence of valve stent dislocation or deformation and normal valvular and cardiac functionality. The cardiac catheter examination showed the peak-peak transvalvular pressure gradient of the polymeric valves was 11.9±5.0 mmHg, while that of two bovine pericardium valves were 11 and 17 mmHg. Gross morphology demonstrated good opening and closure characteristics. No thrombus or calcification was seen

Early Outcomes for Valve-in-valve Transcatheter Aortic Valve Replacement in Degenerative Freestyle Bioprostheses.

PubMed

Sang, Stephane Leung Wai; Beute, Tyler; Heiser, John; Berkompas, Duane; Fanning, Justin; Merhi, William

2017-11-20

Transcatheter aortic valve replacement (TAVR) is used increasingly to treat bioprosthetic valve failure. A paucity of data exists regarding valve-in-valve (ViV) TAVR in degenerated Freestyle stentless bioprostheses (FSBs). This study sought to evaluate the feasibility and short-term outcomes of ViV TAVR in previously placed FSB. From October 2014 to September 2016, 22 patients at a single institution underwent ViV TAVR with a self-expanding transcatheter valve for a failing FSB. Patient baseline characteristics and clinical outcomes data were collected retrospectively and entered into a dedicated database. The mean patient age was 74 ± 9years, and the mean Society of Thoracic Surgeons' Risk score was 9.0 ± 7.4%. Ten patients presented with acute heart failure requiring urgent intervention. The most common mode of failure of the FSB was regurgitation caused by a flail or malcoapting leaflet. Seventeen (77%) patients had a modified subcoronary implantation, 3 (14%) had a full root replacement, and 2 (9%) had a root inclusion. Device success using a self-expanding transcatheter valve was 95%, all via transfemoral approach. The mean implant depth was 7 ± 3 mm. Thirty-day survival was 100%. No patient had more than mild paravalvular regurgitation at 30days, and the permanent pacemaker rate was 9%. The mean hospital stay after intervention was 5 ± 2days. ViV TAVR using a self-expanding transcatheter valve is safe, feasible, and can be used successfully to treat a failed FSB. Procedural challenges suggest referral to valve centers of excellence. Copyright © 2017 Elsevier Inc. All rights reserved.

Aqueous shunt implantation in glaucoma

PubMed Central

Wang, Jing; Barton, Keith

2017-01-01

Aqueous shunts or glaucoma drainage devices are increasingly utilized in the management of refractory glaucoma. The general design of the most commonly-used shunts is based on the principles of the Molteno implant: ie. a permanent sclerostomy (tube), a predetermined bleb area (plate) and diversion of aqueous humour to the equatorial region and away from the limbal subconjunctival space. These three factors make aqueous shunts more resistant to scarring as compared to trabeculectomy. The two most commonly used shunts are the Ahmed Glaucoma Valve, which contains a flow-restrictor, and the non-valved Baervedlt Glaucoma Implant. While the valved implants have a lower tendency to hypotony and related complications, the non-valved implants with larger, more-biocompatible end plate design, achieve lower intraocular pressures with less encapsulation. Non-valved implants require additional suturing techniques to prevent early hypotony and a number of these methods will be described. Although serious shunt-related infection is rare, corneal decompensation and diplopia are small but significant risks. PMID:29034151

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. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The Leipzig experience with robotic valve surgery.

PubMed

Autschbach, R; Onnasch, J F; Falk, V; Walther, T; Krüger, M; Schilling, L O; Mohr, F W

2000-01-01

The study describes the single-center experience using robot-assisted videoscopic mitral valve surgery and the early results with a remote telemanipulator-assisted approach for mitral valve repair. Out of a series of 230 patients who underwent minimally invasive mitral valve surgery, in 167 patients surgery was performed with the use of robotic assistance. A voice-controlled robotic arm was used for videoscopic guidance in 152 cases. Most recently, a computer-enhanced telemanipulator was used in 15 patients to perform the operation remotely. The mitral valve was repaired in 117 and replaced in all other patients. The voice-controlled robotic arm (AESOP 3000) facilitated videoscopic-assisted mitral valve surgery. The procedure was completed without the need for an additional assistant as "solo surgery." Additional procedures like radiofrequency ablation and tricuspid valve repair were performed in 21 and 4 patients, respectively. Duration of bypass and clamp time was comparable to conventional procedures (107 A 34 and 50 A 16 min, respectively). Hospital mortality was 1.2%. Using the da Vinci telemanipulation system, remote mitral valve repair was successfully performed in 13 of 15 patients. Robotic-assisted less invasive mitral valve surgery has evolved to a reliable technique with reproducible results for primary operations and for reoperations. Robotic assistance has enabled a solo surgery approach. The combination with radiofrequency ablation (Mini Maze) in patients with chronic atrial fibrillation has proven to be beneficial. The use of telemanipulation systems for remote mitral valve surgery is promising, but a number of problems have to be solved before the introduction of a closed chest mitral valve procedure.

One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study.

PubMed

Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

2013-05-01

The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

[Management of corneal endothelial decompensation with Descemet's membrane endothelial keratoplasty in a patient with Ahmed glaucoma valve implant].

PubMed

Röck, T; Bartz-Schmidt, K-U; Röck, D; Yoeruek, E

2014-05-01

Currently, the main causes for developing bullous keratopathy are from problems related to intraocular surgery, trauma, infection, Fuchs' endothelial dystrophy and chronically elevated intraocular pressure. In the 1990s penetrating keratoplasty was once considered the therapy of choice for treatment of bullous keratopathy but in recent years it has been replaced by posterior lamellar keratoplasty. The Descemet membrane endothelial keratoplasty (DMEK) procedure represents the final development of posterior lamellar keratoplasty. The question now arises whether DMEK can be used in patients with bullous keratopathy and Ahmed glaucoma valve implant. A 72-year-old man was referred to our hospital for further evaluation with the diagnosis of bullous keratopathy and pseudoexfoliative glaucoma. The bullous keratopathy was caused by a variety of previous operations as well as decompensation of intraocular pressure. This article describes the therapy of bullous keratopathy by DMEK with existing Ahmed glaucoma valve implant. After surgery the cornea became clear and the best-corrected visual acuity improved from hand movement to 0.2. The intraocular pressure remained normal (10-14 mmHg) without antiglaucoma medication and the endothelial cell count decreased only slightly over a follow-up of 13 months. No complications were encountered. The DMEK surgical procedure seems to be possible in patients with Ahmed glaucoma valve implant and endothelial decompensation. However, further studies with a larger number of patients should follow to validate the replacement of penetrating keratoplasty and other posterior lamellar procedures by DMEK.

Anesthetic Management of Cardioband Implantation: Data From a Preliminary Experience and New Insights.

PubMed

Pieri, Marina; Belletti, Alessandro; Oriani, Alessandro; Landoni, Giovanni; Latib, Azeem; Mangieri, Antonio; Colombo, Antonio; Zangrillo, Alberto; Monaco, Fabrizio

2017-04-01

Percutaneous procedures for the treatment of mitral valve disease represent valuable therapeutic options for high-risk patients. The anesthetic management of these patients is complex, as they often suffer from cardiac failure and present multiple comorbidities. A recently developed device for transcatheter mitral valve annuloplasty (Cardioband - Valtech Cardio, Or Yehuda, Israel) is now available in clinical practice. The aim of this study was to present the authors' experience with Cardioband device implantation and to describe their anesthetic strategy. Retrospective study. Cardiac catheterization laboratory of a teaching hospital. Thirteen patients undergoing Cardioband implantation. All the procedures were performed under general anesthesia with continuous transesophageal echocardiographic monitoring. Three-dimensional echocardiography, inotropic therapy, cardiac pacing, and mechanical circulatory support always were available and performed as needed. Mean age was 73±7.1 years, and mean preoperative ejection fraction was 38±7.4%. No complications related to anesthetic management were recorded. The authors observed 1 episode of device malfunction and 1 case of accidental damage to the circumflex artery. Postoperative complications were observed in 3 patients, involving detachment of the anchors, anemia requiring transfusions, vascular injury, and new-onset atrial fibrillation. Six patients (46%) required ICU admission. All patients (100%) were discharged from the hospital. Cardioband device implantation under general anesthesia is a feasible approach when performed by skilled physicians with all the expertise and the resources of high-volume centers used to dealing with severely ill patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up.

PubMed

Zhu, Da; Chen, Yucheng; Guo, Yingqiang; Hu, Jia; Zhang, Ji; Wei, Xin; Tang, Hong; Shi, Yingkang

2015-11-15

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis (AS) or pure/dominant aortic regurgitation (AR) using the J-Valve™ system. Twenty patients with isolated aortic valve disease (11 with pure/dominant AR and 9 with AS) at high risk for open-heart surgery were enrolled in this study. The mean Logistic Euro-SCORE I was 27.2±8.2% (mean age 74.5±4.7years). Four sizes of prosthesis were used for annular size up to 21 mm (n=1), 23mm (n=2), 25mm (n=10) and 27mm (n=7). Clinical and echocardiographic evaluations were performed at baseline, post-procedure and follow-up. The primary endpoint was all-cause mortality. Secondary endpoints were procedural success, major adverse events as well as echocardiographic performance. TAVI with the J-Valve™ device was successfully performed in 19 patients (95%). Conversion to surgical valve replacement was necessary in one patient due to prosthesis embolization. No mortality occurred during 90 days follow-up. Pacemaker implantation for new onset conduction disorders was necessary in one patient (5%). For patient with severe AS, post-procedure TAVI resulted in favorable reduction of mean transvalvular gradients (55.3±8.5 vs. 16.4±13.3 mmHg, P<0.01). Mean transvalvular gradient was also favorable in AR patients after valve implantation (6.9±1mmHg). The majority of patients had none or trivial paravalvular regurgitation (17/19) while none had moderate or severe paravalvular regurgitation. Trans-apical TAVI using the J-Valve™ prosthesis is potentially an effective treatment option for patients with AS or pure/dominant AR at high risk for open-heart surgery. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Low pacemaker incidence with continuous-sutured valves: a retrospective analysis.

PubMed

Niclauss, Lars; Delay, Dominique; Pfister, Raymond; Colombier, Sebastien; Kirsch, Matthias; Prêtre, René

2017-06-01

Background Permanent pacemaker implantation after surgical aortic valve replacement depends on patient selection and risk factors for conduction disorders. We aimed to identify risk criteria and obtain a selected group comparable to patients assigned to transcatheter aortic valve implantation. Methods Isolated sutured aortic valve replacements in 994 patients treated from 2007 to 2015 were reviewed. Demographics, hospital stay, preexisting conduction disorders, surgical technique, and etiology in patients with and without permanent pacemaker implantation were compared. Reported outcomes after transcatheter aortic valve implantation were compared with those of a subgroup including only degenerative valve disease and first redo. Results The incidence of permanent pacemaker implantation was 2.9%. Longer hospital stay ( p = 0.01), preexisting rhythm disorders ( p < 0.001), complex prosthetic endocarditis ( p = 0.01), and complex redo ( p < 0.001) were associated with permanent pacemaker implantation. Although prostheses were sutured with continuous monofilament in the majority of cases (86%), interrupted pledgetted sutures were used more often in the pacemaker group ( p = 0.002). In the subgroup analysis, the incidence of permanent pacemaker implantation was 2%; preexisting rhythm disorders and the suture technique were still major risk factors. Conclusion Permanent pacemaker implantation depends on etiology, preexisting rhythm disorders, and suture technique, and the 2% incidence compares favorably with the reported 5- to 10-fold higher incidence after transcatheter aortic valve implantation. Cost analysis should take this into account. Often dismissed as minor complication, permanent pacemaker implantation increases the risks of endocarditis, impaired myocardial recovery, and higher mortality if associated with prosthesis regurgitation.

Clinical and hemodynamic results after direct transcatheter aortic valve replacement versus pre-implantation balloon aortic valvuloplasty: A case-matched analysis.

PubMed

Ferrera, Carlos; Nombela-Franco, Luis; Garcia, Eulogio; Jimenez-Quevedo, Pilar; Biagioni, Corina; Gonzalo, Nieves; Nuñez-Gil, Ivan; Viana-Tejedor, Ana; Salinas, Pablo; Alberto de Agustin, Jose; Almeria, Carlos; Islas, Fabian; Perez de Isla, Leopoldo; Fernandez-Perez, Cristina; Escaned, Javier; Fernández-Ortiz, Antonio; Macaya, Carlos

2017-11-01

To evaluate the safety and midterm hemodynamic results of direct transcatheter aortic valve replacement (TAVR) without pre-implantation balloon aortic valvuloplasty (BAV). BAV was considered a mandatory previous step in TAVR procedures. A total of 339 consecutive patients who underwent transfemoral TAVR were prospectively selected. A 1:1 matching was conducted, pairing age, prosthesis type (self-expandable or balloon expandable) and size, and valve calcification grade (48% with moderate to severe valve calcification). Finally, 102 pairs (102 patients with previous BAV and 102 without BAV) were obtained. Direct TAVR was feasible in all patients without any crossover to BAV group. Device success was achieved in 91.2% and 90.2% of cases in direct TAVR and pre-BAV groups (P = 0.810), respectively, without any differences in balloon postdilation rate and residual aortic regurgitation. The amount of contrast agent, acute kidney injury and myocardial injury was significantly lower in the direct implantation group (P < 0.05). No differences were found in 30-day and 1-year mortality between both groups (4.9% vs. 9.8%, P = 0.177 and 14.0% vs. 23.8%, P = 0.771, respectively). Hemodynamic parameters remained stable after 1-year follow-up in both groups. Direct transfemoral TAVR without prior BAV was safe in patients with calcified severe aortic stenosis. Pre-implantation BAV could be omitted in patients undergoing TAVR, without influence in procedure success rate, and subsequent patients' clinical course and valve hemodynamic performance. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Long-Term Durability of Bioprosthetic Aortic Valves: Implications From 12,569 Implants

PubMed Central

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.

2016-01-01

Background 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). Methods 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. Results 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. Conclusions 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. PMID:25662439

Continuous PECS II block for postoperative analgesia in patients undergoing transapical transcatheter aortic valve implantation.

PubMed

Shakuo, Tomoharu; Kakumoto, Shinichi; Kuribayashi, Junya; Oe, Katsunori; Seo, Katsuhiro

2017-01-01

It has been reported that PECS II block can alleviate postoperative pain following transapical transcatheter aortic valve implantation (TA-TAVI). However, the effectiveness of continuous PECS II block with catheterization has not yet been reported on the postoperative pain in patients undergoing TA-TAVI. We experienced two cases of TA-TAVI who received PECS II block with catheterization to manage postoperative pain. In the first case, a bolus injection for intraoperative pain and subsequent catheterization were performed before the implantation. However, the patient developed severe pain postoperatively in spite of the continuous block due to displacement of the catheter. In the second case, a bolus injection and the catheterization for the continuous block were performed before and after the implantation, respectively, which provided high-quality pain control. Continuous PECS II block may be useful to control perioperative pain associated with TA-TAVI. The insertion of the catheter after the implantation could be useful to avoid its displacement during the surgery.

Late complications in patients with Björk-Shiley and St. Jude Medical heart valve replacement.

PubMed

Horstkotte, D; Körfer, R; Seipel, L; Bircks, W; Loogen, F

1983-09-01

Valve-related complications after Björk-Shiley mitral valve implantation (n = 475), aortic valve implantation (n = 424), or mitral-aortic valve implantation (n = 119) were compared with those after St. Jude Medical mitral valve replacement (n = 173), aortic valve replacement (n = 152), or mitral-aortic valve replacement (n = 69). All patients were placed on anticoagulant therapy with phenprocoumon early after operation. All patients had a comparable follow-up time of approximately 23 months, which showed that cumulative thromboembolic rates were significantly higher after St. Jude valve implantation than after Björk-Shiley valve implantation. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2.2%), or prosthetic valve endocarditis with perivalvular regurgitation (0.46%). One Björk-Shiley mitral valve prosthesis had to be replaced because of fracture of the outlet strut. Without significant intergroup differences, hemorrhage due to anticoagulant treatment was the most frequent complication. Thromboembolic complications were significantly more frequent after Björk-Shiley mitral, aortic, and double valve replacements than after St. Jude valve implantation. This may lead to consideration of changes in the prophylaxis of thrombus formations in the St. Jude valve, especially in aortic valve replacements, in patients with sinus rhythm.

Cardiovascular effects of right ventricle-pulmonary artery valved conduit implantation in experimental pulmonic stenosis.

PubMed

Saida, Yuuto; Tanaka, Ryou; Fukushima, Ryuji; Hoshi, Katsuichiro; Hira, Satoshi; Soda, Aiko; Iizuka, Tomoya; Ishikawa, Taisuke; Nishimura, Taiki; Yamane, Yoshihisa

2009-04-01

Right ventricle (RV)-pulmonary artery (PA) valved conduit (RPVC) implantation decreases RV systolic pressure in pulmonic stenosis (PS) by forming a bypass route between the RV and the PA. The present study evaluates valved conduits derived from canine aortae in a canine model of PS produced by pulmonary artery banding (PAB). Pulmonary stenosis was elicited using PAB in 10 conditioned beagles aged 8 months. Twelve weeks after PAB, the dogs were assigned to one group that did not undergo surgical intervention and another that underwent RPVC using denacol-treated canine aortic valved grafts (PAB+RPVC). Twelve weeks later, the rate of change in the RV-PA systolic pressure gradient was significantly decreased in the PAB+RPVC, compared with the PAB group (60.5 +/- 16.7% vs. 108.9 +/- 22.9%; p<0.01). In addition, the end-diastolic RV free wall thickness (RVFWd) was significantly reduced in the PAB+RPVC, compared with the PAB group (8.2 +/- 0.2 vs. 9.4 +/- 0.7 mm; p<0.05). Thereafter, regurgitation was not evident beyond the conduit valve and the decrease in RV pressure overload induced by RPVC was confirmed. The present results indicate that RPVC can be performed under a beating heart without cardiopulmonary bypass and adapted to dogs with various types of PS, including "supra valvular" PS or PS accompanied by dysplasia of the pulmonary valve. Therefore, we consider that this method is useful for treating PS in small animals.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study.

PubMed

Piazza, Nicolo; Wenaweser, Peter; van Gameren, Menno; Pilgrim, Thomas; Tzikas, Apostolos; Tsikas, Apostolos; Otten, Amber; Nuis, Rutger; Onuma, Yoshinobu; Cheng, Jin Ming; Kappetein, A Pieter; Boersma, Eric; Juni, Peter; de Jaegere, Peter; Windecker, Stephan; Serruys, Patrick W

2010-02-01

Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or "inoperable" patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% +/- 13.9% vs STS 6.7% +/- 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES > or =15%, 16% had an STS > or =10%, and 40% had an LES > or =20% or STS > or =10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making. Copyright (c) 2010 Mosby, Inc. All rights

Cracking a tricuspid perimount bioprosthesis to optimize a second transcatheter sapien valve-in-valve placement.

PubMed

Brown, Stephen C; Cools, Bjorn; Gewillig, Marc

2016-09-01

Bioprosthetic valves degenerate over time. Transcatheter valve-in-valve procedures have become an attractive alternative to surgery. However, every valve increasingly diminishes the diameter of the valvar orifice. We report a 12-year-old female who had a previous transcatheter tricuspid valve-in-valve procedure; cracking the ring of a Carpentier Edwards Perimount valve by means of an ultrahigh pressure balloon allowed implantation of a further larger percutaneous valve. The advantage of this novel approach permits enlarging the inner valve diameter and may facilitate future interventions and prolong time to surgery. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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

PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).

PubMed

Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

2012-08-01

Transapical (TA) aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN XT™ prosthesis in a prospective multicentre clinical trial. A total of 150 patients (age: 81.6 ± 5.8 years; 40.7% female) were included. Prosthetic valves (diameter: 23 mm (n = 36), 26 mm (n = 57) and 29 mm (n = 57)) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3 ± 7.0%, and mean STS score 7.5 ± 4.4%. All patients gave written informed consent. Off-pump AVI was performed using femoral arterial and venous access wires as a safety net. All but two patients received TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary cardiopulmonary bypass support. Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring rethoracotomy in four, respiratory complication requiring reintubation in eight and sepsis in four patients, respectively. Thirty-day mortality was 13 (8.7%) for the total cohort and 2/57 (3.5%) for patients receiving the 29-mm valve, respectively. Echocardiography at discharge showed none or trivial aortic incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly paravalvular and ≥ 2+ in 7% of patients. One patient required reoperation for AI within 30 days. The PREVAIL TA multicentre trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN XT™ prosthesis and its second-generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT™ valve for the benefit of high-risk elderly patients.

Initial experience with xenograft bioconduit for the treatment of complex prosthetic valve endocarditis.

PubMed

Roubelakis, Apostolos; Karangelis, Dimos; Sadeque, Syed; Yanagawa, Bobby; Modi, Amit; Barlow, Clifford W; Livesey, Steven A; Ohri, Sunil K

2017-07-01

The treatment of complex prosthetic valve endocarditis (PVE) with aortic root abscess remains a surgical challenge. Several studies support the use of biological tissues to minimize the risk of recurrent infection. We present our initial surgical experience with the use of an aortic xenograft conduit for aortic valve and root replacement. Between October 2013 and August 2015, 15 xenograft bioconduits were implanted for complex PVE with abscess (13.3% female). In 6 patients, concomitant procedures were performed: coronary bypass (n=1), mitral valve replacement (n=5) and tricuspid annuloplasty (n=1). The mean age at operation was 60.3±15.5 years. The mean Logistic European system for cardiac operating risk evaluation (EuroSCORE) was 46.6±23.6. The median follow-up time was 607±328 days (range: 172-1074 days). There were two in-hospital deaths (14.3% mortality), two strokes (14.3%) and seven patients required permanent pacemaker insertion for conduction abnormalities (46.7%). The mean length of hospital stay was 26 days. At pre-discharge echocardiography, the conduit mean gradient was 9.3±3.3mmHg and there was either none (n=6), trace (n=6) or mild aortic insufficiency (n=1). There was no incidence of mid-term death, prosthesis-related complications or recurrent endocarditis. Xenograft bioconduits may be safe and effective for aortic valve and root replacement for complex PVE with aortic root abscess. Although excess early mortality reflects the complexity of the patient population, there was good valve hemodynamics, with no incidence of recurrent endocarditis or prosthesis failure in the mid-term. Our data support the continued use and evaluation of this biological prosthesis in this high-risk patient cohort.

Catheter-based tricuspid valve replacement: first experimental data of a newly designed bileaflet stent graft prosthesis.

