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.

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.

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

Fluid Structure Interaction simulation of heart prosthesis in patient-specific left-ventricle/aorta anatomies

NASA Astrophysics Data System (ADS)

Le, Trung; Borazjani, Iman; Sotiropoulos, Fotis

2009-11-01

In order to test and optimize heart valve prosthesis and enable virtual implantation of other biomedical devices it is essential to develop and validate high-resolution FSI-CFD codes for carrying out simulations in patient-specific geometries. We have developed a powerful numerical methodology for carrying out FSI simulations of cardiovascular flows based on the CURVIB approach (Borazjani, L. Ge, and F. Sotiropoulos, Journal of Computational physics, vol. 227, pp. 7587-7620 2008). We have extended our FSI method to overset grids to handle efficiently more complicated geometries e.g. simulating an MHV implanted in an anatomically realistic aorta and left-ventricle. A compliant, anatomic left-ventricle is modeled using prescribed motion in one domain. The mechanical heart valve is placed inside the second domain i.e. the body-fitted curvilinear mesh of the anatomic aorta. The simulations of an MHV with a left-ventricle model underscore the importance of inflow conditions and ventricular compliance for such simulations and demonstrate the potential of our method as a powerful tool for patient-specific simulations.

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.

Advances in material design for regenerative medicine, drug delivery and targeting/imaging

USDA-ARS?s Scientific Manuscript database

Many of the major breakthroughs and paradigm shifts in medicine to date have occurred due to innovations and materials and/or application/implementation of materials in clinical medicine. Artificial heart valves, implantable cardiac devices, limb prosthesis, cardiovascular stents, orthopedic implan...

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.

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.

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.

[Analysis of vascular complications of IABP therapy in open-heart surgery patients 1999-2004].

PubMed

Kovács, Endre; Becker, Dávid; Daróczi, László; Gálfy, Ildikó; Hüttl, Tivadar; Laczkó, Agnes; Paukovits, Tamas; Vargha, Péter; Szabolcs, Zoltán

2006-04-01

Intraaortic balloon pump (IABP) is being used in cardiac surgery in an increased ratio. IABP therapy involves considerable risk, mainly vascular complications, postoperative bleeding and infection can represent danger. Between 1999 and 2004 out of 4443 open heart surgery operations we have performed intraaortic balloon pump treatment in case of 75 patients. The mean age was 64 years, 23 patients had diabetes mellitus, 47 patients had hypertension, 20 patients had peripheral vascular disease as well. We performed IABP therapy most frequently during isolated coronary bypass operations (42 cases), but also combined operations (implantation of valve prosthesis + coronary bypass) represent a significant part (implantation of aortic valve prosthesis + CABG: 5 cases, implantation of mitral valve prosthesis + CABG: 8 cases). Vascular complications occurred in 10 cases--13.3%--out of 75 patients, including 7 fatal ones. Three cases are due to the IABP treatment itself: Crush syndrome was developed leading to the loss of the patient. Applying the multiple logistic regression model we have examined the effect of the following factors on the occurrence of vascular complications: gender, age, body surface, accompanying diseases (hypertension, diabetes, peripheral vascular disease), the method and timing of insertion. Peripheral vascular disease (p < 0.005) and hypertension (p = 0.01) represent independent risk factors regarding the occurrence of complications. Having performed chi-square test we have not identified significant correlations between mortality and vascular complications. In case of prevailing peripheral vascular disease, the application of alternative insertion techniques--via the ascending aorta, the axillary artery--are recommended.

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.

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.

Mitral valve-sparing procedures and prosthetic heart valve failure: A case report

PubMed Central

Khan, Nasir A; Butany, Jagdish; Leong, Shaun W; Rao, Vivek; Cusimano, Robert J; Ross, Heather J

2009-01-01

Prosthetic heart valve dysfunction due to thrombus or pannus formation can be a life-threatening complication. The present report describes a 47-year-old woman who developed valvular cardiomyopathy after chorda-sparing mitral valve replacement, and subsequently underwent heart transplantation for progressive heart failure. The explanted mitral valve prosthesis showed significant thrombus and pannus leading to reduced leaflet mobility and valvular stenosis. The present report illustrates the role of the subvalvular apparatus and pannus in prosthesis dysfunction. PMID:19279993

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.

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.

A biomimetic bi-leaflet mitral prosthesis with enhanced physiological left ventricular swirl restorative capability

NASA Astrophysics Data System (ADS)

Tan, Sean Guo-Dong; Kim, Sangho; Leo, Hwa Liang

2016-06-01

Mechanical heart valve prostheses are often implanted in young patients due to their durability and long-term reliability. However, existing designs are known to induce elevated levels of blood damage and blood platelet activation. As a result, there is a need for patients to undergo chronic anti-coagulation treatment to prevent thrombosis, often resulting in bleeding complications. Furthermore, recent studies have suggested that the implantation of a mechanical prosthetic valve at the mitral position results in a significant alteration of the left ventricular flow field which may contribute to flow turbulence. This study proposes a bi-leaflet mechanical heart valve design (Bio-MHV) that mimics the geometry of a human mitral valve, with the aim of reducing turbulence levels in the left ventricle by replicating physiological flow patterns. An in vitro three-dimensional particle velocimetry imaging experiment was carried out to compare the hemodynamic performance of the Bio-MHV with that of the clinically established ATS valve. The Bio-MHV was found to replicate physiological left ventricular flow patterns and produced lower turbulence levels.