PubMed

Lausberg, Henning F; Gryszkiewicz, Rafal; Kuetting, Maximilian; Baumgaertner, Moritz; Centola, Marcos; Wendel, Hans-Peter; Nowak-Machen, Martina; Schibilsky, David; Kruger, Tobias; Schlensak, Christian

2017-07-01

Moderate or severe degree tricuspid valve regurgitation (TVR) is associated with high rates of morbidity and mortality. Surgical correction as the only therapeutic option offers unsatisfactory results. Recently, several interventional procedures have been introduced clinically in a limited cohort. We present our initial experiments with an innovative interventional valved stent graft for treatment of TVR. A newly designed porcine pericardium-covered nitinol stent graft with a lateral bicuspid valve was adapted to size in a cadaver study. After haemodynamic testing in an ex vivo perfusion setup, vascular access, valve delivery and function were investigated in an ovine animal model ( n  = 7). The device was implanted successfully in all animals. Vascular access was established surgically via the femoral vein without any vascular complications. Angiography demonstrated the correct position of the device with proper sealing of both venae cavae in 6 animals. In 1 extremely large animal, the position of the device was considered too cranial but still acceptable. Correct valve function was verified in all animals by both angiography and echocardiography. There were no persistent arrhythmias other than during valve implant. All animals survived the implant procedure and were sacrificed electively. This study demonstrated that this new valved stent graft could be delivered safely with correct positioning and valve function in this ovine model. Further long-term studies in animals implanted with the device after creation of tricuspid regurgitation are necessary to prove the haemodynamic benefit of this procedure. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

FLUID MECHANICS OF ARTIFICIAL HEART VALVES

PubMed Central

Dasi, Lakshmi P; Simon, Helene A; Sucosky, Philippe; Yoganathan, Ajit P

2009-01-01

SUMMARY 1. Artificial heart valves have been in use for over five decades to replace diseased heart valves. Since the first heart valve replacement performed with a caged-ball valve, more than 50 valve designs have been developed, differing principally in valve geometry, number of leaflets and material. To date, all artificial heart valves are plagued with complications associated with haemolysis, coagulation for mechanical heart valves and leaflet tearing for tissue-based valve prosthesis. For mechanical heart valves, these complications are believed to be associated with non-physiological blood flow patterns. 2. In the present review, we provide a bird’s-eye view of fluid mechanics for the major artificial heart valve types and highlight how the engineering approach has shaped this rapidly diversifying area of research. 3. Mechanical heart valve designs have evolved significantly, with the most recent designs providing relatively superior haemodynamics with very low aerodynamic resistance. However, high shearing of blood cells and platelets still pose significant design challenges and patients must undergo life-long anticoagulation therapy. Bioprosthetic or tissue valves do not require anticoagulants due to their distinct similarity to the native valve geometry and haemodynamics, but many of these valves fail structurally within the first 10–15 years of implantation. 4. These shortcomings have directed present and future research in three main directions in attempts to design superior artificial valves: (i) engineering living tissue heart valves; (ii) development of advanced computational tools; and (iii) blood experiments to establish the link between flow and blood damage. PMID:19220329

Fluid mechanics of artificial heart valves.

PubMed

Dasi, Lakshmi P; Simon, Helene A; Sucosky, Philippe; Yoganathan, Ajit P

2009-02-01

1. Artificial heart valves have been in use for over five decades to replace diseased heart valves. Since the first heart valve replacement performed with a caged-ball valve, more than 50 valve designs have been developed, differing principally in valve geometry, number of leaflets and material. To date, all artificial heart valves are plagued with complications associated with haemolysis, coagulation for mechanical heart valves and leaflet tearing for tissue-based valve prosthesis. For mechanical heart valves, these complications are believed to be associated with non-physiological blood flow patterns. 2. In the present review, we provide a bird's-eye view of fluid mechanics for the major artificial heart valve types and highlight how the engineering approach has shaped this rapidly diversifying area of research. 3. Mechanical heart valve designs have evolved significantly, with the most recent designs providing relatively superior haemodynamics with very low aerodynamic resistance. However, high shearing of blood cells and platelets still pose significant design challenges and patients must undergo life-long anticoagulation therapy. Bioprosthetic or tissue valves do not require anticoagulants due to their distinct similarity to the native valve geometry and haemodynamics, but many of these valves fail structurally within the first 10-15 years of implantation. 4. These shortcomings have directed present and future research in three main directions in attempts to design superior artificial valves: (i) engineering living tissue heart valves; (ii) development of advanced computational tools; and (iii) blood experiments to establish the link between flow and blood damage.

Percutaneous re-revalvulation of the tricuspid valve.

PubMed

Gewillig, Marc; Dubois, Christophe

2011-04-01

We report a successful percutaneous revalvulation of a dysfunctional tricuspid bioprothesis in an 8-year-old child. Five years after implanting a 25-mm Carpentier-Edwards valve in the tricuspid position, the prosthesis showed significant dysfunction with clinical right heart failure. A 26-mm Edwards-Sapien XT inverted aortic valve was successfully implanted through a 19F sheath using a jugular approach. Such procedure can significantly postpone the need for surgical replacement of a biological valve. Copyright © 2011 Wiley-Liss, Inc.

Implantation of the Medtronic Harmony Transcatheter Pulmonary Valve Improves Right Ventricular Size and Function in an Ovine Model of Postoperative Chronic Pulmonary Insufficiency.

PubMed

Schoonbeek, Rosanne C; Takebayashi, Satoshi; Aoki, Chikashi; Shimaoka, Toru; Harris, Matthew A; Fu, Gregory L; Kim, Timothy S; Dori, Yoav; McGarvey, Jeremy; Litt, Harold; Bouma, Wobbe; Zsido, Gerald; Glatz, Andrew C; Rome, Jonathan J; Gorman, Robert C; Gorman, Joseph H; Gillespie, Matthew J

2016-10-01

Pulmonary insufficiency is the nexus of late morbidity and mortality after transannular patch repair of tetralogy of Fallot. This study aimed to establish the feasibility of implantation of the novel Medtronic Harmony transcatheter pulmonary valve (hTPV) and to assess its effect on pulmonary insufficiency and ventricular function in an ovine model of chronic postoperative pulmonary insufficiency. Thirteen sheep underwent baseline cardiac magnetic resonance imaging, surgical pulmonary valvectomy, and transannular patch repair. One month after transannular patch repair, the hTPV was implanted, followed by serial magnetic resonance imaging and computed tomography imaging at 1, 5, and 8 month(s). hTPV implantation was successful in 11 animals (85%). There were 2 procedural deaths related to ventricular fibrillation. Seven animals survived the entire follow-up protocol, 5 with functioning hTPV devices. Two animals had occlusion of hTPV with aneurysm of main pulmonary artery. A strong decline in pulmonary regurgitant fraction was observed after hTPV implantation (40.5% versus 8.3%; P=0.011). Right ventricular end diastolic volume increased by 49.4% after transannular patch repair (62.3-93.1 mL/m 2 ; P=0.028) but was reversed to baseline values after hTPV implantation (to 65.1 mL/m 2 at 8 months, P=0.045). Both right ventricular ejection fraction and left ventricular ejection fraction were preserved after hTPV implantation. hTPV implantation is feasible, significantly reduces pulmonary regurgitant fraction, facilitates right ventricular volume improvements, and preserves biventricular function in an ovine model of chronic pulmonary insufficiency. This percutaneous strategy could potentially offer an alternative for standard surgical pulmonary valve replacement in dilated right ventricular outflow tracts, permitting lower risk, nonsurgical pulmonary valve replacement in previously prohibitive anatomies. © 2016 American Heart Association, Inc.

Novel self-expandable, stent-based transcatheter pulmonic valve: a preclinical animal study.

PubMed

Kim, Gi Beom; Lim, Hong-Gook; Kim, Yong Jin; Choi, Eun Young; Kwon, Bo Sang; Jeong, Saeromi

2014-04-15

Because transcatheter implantation of pulmonary valve is indicated for limited-size dysfunctional right ventricular outflow tract only as a balloon-expandable stent, we investigated the feasibility of a large-diameter self-expandable valved stent and the durability of the valve after >6 months. We made a nitinol-wire-based, self-expandable valved stent with leaflets made from porcine pericardium. The porcine pericardium was treated with α-galactosidase, glutaraldehyde, and glycine after decellularization. After cutting the inguinal or cervical area, we implanted a valved stent in 12 sheep through the femoral or jugular vein by using an 18-Fr delivery catheter, controlling the catheter handles and hook block under fluoroscopic and echocardiographic guidance. The mean body weight of sheep was 43.9 kg. We successfully implanted valved stents (diameter: 24 mm in 7 sheep, 26 mm in 5 sheep) in good position in 8 sheep, in the main pulmonary artery (PA) in 2 sheep, and in the right ventricular outlet tract (RVOT) in 2 sheep. We sacrificed 8 sheep (6 sheep in good position, 1 sheep in the main PA, and 1 sheep in the RVOT) after >6 months. Five of the 6 sheep implanted in good position showed well-preserved valve morphology at the time of sacrifice. Histologic findings after routine sacrifice showed well-maintained collagen wave structure and no visible calcification in all explanted valve leaflets. Transcatheter implantation of a nitinol-wire-based, self-expandable valved stent in the pulmonic valve was feasible, and stents implanted in good position showed well-preserved valve leaflets with functional competence in the mid-term results. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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.

[Transcatheter aortic valve replacement].

PubMed

Sawa, Yoshiki

2014-07-01

While transcatheter aortic valve replacement( TAVR) has spread rapidly all over the world for highrisk patients with severe aortic stenosis (AS), SAPIEN XT was approved in Japan in October 2013. Since that, approximately 400 TAVR cases were performed in Japan. In our institute, we have performed 164 cases since first case in Japan in 2009 and have achieved satisfactory early results(30-day mortality:1.2%). At the same time, however, simultaneously various TAVR-related complications including a paravalvular leak, stroke, vascular complications, and coronary obstruction were observed. A reduction in the incidence and severity of these complications had led technical improvements in various new devices(2nd generation TAVR device such as the SAPIEN 3, ACURATE, and JenaValve) and in implantation techniques including repositioning/recapturing features, paravalvular sealing technologies, and prevention of coronary obstruction. Furthermore, there is also increasing experience with special indications for TAVR such as pure aortic valve insufficiency or valve-in-valve techniques. Currently, an increasing number of publications of midterm results demonstrate good prosthetic valve function and durability, with good quality of life and low morbidity after TAVR. There are also some randomized trials such as PARTNER 2 or SURTAVI to investigate potential benefits of TAVR for intermediate-risk patients. These improvements in the TAVR devices promises the expansion of TAVR towards the treatment of lower-risk patients in the near future.

Strut fracture of Björk-Shiley convexo-concave valve in Japan--risk of small valve size--.

PubMed

Watarida, S; Shiraishi, S; Nishi, T; Imura, M; Yamamoto, Y; Hirokawa, R; Fujita, M

2001-08-01

The Björk-Shiley convexo-concave (BSCC) prosthetic valve was introduced in 1979. Between 1979 and 1986, approximately 86,000 BSCC valves were implanted. By December 31, 1994, 564 complete strut fractures had been reported to the manufacture. We experienced a case of an outlet strut fracture and investigated the risk of BSCC prosthetic valve fractures in Japan. To investigate the risk factor of a strut fracture in Japan, we investigated published cases of strut fractures. Between 1979 and 1986, 2021 BSCC valves were implanted in Japan. By January 31, 2000, 11 complete strut fractures of 60-degree BSCC valves including our case had occurred. The patients were eight males and three females. The average age at valve replacement was 42.4+/-8.1 years, and nine of eleven (81.8%) were patients < 50 years-old. The average age of the patients when the BSCC valve fractured was 47.7+/-6.4 years, and eight of eleven (72.7%) were patients <= 50 years old. All patients were implanted in the mitral position. The sizes of the BSCC valve were 27 mm (n=5) (45.5%), 29 mm (n=3) (27.2%), and 31 mm (n=3) (27.2%). Four patients died and seven patients survived. Although only 11 BSCC valve struts fractured and statistical analysis could not be performed, our findings suggest that the high risk group for a strut fracture in Japan is young male patients with a mitral valve, >= 27 mm in size with BSCC models manufactured before March 1982. When following-up patients with BSCC models manufactured before March 1982, the possibility of a strut fracture in all BSCC valve sizes should be kept in mind.

Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve - rationale and design of a multicenter registry (EASE-IT).

PubMed

Bramlage, Peter; Strauch, Justus; Schröfel, Holger

2014-11-18

In patients with severe calcific aortic stenosis, balloon aortic valvuloplasty (BAV) is routinely performed in order to pre-dilate the stenosed aortic valve prior to transcatheter aortic valve implantation (TAVI). Although pre-dilation is considered to be essential for the preparation of the valve landing zone, there is no clear evidence to support its clinical value. In contrast, BAV has been suggested to be linked to several complications. Notably, while preliminary evidence has supported the feasibility and safety of TAVI without pre-dilation, larger studies directly comparing the benefit/risk profile of TAVI in the presence and absence of pre-dilation are required. Therefore, a prospective, two-armed, multicenter registry (EASE-IT) was designed to obtain essential data concerning procedural success rates, adverse events, and mortality in a large cohort of patients undergoing transapical (TA)-TAVI using the Edwards SAPIEN 3 balloon expandable heart valves with and without pre-ballooning. Data provided by EASE-IT will be used to assess the relevance of BAV during the TAVI procedure and to investigate associations between patient characteristics and outcomes. Therefore, results obtained from the EASE-IT registry could contribute to reduced rates of TAVI-associated morbidity and mortality in patients with severe, calcific aortic stenosis. ClinicalTrials.gov Identifier: NCT02127580.

Impact of different aortic valve calcification patterns on the outcome of transcatheter aortic valve implantation: A finite element study.

PubMed

Sturla, Francesco; Ronzoni, Mattia; Vitali, Mattia; Dimasi, Annalisa; Vismara, Riccardo; Preston-Maher, Georgia; Burriesci, Gaetano; Votta, Emiliano; Redaelli, Alberto

2016-08-16

Transcatheter aortic valve implantation (TAVI) can treat symptomatic patients with calcific aortic stenosis. However, the severity and distribution of the calcification of valve leaflets can impair the TAVI efficacy. Here we tackle this issue from a biomechanical standpoint, by finite element simulation of a widely adopted balloon-expandable TAVI in three models representing the aortic root with different scenarios of calcific aortic stenosis. We developed a modeling approach realistically accounting for aortic root pressurization and complex anatomy, detailed calcification patterns, and for the actual stent deployment through balloon-expansion. Numerical results highlighted the dependency on the specific calcification pattern of the "dog-boning" of the stent. Also, local stent distortions were associated with leaflet calcifications, and led to localized gaps between the TAVI stent and the aortic tissues, with potential implications in terms of paravalvular leakage. High stresses were found on calcium deposits, which may be a risk factor for stroke; their magnitude and the extent of the affected regions substantially increased for the case of an "arc-shaped" calcification, running from commissure to commissure. Moreover, high stresses due to the interaction between the aortic wall and the leaflet calcifications were computed in the annular region, suggesting an increased risk for annular damage. Our analyses suggest a relation between the alteration of the stresses in the native anatomical components and prosthetic implant with the presence and distribution of relevant calcifications. This alteration is dependent on the patient-specific features of the calcific aortic stenosis and may be a relevant indicator of suboptimal TAVI results. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

First percutaneous Micra leadless pacemaker implantation and tricuspid valve repair with MitraClip NT for lead-associated severe tricuspid regurgitation.

PubMed

Tang, Gilbert H L; Kaple, Ryan; Cohen, Martin; Dutta, Tanya; Undemir, Cenap; Ahmad, Hasan; Poniros, Angelica; Bennett, Joanne; Feng, Cheng; Lansman, Steven

2017-02-03

Pacemaker lead-associated severe tricuspid regurgitation (TR) can lead to right heart failure and poor prognosis. Surgery in these patients carries significant morbidities. We describe a successful treatment of symptomatic severe TR by leadless pacemaker implantation followed by tricuspid valve (TV) repair with the MitraClip NT. A 71-year-old frail female with poor functional status, chronic atrial fibrillation and permanent pacemaker implantation in 2012 presented with symptomatic moderate-severe mitral regurgitation (MR) and severe TR with the pacemaker lead as the culprit. She was deemed extreme risk for double valve surgery and, because of her pacemaker dependency, the decision was to stage her interventions first with transcatheter mitral repair, then laser lead extraction and leadless pacemaker implantation to free the TV from tethering, then TV repair. An obstructive LAD lesion was identified and treated during mitral repair with the MitraClip NT. The Micra leadless pacemaker implantation and subsequent TV repair with the MitraClip NT were successful and the patient's MR improved to mild and TR to moderate, respectively. We report here a first successful transcatheter strategy to treat lead-associated severe TR by leadless pacemaker and MitraClip. Removing the pacemaker lead relieved leaflet tethering and improved the reparability of the TV.

Mitral valve replacement for mitral stenosis: A 15-year single center experience.

PubMed

Al Mosa, Alqasem F; Omair, Aamir; Arifi, Ahmed A; Najm, Hani K

2016-10-01

Mitral valve replacement with either a bioprosthetic or a mechanical valve is the treatment of choice for severe mitral stenosis. However, choosing a valve implant type is still a subject of debate. This study aimed to evaluate and compare the early and late outcomes of mitral valve replacement [mechanical (MMV) vs. bioprosthetic (BMV)] for severe mitral stenosis. A retrospective cohort study was performed on data involving mitral stenosis patients who have undergone mitral valve replacement with either BMV (n = 50) or MMV (n = 145) valves from 1999 to 2012. Data were collected from the patients' records and follow-up through telephone calls. Data were analyzed for early and late mortality, New York Heart Association (NYHA) functional classes, stroke, pre- and postoperative echocardiographic findings, early and late valve-related complications, and survival. Chi-square test, logistic regression, Kaplan-Meier curve, and dependent proportions tests were some of the tests employed in the analysis. A total of 195 patients were included in the study with a 30-day follow-up echocardiogram available for 190 patients (97.5%), while 103 (53%) were available for follow-up over the telephone. One patient died early postoperatively; twelve patients died late in the postoperative period, six in the bioprosthesis group and six in the mechanical group. The late mortality had a significant association with postoperative stroke (p < 0.001) and postoperative NYHA Classes III and IV (p = 0.002). Postoperative NYHA class was significantly associated with age (p = 0.003), pulmonary disease (p = 0.02), mitral valve implant type (p = 0.01), and postoperative stroke (p = 0.02); 14 patients had strokes in the mechanical (9) and in the bioprosthetic (5) groups. NYHA classes were significantly better after the replacement surgeries (p < 0.001). BMV were significantly associated with worse survival (p = 0.03), worse NYHA postoperatively (p = 0.01), and more reoperations

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

PubMed

Miraftabi, Arezoo; Nilforushan, Naveed

2016-01-01

To report a complication pertaining to subconjunctival bevacizumab injection as an adjunct to Ahmed Glaucoma Valve (AGV) implantation. 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. The potential adverse effect of subconjunctival bevacizumab injection on wound healing should be considered in AGV surgery.

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.

Valve-in-valve using an Edwards Sapien XT into a JenaValve in a patient with a low originating left coronary artery and a heavily calcified aorta.

PubMed

Fujita, Buntaro; Scholtz, Smita; Ensminger, Stephan

2016-04-01

Coronary obstruction during transcatheter aortic valve implantation is a potentially life-threatening complication. Most of the widely used transcatheter heart valves require a certain distance between the basal aortic annular plane and the origins of the coronary arteries. We report the case of a successful valve-in-valve procedure with an Edwards SAPIEN XT valve into a JenaValve as a bail-out procedure in a patient with a low originating left coronary artery and a heavily calcified aorta. © 2015 Wiley Periodicals, Inc.

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.

The utility of trans-catheter aortic valve replacement after commercialization: does the European experience provide a glimpse into the future use of this technology in the United States?

PubMed

Linke, Axel; Walther, Thomas; Schuler, Gerhard

2010-03-01

Treatment of aortic stenosis remains challenging in older individuals, as their perioperative mortality for open heart surgery is increased due to comorbidities. Transcatheter aortic valve implantation using the CoreValve ReValving System (Medtronic, Minneapolis, USA) and the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifescience, Irvine, California, USA) represents an alternative to conventional valve replacement in elderly patients that have a high risk for conventional surgery. This article summarizes the evidence-base from recent clinical trials. The early results of these landmark studies suggest that transcatheter aortic valve implantation with either one of the prosthesis is feasible, safe, improves hemodynamics and, therefore, might be an alternative to conventional aortic valve replacement in very high-risk patients. However, all of the available transcatheter heart valves have certain disadvantages, limiting their use in daily clinical practice. The process of decision making, which valve to use and which access route to choose is illustrated in this article through clinical case scenarios. Additionally, the lessons learned thus far from the European perspective and the potential impact on the future use in the US are discussed. Despite of the progress in this field, we are still lacking an optimal transcatheter heart valve. Once it is available, we can take the plunge to compare transcatheter valve implantation with convention surgery in severe aortic stenosis!

Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation: Predictors of functional and psychocognitive recovery.

PubMed

Eichler, Sarah; Salzwedel, Annett; Reibis, Rona; Nothroff, Jörg; Harnath, Axel; Schikora, Martin; Butter, Christian; Wegscheider, Karl; Völler, Heinz

2017-02-01

Background In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results One hundred and thirty-six patients (80.6 ± 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 ± 65.3 m ( p < 0.001) and 8.0 ± 14.9 watts ( p < 0.001), respectively. An improvement in SF-12 (physical 2.5 ± 8.7, p = 0.001, mental 3.4 ± 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday

Transcatheter mitral valve repair in osteogenesis imperfecta associated mitral valve regurgitation.

PubMed

van der Kley, Frank; Delgado, Victoria; Ajmone Marsan, Nina; Schalij, Martin J

2014-08-01

Osteogenesis imperfecta is associated with increased prevalence of significant mitral valve regurgitation. Surgical mitral valve repair and replacement are feasible but are associated with increased risk of bleeding and dehiscence of implanted valves may occur more frequently. The present case report describes the outcomes of transcatheter mitral valve repair in a patient with osteogenesis imperfecta. A 60 year-old patient with osteogenesis imperfecta and associated symptomatic moderate to severe mitral regurgitation underwent transthoracic echocardiography which showed a nondilated left ventricle with preserved systolic function and moderate to severe mitral regurgitation. On transoesophageal echocardiography the regurgitant jet originated between the anterolateral scallops of the anterior and posterior leaflets (A1-P1). Considering the comorbidities associated with osteogenesis imperfecta the patient was accepted for transcatheter mitral valve repair using the Mitraclip device (Abbott vascular, Menlo, CA). Under fluoroscopy and 3D transoesophageal echocardiography guidance, a Mitraclip device was implanted between the anterolateral and central scallops with significant reduction of mitral regurgitation. The postoperative evolution was uneventful. At one month follow-up, transthoracic echocardiography showed a stable position of the Mitraclip device with no mitral regurgitation. Transcatheter mitral valve repair is feasible and safe in patients with osteogenesis imperfecta and associated symptomatic significant mitral regurgitation. Copyright © 2014 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Recellularization of decellularized heart valves: Progress toward the tissue-engineered heart valve

PubMed Central

VeDepo, Mitchell C; Detamore, Michael S; Hopkins, Richard A; Converse, Gabriel L

2017-01-01

The tissue-engineered heart valve portends a new era in the field of valve replacement. Decellularized heart valves are of great interest as a scaffold for the tissue-engineered heart valve due to their naturally bioactive composition, clinical relevance as a stand-alone implant, and partial recellularization in vivo. However, a significant challenge remains in realizing the tissue-engineered heart valve: assuring consistent recellularization of the entire valve leaflets by phenotypically appropriate cells. Many creative strategies have pursued complete biological valve recellularization; however, identifying the optimal recellularization method, including in situ or in vitro recellularization and chemical and/or mechanical conditioning, has proven difficult. Furthermore, while many studies have focused on individual parameters for increasing valve interstitial recellularization, a general understanding of the interacting dynamics is likely necessary to achieve success. Therefore, the purpose of this review is to explore and compare the various processing strategies used for the decellularization and subsequent recellularization of tissue-engineered heart valves. PMID:28890780

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

Transcatheter aortic valve implantation and off-pump coronary artery bypass surgery: an effective hybrid procedure in selected patients.