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.

Dysfunction of an On-X Heart Valve by Pannus.

PubMed

Abad, Cipriano; Urso, Stefano; Gomez, Elsa; De la Vega, Maria

2016-09-01

A 68-year-old woman with a history of previous double-valve replacement with On-X mechanical heart valves presented with clinical, echocardiographic and cardiac catheterization signs of obstruction of the On-X tricuspid heart valve prosthesis. The patient was successfully reoperated, but at surgery the valve was seen to be invaded by an abnormal overgrowth of pannus that blocked one of the leaflets. A small amount of non-obstructive fresh thrombus was also observed. The valve was successfully replaced with a biological heart valve prosthesis. The patient was discharged home, and is doing well four months after the operation, when echocardiography demonstrated normal function in the tricuspid valve. The present case represents the first ever report of pannus formation and subsequent dysfunction in an On-X heart valve, and also the first case of tricuspid valve malfunction and obstruction using this type of heart valve substitute.

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.

Hereditary spherocytosis and elliptocytosis associated with prosthetic heart valve replacement: rheological study of erythrocyte modifications.

PubMed

Caprari, Patrizia; Tarzia, Anna; Mojoli, Giorgio; Cianciulli, Paolo; Mannella, Emilio; Martorana, Maria Cristina

2009-04-01

The implantation of a prosthetic heart valve (HVP) in patients with hereditary spherocytosis (HS) and hereditary elliptocytosis (HE) is rare, and the changes in the structure and deformability of erythrocytes that follow implantation in these patients have been poorly described. In the present study, the erythrocytes in HS and HE patients with mechanical HVP were compared to the erythrocytes in patients with only congenital membrane defects, in terms of biochemical modifications and rheological behaviour. Integral and cytoskeletal erythrocyte membrane proteins were studied, and blood viscosity (shear rate/shear stress ratio), aggregation ratio [eta(1 s(-1))/eta(200 s(-1))], and red cell visco-elasticity were determined. Valve replacement with a mechanical prosthesis worsened anaemia and resulted in a change in haemolysis, from sub-clinical to evident. The rheological investigation of erythrocytes from HS patients confirmed the characteristic increased viscosity and aggregation ratio and the decreased deformability. The rheological behaviour of erythrocytes from patients with HVP showed a decrease in viscosity and an increase in elastic modulus. In these patients, the prosthesis seems to have induced traumatic damage to the erythrocyte membrane, leading to fragmentation and lysis, which in turn modified rheological parameters. The biochemical and rheological investigation allowed us to understand the clinical and haematological pictures of the patients and to describe the role played by different factors in haemolytic anaemia.

Noninvasive radioisotopic technique for detection of platelet deposition in mitral valve prostheses and quantitation of visceral microembolism in dogs

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

Dewanjee, M.K.; Fuster, V.; Rao, S.A.

1983-05-01

A noninvasive technique has been developed in the dog model for imaging, with a gamma camera, the platelet deposition on Bjoerk-Shiley mitral valve prostheses early postoperatively. At 25 hours after implantation of the prosthesis and 24 hours after intravenous administration of 400 to 500 microCi of platelets labeled with indium-111, the platelet deposition in the sewing ring and perivalvular cardiac tissue can be clearly delineated in a scintiphotograph. An in vitro technique was also developed for quantitation of visceral microemboli in brain, lungs, kidneys, and other tissues. Biodistribution of the labeled platelets was quantitated, and the tissue/blood radioactivity ratio wasmore » determined in 22 dogs in four groups: unoperated normal dogs, sham-operated dogs, prosthesis-implanted dogs, and prosthesis-implanted dogs treated with dipyridamole before and aspirin and dipyridamole immediately after operation. Fifteen to 20% of total platelets were consumed as a consequence of the surgical procedure. On quantitation, we found that platelet deposition on the components of the prostheses was significantly reduced in prosthesis-implanted animals treated with dipyridamole and aspirin when compared with prosthesis-implanted, untreated dogs. All prosthesis-implanted animals considered together had a twofold to fourfold increase in tissue/blood radioactivity ratio in comparison with unoperated and sham-operated animals, an indication that the viscera work as filters and trap platelet microemboli that are presumably produced in the region of the mitral valve prostheses. In the dog model, indium-111-labeled platelets thus provide a sensitive marker for noninvasive imaging of platelet deposition on mechanical mitral valve prostheses, in vitro evaluation of platelet microembolism in viscera, in vitro quantitation of surgical consumption of platelets, and evaluation of platelet-inhibitor drugs.« less

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.

Insidious strut fractures in a DeBakey-Surgitool aortic valve prosthesis.

PubMed

Scott, S M; Sethi, G K; Paulson, D M; Takaro, T

1978-04-01

Recent reports of cage wear occurring in DeBakey-Surgitool aortic valve prostheses prompted us to examine with image intensification all our patients who have had this type of prosthesis implanted. One patient, who was asymptomatic, was discovered to have a prosthesis with two fractured struts. This patient's prosthetic valve was replaced successfully with a stented porcine heterograft prosthesis. Including the valve removed from this patient, 8 DeBakey-Surgitool aortic valves with structural defects have been reported to the manufacturer. In the absence of a catastrophic event, patients with valves having fractured or worn struts may be totally asymptomatic, and routine periodic roentgenographic examination may be the only way of detecting strut wear or fracture.

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

Strut fracture in a Bjork-Shiley aortic valve prosthesis.

PubMed

Lifschultz, B D; Donoghue, E R

1985-10-01

Strut fracture can be a life-threatening adverse effect of mechanical prosthetic heart valves. This complication has occurred in the DeBakey, the Beall, the Cooley-Cutter and, most recently, the Bjork-Shiley valves. We report the case of a 35-year-old man who died suddenly 16 months after a 60 degree Bjork-Shiley Convexo-Concave heart valve prosthesis was inserted in the aortic position. At autopsy, the two welded attachments of the valve's outlet strut had fractured. The valve's tilting disc was found in his abdominal aorta.

A new beating-heart mitral and aortic valve assessment model with implications for valve intervention training.

PubMed

Bouma, Wobbe; Jainandunsing, Jayant S; Khamooshian, Arash; van der Harst, Pim; Mariani, Massimo A; Natour, Ehsan

2017-02-01

A thorough understanding of mitral and aortic valve motion dynamics is essential in mastering the skills necessary for performing successful valve intervention (open or transcatheter repair or replacement). We describe a reproducible and versatile beating-heart mitral and aortic valve assessment and valve intervention training model in human cadavers. The model is constructed by bilateral ligation of the pulmonary veins, ligation of the supra-aortic arteries, creating a shunt between the descending thoracic aorta and the left atrial appendage with a vascular prosthesis, anastomizing a vascular prosthesis to the apex and positioning an intra-aortic balloon pump (IABP) in the vascular prosthesis, cross-clamping the descending thoracic aorta, and finally placing a fluid line in the shunt prosthesis. The left ventricle is filled with saline to the desired pressure through the fluid line, and the IABP is switched on and set to a desired frequency (usually 60-80 bpm). Prerepair valve dynamic motion can be studied under direct endoscopic visualization. After assessment, the IABP is switched off, and valve intervention training can be performed using standard techniques. This high-fidelity simulation model has known limitations, but provides a realistic environment with an actual beating (human) heart, which is of incremental value. The model provides a unique opportunity to fill a beating heart with saline and to study prerepair mitral and aortic valve dynamic motion under direct endoscopic visualization. The entire set-up provides a versatile beating-heart mitral and aortic valve assessment model, which may have important implications for future valve intervention training. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Perivalvular pannus and valve thrombosis: two concurrent mechanisms of mechanical valve prosthesis dysfunction.

PubMed

Arnáiz-García, María Elena; González-Santos, Jose María; Bueno-Codoñer, María E; López-Rodríguez, Javier; Dalmau-Sorlí, María José; Arévalo-Abascal, Adolfo; Arribas-Jiménez, Antonio; Diego-Nieto, Alejandro; Rodríguez-Collado, Javier; Rodríguez-López, Jose María

2015-02-01

A 78-year-old woman was admitted to our institution with progressive dyspnea. She had previously been diagnosed with rheumatic heart disease and had undergone cardiac surgery for mechanical mitral valve replacement ten years previously. Transesophageal echocardiography revealed blockage of the mechanical prosthesis and the patient was scheduled for surgery, in which a thrombus was removed from the left atrial appendage. A partial thrombosis of the mechanical prosthesis and circumferential pannus overgrowth were concomitantly detected. Prosthetic heart valve blockage is a rare but life-threatening complication, the main causes of which are thrombosis and pannus formation. The two conditions are different but both are usually misdiagnosed. Two concurrent mechanisms of prosthesis blockage were found in this patient. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

A predictive model for early mortality after surgical treatment of heart valve or prosthesis infective endocarditis. The EndoSCORE.