PubMed

Mayr, Benedikt; Firschke, Christian; Erlebach, Magdalena; Bleiziffer, Sabine; Krane, Markus; Joner, Michael; Herold, Ulf; Nöbauer, Christian; Lange, Rüdiger; Deutsch, Marcus-André

2018-02-26

Simultaneous surgical off-pump coronary revascularization and transcatheter aortic valve implantation (TAVI) as a hybrid procedure may be a therapeutic option for patients with a TAVI indication who are not suitable for percutaneous coronary intervention and for patients who have an indication for combined surgical aortic valve implantation and coronary artery bypass grafting but present with a porcelain aorta. Early outcomes of these patients are analysed in this study. From February 2011 to April 2017, hybrid TAVI/off-pump coronary artery bypass (OPCAB) was performed in 12 (60%) patients, hybrid TAVI/minimally invasive direct coronary artery bypass in 6 (30%) patients and staged TAVI/OPCAB in 2 (10%) patients. Endpoints of this study were 30-day mortality, device success and postoperative adverse events as defined by the updated Valve Academic Research Consortium (VARC-2). The median age at the time of surgery was 77 years [interquartile range (IQR), 70-81] with a median logistic EuroSCORE and Society of Thoracic Surgeons' Predicted Risk score of 16.1% (IQR, 9.3-28.1) and 3.9% (IQR, 2.2-5.6), respectively. The median Synergy between PCI with Taxus and Cardiac Surgery score was 16.5 (IQR, 9.8-22.8). TAVI implantation routes were transaortic in 9 (45%) patients, transapical and transfemoral in 5 (25%) patients each and transsubclavian in 1 (5%) patient. Complete myocardial revascularization was achieved in 75% of patients. Device success rate was 100%. Paravalvular aortic regurgitation did not exceed mild in any patient. Stroke/transient ischaemic attack, vascular complications and myocardial infarction were not observed. Re-exploration for bleeding was required in 1 (5%) patient. Thirty-day mortality was 0%. Hybrid OPCAB/MIDCAB and TAVI prove to be a safe and effective alternative treatment option in selected higher risk patients.

Effectiveness of rivaroxaban for thromboprophylaxis of prosthetic heart valves in a porcine heterotopic valve model.

PubMed

Greiten, Lawrence E; McKellar, Stephen H; Rysavy, Joseph; Schaff, Hartzell V

2014-05-01

Warfarin is used to reduce the risk of stroke and thromboembolic complications in patients with mechanical heart valves. Yet, despite frequent blood testing, its poor pharmacokinetic and pharmacodynamic profiles often result in variable therapeutic levels. Rivaroxaban is a direct competitive factor Xa inhibitor that is taken orally. It inhibits the active site of factor Xa without the need for the cofactor antithrombin, and thus, its mechanism of action is differentiated from that of the fractionated heparins and indirect factor Xa inhibitors. No in vivo data exist regarding the effectiveness of rivaroxaban in preventing thromboembolic complications of mechanical heart valves. We tested the hypothesis that rivaroxaban is as effective as enoxaparin for thromboprophylaxis of mechanical valves that use a previously described heterotopic aortic valve porcine model. A modified bileaflet mechanical valved conduit that bypassed the native, ligated descending thoracic aorta was implanted into 30 swine. Postoperatively, the animals were randomly assigned to groups receiving no anticoagulation (n = 10), enoxaparin at 2 mg/kg subcutaneously twice daily (n = 10) or rivaroxaban at 2 mg/kg orally twice daily (n = 10). The amount of valve thrombus was measured on post-implantation day 30 as the primary end point. Quantitative evaluation of radiolabelled platelet deposition on the valve prostheses was done and embolic and haemorrhagic events were measured as secondary end points. Animals with no anticoagulation had a thrombus mean of 759.9 mg compared with 716.8 mg with enoxaparin treatment and 209.6 mg with rivaroxaban treatment (P = 0.05 for enoxaparin vs rivaroxaban). Similarly, the mean number of platelets deposited on the valve prosthesis was lower in the rivaroxaban group (6.13 × 10(9)) than in the enoxaparin group (3.03 × 10(10)) (P = 0.03). In this study, rivaroxaban was more effective than enoxaparin for short-term thromboprophylaxis of mechanical valve prosthetics in

Outcomes of Solo Smart valve in a single-center experience of 270 patients.

PubMed

Liu, Hao; Khani-Hanjani, Abbas; Yang, Siyuan; Wang, Wei; Sidhu, Surita; Mullen, John; Modry, Dennis; Wang, Shaohua

2018-04-03

The Solo Smart pericardial aortic valve has been widely used in Europe as an option for aortic valve replacement (AVR). We are reporting early and midterm clinical outcomes of AVR with the Solo Smart valve in a single North America center. This is a retrospective study of 270 consecutive patients who had AVR at Mazankowski Alberta Heart Institute from February 2011 to March 2015. Follow-up and echocardiographic data were collected retrospectively from electronic and paper charts. Univariate and multivariate analysis were performed to evaluate the results. The mean age was 71.2±10.0 years, 67.4% were male, and 79.3% had combined procedures. Mean STS Score was 4.18±3.91. Early mortality was 3.7% for the entire group and 0% for isolated aortic valve replacement group. Mean cross-clamp time for isolated AVR and AVR with concomitant procedure was 70.8±12.7min and 117.0±45.0min, respectively. Permanent pacemaker implantation was necessary in 2.2% of patients. Echocardiography demonstrated a reduction in mean gradients from 40.8±17.4mmHg to 7.6±3.7 mmHg and peak gradient from 72.5 ± 48.8 mmHg to 15.5±7.5 mmHg. The 1-, 3-, and 5- year overall survival was 93.0%, 86.5% and 75.9%, respectively. At 5 years, freedom from valve-related death was 92.4%, freedom from structural valve deterioration and freedom from aortic valve reoperation were 96.4% and 98%, respectively. The Solo Smart valve is safe and has excellent hemodynamic performance. Aortic valve reoperation and rates of valve-related adverse events during midterm follow-up were low.

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes

PubMed Central

Chew, Nicholas; Hon, Jimmy Kim Fatt; Yip, Wei Luen James; Chan, Siew Pang; Poh, Kian-Keong; Kong, William Kok-Fai; Teoh, Kristine Leok Kheng; Yeo, Tiong Cheng; Tan, Huay Cheem; Tay, Edgar Lik Wui

2017-01-01

INTRODUCTION Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. METHODS This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. RESULTS Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). CONCLUSION Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI. PMID:27516113

Mid-term study of transcatheter aortic valve implantation in an Asian population with severe aortic stenosis: two-year Valve Academic Research Consortium-2 outcomes.

PubMed

Chew, Nicholas; Hon, Jimmy Kim Fatt; Yip, Wei Luen James; Chan, Siew Pang; Poh, Kian-Keong; Kong, William Kok-Fai; Teoh, Kristine Leok Kheng; Yeo, Tiong Cheng; Tan, Huay Cheem; Tay, Edgar Lik Wui

2017-09-01

Transcatheter aortic valve implantation (TAVI) is an effective treatment for high-risk or inoperative patients with severe aortic stenosis. Given the unique characteristics of Asian populations, questions regarding mid-term outcomes in Asians undergoing TAVI have yet to be addressed. We evaluated the two-year clinical outcomes of TAVI in an Asian population using Valve Academic Research Consortium-2 definitions. This prospective study recruited 59 patients from a major academic medical centre in Singapore. The main outcomes were two-year survival rates, peri-procedural complications, symptom improvement, valvular function and assessment of learning curve. Mean age was 76.8 years (61.0% male), mean body surface area 1.6 m 2 and mean logistic EuroSCORE 18.7%. Survival was 93.2%, 86.0% and 79.1% at 30 days, one year and two years, respectively. At 30 days post TAVI, the rate of stroke was 1.7%, life-threatening bleeding 5.1%, acute kidney injury 25.0%, major vascular complication 5.1%, and new permanent pacemaker implantation 6.8%. 29.3% of TAVI patients were rehospitalised (47.1% cardiovascular-related) within one year. These composite outcomes were measured: device success (93.2%); early safety (79.7%); clinical efficacy (66.1%); and time-related valve safety (84.7%). Univariate analysis found these predictors of two-year all-cause mortality: logistic EuroSCORE (hazard ratio [HR] 1.07; p < 0.001); baseline estimated glomerular filtration rate (HR 0.97; p = 0.048); and acute kidney injury (HR 5.33; p = 0.022). Multivariate analysis identified non-transfemoral TAVI as a predictor of cardiovascular-related two-year mortality (HR 14.64; p = 0.008). Despite the unique clinical differences in Asian populations, this registry demonstrated favourable mid-term clinical and safety outcomes in Asians undergoing TAVI. Copyright: © Singapore Medical Association

Mechanical valve replacement in congenital heart disease.

PubMed

Fiane, A E; Lindberg, H L; Saatvedt, K; Svennevig, J L

1996-05-01

Mechanical valves are the prosthesis of choice in valve replacement in children. However, the problem of somatic growth leading to patient-valve mismatch remains present, and the appropriate anticoagulation regimen remains controversial. We present our experience of valve replacement in a young population over 20 years. Between 1972 and 1992, 48 patients (34 males and 14 females), mean age 11.2 years (range 0.4-27.4 years), underwent mechanical valve replacement at our institution. Aortic valve replacement was performed in 28 patients (58.3%), mitral valve replacement in 13 (27.1%), tricuspid valve replacement in six (12.5%) and pulmonary valve replacement in one patient (2.1%). The prostheses used were: St. Jude Medical (n = 2), Björk-Shiley (n = 14), Medtronic Hall (n = 16), Duromedics (n = 2) and CarboMedics (n = 14). Early mortality was 14.3%, 10.7% for aortic valve replacement and 30.8% for mitral valve replacement. Mean follow up for all patients was 8.3 years (range 0-22 years), with a total of 398 patient-years. Seven patients died during the follow up (17.1%). Survival after 10 years, including operative mortality, was 81% for aortic valve replacement, 33% for mitral valve replacement, 83% for tricuspid valve replacement and 100% for pulmonary valve replacement. All patients were anticoagulated with warfarin. In eight patients (16.7%) an antiplatelet drug (aspirin or dipyridamole) was added. Major events included paravalvular leak in six patients (1.5%/pty), valve thrombosis in five (mitral position in two, tricuspid in three) (1.3%/pty) and endocarditis in one patient (0.3%/pty). Minor thromboembolic events occurred in three patients (0.8%/pty) and minor hemorrhagic events in three (0.8%/pty). No patients developed hemolytic anemia and there was no case of structural failure. In our experience, mechanical prostheses in congenital heart disease were associated with significant morbidity and mortality, however long term survival after aortic valve

Characteristic Analysis and Experiment of a Dynamic Flow Balance Valve

NASA Astrophysics Data System (ADS)

Bin, Li; Song, Guo; Xuyao, Mao; Chao, Wu; Deman, Zhang; Jin, Shang; Yinshui, Liu

2017-12-01

Comprehensive characteristics of a dynamic flow balance valve of water system were analysed. The flow balance valve can change the drag efficient automatically according to the condition of system, and the effective control flowrate is constant in the range of job pressure. The structure of the flow balance valve was introduced, and the theoretical calculation formula for the variable opening of the valve core was derived. A rated pressure of 20kPa to 200kPa and a rated flowrate of 10m3/h were offered in the numerical work. Static and fluent CFX analyses show good behaviours: through the valve core structure optimization and improve design of the compressive spring, the dynamic flow balance valve can stabilize the flowrate of system evidently. And experiments show that the flow control accuracy is within 5%.

[Ahmed valve in glaucoma surgery].

PubMed

Bikbov, M M; Khusnitdinov, I I

This is a review on Ahmed valve application in glaucoma surgery. It contains, in particular, data on the Ahmed valve efficiency, results of experimental and histological studies of filtering bleb encapsulation, examines the use of antimetabolites and anti-VEGF agents, and discusses implantation techniques. The current appraisal of antimetabolites delivery systems integrated into the Ahmed valve is presented. Various complications encountered in practice and preventive measures are also covered.

New-Onset Left Bundle Branch Block Induced by Transcutaneous Aortic Valve Implantation.

PubMed

Massoullié, Grégoire; Bordachar, Pierre; Ellenbogen, Kenneth A; Souteyrand, Géraud; Jean, Frédéric; Combaret, Nicolas; Vorilhon, Charles; Clerfond, Guillaume; Farhat, Mehdi; Ritter, Philippe; Citron, Bernard; Lusson, Jean-R; Motreff, Pascal; Ploux, Sylvain; Eschalier, Romain

2016-03-01

New-onset left bundle branch block (LBBB) is a specific concern of transcutaneous aortic valve implantation (TAVI) given its estimated incidence ranging from 5% to 65%. This high rate of occurrence is dependent on the type of device used (size and shape), implantation methods, and patient co-morbidities. The appearance of an LBBB after TAVI reflects a very proximal lesion of the left bundle branch as it exits the bundle of His. At times transient, its persistence can lead to permanent pacemaker implantation in 15% to 20% of cases, most often for high-degree atrioventricular block. The management of LBBB after TAVI is currently not defined by international societies resulting in individual centers developing their own management strategy. The potential consequences of LBBB are dysrhythmias (atrioventricular block, syncope, and sudden death) and functional (heart failure) complications. Prompt postprocedural recognition and management (permanent pacemaker implantation) of patients prevents the occurrence of potential complications and may constitute the preferred approach in this frail and elderly population despite additional costs and complications of cardiac pacing. Moreover, the expansion of future indications for TAVI necessitates better identification of the predictive factors for the development of LBBB. Indeed, long-term right ventricular pacing may potentially increase the risk of developing heart failure in this population. In conclusion, it is thus imperative to not only develop new aortic prostheses with a less-deleterious impact on the conduction system but also to prescribe appropriate pacing modes in this frail population. Copyright © 2016 Elsevier Inc. All rights reserved.

Flow in prosthetic heart valves: state-of-the-art and future directions.

PubMed

Yoganathan, Ajit P; Chandran, K B; Sotiropoulos, Fotis

2005-12-01

Since the first successful implantation of a prosthetic heart valve four decades ago, over 50 different designs have been developed including both mechanical and bioprosthetic valves. Today, the most widely implanted design is the mechanical bileaflet, with over 170,000 implants worldwide each year. Several different mechanical valves are currently available and many of them have good bulk forward flow hemodynamics, with lower transvalvular pressure drops, larger effective orifice areas, and fewer regions of forward flow stasis than their earlier-generation counterparts such as the ball-and-cage and tilting-disc valves. However, mechanical valve implants suffer from complications resulting from thrombus deposition and patients implanted with these valves need to be under long-term anti-coagulant therapy. In general, blood thinners are not needed with bioprosthetic implants, but tissue valves suffer from structural failure with, an average life-time of 10-12 years, before replacement is needed. Flow-induced stresses on the formed elements in blood have been implicated in thrombus initiation within the mechanical valve prostheses. Regions of stress concentration on the leaflets during the complex motion of the leaflets have been implicated with structural failure of the leaflets with bioprosthetic valves. In vivo and in vitro experimental studies have yielded valuable information on the relationship between hemodynamic stresses and the problems associated with the implants. More recently, Computational Fluid Dynamics (CFD) has emerged as a promising tool, which, alongside experimentation, can yield insights of unprecedented detail into the hemodynamics of prosthetic heart valves. For CFD to realize its full potential, however, it must rely on numerical techniques that can handle the enormous geometrical complexities of prosthetic devices with spatial and temporal resolution sufficiently high to accurately capture all hemodynamically relevant scales of motion. Such

Clinical outcomes after combined Ahmed glaucoma valve implantation and penetrating keratoplasty or pars plana vitrectomy.

PubMed

Lee, Jin Young; Sung, Kyung Rim; Tchah, Hung Won; Yoon, Young Hee; Kim, June Gone; Kim, Myoung Joon; Kim, Jae Yong; Yun, Sung-Cheol; Lee, Joo Yong

2012-12-01

To evaluate whether a combination of penetrating keratoplasty (PKP) or pars plana vitrectomy (PPV) and Ahmed glaucoma valve (AGV) implantation affords a level of success similar to that of AGV implantation alone. Eighteen eyes underwent simultaneous PPV and AGV, 14 eyes with PKP and AGV and 30 eyes with AGV implantation alone were evaluated. Success was defined as attainment of an intraocular pressure (IOP) >5 and <22 mmHg, with or without use of anti-glaucoma medication. Kaplan-Meier survival analysis was performed to compare cumulative survival between the combined surgery groups and the AGV implantation-alone group. Cox proportional hazard regression analysis was conducted to identify factors predictive of success in each of the three groups. Mean (±standard deviation) preoperative IOP was 30.2 ± 10.2 mmHg in the PKP + AGV, 35.2 ± 9.8 mmHg in the PPV + AGV, and 36.2 ± 10.1 mmHg in the AGV implantation-alone group. The cumulative success rate at 18 months was 66.9%, 73.2%, and 70.8% in the three groups, respectively. Neither combined surgery group differed significantly in terms of cumulative success rate compared with the AGV implantation-alone group (p = 0.556, p = 0.487, respectively). The mean number of preoperative anti-glaucoma medications prescribed was significantly associated with success in the PKP + AGV implantation group (hazard ratio, 2.942; p = 0.024). Either PKP or PPV performed in conjunction with AGV implantation afforded similar success rates compared to patients treated with AGV implantation alone. Therefore, in patients with refractory glaucoma who have underlying corneal or retinal pathology requiring treatment with PKP or PPV, AGV implantation can be performed simultaneously.

Surgical site infections following transcatheter apical aortic valve implantation: incidence and management.

PubMed

Baillot, Richard; Fréchette, Éric; Cloutier, Daniel; Rodès-Cabau, Josep; Doyle, Daniel; Charbonneau, Éric; Mohammadi, Siamak; Dumont, Éric

2012-11-13

The present study was undertaken to examine the incidence and management of surgical site infection (SSI) in patients submitted to transapical transcatheter aortic valve implantation (TA-TAVI). From April 2007 to December 2011, 154 patients underwent TA-TAVI with an Edwards Sapien bioprosthesis (ES) at the Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ) as part of a multidisciplinary program to prospectively evaluate percutaneous aortic valve implantation. Patient demographics, perioperative variables, and postoperative complications were recorded in a prospective registry. Five (3.2%) patients in the cohort presented with an SSI during the study period. The infections were all hospital-acquired (HAI) and were considered as organ/space SSI's based on Center for Disease Control criteria (CDC). Within the first few weeks of the initial procedure, these patients presented with an abscess or chronic draining sinus in the left thoracotomy incision and were re-operated. The infection spread to the apex of the left ventricle in all cases where pledgeted mattress sutures could be seen during debridement. Patients received multiple antibiotic regimens without success until the wound was surgically debrided and covered with viable tissue. The greater omentum was used in three patients and the pectoralis major muscle in the other two. None of the patients died or had a recurrent infection. Three of the patients were infected with Staphylococcus epidermidis, one with Staphylococcus aureus, and one with Enterobacter cloacae. Patients with surgical site infections were significantly more obese with higher BMI (31.4±3.1 vs 26.2±4.4 p=0.0099) than the other patients in the cohort. While TA-TAVI is a minimally invasive technique, SSIs, which are associated with obesity, remain a concern. Debridement and rib resection followed by wound coverage with the greater omentum and/or the pectoralis major muscle were used successfully in these patients.

Mitral valve repair in dogs using an ePTFE chordal implantation device: a pilot study.

PubMed

Borgarelli, M; Lanz, O; Pavlisko, N; Abbott, J A; Menciotti, G; Aherne, M; Lahmers, S M; Lahmers, K K; Gammie, J S

2017-06-01

Mitral valve (MV) regurgitation due to degenerative MV disease is the leading cause of cardiac death in dogs. We carried out preliminary experiments to determine the feasibility and short-term effects of beating-heart MV repair using an expanded polytetrafluorethylene (ePTFE) chordal implantation device (Harpoon TSD-5) in dogs. This study involved six healthy purpose-bred Beagles (weight range 8.9-11.4 kg). Following a mini-thoracotomy performed under general anesthesia, the TSD-5 was used to place 1 or 2 artificial ePTFE cords on the anterior MV leaflet or the posterior MV leaflet via a left-ventricular transapical approach. The procedure was guided and monitored by transesophageal echocardiography. Postoperative antithrombotic treatment consisted of clopidogrel or a combination of clopidogrel and apixaban. Dogs were serially evaluated by transthoracic echocardiography at day 1, 7, 14, 21, and 30. The hearts were then examined for evaluation of tissues reactions and to detect signs of endothelialization. One or two chords were successfully implanted in five dogs. Four dogs completed the 30 days follow-up. One dog died intra-operatively because of aortic perforation. One dog died early post-operatively from a hemorrhagic pleural effusion attributed to overly aggressive antithrombotic treatment. One dog developed a thrombus surrounding both the knot and the synthetic cord. Postmortem exam confirmed secure placement of ePTFE knots in the mitral leaflets in all dogs and the presence of endothelialization of the knots and chords. These preliminary results demonstrate the feasibility of artificial chordal placement using an ePTFE cordal implantation device in dogs. Copyright © 2017 Elsevier B.V. All rights reserved.