PubMed

Di Mauro, Michele; Dato, Guglielmo Mario Actis; Barili, Fabio; Gelsomino, Sandro; Santè, Pasquale; Corte, Alessandro Della; Carrozza, Antonio; Ratta, Ester Della; Cugola, Diego; Galletti, Lorenzo; Devotini, Roger; Casabona, Riccardo; Santini, Francesco; Salsano, Antonio; Scrofani, Roberto; Antona, Carlo; Botta, Luca; Russo, Claudio; Mancuso, Samuel; Rinaldi, Mauro; De Vincentiis, Carlo; Biondi, Andrea; Beghi, Cesare; Cappabianca, Giangiuseppe; Tarzia, Vincenzo; Gerosa, Gino; De Bonis, Michele; Pozzoli, Alberto; Nicolini, Francesco; Benassi, Filippo; Rosato, Francesco; Grasso, Elena; Livi, Ugolino; Sponga, Sandro; Pacini, Davide; Di Bartolomeo, Roberto; De Martino, Andrea; Bortolotti, Uberto; Onorati, Francesco; Faggian, Giuseppe; Lorusso, Roberto; Vizzardi, Enrico; Di Giammarco, Gabriele; Marinelli, Daniele; Villa, Emmanuel; Troise, Giovanni; Picichè, Marco; Musumeci, Francesco; Paparella, Domenico; Margari, Vito; Tritto, Francesco; Damiani, Girolamo; Scrascia, Giuseppe; Zaccaria, Salvatore; Renzulli, Attilio; Serraino, Giuseppe; Mariscalco, Giovanni; Maselli, Daniele; Foschi, Massimiliano; Parolari, Alessandro; Nappi, Giannantonio

2017-08-15

The aim of this large retrospective study was to provide a logistic risk model along an additive score to predict early mortality after surgical treatment of patients with heart valve or prosthesis infective endocarditis (IE). From 2000 to 2015, 2715 patients with native valve endocarditis (NVE) or prosthesis valve endocarditis (PVE) were operated on in 26 Italian Cardiac Surgery Centers. The relationship between early mortality and covariates was evaluated with logistic mixed effect models. Fixed effects are parameters associated with the entire population or with certain repeatable levels of experimental factors, while random effects are associated with individual experimental units (centers). Early mortality was 11.0% (298/2715); At mixed effect logistic regression the following variables were found associated with early mortality: age class, female gender, LVEF, preoperative shock, COPD, creatinine value above 2mg/dl, presence of abscess, number of treated valve/prosthesis (with respect to one treated valve/prosthesis) and the isolation of Staphylococcus aureus, Fungus spp., Pseudomonas Aeruginosa and other micro-organisms, while Streptococcus spp., Enterococcus spp. and other Staphylococci did not affect early mortality, as well as no micro-organisms isolation. LVEF was found linearly associated with outcomes while non-linear association between mortality and age was tested and the best model was found with a categorization into four classes (AUC=0.851). The following study provides a logistic risk model to predict early mortality in patients with heart valve or prosthesis infective endocarditis undergoing surgical treatment, called "The EndoSCORE". Copyright © 2017. Published by Elsevier B.V.

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.

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 the heterotopic aortic position. It reduced valve thrombus and platelet deposition on day 30 following implantation without increased adverse events. Future studies would provide additional support for clinical trials evaluating rivaroxaban as an alternative to warfarin for appropriately selected patients with prosthetic aortic valves.

Excessive strut wear allowing ball-poppet embolization in a DeBakey-Surgitool aortic valve prosthesis.

PubMed

Sutherland, R D; Guynes, W A; Nichols, C T; Martinez, H E

1982-01-01

Excessive cage strut wear allowing ball-poppet embolization caused the sudden death of a 47 year old lady in whom a DeBakey-Surgitool aortic prosthesis had been implanted nine years earlier. Patients with this type of prosthesis should have periodic valvular cine fluoroscopy with image intensification to allow visualization of significant strut wear or fracture, and appropriate prosthetic valve replacement.

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.

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.

Should the automatic exposure control system of CT be disabled when scanning patients with endoaortic stents or mechanical heart valves? A phantom study.

PubMed

Di Leo, Giovanni; Spadavecchia, Chiara; Zanardo, Moreno; Secchi, Francesco; Veronese, Ivan; Cantone, Marie Claire; Sardanelli, Francesco

2017-07-01

To estimate the impact of endoaortic stents/mechanical heart valves on the output of an automatic exposure control (AEC) system and CT radiation dose. In this phantom study, seven stents and two valves were scanned with varying tube voltage (80/100/120 kVp), AEC activation (enabled/disabled) and prosthesis (present/absent), for a total of 540 scans. For each prosthesis, the dose-length product (DLP) was compared between scans with the AEC enabled and disabled. Percentage confidence levels for differences due to the prosthesis were calculated. Differences between results with the AEC enabled and disabled were not statistically significant (p ≥ 0.059). In the comparison with and without the prosthesis, DLP was unchanged at 80 kVp and 100 kVp, while a slight increase was observed at 120 kVp. The radiation dose varied from 1.8 mGy to 2.4 mGy without the prosthesis and from 1.8 mGy to 2.5 mGy with the prosthesis (confidence level 37-100%). The effect of the prosthesis on the AEC system was negligible and not clinically relevant. Therefore, disabling the AEC system when scanning these patients is not likely to provide a benefit. • CT-AEC system is not impaired in patients with endoaortic prostheses/heart valves. • Negligible differences may be observed only at 120 kVp. • Disabling the AEC system in these patients is not recommended.

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.

Experimental investigations on the fluid-mechanics of an electrospun heart valve by means of particle image velocimetry.

PubMed

Del Gaudio, Costantino; Gasbarroni, Pier Luca; Romano, Giovanni Paolo

2016-12-01

End-stage failing heart valves are currently replaced by mechanical or biological prostheses. Both types positively contribute to restore the physiological function of native valves, but a number of drawbacks limits the expected performances. In order to improve the outcome, tissue engineering can offer an alternative approach to design and fabricate innovative heart valves capable to support the requested function and to promote the formation of a novel, viable and correctly operating physiological structure. This potential result is particularly critical if referred to the aortic valve, being the one mainly exposed to structural and functional degeneration. In this regard, the here proposed study presents the fabrication and in vitro characterization of a bioresorbable electrospun heart valve prosthesis using the particle image velocimetry technique either in physiological and pathological fluid dynamic conditions. The scaffold was designed to reproduce the aortic valve geometry, also mimicking the fibrous structure of the natural extracellular matrix. To evaluate its performances for possible implantation, the flow fields downstream the valve were accurately investigated and compared. The experimental results showed a correct functionality of the device, supported by the formation of vortex structures at the edge of the three cusps, with Reynolds stress values below the threshold for the risk of hemolysis (which can be comprised in the range 400-4000N/m(2) depending on the exposure period), and a good structural resistance to the mechanical loads generated by the driving pressure difference. Copyright © 2016 Elsevier Ltd. 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.

Laser Doppler anemometry measurements of steady flow through two bi-leaflet prosthetic heart valves

PubMed Central

Bazan, Ovandir; Ortiz, Jayme Pinto; Vieira Junior, Francisco Ubaldo; Vieira, Reinaldo Wilson; Antunes, Nilson; Tabacow, Fabio Bittencourt Dutra; Costa, Eduardo Tavares; Petrucci Junior, Orlando

2013-01-01

Introduction In vitro hydrodynamic characterization of prosthetic heart valves provides important information regarding their operation, especially if performed by noninvasive techniques of anemometry. Once velocity profiles for each valve are provided, it is possible to compare them in terms of hydrodynamic performance. In this first experimental study using laser doppler anemometry with mechanical valves, the simulations were performed at a steady flow workbench. Objective To compare unidimensional velocity profiles at the central plane of two bi-leaflet aortic prosthesis from St. Jude (AGN 21 - 751 and 21 AJ - 501 models) exposed to a steady flow regime, on four distinct sections, three downstream and one upstream. Methods To provide similar conditions for the flow through each prosthesis by a steady flow workbench (water, flow rate of 17L/min. ) and, for the same sections and sweeps, to obtain the velocity profiles of each heart valve by unidimensional measurements. Results It was found that higher velocities correspond to the prosthesis with smaller inner diameter and instabilities of flow are larger as the section of interest is closer to the valve. Regions of recirculation, stagnation of flow, low pressure, and flow peak velocities were also found. Conclusions Considering the hydrodynamic aspect and for every section measured, it could be concluded that the prosthesis model AGN 21 - 751 (RegentTM) is superior to the 21 AJ - 501 model (Master Series). Based on the results, future studies can choose to focus on specific regions of the these valves. PMID:24598950

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.

Seventeen-millimeter St. Jude Medical Regent valve in patients with small aortic annulus: dose moderate prosthesis-patient mismatch matter?

PubMed

Hu, Jia; Qian, Hong; Li, Ya-jiao; Gu, Jun; Zhao, Jing Janice; Zhang, Er-yong

2014-01-17

The study was designed to evaluate the effects of moderate prosthesis-patient mismatch (defined as 0.65 cm(2)/m(2) 

Biomechanical Behavior of Bioprosthetic Heart Valve Heterograft Tissues: Characterization, Simulation, and Performance

PubMed Central

Soares, Joao S.; Feaver, Kristen R.; Zhang, Will; Kamensky, David; Aggarwal, Ankush; Sacks, Michael S.

2017-01-01

The use of replacement heart valves continues to grow due to the increased prevalence of valvular heart disease resulting from an ageing population. Since bioprosthetic heart valves (BHVs) continue to be the preferred replacement valve, there continues to be a strong need to develop better and more reliable BHVs through and improved the general understanding of BHV failure mechanisms. The major technological hurdle for the lifespan of the BHV implant continues to be the durability of the constituent leaflet biomaterials, which if improved can lead to substantial clinical impact. In order to develop improved solutions for BHV biomaterials, it is critical to have a better understanding of the inherent biomechanical behaviors of the leaflet biomaterials, including chemical treatment technologies, the impact of repetitive mechanical loading, and the inherent failure modes. This review seeks to provide a comprehensive overview of these issues, with a focus on developing insight on the mechanisms of BHV function and failure. Additionally, this review provides a detailed summary of the computational biomechanical simulations that have been used to inform and develop a higher level of understanding of BHV tissues and their failure modes. Collectively, this information should serve as a tool not only to infer reliable and dependable prosthesis function, but also to instigate and facilitate the design of future bioprosthetic valves and clinically impact cardiology. PMID:27507280

Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease.