Transcatheter valve underexpansion limits leaflet durability: implications for valve-in-valve procedures

PubMed Central

Martin, Caitlin; Sun, Wei

2016-01-01

Transcatheter aortic valve (TAV) implantation within a failed bioprosthetic valve is a growing trend for high-risk patients. The non-compliant stent of the previous prosthesis may prevent full expansion of the TAV, which has been shown to distort the leaflet configuration, and has been hypothesized to adversely affect durability. In this study, TAV leaflet fatigue damage under cyclic pressurization in the setting of stent underexpansion by 0 (fully expanded), 1, 2 and 3 mm was simulated using finite element analysis to test this hypothesis. In the 2 and 3 mm underexpanded devices, the TAV leaflets exhibited severe pin-wheeling during valve closure, which increased leaflet stresses dramatically, and resulted in accelerated fatigue damage of the leaflets. The leaflet fatigue damage in the 1 mm underexpanded case was similar to that in the fully expanded case. Clinically a range of 10% to 15% underexpansion is generally considered acceptable; however, it was observed in this study that ≥2 mm (≥9.1%) underexpansion, will significantly impact device durability. Further study is necessary to determine the impact of various deployment conditions, i.e. non-uniform and non-circular deployments and different implantation heights, on differing TAV devices, but it is clear that the normal TAV leaflet configuration must be preserved in order to preserve durability. PMID:27734178

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.

Coupling of HRT II and AS-OCT to evaluate corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant.

PubMed

Mendrinos, E; Dosso, A; Sommerhalder, J; Shaarawy, T

2009-09-01

To report corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant in eyes with refractory glaucoma. Ten eyes underwent Ahmed valve implant surgery and were followed-up for 12 months. Data collected included intraocular pressure (IOP), number of antiglaucoma medications and surgery-related complications. At 6 and 12 months postoperatively, the intracameral length of the drainage tube (ICL) and the distance between the tube and the cornea (T-C distance), and the iris (T-I distance) were assessed using anterior segment optical coherence tomography (AS-OCT). Heidelberg cornea tomograph II (HRT II) was used to measure the corneal endothelial cell density. Mean (+/-SEM) preoperative IOP was 29.5+/-4 mmHg. Mean postoperative IOP was 11.6+/-2 at 12 months (P<0.01). Over a 6-month period, mean corneal endothelial loss was 7.9%+/-2.5 in the central and 7.5%+/-2.4 in the peripheral cornea (P<0.01). There was no correlation between central or peripheral corneal endothelial cell loss and the T-C, T-I distance or the ICL of the tube. Corneal endothelial cell loss occurs following Ahmed valve implant surgery, this appears to be multifactorial. AS-OCT and HRT II are promising methods for the follow-up of patients with a glaucoma drainage device.

Early experience of transaortic TAVI--the future of surgical TAVI?

PubMed

Clarke, Andrew; Wiemers, Paul; Poon, Karl K C; Aroney, Constantine N; Scalia, Gregory; Burstow, Darryl; Walters, Darren L; Tesar, Peter

2013-04-01

Trans-catheter aortic valve implantation (TAVI) is now a well recognised procedure for the high risk surgical patient with native or bioprosthetic aortic valve stenosis. Transfemoral and transapical implantation techniques are well described. With increasing referral of more marginal transapical patients, we describe our experience of a transaortic TAVI approach which we believe reduces the postoperative wound pain, respiratory complications, operative risk and hospital stay. Patients referred for surgical TAVI underwent trans-catheter aortic valve implantation via an upper sternotomy and direct cannulation of the ascending aorta. Thirteen patients with a mean age of 81 years underwent transaortic Edwards SAPIEN valve implantation. There was no in hospital mortality in our series. One patient required insertion of a permanent pacemaker for complete heart block. There were no aortic cannulation complications. The transaortic TAVI approach provides good exposure of the distal ascending aorta, a familiar cannulation site for cardiac surgeons. Our initial experience demonstrates the approach to be a safe technique with the potential for faster and less complicated recovery in patients undergoing surgical TAVI procedures. With further experience and greater acceptance, the transaortic approach may ultimately become the procedure of choice for patients unsuitable for a transfemoral approach. Crown Copyright © 2012. Published by Elsevier B.V. All rights reserved.

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

PubMed

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

2015-01-01

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. 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. 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. 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.

Tricuspid valve and percutaneous approach: No longer the forgotten valve!

PubMed

Bouleti, Claire; Juliard, Jean-Michel; Himbert, Dominique; Iung, Bernard; Brochet, Eric; Urena, Marina; Dilly, Marie-Pierre; Ou, Phalla; Nataf, Patrick; Vahanian, Alec

2016-01-01

Tricuspid valve disease is mainly represented by tricuspid regurgitation (TR), which is a predictor of poor outcome. TR is usually secondary, caused by right ventricle pressure or volume overload, the leading cause being left-sided heart valve diseases. Tricuspid surgery for severe TR is recommended during left valve surgery, and consists of either a valve replacement or, most often, a tricuspid repair with or without prosthetic annuloplasty. When TR persists or worsens after left valvular surgery, redo isolated tricuspid surgery is associated with high mortality. In addition, a sizeable proportion of patients present with tricuspid surgery deterioration over time, and need a reintervention, which is associated with high morbi-mortality rates. In this context, and given the recent major breakthrough in the percutaneous treatment of aortic and mitral valve diseases, the tricuspid valve appears an appealing challenge, although it raises specific issues. The first applications of transcatheter techniques for tricuspid valve disease were valve-in-valve and valve-in-ring implantation for degenerated bioprosthesis or ring annuloplasty. Some concerns remain regarding prosthesis sizing, rapid ventricular pacing and the best approach, but these procedures appear to be safe and effective. More recently, bicuspidization using a transcatheter approach for the treatment of native tricuspid valve has been published, in two patients. Finally, other devices are in preclinical development. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Prosthetic Aortic Valves: Challenges and Solutions

PubMed Central

Musumeci, Lucia; Jacques, Nicolas; Hego, Alexandre; Nchimi, Alain; Lancellotti, Patrizio; Oury, Cécile

2018-01-01

Aortic Valve Disease (AVD) is the most common Valvular Heart Disease (VHD), affecting millions of people worldwide. Severe AVD is treated in most cases with prosthetic aortic valve replacement, which involves the substitution of the native aortic valve with a prosthetic one. In this review we will discuss the different types of prosthetic aortic valves available for implantation and the challenges faced by patients, medical doctors, researchers and manufacturers, as well as the approaches that are taken to overcome them. PMID:29868612

Tissue engineering of heart valves: in vitro experiences.

PubMed

Sodian, R; Hoerstrup, S P; Sperling, J S; Daebritz, S H; Martin, D P; Schoen, F J; Vacanti, J P; Mayer, J E

2000-07-01

Tissue engineering is a new approach, whereby techniques are being developed to transplant autologous cells onto biodegradable scaffolds to ultimately form new functional tissue in vitro and in vivo. Our laboratory has focused on the tissue engineering of heart valves, and we have fabricated a trileaflet heart valve scaffold from a biodegradable polymer, a polyhydroxyalkanoate. In this experiment we evaluated the suitability of this scaffold material as well as in vitro conditioning to create viable tissue for tissue engineering of a trileaflet heart valve. We constructed a biodegradable and biocompatible trileaflet heart valve scaffold from a porous polyhydroxyalkanoate (Meatabolix Inc, Cambridge, MA). The scaffold consisted of a cylindrical stent (1 x 15 x 20 mm inner diameter) and leaflets (0.3 mm thick), which were attached to the stent by thermal processing techniques. The porous heart valve scaffold (pore size 100 to 240 microm) was seeded with vascular cells grown and expanded from an ovine carotid artery and placed into a pulsatile flow bioreactor for 1, 4, and 8 days. Analysis of the engineered tissue included biochemical examination, enviromental scanning electron microscopy, and histology. It was possible to create a trileaflet heart valve scaffold from polyhydroxyalkanoate, which opened and closed synchronously in a pulsatile flow bioreactor. The cells grew into the pores and formed a confluent layer after incubation and pulsatile flow exposure. The cells were mostly viable and formed connective tissue between the inside and the outside of the porous heart valve scaffold. Additionally, we demonstrated cell proliferation (DNA assay) and the capacity to generate collagen as measured by hydroxyproline assay and movat-stained glycosaminoglycans under in vitro pulsatile flow conditions. Polyhydroxyalkanoates can be used to fabricate a porous, biodegradable heart valve scaffold. The cells appear to be viable and extracellular matrix formation was induced

The Freedom Solo pericardial stentless valve: Single-center experience, outcomes, and long-term durability.

PubMed

Stanger, Olaf; Bleuel, Irina; Gisler, Fabian; Göber, Volkhard; Reineke, Sylvia; Gahl, Brigitta; Aymard, Thierry; Englberger, Lars; Carrel, Thierry; Tevaearai, Hendrik

2015-07-01

To report our institutional experience and long-term results with the Freedom Solo bovine pericardial stentless bioprosthesis (Sorin Group, Saluggia, Italy). Between January 2005 and November 2009, 149 patients (mean age, 73.6 ± 8.7 years; 68 [45.6%] female) underwent isolated (n = 75) or combined (n = 74) aortic valve replacement (AVR) using the Solo in our institution. Follow-up was 100% complete with an average follow-up time of 5.9 ± 2.6 years (maximum, 9.6 years) and a total of 885.3 patient years. Operative (30-day) mortality was 2.7% (1.3% for isolated AVR [n = 1] and 4.0% for combined procedures [n = 3]). All causes of death were not valve-related. Preoperative peak (mean) gradients of 74.2 ± 23.0 mm Hg (48.6 ± 16.3 mm Hg) decreased to 15.6 ± 5.4 mm Hg (8.8 ± 3.0 mm Hg) after AVR, and remained low for up to 9 years. The postoperative effective orifice area was 1.6 ± 0.57 cm(2), 1.90 ± 0.45 cm(2), 2.12 ± 0.48 cm(2), and 2.20 ± 0.66 cm(2) for the valve sizes 21, 23, 25, and 27, respectively, with absence of severe prosthesis-patient mismatch and 0.7% (n = 1) experienced moderate prosthesis-patient mismatch. During follow-up, 26 patients experienced structural valve deterioration (SVD) and 14 patients underwent explantation. Kaplan-Meier estimates for freedom from death, explantation, and SVD at 9 years averaged 0.57 (range, 0.47-0.66), 0.82 (range, 0.69-0.90), and 0.70 (range, 0.57-0.79), respectively. The Freedom Solo stentless aortic valve is safe to implant and shows excellent early and midterm hemodynamic performance. However, SVD was observed in a substantial number of patients after only 5-6 years and the need for explantation increased markedly, suggesting low durability. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

First uses of HAART 300 rings for aortic valve repair in Poland - 4 case studies.

PubMed

Juściński, Jacek H; Koprowski, Andrzej; Kołaczkowska, Magdalena; Kowalik, Maciej M; Rogowski, Jan A; Rankin, James S

2018-03-01

Aortic valve reconstructions using geometric annuloplasty rings HAART 300/200 open new era in aortic valve surgery. The HAART technology resizes, reshapes, stabilizes and simplifies aortic valve repair. The HAART aortic repair rings are designed to be implanted directly into aortic annulus (under aortic valve leaflets). We present first in Poland 4 cases of aortic valve reconstructions using geometric annuloplasty rings HAART 300. Two patients had type IA aortic insufficiency (due to El-Khoury classification) - they were treated by HAART 300 ring insertion and ascending aorta prosthesis implantation. Third patient, Marfan with type IB aortic insufficiency was repaired by HAART 300 ring implantation followed by remodeling (Yacoub) procedure. Fourth patient with type II aortic insufficiency (due to RCC prolapse) was repaired by HAART 300 implantation and cusp plication. All patients shows good results on 6 months postoperative 3D TTE examinations. Presented technique is reproducible and simplify aortic valve reconstructions.

Early Outcomes of Sutureless Aortic Valves.

PubMed

Hanedan, Muhammet Onur; Mataracı, İlker; Yürük, Mehmet Ali; Özer, Tanıl; Sayar, Ufuk; Arslan, Ali Kemal; Ziyrek, Uğur; Yücel, Murat

2016-06-01

In elderly high-risk surgical patients, sutureless aortic valve replacement (AVR) should be an alternative to standard AVR. The potential advantages of sutureless aortic prostheses include reducing cross-clamping and cardiopulmonary bypass (CPB) time and facilitating minimally invasive surgery and complex cardiac interventions, while maintaining satisfactory hemodynamic outcomes and low rates of paravalvular leakage. The current study reports our single-center experience regarding the early outcomes of sutureless aortic valve implantation. Between October 2012 and June 2015, 65 patients scheduled for surgical valve replacement with symptomatic aortic valve disease and New York Heart Association function of class II or higher were included to this study. Perceval S (Sorin Biomedica Cardio Srl, Sallugia, Italy) and Edwards Intuity (Edwards Lifesciences, Irvine, CA, USA) valves were used. The mean age of the patients was 71.15±8.60 years. Forty-four patients (67.7%) were female. The average preoperative left ventricular ejection fraction was 56.9±9.93. The CPB time was 96.51±41.27 minutes and the cross-clamping time was 60.85±27.08 minutes. The intubation time was 8.95±4.19 hours, and the intensive care unit and hospital stays were 2.89±1.42 days and 7.86±1.42 days, respectively. The mean quantity of drainage from chest tubes was 407.69±149.28 mL. The hospital mortality rate was 3.1%. A total of five patients (7.69%) died during follow-up. The mean follow-up time was 687.24±24.76 days. The one-year survival rate was over 90%. In the last few years, several models of valvular sutureless bioprostheses have been developed. The present study evaluating the single-center early outcomes of sutureless aortic valve implantation presents the results of an innovative surgical technique, finding that it resulted in appropriate hemodynamic conditions with acceptable ischemic time.

Early Outcomes of Sutureless Aortic Valves

PubMed Central

Hanedan, Muhammet Onur; Mataracı, İlker; Yürük, Mehmet Ali; Özer, Tanıl; Sayar, Ufuk; Arslan, Ali Kemal; Ziyrek, Uğur; Yücel, Murat

2016-01-01

Background In elderly high-risk surgical patients, sutureless aortic valve replacement (AVR) should be an alternative to standard AVR. The potential advantages of sutureless aortic prostheses include reducing cross-clamping and cardiopulmonary bypass (CPB) time and facilitating minimally invasive surgery and complex cardiac interventions, while maintaining satisfactory hemodynamic outcomes and low rates of paravalvular leakage. The current study reports our single-center experience regarding the early outcomes of sutureless aortic valve implantation. Methods Between October 2012 and June 2015, 65 patients scheduled for surgical valve replacement with symptomatic aortic valve disease and New York Heart Association function of class II or higher were included to this study. Perceval S (Sorin Biomedica Cardio Srl, Sallugia, Italy) and Edwards Intuity (Edwards Lifesciences, Irvine, CA, USA) valves were used. Results The mean age of the patients was 71.15±8.60 years. Forty-four patients (67.7%) were female. The average preoperative left ventricular ejection fraction was 56.9±9.93. The CPB time was 96.51±41.27 minutes and the cross-clamping time was 60.85±27.08 minutes. The intubation time was 8.95±4.19 hours, and the intensive care unit and hospital stays were 2.89±1.42 days and 7.86±1.42 days, respectively. The mean quantity of drainage from chest tubes was 407.69±149.28 mL. The hospital mortality rate was 3.1%. A total of five patients (7.69%) died during follow-up. The mean follow-up time was 687.24±24.76 days. The one-year survival rate was over 90%. Conclusion In the last few years, several models of valvular sutureless bioprostheses have been developed. The present study evaluating the single-center early outcomes of sutureless aortic valve implantation presents the results of an innovative surgical technique, finding that it resulted in appropriate hemodynamic conditions with acceptable ischemic time. PMID:27298793

A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in "real-world" patients with aortic stenosis and intermediate- to high-risk profile.

PubMed

Muneretto, Claudio; Alfieri, Ottavio; Cesana, Bruno Mario; Bisleri, Gianluigi; De Bonis, Michele; Di Bartolomeo, Roberto; Savini, Carlo; Folesani, Gianluca; Di Bacco, Lorenzo; Rambaldini, Manfredo; Maureira, Juan Pablo; Laborde, Francois; Tespili, Maurizio; Repossini, Alberto; Folliguet, Thierry

2015-12-01

We sought to investigate the clinical outcomes of patients with isolated severe aortic stenosis and an intermediate- to high-risk profile treated by means of conventional surgery (surgical aortic valve replacement), sutureless valve implantation, or transcatheter aortic valve replacement in a multicenter evaluation. Among 991 consecutive patients with isolated severe aortic stenosis and an intermediate- to high-risk profile (Society of Thoracic Surgeons score >4 and logistic European System for Cardiac Operative Risk Evaluation I >10), a propensity score analysis was performed on the basis of the therapeutic strategy: surgical aortic valve replacement (n = 204), sutureless valve implantation (n = 204), and transcatheter aortic valve replacement (n = 204). Primary end points were 30-day mortality and overall survival at 24-month follow-up; the secondary end point was survival free from a composite end point of major adverse cardiac events (defined as cardiac-related mortality, myocardial infarction, cerebrovascular accidents, and major hemorrhagic events) and periprosthetic regurgitation greater than 2. Thirty-day mortality was significantly higher in the transcatheter aortic valve replacement group (surgical aortic valve replacement = 3.4% vs sutureless = 5.8% vs transcatheter aortic valve replacement = 9.8%; P = .005). The incidence of postprocedural was 3.9% in asurgical aortic valve replacement vs 9.8% in sutureless vs 14.7% in transcatheter aortic valve replacement (P< .001) and peripheral vascular complications occurred in 0% of surgicalaortic valve replacement vs 0% of sutureless vs 9.8% transcatheter aortic valve replacement (P< .001). At 24-month follow-up, overall survival (surgical aortic valve replacement = 91.3% ± 2.4% vs sutureless = 94.9% ± 2.1% vs transcatheter aortic valve replacement = 79.5% ± 4.3%; P < .001) and survival free from the composite end point of major adverse cardiovascular events and periprosthetic regurgitation were significantly

The Melody® valve and Ensemble® delivery system for transcatheter pulmonary valve replacement

PubMed Central

McElhinney, Doff B; Hennesen, Jill T

2013-01-01

The Melody® transcatheter pulmonary valve (TPV) is a percutaneous valve system designed for the treatment of obstruction and/or regurgitation of prosthetic conduits placed between the right ventricle and pulmonary arteries in patients with congenital heart disease. In 2000, Melody TPV became the first transcatheter valve implanted in a human; in 2006 it became the first transcatheter valve commercially available anywhere in the world; and in 2010 it was launched as the first commercially available transcatheter valve in the United States. In this review, we present the clinical background against which the Melody valve was developed and implemented, introduce the rationale for and challenges of transcatheter valve technology for this population, outline the history and technical details of its development and use, and summarize currently available data concerning the performance of the device. PMID:23834411

Structural deterioration of the Freestyle aortic valve: mode of presentation and mechanisms.

PubMed

Mohammadi, Siamak; Baillot, Richard; Voisine, Pierre; Mathieu, Patrick; Dagenais, François

2006-08-01

Structural valve deterioration is the major cause of bioprosthetic valve failure. Because of the unique design features and anti-calcification treatment of the Freestyle (Medtronic Inc, Minneapolis, Minn) stentless bioprosthesis, development of structural valve deterioration may differ in comparison with other bioprosthetic valves. This study evaluates the mechanisms and clinical presentation of structural valve deterioration in the Freestyle stentless bioprosthesis. Between January 1993 and August 2005, 608 patients underwent aortic valve replacement with a Freestyle stentless bioprosthesis. The implantation technique was subcoronary in 475 patients and a root replacement in 133 patients. Mean overall follow-up was 5.6 +/- 3.4 years. Follow-up was complete in all patients. Clinical and echocardiographic follow-ups were conducted prospectively. Freedom from structural valve deterioration was 95.8% at 10 years. Twelve patients showed evidence of structural valve deterioration and underwent reoperation for aortic regurgitation (n = 10) or aortic stenosis (n = 2). The mean age of patients with structural valve deterioration was significantly lower than patients without structural valve deterioration (62.6 +/- 8.2 years vs 68.6 +/- 8.3 years, P = .02). The median time between implantation and explantation was 8.7 years (range: 1.9-13.3 years). Eleven structural valve deteriorations occurred after subcoronary implantation, and 1 structural valve deterioration occurred after root implantation (P = .4). The mechanisms of structural valve deterioration were leaflet tears in 10 patients (6 in the left coronary cusp and 4 in the right coronary cusp), severe valve calcification in 1 patient, and cusp fibrosis in 1 patient. The interval between onset of symptoms and reoperation was acute or subacute in 10 patients. At 10 years, the Freestyle stentless bioprosthesis shows excellent freedom from structural valve deterioration. Structural valve deterioration in the Freestyle

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

Thromboembolism in patients with pericardial valves in the absence of chronic anticoagulation: 12 years' experience.

PubMed

García-Bengoechea, J B; González-Juanatey, J R; Rubio, J; Durán, D; Sierra, J

1991-01-01

Between January 1977 and January 1989, 465 pericardial bioprostheses were implanted in 424 patients. The mean age of patients was 59.1 years (range 16-81 y.) At the time of surgery, 68% of the patients suffered from chronic atrial fibrillation. Mitral valve replacement was performed in 167 patients, aortic valve replacement in 216, multiple replacement in 40 (36 mitral and aortic, 3 mitral and tricuspid, and 1 mitral, aortic and tricuspid), and 1 pulmonary valve replacement. The different types of pericardial valve used were: Ionescu-Shiley 408, Mitral Medical 23, Bioflo 30, and Hancock 4. Hospital mortality was 10.1% with an attrition rate of 1.8 episodes per 100 patients/year. The 12-year actuarial survival rate was 65.1%. No patient underwent long-term anticoagulant treatment. The first 144 patients undergoing mitral and multiple valve replacements received temporary anticoagulation for the first 8 weeks after surgery. There was no valve thrombosis observed. Altogether 19 thromboembolic events (6 early and 13 late) were clinically documented. One patient died after an embolic event. The linearized rates of thromboembolism were 1.64 episodes per 100 patients/year for mitral and multiple valve replacements and 0.33 episodes per 100 patients/year for aortic valve replacement, with an overall rate of 1.0 episodes per 100 patients/year. Excluding early thromboembolism, the linearized rate was 1.02 episodes per 100 patients/year overall. The actuarial freedom from embolism was 92.4% overall, 88.2% for the mitral and multiple valve replacement group, and 97.6% for the aortic valve replacement group at a maximum follow-up of 12 years.(ABSTRACT TRUNCATED AT 250 WORDS)

Electrocardiographic Predictors of Long-Term Cardiac Pacing Dependency Following Transcatheter Aortic Valve Implantation.

PubMed

Naveh, Sivan; Perlman, Gidon Y; Elitsur, Yair; Planer, David; Gilon, Dan; Leibowitz, David; Lotan, Chaim; Danenberg, Haim; Alcalai, Ronny

2017-02-01

Conduction disorders requiring permanent pacemaker (PPM) implantation are a known complication of transcatheter aortic valve implantation (TAVI). Indications for permanent pacing in this setting are still controversial. The study aim was to characterize the natural history of conduction disorders related to TAVI, and to identify predictors for long-term pacing dependency. Consecutive patients who underwent TAVI were included in this prospective observational study. The conduction system was investigated by reviewing 12-lead ECGs during hospitalization and up to 1-year follow-up and by analyzing pacemaker interrogation data. Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency. Of 110 patients included in the analysis, 38 (34.5%) underwent PPM implantation. Of those, 26 (68.4%) had a long-term pacing dependency (required PPM), while 12 (31.6%) did not (not-required PPM). Logistic regression revealed that baseline RBBB (P = 0.01, OR = 18.0), baseline PR interval (P = 0.019, OR = 1.14), post-TAVI PR interval and the change in PR interval from baseline (P < 0.001 for both, OR = 1.17 for each 10 milliseconds increment) were independent predictors for long-term pacing dependency. A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency. Increased pre- and postprocedural PR intervals and pre-existing RBBB are reliable predictors for long-term PPM dependency, while left bundle branch block or QRS width are misleading factors. Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval. © 2016 Wiley Periodicals, Inc.

Textile for heart valve prostheses: fabric long-term durability testing.

PubMed

Heim, Frederic; Durand, Bernard; Chakfe, Nabil

2010-01-01

The rapid developments and success in percutaneous vascular surgery over the last two decades with the now common stent grafts implantation, make the noninvasive surgery technique today attractive even for heart valve replacement. Less traumatic for the patient and also less time consuming, percutaneous heart valve replacement is however at its beginning and restricted to end of life patients. The noninvasive procedure expects from the heart valve prosthesis material to be resistant and adapted to folding requirements of the implantation process (catheter). Polyester fabric could be a suited material for heart valve implanted percutaneously. Highly flexible and resistant, polyester fabric proved to be well adapted to the dynamic behavior of a valve and polyester (Dacron) is also widely used for vascular grafts implantation and shows good biocompatibility and durability. However, today there's no data available on long-term durability of fabric used as heart valve material. The purpose of this work is to study the long term behavior of a microdenier polyester fabric construction under combined in vitro flexure and tension fatigue stress. In the novel in vitro testing technique presented, a fabric specimen was subjected to combined flexural and tensile fatigue generated by fluid flow under physiological pressure conditions. The results obtained show how flexural properties change with fatigue time, which reflects directly on the suitability of a fabric in such devices. It was also observed that these fabric structural changes directly influence the in vitro behavior of the textile heart valve prosthesis. (c) 2009 Wiley Periodicals, Inc.

Comparison of frequency, risk factors, and time course of postoperative delirium in octogenarians after transcatheter aortic valve implantation versus surgical aortic valve replacement.

PubMed

Eide, Leslie S P; Ranhoff, Anette H; Fridlund, Bengt; Haaverstad, Rune; Hufthammer, Karl Ove; Kuiper, Karel K J; Nordrehaug, Jan Erik; Norekvål, Tone M

2015-03-15

Postoperative delirium (PD) after transcatheter aortic valve implantation (TAVI) remains to be explored. We sought to (1) determine the incidence of PD in octogenarians who underwent TAVI or surgical aortic valve replacement (SAVR), (2) identify its risk factors, and (3) describe possible differences in the onset and course of PD between treatment groups. A prospective cohort study of consecutive patients aged ≥80 years with severe aortic stenosis who underwent elective TAVI or SAVR (N = 143) was conducted. The incidence of PD was assessed for 5 days using the Confusion Assessment Method (CAM). Risk factors for PD were studied with logistic regression. Patients treated with TAVI were older (p ≤0.001), had lower cognitive scores (p = 0.007), and more co-morbidities (p = 0.003). Despite this, significantly fewer (p = 0.013) patients treated with TAVI (44%) experienced PD compared to patients treated with SAVR (66%). Undergoing SAVR (p = 0.02) and having lower cognitive function (p = 0.03) emerged as risk factors for PD, whereas gender, activities of daily living, frailty, atrial fibrillation, and postoperative use of opioids and anxiolytics did not. Patients treated with TAVI and without PD during the first 2 postoperative days were unlikely to experience PD on subsequent days. The onset of PD after SAVR could occur at any time during the postoperative evaluation. In conclusion, SAVR in octogenarian patients with aortic stenosis might be considered as a predisposing factor for PD. Our data also suggest that the onset of PD was more unpredictable after SAVR. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Successful continuous-flow left ventricular assist device implantation with adjuvant tricuspid valve repair for advanced heart failure.

PubMed

Lee, Chih-Hsien; Wei, Jeng

The prevalence of end-stage heart failure (HF) is on the increase, however, the availability of donor hearts remains limited. Left ventricular assist devices (LVADs) are increasingly being used for treating patients with end-stage HF. LVADs are not only used as a bridge to transplantation but also as a destination therapy. HeartMate II, a new-generation, continuous-flow LVAD (cf-LVAD), is currently an established treatment option for patients with HF. Technological progress and increasing implantation of cf-LVADs have significantly improved survival in patients with end-stage HF. Here we report a case of a patient with end-stage HF who was successfully supported using cf-LVAD implantation with adjuvant tricuspid valve repair in a general district hospital.

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

Percutaneous Pulmonary Valve Placement

PubMed Central

Prieto, Lourdes R.

2015-01-01

Patients with congenital heart disease and pulmonary valve disease need multiple procedures over their lifetimes to replace their pulmonary valves. Chronic pulmonary stenosis, regurgitation, or both have untoward effects on ventricular function and on the clinical status of these patients. To date, all right ventricle–pulmonary artery conduits have had relatively short lifespans. Percutaneous pulmonary valve implantation, although relatively new, will probably reduce the number of operative procedures that these patients will have to undergo over a lifetime. Refinement and further development of this procedure holds promise for the extension of this technology to other patient populations. PMID:26175629

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

PubMed

Kim, Min Su; Kim, Kyoung Nam; Kim, Chang-Sik

2016-12-01

To compare changes in corneal endothelial cell density (CECD) after Ahmed glaucoma valve (AGV) implantation and trabeculectomy. 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. 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). 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.

Initial Experience and Early Results of Mitral Valve Repair with Cardiocel Pericardial Patch.

PubMed

Tomšič, Anton; Bissessar, Daniella D; van Brakel, Thomas J; Marsan, Nina Ajmone; Klautz, Robert J M; Palmen, Meindert

2018-06-07

To assess the performance of a tissue engineering process-treated bovine pericardium patch (CardioCel) in the setting of reconstructive mitral valve surgery. Between 3/2014 and 4/2016, 30 patients (57.2±14.3 years, 27% female) underwent mitral valve leaflet repair with a CardioCel patch. Perioperative mortality was 7% (2 patients, non-graft-related). In 28 remaining patients, pre-discharge echocardiography demonstrated good repaired valve function. At a mean follow-up of 1.7±0.9 years, 3 additional deaths occurred (2 due to infective endocarditis, 1 non-cardiac related). On follow-up echocardiography [follow-up time 1.7±0.8 years, available for 26/28 (93%) hospital survivors], recurrent regurgitation was seen in 2 patients (both infective endocarditis) and 1 underwent reoperation (no infection at the level of patch repair was observed). In the remaining patients, the most recent echocardiogram demonstrated ≤mild regurgitation and stable gradients. The thickness and echodensity of the implanted patch on follow-up echocardiograms were comparable with postoperative echocardiograms. Initial results of the CardioCel patch in mitral valve repair surgery are satisfactory. The resistance to infection and late degeneration will need to be assessed in the future. Copyright © 2018. Published by Elsevier Inc.

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

Evaluation of success after second Ahmed glaucoma valve implantation

PubMed Central

Nilforushan, Naveed; Yadgari, Maryam; Jazayeri, Anis Alsadat; Karimi, Nasser

2016-01-01

Purpose: To evaluate the outcome of the second Ahmed glaucoma valve (AGV) surgery in eyes with failed previous AGV surgery. Design: Retrospective case series. Patients and Methods: Following chart review, 36 eyes of 34 patients with second AGV implantation were enrolled in this study. The primary outcome measure was surgical success defined in terms of intraocular pressure (IOP) control using two criteria: Success was defined as IOP ≤21 mmHg (criterion 1) and IOP ≤16 mmHg (criterion 2), with at least 20% reduction in IOP, either with no medication (complete success) or with no more than two medications (qualified success). Kaplan–Meier survival analysis was used to determine the probability of surgical success. Results: The average age of the patients was 32.7 years (range 4–65), and the mean duration of follow-up was 21.4 months (range 6–96). Preoperatively, the mean IOP was 26.94 mmHg (standard deviation [SD] 7.03), and the patients were using 2.8 glaucoma medications on average (SD 0.9). The mean IOP decreased significantly to 13.28 mmHg (SD 3.59) at the last postoperative visit (P = 0.00) while the patients needed even fewer glaucoma medications on average (1.4 ± 1.1, P = 0.00). Surgical success of second glaucoma drainage devices (Kaplan–Meier analysis), according to criterion 1, at 6, 12, 18, and 42 months was 94%, 85%, 80%, and 53% respectively, and according to criterion 2, was 94%, 85%, 75%, and 45%, respectively. Conclusion: Repeated AGV implantation seems to be a safe modality of treatment with acceptable success rate in cases with failed previous AGV surgery. PMID:27146930

Evaluation of success after second Ahmed glaucoma valve implantation.

PubMed

Nilforushan, Naveed; Yadgari, Maryam; Jazayeri, Anis Alsadat; Karimi, Nasser

2016-03-01

To evaluate the outcome of the second Ahmed glaucoma valve (AGV) surgery in eyes with failed previous AGV surgery. Retrospective case series. Following chart review, 36 eyes of 34 patients with second AGV implantation were enrolled in this study. The primary outcome measure was surgical success defined in terms of intraocular pressure (IOP) control using two criteria: Success was defined as IOP ≤21 mmHg (criterion 1) and IOP ≤16 mmHg (criterion 2), with at least 20% reduction in IOP, either with no medication (complete success) or with no more than two medications (qualified success). Kaplan-Meier survival analysis was used to determine the probability of surgical success. The average age of the patients was 32.7 years (range 4-65), and the mean duration of follow-up was 21.4 months (range 6-96). Preoperatively, the mean IOP was 26.94 mmHg (standard deviation [SD] 7.03), and the patients were using 2.8 glaucoma medications on average (SD 0.9). The mean IOP decreased significantly to 13.28 mmHg (SD 3.59) at the last postoperative visit (P = 0.00) while the patients needed even fewer glaucoma medications on average (1.4 ± 1.1, P = 0.00). Surgical success of second glaucoma drainage devices (Kaplan-Meier analysis), according to criterion 1, at 6, 12, 18, and 42 months was 94%, 85%, 80%, and 53% respectively, and according to criterion 2, was 94%, 85%, 75%, and 45%, respectively. Repeated AGV implantation seems to be a safe modality of treatment with acceptable success rate in cases with failed previous AGV surgery.

Use of Mitomycin C to reduce the incidence of encapsulated cysts following ahmed glaucoma valve implantation in refractory glaucoma patients: a new technique.

PubMed

Zhou, Minwen; Wang, Wei; Huang, Wenbin; Zhang, Xiulan

2014-09-06

To evaluate the surgical outcome of Ahmed glaucoma valve (AGV) implantation with a new technique of mitomycin C (MMC) application. This is a retrospective study. All patients with refractory glaucoma underwent FP-7 AGV implantation. Two methods of MMC application were used. In the traditional technique, 6 × 4 mm cotton soaked with MMC (0.25-0.33 mg/ml) was placed in the implantation area for 2-5mins; in the new technique, the valve plate first was encompassed with a thin layer of cotton soaked with MMC, then inserted into the same area. A 200 ml balanced salt solution was applied for irrigation of MMC. The surgical success rate, intraocular pressure (IOP), number of anti-glaucoma medications used, and postoperative complications were analyzed between the groups. The surgical outcomes of two MMC applied techniques were compared. The new technique group had only one case (2.6%) of encapsulated cyst formation out of 38 eyes, while there were eight (19.5%) cases out of 41 eyes the in traditional group. The difference was statistically significant (P = 0.030). According to the definition of success rate, there was 89.5% in the new technique group and 70.7% in the traditional group at the follow-up end point. There was a significant difference between the two groups (P = 0.035). Mean IOP in the new technique group were significantly lower than those of the traditional group at 3 and 6 months (P < 0.05). By using a thin layer of cotton soaked with MMC to encompass the valve plate, the new MMC application technique could greatly decrease the incidence of encapsulated cyst and increase the success rate following AGV implantation.

Volumetric velocimetry downstream of a percutaneous heart valve

NASA Astrophysics Data System (ADS)

Raghav, Vrishank; Clifford, Christopher; Midha, Prem; Okafor, Ikechukwu; Thurow, Brian; Yoganathan, Ajit; Auburn University Collaboration; Georgia Institute of Technology Collaboration

2017-11-01

Transcatheter aortic valve replacement has emerged as a safe and effective treatment for severe, symptomatic aortic stenosis in intermediate or greater surgical risk patients. However, despite excellent short-term outcomes, improved imaging and awareness has led to the identification of leaflet thrombosis on the aortic side of the prosthesis. Upon implantation, the transcatheter heart valve (THV) becomes enclosed in the native aortic valve leaflet tissue dividing the native sinus into two regions - a smaller anatomical sinus and a neo-sinus. To understand the causes for thrombosis, plenoptic Particle Image Velocimetry (PIV) is used to investigate the pulsatile three-dimensional flow in the sinus and neo-sinus region of the THV. Experiments are conducted on both a real and a transparent THV model in a pulsatile flow loop capable of replicating physiological hemodynamics. Comparisons with planar PIV results demonstrate the feasibility of using Plenoptic PIV to study heart valve fluid dynamics. Large three-dimensional regions of low velocity magnitude and low viscous shear stress were observed near the heart valve which could increase particle residence time potentially leading to formation of clots the THV leaflet.

Bioprinting a cardiac valve.

PubMed

Jana, Soumen; Lerman, Amir

2015-12-01

Heart valve tissue engineering could be a possible solution for the limitations of mechanical and biological prostheses, which are commonly used for heart valve replacement. In tissue engineering, cells are seeded into a 3-dimensional platform, termed the scaffold, to make the engineered tissue construct. However, mimicking the mechanical and spatial heterogeneity of a heart valve structure in a fabricated scaffold with uniform cell distribution is daunting when approached conventionally. Bioprinting is an emerging technique that can produce biological products containing matrix and cells, together or separately with morphological, structural and mechanical diversity. This advance increases the possibility of fabricating the structure of a heart valve in vitro and using it as a functional tissue construct for implantation. This review describes the use of bioprinting technology in heart valve tissue engineering. Copyright © 2015 Elsevier Inc. All rights reserved.

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

PubMed

Conrotto, Federico; D'Ascenzo, Fabrizio; D'Onofrio, Augusto; Agrifoglio, Marco; Chieffo, Alaide; Cioni, Micaela; Regesta, Tommaso; Tarantini, Giuseppe; Gabbieri, Davide; Saia, Francesco; Tamburino, Corrado; Ribichini, Flavio; Cugola, Diego; Aiello, Marco; Sanna, Francesco; Iadanza, Alessandro; Pompei, Esmeralda; Stolcova, Miroslava; Cappai, Antioco; Minati, Alessandro; Cassese, Mauro; Martinelli, Gian Luca; Agostinelli, Andrea; Gerosa, Gino; Gaita, Fiorenzo; Rinaldi, Mauro; Salizzoni, Stefano

2016-11-01

Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS 2 and CHA 2 DS 2 -VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA 2 DS 2 -VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS 2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA 2 DS 2 -VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA 2 DS 2 -VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS 2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). In TAVI patients, CHA 2 DS 2 -VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Hybrid textile heart valve prosthesis: preliminary in vitro evaluation.

PubMed

Vaesken, Antoine; Pidancier, Christian; Chakfe, Nabil; Heim, Frederic

2016-09-22

Transcatheter aortic valve implantation (TAVI) is nowadays a popular alternative technique to surgical valve replacement for critical patients. Biological valve tissue has been used in these devices for over a decade now with over 100,000 implantations. However, material degradations due to crimping for catheter insertion purpose have been reported, and with only 6-year follow-up, no information is available about the long-term durability of biological tissue. Moreover, expensive biological tissue harvesting and chemical treatment procedures tend to promote the development of synthetic valve leaflet materials. Textile polyester (PET) material is characterized by outstanding folding and strength properties combined with proven biocompatibility and could therefore be considered as a candidate to replace biological valve leaflets in TAVI devices. Nevertheless, the material should be preferentially partly elastic in order to limit water hammer effects at valve closing time and prevent exaggerated stress from occurring into the stent and the valve. The purpose of the present work is to study in vitro the mechanical as well as the hydrodynamic behavior of a hybrid elastic textile valve device combining non-deformable PET yarn and elastic polyurethane (PU) yarn. The hybrid valve properties are compared with those of a non-elastic textile valve. Testing results show improved hydrodynamic properties with the elastic construction. However, under fatigue conditions, the interaction between PU and PET yarns tends to limit the valve durability.

Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma.

PubMed

Lee, Chang Kyu; Ma, Kyoung Tak; Hong, Young Jae; Kim, Chan Yun

2017-01-01

To evaluate the long-term efficacy of intraocular pressure (IOP) reduction and complications of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma. Retrospective study. The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013. An operation was defined as successful when (1) the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2) there was no loss of light perception or vision-threatening severe complications, and (3) no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed. IOP, anti-glaucoma medications, and complications. The mean follow-up period was 62.25 months (range, 6 to 190 months). The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05). AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure.

Long-term clinical outcomes of Ahmed valve implantation in patients with refractory glaucoma

PubMed Central

Lee, Chang Kyu; Ma, Kyoung Tak; Hong, Young Jae

2017-01-01

Purpose To evaluate the long-term efficacy of intraocular pressure (IOP) reduction and complications of Ahmed Glaucoma Valve (AGV) implantation in patients with refractory glaucoma. Design Retrospective study. Subjects The study involved 302 refractory glaucoma patients who underwent AGV implantation and had a minimum follow-up of 6 months between March 1995 and December 2013. Methods An operation was defined as successful when (1) the postoperative IOP remained between 5 and 21 mmHg and was reduced 30% compared to the baseline IOP with or without medication, (2) there was no loss of light perception or vision-threatening severe complications, and (3) no additional filtering or aqueous drainage surgery was required. Clinical records were reviewed. Main outcome measures IOP, anti-glaucoma medications, and complications Results The mean follow-up period was 62.25 months (range, 6 to 190 months). The cumulative probability of success was 89% at 6 months, 81% at 1 year, 66% at 3 years, 44% at 10 years, and 26% at 15 years. IOP was reduced from a mean of 32.2 ± 10.5 mmHg to 18.6 ± 9.1 mmHg at 1 month, 15.2 ± 7.0 mmHg at 6 months, and 14.2 ± 3.5 mmHg at 15 years. Surgical failures were significantly increased when preoperative IOP was high, and when severe complications occurred after AGV implantation (P < 0.05). Conclusion AGV implantation was successful for IOP control in patients with refractive glaucoma in the long term. However, the success rate of surgery decreased over time. Preoperative high IOP and severe complications related to the operation were significant risk factors for failure. PMID:29095931

The flaws in the detail of an observational study on transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate-risks patients.

PubMed

Barili, Fabio; Freemantle, Nick; Folliguet, Thierry; Muneretto, Claudio; De Bonis, Michele; Czerny, Martin; Obadia, Jean Francois; Al-Attar, Nawwar; Bonaros, Nikolaos; Kluin, Jolanda; Lorusso, Roberto; Punjabi, Prakash; Sadaba, Rafael; Suwalski, Piotr; Benedetto, Umberto; Böning, Andreas; Falk, Volkmar; Sousa-Uva, Miguel; Kappetein, Pieter A; Menicanti, Lorenzo

2017-06-01

The PARTNER group recently published a comparison between the latest generation SAPIEN 3 transcatheter aortic valve implantation (TAVI) system (Edwards Lifesciences, Irvine, CA, USA) and surgical aortic valve replacement (SAVR) in intermediate-risk patients, apparently demonstrating superiority of the TAVI and suggesting that TAVI might be the preferred treatment method in this risk class of patients. Nonetheless, assessment of the non-randomized methodology used in this comparison reveals challenges that should be addressed in order to elucidate the validity of the results. The study by Thourani and colleagues showed several major methodological concerns: suboptimal methods in propensity score analysis with evident misspecification of the propensity scores (PS; no adjustment for the most significantly different covariates: left ventricular ejection fraction, moderate-severe mitral regurgitation and associated procedures); use of PS quintiles rather than matching; inference on not-adjusted Kaplan-Meier curves, although the authors correctly claimed for the need of balancing score adjusting for confounding factors in order to have unbiased estimates of the treatment effect; evidence of poor fit; lack of data on valve-related death.These methodological flaws invalidate direct comparison between treatments and cannot support authors' conclusions that TAVI with SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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

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.

Hemodynamics of Pericardial Aortic Valves: Contemporary Stented versus Stentless Valves in a Matched Comparison

PubMed Central

Holinski, Sebastian; Zhigalov, Konstantin; Zielinski, Christina Barbara; Grubitzsch, Herko

2017-01-01

Purpose: Hemodynamic performance of aortic valve bioprostheses is essential for reliable function and durability. So far, the supra-annularly implanted stentless Sorin Freedom Solo (SFS) demonstrated unsurpassed hemodynamic properties. As contemporary stented and externally mounted pericardial bioprostheses, like the Labcor Dokimos Plus (LDP), also improve hemodynamic performance, these types of valves were compared in this study. Methods: A total of 218 patients, who underwent aortic valve replacement with the LDP or the SFS, were matched retrospectively 1:1 on variables affecting hemodynamic measurements: implanted valve size, age, sex, and body surface area (BSA). With matching tolerance for valve size and gender of 0%, for age and BSA of 5%, 57 patient-pairs were yielded. Operative data, clinical, and hemodynamic outcome were analyzed. Results: Except for slightly higher left ventricular function and lower procedural times in the SFS group, preoperative, operative, and postoperative characteristics of patient-pairs did not differ significantly. Mean pressure gradients, effective orifice areas (EOAs), and indexed EOAs were comparable. Corresponding to valve sizes of 21, 23, 25, and 27 mm, the indexed EOAs of the LDP and SFS prostheses were 1.08 ± 0.33, 0.92 ± 0.19, 0.93 ± 0.24, 0.99 ± 0.13 cm2/m2 and 0.81 ± 0.13, 0.92 ± 0.28, 0.95 ± 0.20, 1.04 ± 0.27 cm2/m2, respectively. Conclusion: Contemporary stented and stentless pericardial bioprostheses showed excellent hemodynamic properties without significant differences in EOAs and indexed EOAs. PMID:28890465

Kangaroo versus porcine aortic valve tissue--valve geometry morphology, tensile strength and calcification potential.