PubMed

van Slooten, Ymkje J; van Melle, Joost P; Freling, Hendrik G; Bouma, Berto J; van Dijk, Arie Pj; Jongbloed, Monique Rm; Post, Martijn C; Sieswerda, Gertjan T; Huis In 't Veld, Anna; Ebels, Tjark; Voors, Adriaan A; Pieper, Petronella G

2016-01-01

To report the prevalence of aortic valve prosthesis-patient mismatch (PPM) in an adult population with congenital heart disease (CHD) and its impact on exercise capacity. Adults with congenital heart disease (ACHD) with a history of aortic valve replacement may outgrow their prosthesis later in life. However, the prevalence and clinical consequences of aortic PPM in ACHD are presently unknown. From the national Dutch Congenital Corvitia (CONCOR) registry, we identified 207 ACHD with an aortic valve prosthesis for this cross-sectional cohort study. Severe PPM was defined as an indexed effective orifice area ≤0.65 cm2/m2 and moderate PPM as an indexed orifice area ≤0.85 cm2/m2 measured using echocardiography. Exercise capacity was reported as percentage of predicted exercise capacity (PPEC). Of the 207 patients, 68% was male, 71% had a mechanical prosthesis and mean age at inclusion was 43.9 years ±11.4. The prevalence of PPM was 42%, comprising 23% severe PPM and 19% moderate PPM. Prevalence of PPM was higher in patients with mechanical prostheses (p<0.001). PPM was associated with poorer exercise capacity (mean PPEC 84% vs. 92%; p=0.048, mean difference =-8.3%, p=0.047). Mean follow-up was 2.6±1.1 years during which New York Heart Association (NYHA) class remained stable in most patients. PPM showed no significant effect on death or hospitalisation during follow-up (p=0.218). In this study we report a high prevalence (42%) of PPM in ACHD with an aortic valve prosthesis and an independent association of PPM with diminished exercise capacity. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Development of an algorithm to plan and simulate a new interventional procedure.

PubMed

Fujita, Buntaro; Kütting, Maximilian; Scholtz, Smita; Utzenrath, Marc; Hakim-Meibodi, Kavous; Paluszkiewicz, Lech; Schmitz, Christoph; Börgermann, Jochen; Gummert, Jan; Steinseifer, Ulrich; Ensminger, Stephan

2015-07-01

The number of implanted biological valves for treatment of valvular heart disease is growing and a percentage of these patients will eventually undergo a transcatheter valve-in-valve (ViV) procedure. Some of these patients will represent challenging cases. The aim of this study was to develop a feasible algorithm to plan and in vitro simulate a new interventional procedure to improve patient outcome. In addition to standard diagnostic routine, our algorithm includes 3D printing of the annulus, hydrodynamic measurements and high-speed analysis of leaflet kinematics after simulation of the procedure in different prosthesis positions as well as X-ray imaging of the most suitable valve position to create a 'blueprint' for the patient procedure. This algorithm was developed for a patient with a degenerated Perceval aortic sutureless prosthesis requiring a ViV procedure. Different ViV procedures were assessed in the algorithm and based on these results the best option for the patient was chosen. The actual procedure went exactly as planned with help of this algorithm. Here we have developed a new technically feasible algorithm simulating important aspects of a novel interventional procedure prior to the actual procedure. This algorithm can be applied to virtually all patients requiring a novel interventional procedure to help identify risks and find optimal parameters for prosthesis selection and placement in order to maximize safety for the patient. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

[Lessons from a heart valve prosthesis controversy].

PubMed

Vandenbroucke, J P; Grobbee, D E

1998-07-18

Two lessons are to be learnt from the Björk-Shiley heart valve prosthesis tragedy. In the first place pharmacoepidemiologic studies are seriously hampered by recent privacy legislation. Individual patients carrying such a prosthesis cannot be traced and advised as to their health risks any more, because their legal autonomy has to be respected. This is clearly not to their advantage. In the second place the atmosphere of marketing and litigation and the increasing dependency of researchers on money from sources with conflicting interests is not conducive to a well-informed and balanced judgement of the epidemiological evidence of safety and efficacy of medical treatments.