PubMed

Neethling, W M; Papadimitriou, J M; Swarts, E; Hodge, A J

2000-06-01

Valve related factors and patient related factors are responsible for calcification of valvular bioprostheses. Recent studies showed different donor and recipient species have different influences on the total calcification rate of bioprostheses. This study was performed to evaluate and compare Kangaroo aortic valve leaflets with porcine aortic valve leaflets. Experimental design. Prospective study. Setting. Cardio-thoracic experimental research of a university department. Glutaraldehyde-fixed Kangaroo and porcine valve leaflets were evaluated in vitro according to valve geometry (internal diameter and leaflet thickness), morphology (light and electron microscopy) and tensile strength. In vivo evaluation consisted of implantation in a rat model for 8 weeks, Von Kossa stain for calcium and atomic absorption spectrophotometry for total extractable calcium content. Kangaroo valves indicated a smaller internal valve diameter as well as a thinner valve leaflet (p<0.01, ANOVA) at corresponding body weight, less proteoglycan spicules in the fibrosa, increased elasticity (p<0.05) and low calcification potential (p<0.01, confidence interval 95%). Kangaroo aortic valve leaflets have different valvular qualities compared to porcine valve tissue. Kangaroo valve leaflets are significantly superior to porcine valve leaflets as far as calcification is concerned. These results are encouraging and suggest further in vivo evaluation in a larger animal model before clinical application can be considered.

Triple valve surgery: a 25-year experience.

PubMed

Yilmaz, Mustafa; Ozkan, Murat; Böke, Erkmen

2004-09-01

Surgical treatment of rheumatic valvular disease still constitutes a significant number of cardiac operations in developing countries. Despite improvements in myocardial protection and cardiopulmonary bypass techniques, triple valve operations (aortic, mitral and tricuspid valves) are still challenging because of longer duration of cardiopulmonary bypass and higher degree of myocardial decompensation. This study was instituted in order to assess results of triple valve surgery. Between 1977 and 2002, 34 patients underwent triple valve surgery in our clinic by the same surgeon (EB). Eleven patients underwent triple valve replacement (32.4%) and 23 underwent tricuspid valve annuloplasty with aortic and mitral valve replacements (67.6%). There was no significant difference between the two groups of patients who underwent triple valve replacement and aortic and mitral valve replacement with tricuspid valve annuloplasty. There were 4 hospital deaths (11.8%) occurring within 30 days. The duration of follow-up for 30 survivors ranged from 6 to 202 months (mean 97 months). The actuarial survival rates were 85%, 72%, and 48% at 5, 10, and 15 years respectively. Actuarial freedom from reoperation rates at 5, 10, and 15 years was 86.3%, 71.9%, and 51.2%, respectively. Freedom from cerebral thromboembolism and anticoagulation-related hemorrhage rates, expressed in actuarial terms was 75.9% and 62.9% at 5 and 10 years. Major cerebral complications occurred in 10 of the 30 patients. We prefer replacing, if repairing is not possible, the tricuspid valve, with a bileaflet mechanical prosthesis in a patient with valve replacement of the left heart who will be anticoagulated in order to avoid unfavorable properties of bioprosthesis like degeneration and of old generation mechanical prosthesis like thrombosis and poor hemodynamic function. In recent years, results of triple valve surgery either with tricuspid valve conservation or valve replacement in suitable cases have become

Atrial fibrillation in transcatheter aortic valve implantation patients: Incidence, outcome and predictors of new onset.

PubMed

Zweiker, David; Fröschl, Mario; Tiede, Stephanie; Weidinger, Paul; Schmid, Johannes; Manninger, Martin; Brussee, Helmut; Zweiker, Robert; Binder, Josepha; Mächler, Heinrich; Marte, Wolfgang; Maier, Robert; Luha, Olev; Schmidt, Albrecht; Scherr, Daniel

There is controversial evidence if atrial fibrillation (AF) alters outcome after transcatheter aortic valve implantation (TAVI). TAVI itself may promote new-onset AF (NOAF). We performed a single-center study including 398 consecutive patients undergoing TAVI. Before TAVI, patients were divided into a sinus rhythm (SR) group (n=226, 57%) and baseline AF group (n=172, 43%) according to clinical records and electrocardiograms. Furthermore, incidence and predictors of NOAF were recorded. Baseline AF patients had a significantly higher 1-year mortality than the baseline SR group (19.8% vs. 11.5%, p=0.02). NOAF occurred in 7.1% of patients with prior SR. Previous valve surgery was the only significant predictor of NOAF (HR 5.86 [1.04-32.94], p<0.05). NOAF was associated with higher rehospitalization rate (62.5 vs. 34.8%, p=0.04), whereas mortality was unaffected. This study shows that NOAF is associated with higher rates of rehospitalization but not mortality after TAVI. Overall, patients with pre-existing AF have higher mortality. Copyright © 2017 Elsevier Inc. All rights reserved.

Multicenter Analysis of Clinical Follow-Ups in Patients with a Star GK Cardiac Valve Replacement for More than One Year.

PubMed

Li, Mingwen; Xiao, Yingbin; Chen, Daozhong; Liu, Liming; Ma, Liming; Wang, Pingfan; Jia, Kui; Yang, Kai; Chen, Lin

2016-05-18

Star GK valves were widely used in China, and we studied the clinical follow-up results of patients with Star GK valve implants for more than one year.  Clinical data were collected from those patients who had Star GK valve implants for over one year. Patients were divided into three groups: (1) AVR group: received aortic valve replacement surgery. Based on the valve model this group was further sub-divided into two groups: 21A group, and 23A group; (2) MVR group: received mitral valve replacement surgery. Based on the valve model this group was further sub-divided into three groups: 25M group, 27M group, and 29M group; (3) DVR group: received combined replacement surgeries including AVR + MVR. According to postoperative follow-up time these patients were divided into two groups: 1-year group and 3-year group. Follow-up data were collected by telephone, outpatient visits, or correspondence. Clinical data were aggregated by professional data scientists to conduct independent analyses.  959 patients were included in the study following Star GK valve implant. Follow-up after 1 year found that thrombosis occurred in 4 cases, hemorrhage in 15 cases, left heart failure in 13 cases, paravalvular leakage in 5 cases, and death due to cardiac causes in 2 cases.  The long-term efficacy of Star GK valve implants was satisfactory with low incidence of valve-related complications, and following Star GK valve implant, valve and blood were highly compatible and blood component damage was minor. Very low incidence rate of thrombosis was observed following Star GK valve implant, however, attention should be paid to adjust the anticoagulation intensity.

Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes.

PubMed

Stortecky, Stefan; Windecker, Stephan; Pilgrim, Thomas; Heg, Dik; Buellesfeld, Lutz; Khattab, Ahmed A; Huber, Christoph; Gloekler, Steffen; Nietlispach, Fabian; Mattle, Heinrich; Jüni, Peter; Wenaweser, Peter

2012-05-15

Cerebrovascular accidents (CVA) are considered among the most serious adverse events after transcatheter aortic valve implantation (TAVI). The objective of the present study was to evaluate the frequency and timing of CVA after TAVI and to investigate the impact on clinical outcomes within 30 days of the procedure. Between August 2007 and October 2011, 389 high-risk elderly patients with symptomatic severe aortic stenosis underwent TAVI via transfemoral, transapical or subclavian access. A total of 14 patients (3.6%) experienced at least one CVA within 30 days of follow-up and most events (74%) occurred within the first day of the procedure. Patients with CVA had an increased risk of all-cause (42.3% vs. 5.1%, ORadjusted 11.7, 95% CI 3.4-40.3, p<0.001) and cardiovascular mortality (38.4% vs. 4.6%, ORadjusted 10.5, 95% CI 2.9-37.8, p<0.001) compared to patients without CVA at 30 days of follow-up. Repeated device implantation attempts (ORadjusted 8.3, CI 2.1-33.3, p<0.003), chronic pulmonary disease (ORadjusted 4.7, CI 1.3-16.8, p=0.02) and body mass index <25 kg/m2 (ORadjusted 0.8, CI 0.7-0.9, p<0.01) emerged as independent predictors of periprocedural CVA. Cerebrovascular accidents among patients undergoing TAVI occur predominantly during the periprocedural period, are associated with multiple implantation attempts of the bioprosthesis and significantly impair prognosis.

[Ministernotomy: a preliminary experience in heart valve surgery].

PubMed

Kovarević, Pavle; Mihajlović, Bogoljub; Velicki, Lazar; Redzek, Aleksandar; Ivanović, Vladimir; Komazec, Nikola

2011-05-01

The last decade of the 20th century brought up a significant development in the field of minimally invasive approaches to the valvular heart surgery. Potential benefits of this method are: good esthetic appearance, reduced pain, reduction of postoperative hemorrhage and incidence of surgical site infection, shorter postoperative intensive care units (ICU) period and overall in-hospital period. Partial upper median stemotomy currently presents as a state-of-the art method for minimally invasive surgery of cardiac valves. The aim of this study was to report on initial experience in application of this surgical method in the surgery of mitral and aortic valves. The study was designed and conducted in a prospective manner and included all the patients who underwent minimally invasive cardiac valve surgery through the partial upper median stemotomy during the period November 2008 - August 2009. We analyzed the data on mean age of patients, mean extubation time, mean postoperative drainage, mean duration of hospital stay, as well as on occurance of postoperative complications (postoperative bleeding, surgical site infection and cerebrovascular insult). During the observed period, in the Institute for Cardiovascular Diseases of Vojvodina, Clinic for Cardiovascular Surgery, 17 ministernotomies were performed, with 14 aortic valve replacements (82.35%) and 3 mitral valve replacements (17.65%). Mean age of the patients was 60.78 +/- 12.99 years (64.71% males, 35.29% females). Mean extubation time was 12.53 +/- 8.87 hours with 23.5% of the patients extubated in less than 8 hours. Mean duration of hospital stay was 12.35 +/- 10.17 days (in 29.4% of the patients less than 8 days). Mean postoperative drainage was 547.06 +/- 335.2 mL. Postoperative complications included: bleeding (5.88%) and cerebrovascular insult (5.88%). One patient (5.88%) required conversion to full stemotomy. Partial upper median sternotomy represents the optimal surgical method for the interventions on the

Comparison of outcomes of patients with left ventricular ejection fractions ≤30% versus ≥30% having transcatheter aortic valve implantation (from the German Transcatheter Aortic Valve Interventions Registry).

PubMed

Schaefer, Ulrich; Zahn, Ralf; Abdel-Wahab, Mohamed; Gerckens, Ulrich; Linke, Axel; Schneider, Steffen; Eggebrecht, Holger; Sievert, Horst; Figulla, Hans Reiner; Senges, Jochen; Kuck, Karl Heinz

2015-03-01

Transcatheter aortic valve implantation (TAVI) is rapidly evolving in Germany. Especially severe reduced left ventricular ejection fraction (LVEF) is known as a prominent risk factor for adverse outcome in open heart surgery. Thus, the data of the prospective multicenter German Transcatheter Aortic Valve Interventions Registry were analyzed for outcomes in patients with severe depressed LVEF. Data of 1,432 patients were consecutively collected after transcatheter aortic valve implantation. Patients were divided into 2 groups (A: LVEF ≤30%, n = 169, age 79.9 ± 6.7 years, logES 34.2 ± 17.8%; B: LVEF >30%, n = 1,263, age 82.0 ± 6.1 years, logES 18.9 ± 12.0%), and procedural success rates, New York Heart Association classification, and quality of life were compared at 30 days and 1 year, respectively. Technical success was achieved in 95.9% (A) and 97.6% (B). Survival and the New York Heart Association classification at 30 days demonstrated an excellent outcome in both groups. There was a significant improvement according to the self-assessment in health condition (0 to 100 scale) with a much larger gain in group A (28 vs 19 patients, p <0.0001). Nevertheless, low cardiac output syndrome (12.3% vs 5.9%, p <0.01) and resuscitation (10.4% vs 5.6%, p <0.05) were more frequently seen in group A, contributing to a higher mortality at 30 days (14.3% vs 7.2%) and 1 year (33.7% vs 18.1%, p <0.001). In conclusion, this real-world registry demonstrated a comparably high success rate for patients with severe reduced LVEF and an early improvement in functional status as demonstrated by substantial benefit, despite a doubled postprocedural mortality. Copyright © 2015 Elsevier Inc. All rights reserved.

Impact of mitral valve intervention with left ventricular assist device implantation on postoperative outcomes and morphologic change.

PubMed

Hata, Hiroki; Fujita, Tomoyuki; Ishibashi-Ueda, Hatsue; Kuroda, Kensuke; Seguchi, Osamu; Matsumoto, Yorihiko; Yanase, Masanobu; Sato, Takuma; Nakajima, Seiko; Fukushima, Norihide; Kobayashi, Junjiro

2018-06-01

Although mitral regurgitation (MR) is prevalent in patients with end-stage heart failure, the impact of mitral valve (MV) surgery on outcomes after left ventricular assist device (LVAD) implantation and morphologic changes of MV remains unclear. We retrospectively reviewed 74 patients who underwent LVAD implantation as a bridge to transplant. Of these, 11 (15%) underwent MV repair concomitant with or prior to LVAD implantation, while 27 patients with preoperative significant (moderate or greater) MR did not undergo concomitant MV surgery. The mean interval between LVAD implantation and the last echocardiographic examination was 913 days. Irrespective of MV surgery, significant LV reverse remodeling including decreased LV and left atrial dimension and improved MR severity was observed in all patients except for patients with prior MV surgery. Histopathological examination of explanted hearts removed at heart transplantation (n = 69) or autopsy (n = 5) revealed that the MV annulus was still dilated (mean perimeter 11.7 cm) in the patients with preoperative significant MR and no concomitant MV surgery. Concomitant MV surgery at the time of LVAD implantation for significant MR might not be always necessary for bridge to transplant or destination therapy cases. However, it might be required in patients having potential for cardiac recovery or patients with severe pulmonary hypertension and depressed right ventricle.

Outcomes following transcatheter aortic valve replacement in patients with native aortic valve regurgitation

PubMed Central

Bob-Manuel, Tamunoinemi; Kadire, Siri; Heckle, Mark R.; Wang, Jiajing

2018-01-01

Due to the absence of annular calcification for device anchoring, it is presumed that transcatheter aortic valve replacement (TAVR) is not suitable for the treatment of native aortic valve regurgitation (NAVR) resulting in very limited data and experience concerning its safety and efficacy. We sought to review published data on the safety and efficacy of TAVR in high-risk patients with NAVR. Studies including case reports, case series and original articles published between 2002 and 2016 on TAVR in patients with NAVR were identified with a systematic electronic search using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Only studies reporting data on demographic and procedural characteristics, management and follow up outcomes were analyzed. A total of 30 publications describing 182 patients were identified. Most patients (54%) were men, with a mean age of 70.1±2.6 years, mean logistic European System for Cardiac Operative Risk Evaluation score (EuroSCORE) of 21.8%±4.5% and mean Society of Thoracic Surgeons (STS) score of 8%±1.8% for mortality. The majority (87%) of patients had severe NAVR with no valvular calcification. TAVR was mostly performed through the femoral (58.8%) and apical (33.1%) approach. Device success, defined by VARC-2, was achieved in 86.3% of our study population. A second valve was required in 17 patients (9.3%) during the index procedure for residual aortic regurgitation or malposition. Post-procedure aortic regurgitation of grade 1 or less was present in 80 patients (81%). Pacemaker implantation was required post procedure in 17 patients (9.3%). The 30-day and 1-year mortality was 11.9% and 16.2%, respectively. TAVR is associated with favorable pacemaker implantation and 1-year mortality rates with a high 30-day mortality among selected patients with NAVR. PMID:29404354

Valve replacement in children: a challenge for a whole life.

PubMed

Henaine, Roland; Roubertie, François; Vergnat, Mathieu; Ninet, Jean

2012-10-01

Valvular pathology in infants and children poses numerous challenges to the paediatric cardiac surgeon. Without question, valvular repair is the goal of intervention because restoration of valvular anatomy and physiology using native tissue allows for growth and a potentially better long-term outcome. When reconstruction fails or is not feasible, valve replacement becomes inevitable. Which valve for which position is controversial. Homograft and bioprosthetic valves achieve superior haemodynamic results initially but at the cost of accelerated degeneration. Small patient size and the risk of thromboembolism limit the usefulness of mechanical valves, and somatic outgrowth is an universal problem with all available prostheses. The goal of this article is to address valve replacement options for all four valve positions within the paediatric population. We review current literature and our practice to support our preferences. To summarize, a multitude of opinions and surgical experiences exist. Today, the valve choices that seem without controversy are bioprosthetic replacement of the tricuspid valve and Ross or Ross-Konno procedures when necessary for the aortic valve. On the other hand, bioprostheses may be implanted when annular pulmonary diameter is adequate; if not or in case of right ventricular outflow tract discontinuity, it is better to use a pulmonary homograft with the Ross procedure. Otherwise, a valved conduit. Mitral valve replacement remains the most problematic; the mechanical prosthesis must be placed in the annular position, avoiding oversizing. Future advances with tissue-engineered heart valves for all positions and new anticoagulants may change the landscape for valve replacement in the paediatric population. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE).

PubMed

Rahmani, Benyamin; Tzamtzis, Spyros; Sheridan, Rose; Mullen, Michael J; Yap, John; Seifalian, Alexander M; Burriesci, Gaetano

2017-04-01

This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

Ahmed Glaucoma Valve Implantation for Uveitic Glaucoma Secondary to Behçet Disease.

PubMed

Satana, Banu; Yalvac, Ilgaz S; Sungur, Gulten; Eksioglu, Umit; Basarir, Berna; Altan, Cigdem; Duman, Sunay

2015-01-01

To evaluate outcomes of patients with uveitic glaucoma secondary to Behçet disease (BD) who underwent Ahmed glaucoma valve (AGV) implantation. A retrospective chart review of 14 eyes of 10 patients with uveitic glaucoma associated with BD who underwent AGV implantation at a tertiary referral center. Treatment success was defined as intraocular pressure (IOP) between 6 and 21 mm Hg with or without antiglaucoma medication, without further additional glaucoma surgery or loss of light perception. The main outcome measures were IOP, best-corrected visual acuity measured with Snellen charts, and number of glaucoma medications. Mean duration of postoperative follow-up was 18.2±6.6 months (range, 6 to 31 mo). Of the 14 eyes, 10 (71.4%) were pseudophakic and 5 (35.7%) had primary AGV implantation without a history of previous glaucoma surgery. At the most recent follow-up visit, 13 of the 14 eyes had an IOP between 6 and 21 mm Hg. Mean IOP was significantly reduced during follow-up, as compared with preoperative values (P≤0.005). The cumulative probability of surgical success rate was 90.9% at 18 months based on Kaplan-Meier survival analysis. The mean number of antiglaucoma medications required to achieve the desired IOP decreased from 3.4±0.5 preoperatively to 1.0±1.1 postoperatively (P≤0.05). Visual acuity loss of >2 lines occurred in 4 eyes (28.5%) due to optic atrophy associated with retinal vasculitis. Temporary hypotony developed during follow-up in 4 eyes (28.5%) at first postoperative week. For the management of uveitic glaucoma associated with BD, AGV implantation is a successful method for glaucoma control but requires additional surgical interventions for high early hypotony rates.

Ahmed glaucoma valve in uveitic patients with fluocinolone acetonide implant-induced glaucoma: 3-year follow-up.

PubMed

Kubaisi, Buraa; Maleki, Arash; Ahmed, Aseef; Lamba, Neel; Sahawneh, Haitham; Stephenson, Andrew; Montieth, Alyssa; Topgi, Shobha; Foster, C Stephen

2018-01-01

To evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) in eyes with noninfectious uveitis that had fluocinolone acetonide intravitreal implant (Retisert™)-induced glaucoma. This retrospective study reviewed the safety and efficacy of AGV implantation in patients with persistently elevated intraocular pressure (IOP) after implantation of a fluocinolone acetonide intravitreal implant at the Massachusetts Eye Research and Surgery Institution between August 2006 and November 2015. Nine patients with 10 uveitic eyes were included in this study, none of which had preexisting glaucoma in the study eye. Mean patient age was 42 years; 6 patients were female and 3 were male. Baseline mean IOP was 30.6 mmHg prior to AGV placement while mean IOP-lowering medications were 2.9. In the treatment groups, there was a statistically significant reduction in post-AGV IOP. IOP was lowest at 1-week after AGV implantation (9.0 mmHg). Nine out of 10 eyes achieved an IOP below target value of 22 mmHg and/or a 20% reduction in IOP from baseline 1 month and 1 year following AGV placement. All other postoperative time points showed all 10 eyes reaching this goal. A statistically significant decrease in IOP-lowering medication was seen at the 1-week, 1-month, and 3-year time points compared to baseline, while a statistically significant increase was seen at the 3-month, 6-month, and 2-year post-AGV time points. No significant change in retinal nerve thickness or visual field analysis was found. AGV is an effective and safe method of treatment in fluocinolone acetonide intravitreal implant-induced glaucoma. High survival rate is expected for at least 3 years.

Adjustable shunt valve-induced magnetic resonance imaging artifact: a comparative study.

PubMed

Toma, Ahmed K; Tarnaris, Andrew; Grieve, Joan P; Watkins, Laurence D; Kitchen, Neil D

2010-07-01

In this paper, the authors' goal was to compare the artifact induced by implanted (in vivo) adjustable shunt valves in spin echo, diffusion weighted (DW), and gradient echo MR imaging pulse sequences. The MR images obtained in 8 patients with proGAV and 6 patients with Strata II adjustable shunt valves were assessed for artifact areas in different planes as well as the total volume for different pulse sequences. Artifacts induced by the Strata II valve were significantly larger than those induced by proGAV valve in spin echo MR imaging pulse sequence (29,761 vs 2450 mm(3) on T2-weighted fast spin echo, p = 0.003) and DW images (100,138 vs 38,955 mm(3), p = 0.025). Artifacts were more marked on DW MR images than on spin echo pulse sequence for both valve types. Adjustable valve-induced artifacts can conceal brain pathology on MR images. This should influence the choice of valve implantation site and the type of valve used. The effect of artifacts on DW images should be highlighted pending the development of less MR imaging artifact-inducing adjustable shunt valves.

Biventricular Heart Remodeling After Percutaneous or Surgical Pulmonary Valve Implantation: Evaluation by Cardiac Magnetic Resonance.

PubMed

Secchi, Francesco; Resta, Elda C; Cannaò, Paola M; Pluchinotta, Francesca; Piazza, Luciane; Butera, Gianfranco; Carminati, Mario; Sardanelli, Francesco

2017-11-01

The aim of this study was to evaluate the impact of percutaneous pulmonary valve implantation (PPVI) and surgical pulmonary valve replacement (SPVR) on biventricular and pulmonary valve function using cardiac magnetic resonance. Thirty-five patients aged 20±8 years (mean±SD) underwent PPVI, whereas 16 patients aged 30±11 years underwent SPVR. Cardiac magnetic resonance examinations were performed before and after the procedures with an average follow-up interval of 10 months. Cine steady-state free precession sequences for cardiac function and phase-contrast sequences for pulmonary flow were performed. The right ventricle (RV) and left ventricle (LV) functions were evaluated using a dedicated software. The RV end-diastolic volume index (mL/m) decreased significantly after PPVI and SPVR, from 74 to 64 (P=0.030) and from 137 to 83 (P=0.001), respectively. The RV ejection fraction increased significantly after SPVR, from 47% to 53% (P=0.038). The LV end-diastolic volume index increased significantly after PPVI, from 66 to 76 mL/m (P<0.001). The LV stroke volume index increased significantly after PPVI, from 34 to 43 mL/m (P=0.004). The analysis of bivariate correlations showed that in patients undergoing SPVR the RV changes after the procedure were positively correlated to LV changes in terms of end-systolic volume index (r=0587; P=0.017) and ejection fraction (r=0.681; P=0.004). A RV volumetric reduction and a positive effect on ventricular-ventricular interaction were observed after both PPVI and SPVR. After PPVI, a positive volumetric LV remodeling was found. No LV remodeling was found after SPVR. After both procedures, the replaced pulmonary valve functioned well.

Failing left ventricle to ascending aorta conduit-Hybrid implantation of a melody valve and NuMed covered stent.

PubMed

Gössl, Mario; Johnson, Jonathan N; Hagler, Donald J

2014-04-01

We present the case of a 36-year-old woman with increasing shortness of breath, a new 3/4 diastolic murmur, and a complex history of LV outflow tract obstruction. She has undergone multiple surgeries including the replacement of her old LV apex to ascending aorta conduit with a 20-mm Gore-Tex tube graft, addition of a 24-mm homograft sutured between the conduit and the LV apex, and insertion of a 21-mm Freestyle porcine valve conduit between the Gore-Tex tube graft and allograft at age 23. The current assessment showed a failing Freestyle conduit prosthesis leading to left heart decompensation. Due to substantial surgical risk, the patient underwent successful implantation of a Melody valve into the Gore-Tex tube and exclusion of the failing Freestyle bioprosthesis with a NuMed CP stent in a hybrid procedure. The case nicely illustrates the collaborative potential of cardiovascular surgeons and interventional cardiologists in the new arena of a hybrid operating room. Complex hybrid procedures like the current one, especially those including percutaneous placements of valves, offer therapeutic options for patients that are otherwise too high risk for conventional open heart surgery. Copyright © 2013 Wiley Periodicals, Inc.

Polyurethane-covered mammary implants: a 12-year experience.

PubMed

Gasperoni, C; Salgarello, M; Gargani, G

1992-10-01

Polyurethane-covered mammary implants are the implants of choice in aesthetic and reconstructive mammary surgery. These implants give very good results in regard to breast contour and consistency, and have a very low complication rate. We present our 12-year experience using polyurethane-covered prostheses. We place the implant mostly in the subglandular or subcutaneous site, and their capsular contracture rate is extremely low (3.3%). Based on our experience, we also review the other complications and side effects occurring with polyurethane prostheses and discuss them in detail.

Mortality Risk After Transcatheter Aortic Valve Implantation: Analysis of the Predictive Accuracy of the Transcatheter Valve Therapy Registry Risk Assessment Model.

PubMed

Codner, Pablo; Malick, Waqas; Kouz, Remi; Patel, Amisha; Chen, Cheng-Han; Terre, Juan; Landes, Uri; Vahl, Torsten Peter; George, Isaac; Nazif, Tamim; Kirtane, Ajay J; Khalique, Omar K; Hahn, Rebecca T; Leon, Martin B; Kodali, Susheel

2018-05-08

Risk assessment tools currently used to predict mortality in transcatheter aortic valve implantation (TAVI) were designed for patients undergoing cardiac surgery. We aim to assess the accuracy of the TAVI dedicated American College of Cardiology / Transcatheter Valve Therapies (ACC/TVT) risk score in predicting mortality outcomes. Consecutive patients (n=1038) undergoing TAVI at a single institution from 2014 to 2016 were included. The ACC/TVT registry mortality risk score, the Society of Thoracic Surgeons - Patient Reported Outcomes (STS-PROM) score and the EuroSCORE II were calculated for all patients. In hospital and 30-day all-cause mortality rates were 1.3% and 2.9%, respectively. The ACC/TVT risk stratification tool scored higher for patients who died in-hospital than in those who survived the index hospitalization (6.4 ± 4.6 vs. 3.5 ± 1.6, p = 0.03; respectively). The ACC/TVT score showed a high level of discrimination, C-index for in-hospital mortality 0.74, 95% CI [0.59 - 0.88]. There were no significant differences between the performance of the ACC/TVT registry risk score, the EuroSCORE II and the STS-PROM for in hospital and 30-day mortality rates. The ACC/TVT registry risk model is a dedicated tool to aid in the prediction of in-hospital mortality risk after TAVI.

[Pannus Formation Six-years after Aortic and Mitral Valve Replacement with Tissue Valves;Report of a Case].

PubMed

Nakamura, Makoto; Muraoka, Arata; Aizawa, Kei; Akutsu, Hirohiko; Kurumisawa, Soki; Misawa, Yoshio

2015-07-01

A 77-year-old man presented with exertional dyspnea. He had undergone aortic and mitral valve replacement with tissue valves 6-years earlier. The patient's hemoglobin level was 9.8 g/dl and serum aspartate aminotransferase (70 mU/ml) and lactate dehydrogenase (1,112 mU/ml) were elevated. Echocardiography revealed stenosis of the prosthetic valve in the aortic position with peak flow velocity of 3.8 m/second and massive mitral regurgitation. The patient underwent repeat valve replacement. Pannus formation around both implanted valves was observed. The aortic valve orifice was narrowed by the pannus, and one cusp of the prosthesis in the mitral position was fixed and caused the regurgitation, but they were free from cusp laceration or calcification. The patient's postoperative course was uneventful, and he continues to do well 14 months after surgery.

Quality of life in high-risk patients: comparison of transcatheter aortic valve implantation with surgical aortic valve replacement.

PubMed

Amonn, Kathrin; Stortecky, Stefan; Brinks, Henriette; Gahl, Brigitta; Windecker, Stephan; Wenaweser, Peter; Carrel, Thierry; Huber, Christoph

2013-01-01

To compare health-related quality of life (QoL) in patients undergoing transcatheter aortic valve implantation via transapical access (TA TAVI) with patients undergoing surgical aortic valve replacement (SAVR). One hundred and forty-four high-risk patients referred for aortic valve replacement underwent TAVI screening and were assigned to either TA TAVI (n = 51, age 79.7 ± 9.2 years, logistic EuroSCORE 26.5 ± 16.1%, 51% males) or SAVR (n = 93, age 81.1 ± 5.3 years, logistic EuroSCORE 12.1 ± 9.3%, 42% males) by the interdisciplinary heart team. QoL was assessed using the Short Form 36 (SF-36) Health Survey Questionnaire and the Hospital Anxiety and Depression Scale. Furthermore, current living conditions and the degree of independence at home were evaluated. Patients undergoing TA TAVI were at higher risk as assessed by EuroSCORE (26.5 ± 16 vs. 12.1 ± 9, P < 0.001) and STS score (6.7 ± 4 vs. 4.4 ± 3, P < 0.001) compared with SAVR patients. At the 30-day follow-up, the rate of mortality was similar and amounted to 7.8% for TA TAVI and 7.5% for SAVR patients and raised to 25.5% in TA TAVI and 18.3% in SAVR patients after a follow-up period of 15 ± 10 months. Assessment of QoL revealed no differences in terms of anxiety and depression between TA TAVI and SAVR patients. The SF-36 mental health metascore was similar in both groups (65.6 ± 19 vs. 68.8 ± 22, P = 0.29), while a significant difference was observed in the physical health metascore (49.7 ± 21 vs. 62.0 ± 21, P = 0.015). After adjustment for baseline characteristics, this difference disappeared. However, every added point in the preoperative risk assessment with the STS score decreased the SF-36 physical health dimension by two raw points at the follow-up assessment. Selected high-risk patients undergoing TAVI by using a transapical access achieve similar clinical outcomes and QoL compared with patients undergoing SAVR. Increased STS scores predict worse QoL outcomes.

A low-cost bioprosthetic semilunar valve for research, disease modelling and surgical training applications.

PubMed

Rosa, Benoit; Machaidze, Zurab; Shin, Borami; Manjila, Sunil; Brown, David W; Baird, Christopher W; Mayer, John E; Dupont, Pierre E

2017-11-01

This paper provides detailed instructions for constructing low-cost bioprosthetic semilunar valves for animal research and clinical training. This work fills an important gap between existing simulator training valves and clinical valves by providing fully functioning designs that can be employed in ex vivo and in vivo experiments and can also be modified to model valvular disease. Valves are constructed in 4 steps consisting of creating a metal frame, covering it with fabric and attaching a suture ring and leaflets. Computer-aided design files are provided for making the frame from wire or by metal 3D printing. The covering fabric and suturing ring are made from materials readily available in a surgical lab, while the leaflets are made from pericardium. The entire fabrication process is described in figures and in a video. To demonstrate disease modelling, design modifications are described for producing paravalvular leaks, and these valves were evaluated in porcine ex vivo (n = 3) and in vivo (n = 6) experiments. Porcine ex vivo and acute in vivo experiments demonstrate that the valves can replicate the performance of clinical valves for research and training purposes. Surgical implantation is similar, and echocardiograms are comparable to clinical valves. Furthermore, valve leaflet function was satisfactory during acute in vivo tests with little central regurgitation, while the paravalvular leak modifications consistently produced leaks in the desired locations. The detailed design procedure presented here, which includes a tutorial video and computer-aided design files, should be of substantial benefit to researchers developing valve disease models and to clinicians developing realistic valve training systems. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Development and evaluation of a pliable biological valved conduit. Part II: Functional and hemodynamic evaluation.

PubMed

Sung, H W; Witzel, T H; Hata, C; Tu, R; Shen, S H; Lin, D; Noishiki, Y; Tomizawa, Y; Quijano, R C

1993-04-01

Many congenital cardiac malformations may require a valved conduit for the reconstruction of the right ventricular outflow tract. In spite of many endeavors made in the last 25 years, the clinical results of right ventricular outflow tract reconstruction with currently available valved conduits are still not satisfactory. Specific problems encountered clinically include suboptimal hemodynamic performance, conduit kinking or compression, and fibrous peeling from the luminal surface. To address these deficiencies, we undertook the development of a biological valved conduit: a bovine external jugular vein graft with a retained native valve cross-linked with a diglycidyl ether (DE). This study, using a canine model, was to evaluate the functional and hemodynamic performance of this newly developed valved conduit. Three 14 mm conduits, implanted as bypass grafts, right ventricle to pulmonary artery, were evaluated. The evaluation was conducted with a noninvasive color Doppler flow mapping system at pre-implantation, immediately post implantation, one- and three-months post implantation, and prior to retrieval (five-months post implantation). The two-dimensional tomographic inspection of the leaflet motion at various periods post implantation showed that the valvular leaflets in the DE treated conduit was quite pliable. No cardiac failure or valvular dysfunction was observed in any of the studied cases. The color Doppler flow mapping study demonstrated that the valve in the DE treated conduit was competent, with no conduit kinking or compression observed in any of the three cases. The spectral Doppler velocity study evidenced that the transvalvular pressure gradients of the DE treated conduit were minimal as compared to those of the currently available conduits. In conclusion, from the functional and hemodynamic performance points of view, this newly developed valved conduit is superior to those currently available.

Deafblind People's Experiences of Cochlear Implantation

ERIC Educational Resources Information Center

Soper, Janet

2006-01-01

Cochlear implants are electronic devices that create the sensation of hearing in those who cannot obtain any benefit from conventional hearing aids. This article examines the experience of cochlear implantation in a select group of individuals with acquired deafblindness, focusing on three key themes: access to communication, information and…

The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale.

PubMed

Fanning, Jonathon P; Wesley, Allan J; Platts, David G; Walters, Darren L; Eeles, Eamonn M; Seco, Michael; Tronstad, Oystein; Strugnell, Wendy; Barnett, Adrian G; Clarke, Andrew J; Bellapart, Judith; Vallely, Michael P; Tesar, Peter J; Fraser, John F

2014-04-05

The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies. The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies. The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification.

The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale

PubMed Central

2014-01-01

Background The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies. Methods The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies. Discussion The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification. PMID:24708720

Relation between calcium burden, echocardiographic stent frame eccentricity and paravalvular leakage after corevalve transcatheter aortic valve implantation.

PubMed

Di Martino, Luigi F M; Soliman, Osama I I; van Gils, Lennart; Vletter, Wim B; Van Mieghem, Nicolas M; Ren, Ben; Galema, Tjebbe W; Schultz, Carl; de Jaegere, Peter P T; Di Biase, Matteo; Geleijnse, Marcel L

2017-06-01

Paravalvular aortic leakage (PVL) after transcatheter aortic valve implantation (TAVI) is a complication with potentially severe consequences. The relation between native aortic root calcium burden, stent frame eccentricity and PVL was not studied before. Two-hundred-and-twenty-three consecutive patients with severe aortic stenosis who underwent TAVI with a Medtronic CoreValve System© and who had available pre-discharge transthoracic echocardiography were studied. Echocardiographic stent inflow frame eccentricity was defined as major-minor diameter in a short-axis view >2 mm. PVL was scored according to the updated Valve Academic Research Consortium (VARC-2) recommendations. In a subgroup of 162 (73%) patients, the calcium Agatston score was available. Stent frame eccentricity was seen in 77 (35%) of patients. The correlation between the Agatston score and stent frame eccentricity was significant (ρ = 0.241, P = 0.003). Paravalvular leakage was absent in 91 cases (41%), mild in 67 (30%), moderate in 51 (23%), and severe in 14 (6%) cases. The correlation between stent frame eccentricity and PVL severity was significant (ρ = 0.525, P < 0.0001). There was a relation between particular eccentric stent frame shapes and the site of PVL. Calcification of the aortic annulus is associated with a subsequent eccentric shape of the CoreValve prosthesis. This eccentric shape results in more PVL, with the localization of PVL related to the shape of stent frame eccentricity. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Concurrent Transcatheter Aortic Valve Implantation and Percutaneous Transvenous Mitral Commissurotomy for Totally Percutaneous Treatment of Combined Severe Rheumatic Aortic and Mitral Stenosis.

PubMed

Bilge, Mehmet; Alsancak, Yakup; Ali, Sina; Yasar, Ayse Saatci

2015-05-01

Transcatheter aortic valve implantation (TAVI) is a new promising therapeutic option for patients with symptomatic severe calcific aortic valve stenosis (AS) who are inoperable or at high risk for conventional cardiac surgery. Percutaneous transvenous mitral commissurotomy (PTMC) is performed routinely in patients with severe mitral stenosis (MS) having a favorable anatomy. Although concurrent TAVI and PTMC is a theoretically possible approach in the treatment of patients with severe AS and MS who are unsuitable for conventional surgery, no cases have yet been reported in which this combined technique is used. For patients with severe AS and MS, the standard therapy is replacement of both the mitral and aortic valves. Herein are presented the details of a 52-year-old woman with urethral carcinoma, in whom simultaneous TAVI and PTMC was the chosen technique to treat combined severe rheumatic AS and MS in a single procedure.

Flow-induced Flutter of Heart Valves: Experiments with Canonical Models

NASA Astrophysics Data System (ADS)

Dou, Zhongwang; Seo, Jung-Hee; Mittal, Rajat

2017-11-01

For the better understanding of hemodynamics associated with valvular function in health and disease, the flow-induced flutter of heart valve leaflets is studied using benchtop experiments with canonical valve models. A simple experimental model with flexible leaflets is constructed and a pulsatile pump drives the flow through the leaflets. We quantify the leaflet dynamics using digital image analysis and also characterize the dynamics of the flow around the leaflets using particle imaging velocimetry. Experiments are conducted over a wide range of flow and leaflet parameters and data curated for use as a benchmark for validation of computational fluid-structure interaction models. The authors would like to acknowledge Supported from NSF Grants IIS-1344772, CBET-1511200 and NSF XSEDE Grant TG-CTS100002.

Field Experience with Lock Culvert Valves

DTIC Science & Technology

2013-12-01

factors pertaining to valves such as the hoist loads, cavitation parameter, and effects of venting. To reduce the surge in the navigation channel...2 min 15 sec, filling-and-emptying valve opening time) ensures that adequate air is drawn into the culvert to cushion the cavitation implosions...shape can have adverse hydrodynamic loading consequences. The USACE, Mobile District (SAM) is in the process of designing replacement valves that are

In vitro evaluation of flow patterns and turbulent kinetic energy in trans-catheter aortic valve prostheses.

PubMed

Giese, Daniel; Weiss, Kilian; Baeßler, Bettina; Madershahian, Navid; Choi, Yeong-Hoon; Maintz, David; Bunck, Alexander C

2018-02-01

The objective of the current work was to evaluate flow and turbulent kinetic energy in different transcatheter aortic valve implants using highly undersampled time-resolved multi-point 3-directional phase-contrast measurements (4D Flow MRI) in an in vitro setup. A pulsatile flow setup was used with a compliant tubing mimicking a stiff left ventricular outflow tract and ascending aorta. Five different implants were measured using a highly undersampled multi-point 4D Flow MRI sequence. Velocities and turbulent kinetic energy values were analysed and compared. Strong variations of turbulent kinetic energy distributions between the valves were observed. Maximum turbulent kinetic energy values ranged from 100 to over 500 J/m 3 while through-plane velocities were similar between all valves. Highly accelerated 4D Flow MRI for the measurement of velocities and turbulent kinetic energy values allowed for the assessment of hemodynamic parameters in five different implant models. The presented setup, measurement protocol and analysis methods provides an efficient approach to compare different valve implants and could aid future novel valve designs.

Ahmed glaucoma valve in uveitic patients with fluocinolone acetonide implant-induced glaucoma: 3-year follow-up

PubMed Central

Kubaisi, Buraa; Maleki, Arash; Ahmed, Aseef; Lamba, Neel; Sahawneh, Haitham; Stephenson, Andrew; Montieth, Alyssa; Topgi, Shobha; Foster, C Stephen

2018-01-01

Purpose To evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) in eyes with noninfectious uveitis that had fluocinolone acetonide intravitreal implant (Retisert™)-induced glaucoma. Methods This retrospective study reviewed the safety and efficacy of AGV implantation in patients with persistently elevated intraocular pressure (IOP) after implantation of a fluocinolone acetonide intravitreal implant at the Massachusetts Eye Research and Surgery Institution between August 2006 and November 2015. Results Nine patients with 10 uveitic eyes were included in this study, none of which had preexisting glaucoma in the study eye. Mean patient age was 42 years; 6 patients were female and 3 were male. Baseline mean IOP was 30.6 mmHg prior to AGV placement while mean IOP-lowering medications were 2.9. In the treatment groups, there was a statistically significant reduction in post-AGV IOP. IOP was lowest at 1-week after AGV implantation (9.0 mmHg). Nine out of 10 eyes achieved an IOP below target value of 22 mmHg and/or a 20% reduction in IOP from baseline 1 month and 1 year following AGV placement. All other postoperative time points showed all 10 eyes reaching this goal. A statistically significant decrease in IOP-lowering medication was seen at the 1-week, 1-month, and 3-year time points compared to baseline, while a statistically significant increase was seen at the 3-month, 6-month, and 2-year post-AGV time points. No significant change in retinal nerve thickness or visual field analysis was found. Conclusion AGV is an effective and safe method of treatment in fluocinolone acetonide intravitreal implant-induced glaucoma. High survival rate is expected for at least 3 years. PMID:29750012

Performance of stented biological valves for right ventricular outflow tract reconstruction.

PubMed

Buchholz, Christian; Mayr, Andreas; Purbojo, Ariawan; Glöckler, Martin; Toka, Okan; Cesnjevar, Robert A; Rüffer, André

2016-12-01

This retrospective single-centre review presents mid- and long-term results of stented biological valves (SBVs) in the pulmonary position. Fifty-two SBVs (17 Carpentier-Edwards Supraannular; 13 Carpentier-Edwards Perimount; 12 St. Jude Medical Trifecta; 4 Sorin Mitroflow; 4 Sorin Soprano; 2 Sorin More) were implanted between 2000 and 2015. The median valve size, patient age and weight were 23 mm (range 19-27), 22.8 years (range 5-77) and 62.0 kg (range 14-110), respectively. The main cardiac diagnosis was tetralogy of Fallot in 26 patients (50%). Forty-four patients (85%) had previous cardiac surgery; 12 patients (23%) had previous conduit or biological valve replacement. Valve degeneration was defined as a valvular peak pressure gradient >50 mmHg or pulmonary valve regurgitation more than moderate. The mean follow-up was 7.9 ± 5.5 years. Two patients died after 5.8 and 6.1 years of causes not related to SBVs. Eleven SBVs (21%) had to be replaced surgically (n = 6) or interventionally (n = 5) after 9.0 ± 4.1 years due to valve degeneration (n = 8), endocarditis (n = 2) or right ventricular dysfunction (n = 1). The rates of freedom from valve replacement were 100%, 92% [95% confidence interval (CI) 79-97], 81% (CI 64-91) and 60% (CI 40-78) after 1, 5, 10 and 15 years, respectively. Successful interventional valve-in-valve implantation resulted in 100% freedom from surgical valve replacement in all patients older than 19.1 years. Multivariate analysis identified patient age <19.1 years (P = 0.007) as a risk factor for earlier valve degeneration. SBVs in the pulmonary position showed encouraging long-term results in mature patients. The design of SBVs enables interventional valve implantation, postponing the need for reoperation. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Transcatheter aortic valve implantation. Expert Consensus of the Association of Cardiovascular Interventions of the Polish Cardiac Society and the Polish Society of Cardio-Thoracic Surgeons, approved by the Board of the Polish Cardiac Society….

PubMed

Parma, Radosław; Zembala, Michał O; Dąbrowski, Maciej; Jagielak, Dariusz; Witkowski, Adam; Suwalski, Piotr; Dudek, Dariusz; Olszówka, Piotr; Wojakowski, Wojciech; Przybylski, Roman; Gil, Robert; Kuśmierczyk, Mariusz; Lesiak, Maciej; Sadowski, Jerzy; Dobrzycki, Sławomir; Ochała, Andrzej; Hoffman, Piotr; Kapelak, Bogusław; Kaźmierczak, Jarosław; Jasiński, Marek; Stępińska, Janina; Szymański, Piotr; Hryniewiecki, Tomasz; Kochman, Janusz; Grygier, Marek; Zembala, Marian; Legutko, Jacek; Różański, Jacek

2017-01-01

Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and surgical aortic valve replacement can improve symptoms and survival. In recent years, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival in inoperable patients and to be an alternative treatment in patients in whom the risk of surgical morbidity or mortality is high or intermediate. A representative expert committee, summoned by the Association of Cardiovascular Interventions of the Polish Cardiac Society (ACVI) and the Polish Society of Cardio-Thoracic Surgeons, devel-oped this Consensus Statement in transcatheter aortic valve implantation. It endorses the important role of a multi-disciplinary "TAVI team" in selecting patients for TAVI and defines operator and institutional requirements fundamental to the establish-ment of a successful TAVI programme. The article summarises current evidence and provides specific recommendations on organisation and conduct of transcatheter treatment of patients with aortic valve disease in Poland.