Permanent Pacemaker Implantation after TAVR – Predictors and Impact on Outcomes

PubMed Central

Sinning, Jan-Malte; Hammerstingl, Christoph; Werner, Nikos; Grube, Eberhard; Nickenig, Georg

2015-01-01

The number of patients undergoing transcatheter aortic valve replacement (TAVR) worldwide is increasing steadily. Atrioventricular conduction disturbances, with or without the need for permanent pacemaker (PPM) implantation, are one of the most common adverse events after TAVR. Among transcatheter heart valves (THV), rates of conduction abnormalities vary from less than 10 % to more than 50 %. Depending on the reported data referred to, historical data showed that up to one-third of the patients required implantation of a PPM following TAVR. Although generally considered as a minor complication, PPM may have a profound impact on prognosis and quality of life after TAVR. Current data support the hypothesis that conduction abnormalities leading to pacemaker dependency result from mechanical compression of the conduction system by the prosthesis stent frame and individual predisposing conduction defects such as right bundle-branch block (RBBB). With several large randomised trials and registry studies having been published recently and second generation THV having been introduced, the debate about predictors for pacemaker implantation and their impact on outcome after TAVR is still ongoing. PMID:29588683

The extent of aortic annulus calcification is a predictor of postprocedural eccentricity and paravalvular regurgitation: a pre- and postinterventional cardiac computed tomography angiography study.

PubMed

Bekeredjian, Raffi; Bodingbauer, Dorothea; Hofmann, Nina P; Greiner, Sebastian; Schuetz, Moritz; Geis, Nicolas A; Kauczor, Hans U; Bryant, Mark; Chorianopoulos, Emmanuel; Pleger, Sven T; Mereles, Derliz; Katus, Hugo A; Korosoglou, Grigorios

2015-03-01

To investigate if the extent of aortic valve calcification is associated with postprocedural prosthesis eccentricity and paravalvular regurgitation (PAR) in patients undergoing transcatheter aortic valve implantation (TAVI). Cardiac computed tomography angiography (CCTA) was performed before and 3 months after TAVI in 46 patients who received the self-expanding CoreValve and in 22 patients who underwent balloon-expandable Edwards Sapien XT implantation. Aortic annulus calcification was measured with CCTA prior to TAVI and prosthesis eccentricity was assessed with post-TAVI CCTA. Standard echocardiography was also performed in all patients at 3-month follow-up exam. Annulus eccentricity was reduced during TAVI using both implantation systems (from 0.23 ± 0.06 to 0.18 ± 0.07 using CoreValve and from 0.20 ± 0.07 to 0.05 ± 0.03 using Edwards Sapien XT; P<.001 for both). With Edwards Sapien XT, eccentricity reduction at the level of the aortic annulus was significantly higher compared with CoreValve (P<.001). Annulus eccentricity after CoreValve use was significantly related to absolute valve calcification and to valve calcification indexed to body surface area (BSA) (r = 0.48 and 0.50, respectively; P<.001 for both). Furthermore, a significant association was observed between aortic valve calcification and PAR (P<.01 by ANOVA) in patients who received CoreValve. Using ROC analysis, a cut-off value over 913 mm² aortic valve calcification predicted the occurrence of moderate or severe PAR with a sensitivity of 92% and a specificity of 63% (area under the curve = 0.75). Furthermore, multivariable analysis showed that aortic valve calcification was a robust predictor of postprocedural eccentricity and PAR, independent of the aortic annulus size and native valve eccentricity and of CoreValve prosthesis size (adjusted r = 0.46 and 0.50, respectively; P<.01 for both). Such associations were not present with the Edwards Sapien XT system. The extent of native aortic annulus calcification is predictive for postprocedural prosthesis eccentricity and PAR, which is an important marker for long-term mortality in patients undergoing TAVI. This observation applies for the CoreValve, but not for the Edwards Sapien XT valve.

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

Turbulence downstream of subcoronary stentless and stented aortic valves.

PubMed

Funder, Jonas Amstrup; Frost, Markus Winther; Wierup, Per; Klaaborg, Kaj-Erik; Hjortdal, Vibeke; Nygaard, Hans; Hasenkam, J Michael

2011-08-11

Regions of turbulence downstream of bioprosthetic heart valves may cause damage to blood components, vessel wall as well as to aortic valve leaflets. Stentless aortic heart valves are known to posses several hemodynamic benefits such as larger effective orifice areas, lower aortic transvalvular pressure difference and faster left ventricular mass regression compared with their stented counterpart. Whether this is reflected by diminished turbulence formation, remains to be shown. We implanted either stented pericardial valve prostheses (Mitroflow), stentless valve prostheses (Solo or Toronto SPV) in pigs or they preserved their native valves. Following surgery, blood velocity was measured in the cross sectional area downstream of the valves using 10MHz ultrasonic probes connected to a dedicated pulsed Doppler equipment. As a measure of turbulence, Reynolds normal stress (RNS) was calculated at two different blood pressures (baseline and 50% increase). We found no difference in maximum RNS measurements between any of the investigated valve groups. The native valve had significantly lower mean RNS values than the Mitroflow (p=0.004), Toronto SPV (p=0.008) and Solo valve (p=0.02). There were no statistically significant differences between the artificial valve groups (p=0.3). The mean RNS was significantly larger when increasing blood pressure (p=0.0006). We, thus, found no advantages for the stentless aortic valves compared with stented prosthesis in terms of lower maximum or mean RNS values. Native valves have a significantly lower mean RNS value than all investigated bioprostheses. Copyright © 2011 Elsevier Ltd. All rights reserved.