Assessment of cardiovascular function following transcatheter aortic valve implantation based on six-minute walk test.

PubMed

Chodór, Piotr; Wilczek, Krzysztof; Zielińska, Teresa; Przybylski, Roman; Głowacki, Jan; Włoch, Łukasz; Zembala, Marian; Kalarus, Zbigniew

2017-01-01

Transcatheter aortic valve implantation (TAVI) is presently a recognized treatment mo-dality for patients with severe aortic stenosis ineligible for surgery. It reduces mortality as compared to the conservative treatment. It is further expected from this therapy to improve quality of life by improving of the cardiovascular function performance. The aim of this study is to compare patients' cardiovascular system efficiency in the 6-minute walk test (6MWT) made before and after TAVI and at the 6-12-month follow-up. From January 2009 until February 2012, in the Silesian Center for Heart Diseases in Zabrze, TAVI was performed in 104 patients. Eighty-two patients who underwent 6MWT before surgery were qualified for the analysis. The average age of the patients was 76.0 ± 9.17 years, women made 45.1%. The risk of surgical treatment according to the Logistic Euroscore averaged 22.76 ± 12.63%, and by the Society of Thoracic Surgeons - 5.55 ± 3.34%. The 6MWT was performed within 1 month before the TAVI procedure, up to a month after the procedure and during the 6-12-month follow-up. The 6-minute walk test after TAVI was performed by 64 patients, and after 6-12 month follow-up by 46 patients. The average distance in 6MWT increased from 268.4 ± 89.0 m before treat-ment to 290.0 ± 98.2 m after the procedure (p = 0.008) and 276.1 ± 93.5 m to 343.1 ± 96.7 m after 6-12 months (p < 0.0001). Transcatheter aortic valve implantation procedures significantly improve function of the cardiovascular system evaluated by the 6MWT in 1- and 6-12-month observations. (Cardiol J 2017; 24, 2: 167-175).

Long-term results of Ahmed glaucoma valve implantation in Egyptian population

PubMed Central

Elhefney, Eman; Mokbel, Tharwat; Abou Samra, Waleed; Kishk, Hanem; Mohsen, Tarek; El-Kannishy, Amr

2018-01-01

AIM To evaluate the long-term results and complications of Ahmed glaucoma valve (AGV) implantation in a cohort of Egyptian patients. METHODS A retrospective study of 124 eyes of 99 patients with refractory glaucoma who underwent AGV implantation and had a minimum follow-up of 5y was performed. All patients underwent complete ophthalmic examination and intraocular pressure (IOP) measurement before surgery and at 1d, weekly for the 1st month, 3, 6mo, and 1y after surgery and yearly afterward for 5y. IOP was measured by Goldmann applanation tonometry and/or Tono-Pen. Complications and the number of anti-glaucoma medications needed were recorded. Success was defined as IOP less than 21 mm Hg with or without anti-glaucoma medication and without additional glaucoma surgery. RESULTS Mean age was 23.1±19.9y. All eyes had at least one prior glaucoma surgery. IOP was reduced from a mean of 37.2±6.8 to 19.2±5.2 mm Hg after 5y follow-up with a reduced number of medications from 2.64±0.59 to 1.81±0.4. Complete and qualified success rates were 31.5% and 46.0% respectively at the end of follow-up. The most common complications were encapsulated cyst formation in 51 eyes (41.1%), complicated cataract in 9 eyes (7.25%), recessed tube in 8 eyes (6.45%), tube exposure in 6 eyes (4.8%) and corneal touch in 6 eyes (4.8%). Other complications included extruded AGV, endophthalmitis and persistent hypotony. Each of them was recorded in only 2 eyes (1.6%). CONCLUSION Although refractory glaucoma is a difficult problem to manage, AGV is effective and relatively safe procedure in treating refractory glaucoma in Egyptian patients with long-term follow-up. Encapsulated cyst formation was the most common complication, which limits successful IOP control after AGV implantation. However, effective complications management can improve the rate of success. PMID:29600175

Long-term results of Ahmed glaucoma valve implantation in Egyptian population.

PubMed

Elhefney, Eman; Mokbel, Tharwat; Abou Samra, Waleed; Kishk, Hanem; Mohsen, Tarek; El-Kannishy, Amr

2018-01-01

To evaluate the long-term results and complications of Ahmed glaucoma valve (AGV) implantation in a cohort of Egyptian patients. A retrospective study of 124 eyes of 99 patients with refractory glaucoma who underwent AGV implantation and had a minimum follow-up of 5y was performed. All patients underwent complete ophthalmic examination and intraocular pressure (IOP) measurement before surgery and at 1d, weekly for the 1 st month, 3, 6mo, and 1y after surgery and yearly afterward for 5y. IOP was measured by Goldmann applanation tonometry and/or Tono-Pen. Complications and the number of anti-glaucoma medications needed were recorded. Success was defined as IOP less than 21 mm Hg with or without anti-glaucoma medication and without additional glaucoma surgery. Mean age was 23.1±19.9y. All eyes had at least one prior glaucoma surgery. IOP was reduced from a mean of 37.2±6.8 to 19.2±5.2 mm Hg after 5y follow-up with a reduced number of medications from 2.64±0.59 to 1.81±0.4. Complete and qualified success rates were 31.5% and 46.0% respectively at the end of follow-up. The most common complications were encapsulated cyst formation in 51 eyes (41.1%), complicated cataract in 9 eyes (7.25%), recessed tube in 8 eyes (6.45%), tube exposure in 6 eyes (4.8%) and corneal touch in 6 eyes (4.8%). Other complications included extruded AGV, endophthalmitis and persistent hypotony. Each of them was recorded in only 2 eyes (1.6%). Although refractory glaucoma is a difficult problem to manage, AGV is effective and relatively safe procedure in treating refractory glaucoma in Egyptian patients with long-term follow-up. Encapsulated cyst formation was the most common complication, which limits successful IOP control after AGV implantation. However, effective complications management can improve the rate of success.

High Risk Aortic Valve Replacement - The Challenges of Multiple Treatment Strategies with an Evolving Technology.

PubMed

Booth, K; Beattie, R; McBride, M; Manoharan, G; Spence, M; Jones, J M

2016-01-01

Deciding on the optimal treatment strategy for high risk aortic valve replacement is challenging. Transcatheter Aortic Valve implantation (TAVI) has been available in our centre as an alternative treatment modality for patients since 2008. We present our early experience of TAVI and SAVR (surgical Aortic Valve Replacement) in high risk patients who required SAVR because TAVI could not be performed. The database for Surgical aortic valve and Transcatheter aortic valve replacement referrals was interrogated to identify relevant patients. Survival to hospital discharge was 95.5% in the forty five patients who had SAVR when TAVI was deemed technically unsuitable. One year survival was 86%. Defining who is appropriate for TAVI or high risk SAVR is challenging and multidisciplinary team discussion has never been more prudent in this field of evolving technology with ever decreasing risks of surgery. The introduction of TAVI at our institution has seen a rise in our surgical caseload by approximately by 25%. Overall, the option of aortic valve intervention is being offered to more patients in general which is a substantial benefit in the treatment of aortic valve disease.

Bleb Analysis and Short-Term Results of Biodegradable Collagen Matrix-Augmented Ahmed Glaucoma Valve Implantation: 6-Month Follow-up.

PubMed

Rho, Seungsoo; Sung, Youngje; Ma, Kyoung Tak; Rho, Sae Heun; Kim, Chan Yun

2015-09-01

To evaluate the short-term efficacy of a biodegradable collagen matrix (BCM) as an adjuvant for Ahmed valve implantation surgery to prevent the hypertensive phase. This prospective study included 43 refractory glaucoma eyes, all followed for 6 months. Refractory glaucoma was defined as an IOP higher than 20 mm Hg with antiglaucoma eye drops without previous glaucoma surgery. Conventional method was performed in 21 eyes and BCM-augmented Ahmed valve implantation (BAAVI) in 22 eyes. In the BAAVI group, a 10 × 10 × 2-mm BCM was sutured on an Ahmed glaucoma valve FP7 model. Complete success was defined as an IOP of 21 mm Hg or lower (target IOP 1) or 17 mm Hg or lower (target IOP 2) without antiglaucoma medications and qualified success as an IOP of 21 mm Hg or lower with or without medications. Maximal bleb thickness was measured using anterior segment optical coherence tomography images. The preoperative IOPs and numbers of preoperative antiglaucoma medications were similar for both groups. Complete target IOP 1 success rates were 38.1% and 86.4%, complete target IOP 2 success rates were 19.0% and 59.1%, and qualified success rates were 52.4% and 90.9% in the conventional and BAAVI groups, respectively (P < 0.05). The hypertensive phase rate was lower in the BAAVI group (4.5% vs. 47.6%, P = 0.002). Maximal bleb thickness was increased in the BAAVI group on postoperative days 30 and 180 (P < 0.05). Success rates were higher in the BAAVI group than in the conventional group with the change of bleb morphology. Furthermore, use of BCM significantly decreased the need for antiglaucoma medications for at least 6 months postoperatively.

Cells for tissue engineering of cardiac valves.

PubMed

Jana, Soumen; Tranquillo, Robert T; Lerman, Amir

2016-10-01

Heart valve tissue engineering is a promising alternative to prostheses for the replacement of diseased or damaged heart valves, because tissue-engineered valves have the ability to remodel, regenerate and grow. To engineer heart valves, cells are harvested, seeded onto or into a three-dimensional (3D) matrix platform to generate a tissue-engineered construct in vitro, and then implanted into a patient's body. Successful engineering of heart valves requires a thorough understanding of the different types of cells that can be used to obtain the essential phenotypes that are expressed in native heart valves. This article reviews different cell types that have been used in heart valve engineering, cell sources for harvesting, phenotypic expression in constructs and suitability in heart valve tissue engineering. Natural and synthetic biomaterials that have been applied as scaffold systems or cell-delivery platforms are discussed with each cell type. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Effect of glaucoma tube shunt parameters on cornea endothelial cells in patients with Ahmed valve implants.

PubMed

Koo, Euna B; Hou, Jing; Han, Ying; Keenan, Jeremy D; Stamper, Robert L; Jeng, Bennie H

2015-01-01

The aim of this study was to assess the effect of various tube parameters on corneal endothelial cell density (ECD) after insertion of Ahmed valves. Thirty-nine eyes of 33 patients with previous superotemporal (ST) Ahmed valve implantation and 20 eyes of 13 participants with previous uncomplicated phacoemulsification and intraocular lens implantation but no history of glaucoma surgery were evaluated. Various tube parameters were measured with anterior segment optical coherence tomography. ST, central, and inferonasal (IN) ECD and pachymetry were measured. Endothelial cell loss and corneal thickness in the ST cornea was compared with those in the IN cornea. The mean age of the operated patients was 58 ± 22 years, and the mean time since glaucoma surgery was 2.5 ± 2.6 years. Thirty-two of the 39 study eyes were pseudophakic. The ECD was significantly lower in the ST endothelium than in the IN endothelium in eyes with glaucoma tube surgery (P < 0.001), although this relative reduction in ST ECD was not greater than that seen in pseudophakic control eyes (P = 0.16). In univariate analysis, tube angle relative to the cornea and distance from the tip of the tube to the cornea were significant risk factors for decreased ST endothelial cell loss when assessed relative to the IN ECD (P = 0.01 and P = 0.02, respectively). In multivariate analysis, only the distance of the tube tip to the cornea remained significantly associated with ST endothelial cell loss. Although this was a retrospective study with inherent limitations, tubes that are closer to the cornea seem to lead to increased loss of adjacent endothelial cells.

Flow Test to Predict Early Hypotony and Hypertensive Phase After Ahmed Glaucoma Valve (AGV) Surgical Implantation.

PubMed

Cheng, Jason; Beltran-Agullo, Laura; Buys, Yvonne M; Moss, Edward B; Gonzalez, Johanna; Trope, Graham E

2016-06-01

To assess the validity of a preimplantation flow test to predict early hypotony [intraocular pressure (IOP)≤5 mm Hg on 2 consecutive visits and hypertensive phase (HP) (IOP>21 mm Hg) after Ahmed Glaucoma Valve (AGV) implantation. Prospective interventional study on patients receiving an AGV. A preimplantation flow test using a gravity-driven reservoir and an open manometer was performed on all AGVs. Opening pressure (OP) and closing pressure (CP) were defined as the pressure at which fluid was seen to flow or stop flowing through the AGV, respectively. OP and CP were measured twice per AGV. Patients were followed for 12 weeks. In total, 20 eyes from 19 patients were enrolled. At 12 weeks the mean IOP decreased from 29.2±9.1 to 16.8±5.2 mm Hg (P<0.01). The mean AGV OP was 17.5±5.4 mm Hg and the mean CP was 6.7±2.3 mm Hg. Early (within 2 wk postoperative) HP occurred in 37% and hypotony in 16% of cases. An 18 mm Hg cutoff for the OP gave a sensitivity of 0.71, specificity of 0.83, positive predictive value of 0.71, and negative predictive value of 0.83 for predicting an early HP. A 7 mm Hg cutoff for the CP yielded a sensitivity of 1.0, specificity of 0.38, positive predictive value of 0.23, and negative predictive value of 1.0 for predicting hypotony. Preoperative OP and CP may predict early hypotony or HP and may be used as a guide as to which AGV valves to discard before implantation surgery.

Valve repair for traumatic tricuspid regurgitation.

PubMed

Maisano, F; Lorusso, R; Sandrelli, L; Torracca, L; Coletti, G; La Canna, G; Alfieri, O

1996-01-01

The review of six cases of valve repair for traumatic tricuspid regurgitation in our institution and 74 in the literature in order to assess effective methods of treating this lesion. Tricuspid valve regurgitation is a rare complication of blunt chest trauma. Optimal treatment for this condition is still controversial ranging from long-term medical therapy to early surgical correction. We followed the cases of six consecutive patients with post-traumatic tricuspid incompetence who were successfully treated with reparative techniques. All patients were male and their ages ranged from 18 years to 42 years. Valve regurgitation was always secondary to blunt chest trauma due to motor vehicle accident. The mechanism of valve insufficiency was invariably anterior leaflet prolapse due to chordal or papillary muscle rupture associated with annular dilatation. Surgical procedures included Carpentier ring implant (5 patients), Bex posterior annuloplasty (1 patient), implant of artificial chordae (4 patients), papillary muscle reinsertion (2 patients), commissuroplasty (1 patient) and "artificial double orifice" technique (1 patient). Tricuspid insufficiency improved in all patients after the correction. No complications were recorded and all patients were asymptomatic at the follow-up. Since post-traumatic tricuspid regurgitation is effectively correctable with reparative techniques, early operation is recommended to relieve symptoms and to prevent right ventricular dysfunction.

Clinical Outcomes of Ahmed Glaucoma Valve Implantation Using Tube Ligation and Removable External Stents

PubMed Central

Lee, Jong Joo; Kim, Dong Myung; Kim, Tae Woo

2009-01-01

Purpose To investigate the immediate and long-term outcomes of Ahmed glaucoma valve (AGV) implantation with silicone tube ligation and removable external stents. Methods This retrospective non-comparative study investigated the outcomes of AGV implantation with silicone tube ligation and removable external stents in 95 eyes (90 patients) with at least 12 months of postoperative follow-up. Qualified success was defined as an intraocular pressure (IOP) of ≤21 mmHg and ≥6 mmHg regardless of anti-glaucoma medication. Those who required additional glaucoma surgery, implant removal or who had phthisis bulbi were considered failures. Hypotony was defined as an IOP of <6 mmHg. Results Mean IOP reduced from 37.1±9.7 mmHg preoperatively to 15.2±5.6 mmHg at 12 months postoperatively (p<0.001). Qualified success was achieved in 84.2% at 1 year. Hypotony with an IOP of <6 mmHg was seen in 8.4% and an IOP of <5 mmHg in 3.2% on the first postoperative day. No case of hypotony required surgical intervention. Suprachoroidal hemorrhage did not occur in this study. When stents were removed on the first postoperative day because of an insufficient IOP decrease, the mean IOP decreased significantly from 42.0 mmHg to 14.1 mmHg (p<0.001) after 1 hour. The most common complication was hyphema, which occurred in 17.9%. Conclusions Hypotony-related early complications requiring surgical intervention were reduced by ligation and external stents in the tube. In addition, early postoperative high IOPs were managed by removing external stents. The described method can prevent postoperative hypotony after AGV implantation and showed long-term success rates comparable to those reported previously. PMID:19568356

Clinical outcomes of Ahmed glaucoma valve implantation using tube ligation and removable external stents.

PubMed

Lee, Jong Joo; Park, Ki Ho; Kim, Dong Myung; Kim, Tae Woo

2009-06-01

To investigate the immediate and long-term outcomes of Ahmed glaucoma valve (AGV) implantation with silicone tube ligation and removable external stents. This retrospective non-comparative study investigated the outcomes of AGV implantation with silicone tube ligation and removable external stents in 95 eyes (90 patients) with at least 12 months of postoperative follow-up. Qualified success was defined as an intraocular pressure (IOP) of or=6 mmHg regardless of anti-glaucoma medication. Those who required additional glaucoma surgery, implant removal or who had phthisis bulbi were considered failures. Hypotony was defined as an IOP of <6 mmHg. Mean IOP reduced from 37.1+/-9.7 mmHg preoperatively to 15.2+/-5.6 mmHg at 12 months postoperatively (p<0.001). Qualified success was achieved in 84.2% at 1 year. Hypotony with an IOP of <6 mmHg was seen in 8.4% and an IOP of <5 mmHg in 3.2% on the first postoperative day. No case of hypotony required surgical intervention. Suprachoroidal hemorrhage did not occur in this study. When stents were removed on the first postoperative day because of an insufficient IOP decrease, the mean IOP decreased significantly from 42.0 mmHg to 14.1 mmHg (p<0.001) after 1 hour. The most common complication was hyphema, which occurred in 17.9%. Hypotony-related early complications requiring surgical intervention were reduced by ligation and external stents in the tube. In addition, early postoperative high IOPs were managed by removing external stents. The described method can prevent postoperative hypotony after AGV implantation and showed long-term success rates comparable to those reported previously.

Transcatheter aortic valve-in-valve treatment of degenerative stentless supra-annular Freedom Solo valves: A single centre experience.

PubMed

Cockburn, James; Dooley, Maureen; Parker, Jessica; Hill, Andrew; Hutchinson, Nevil; de Belder, Adam; Trivedi, Uday; Hildick-Smith, David

2017-02-15

Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm 2 ), one had severe regurgitation (AR). Median time to failure was 7 years. Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Different indicators for postprocedural mitral stenosis caused by single- or multiple-clip implantation after percutaneous mitral valve repair.

PubMed

Itabashi, Yuji; Utsunomiya, Hiroto; Kubo, Shunsuke; Mizutani, Yukiko; Mihara, Hirotsugu; Murata, Mitsushige; Siegel, Robert J; Kar, Saibal; Fukuda, Keiichi; Shiota, Takahiro

2018-04-01

Postprocedural mitral stenosis (MS) is a main limitation for MitraClip™ (Abbot Vascular, Inc., Santa Clara, CA, USA) procedure. The purpose of this study was to detect the preprocedural predictors of high transmitral pressure gradient (TMPG) after MitraClip™ implantation, which indicated postprocedural mitral stenosis (MS). We studied 79 patients who were implanted with MitraClip™ in our institute. Before the procedure, mitral valve orifice area (MVOA), and anterior-posterior (AP) and medial-lateral (ML) mitral annular diameters were measured at diastole using three-dimensional (3D) transesophageal echocardiography (TEE) data set. After the procedure, the mean TMPG was assessed using continuous-wave (CW) Doppler by periprocedural TEE. Preprocedural MVOA, and AP and ML diameter of left ventricular (LV) inflow orifices were larger in patients with mean TMPG ≤4mmHg than in patients with TMPG >4mmHg after 1-and 2-clip implantation. The large MVOA and ML diameter of LV inflow orifice strongly correlated with the low TMPG after 1- and 2-clip implantation. As a result of the receiver operating characteristic curve analysis, the preprocedural MVOA predicted the low postprocedural TMPG more accurately than the ML diameter of LV inflow orifice after 1-clip implantation either in the degenerative or functional mitral regurgitation (MR) patients. After 2-clip implantation, however, the preprocedural ML diameter of LV inflow orifice predicted it more accurately than the MVOA in the degenerative and functional MR patients. 3D TEE derived MVOA predicts the postprocedural MS after 1-clip implantation, however, preprocedural ML diameter of LV inflow orifice is more useful to predict after 2-clip implantation. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Recent Advances in Transcatheter Aortic Valve Implantation: Novel Devices and Potential Shortcomings

PubMed Central

Blumenstein, J.; Liebetrau, C.; Linden, A. Van; Moellmann, H.; Walther, T.; Kempfert, J.

2013-01-01

During the past years transcatheter aortic valve implantation (TAVI) has evolved to a standard technique for the treatment of high risk patients suffering from severe aortic stenosis. Worldwide the number of TAVI procedures is increasing exponentially. In this context both the transapical antegrade (TA) and the transfemoral retrograde (TF) approach are predominantly used and can be considered as safe and reproducible access sites for TAVI interventions. As a new technology TAVI is in a constant progress regarding the development of new devices. While in the first years only the Edwards SAPIEN™ and the Medtronic CoreValve™ prostheses were commercial available, recently additional devices obtained CE-mark approval and others have entered initial clinical trials. In addition to enhance the treatment options in general, the main driving factor to further develop new device iterations is to solve the drawbacks of the current TAVI systems: paravalvular leaks, occurrence of AV-blocks and the lack of full repositionability. PMID:24313644

Surgical treatment of infective endocarditis with aortic and tricuspid valve involvement using cryopreserved aortic and mitral valve allografts.

PubMed

Ostrovsky, Yury; Spirydonau, Siarhei; Shchatsinka, Mikalai; Shket, Aliaksandr

2015-05-01

Surgical treatment of infective and prosthetic endocarditis using allografts gives good results. Aortic allograft implantation is a common technique, while tricuspid valve replacement with a mitral allograft is very rare. Multiple valve disease in case of infective endocarditis is a surgical challenge as such patients are usually in a grave condition and results of surgical treatment are often unsatisfactory. In this article we describe a clinical case of successful surgical treatment in a patient with active infective endocarditis of aortic and tricuspid valve, complicated by an aortic-right ventricular fistula. The aortic valve and ascending aorta were replaced with a cryopreserved aortic allograft; the tricuspid valve was replaced with a cryopreserved mitral allograft. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Partial Tenon’s capsule resection with adjunctive mitomycin C in Ahmed glaucoma valve implant surgery