Transapical Mitral Valve Implantation for Native Mitral Valve Stenosis Using a Balloon-Expandable Prosthesis.

PubMed

Kiefer, Philipp; Noack, Thilo; Seeburger, Joerg; Hoyer, Alexandro; Linke, Axel; Mangner, Norman; Lehmkuhl, Lukas; Mohr, Friedrich Wilhelm; Holzhey, David

2017-12-01

Transcatheter mitral valve implantation (TMVI) is still in its infancy and is mainly limited to valve-in-valve or valve-in-ring implantations. We present the early experience with TMVI for severe calcified native MV stenosis. Between January 2014 and June 2015, 6 of 11 patients screened (mean age, 77.4 ± 6.3 years; 66% men) with severe native mitral valve (MV) stenosis (mean gradient [Pmean], 11.1 ± 2.1 mm Hg; mean effective orifice area [EOA], 0.9 ± 0.12 cm 2 ) underwent transcatheter MV replacement at our institution as a bailout procedure. Conventional surgical procedures were denied in all patients because of severe annular calcification and extensive comorbidities (mean logistic EuroScore, 31.4% ± 8.3%). The Edwards SAPIEN 3 (29 mm) (Edwards Lifesciences, Irvine, CA) was used in all cases. Procedural access was transapical in 5 cases and concomitant to aortic valve replacement through the left atrium through a sternotomy in 1 case. Initial implantation was successful in 100% of the cases. Because of early migration, 1 patient needed a valve-in-valve procedure. Postoperative echocardiography showed no residual mitral regurgitation in 4 cases (66%) and mild regurgitation in 2 cases (34%). Mean gradients were reduced to 4.2 ± 0.6 mm Hg (mean EOA, 2.8 ± 0.4 cm 2) . No patient had a stroke during hospitalization, and 30-day mortality was seen in 1 patient (17%) resulting from pneumonia. TMV implantation using the SAPIEN 3 aortic prosthesis in patients with heavy annular calcification is feasible and represents a reasonable bailout option for inoperable patients. However, several limitations need to be considered in this special patient population. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

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.

[Late complications following Björk-Shiley and St. Jude Medical heart valve replacement].

PubMed

Horstkotte, D; Körfer, R; Budde, T; Haerten, K; Schulte, H D; Bircks, W; Loogen, F

1983-05-01

Valve-related complications after Björk-Shiley mitral (n = 475), aortic (n = 424), or mitral-aortic implantation (n = 119) were compared to complications after St. Jude mitral (n = 173), aortic (n = 152), and St. Jude mitral and aortic (n = 63) replacements. The 1,018 consecutive patients with Björk-Shiley valves had been operated upon between 1974 and 1982, those with St. Jude valves between 1978 and 1982. All patients were placed on anticoagulant therapy with phenprocoumon early after operation and no significant intergroup differences in the effectiveness of the anticoagulant therapy were found. At a comparable follow-up time of approximately 23 months, 24 major thromboembolic episodes were observed after Björk-Shiley mitral (BSM) and 3 after St. Jude mitral valve implantation (SJM), corresponding to a thromboembolic rate of 2.82/100 patient years with BSM and 0.93/100 patient years with SJM. After aortic valve replacements, 1.93 events in 100 patient years occurred after Björk-Shiley aortic (BSA) and 0.73 after St. Jude aortic implantation (SJA). In patients with double valve replacements, these rates were 3.2 (BSM + BSA) and 0.88 (SJM + SJA), respectively. The cerebral vessels were involved in 52% and the arteries of the extremities in 22% of these major events. Six Björk-Shiley prostheses had to be replaced because of valve thrombosis. The overall incidence of severe hemorrhagic complications was 2.94/100 patient years in BSM and 1.79 in SJM. After aortic valve replacement, we found rates of 1.80/100 patient years (BSA) and 2.57/100 patient years (SJA), respectively. Intravascular hemolysis no longer seems to be a significant clinical problem. However, indications of red cell damage after heart valve replacement were significantly greater in patients with perivalvular leakage, valve thrombosis, or dysfunction than in those with normally functioning prostheses. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2.2%), or prosthetic valve endocarditis with concomitant perivalvular regurgitation (0.46%). One valve had to be replaced because of fracture of the outlet strut of a BSM prosthesis. Hemorrhage due to the anticoagulant treatment was thus the most frequent complication, without significant intergroup differences, while thromboembolic complications were significantly more frequent after Björk-Shiley mitral, aortic, and double valve replacements than after St. Jude implantation. This may lead to the consideration of a change in the prophylaxis of thrombus formations with the St. Jude valve, especially in aortic valve replacements with sinus rhythm.

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.

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.

Direct right ventricular puncture for hemodynamic evaluation of a mechanical tricuspid valve prosthesis: a new indication for an old procedure.

PubMed

Gibson, M A; Carell, E S

1997-11-01

The advent of transvenous right heart catheterization has relegated direct transthoracic right ventricular puncture largely to the role of "interesting historical footnote." However, in the case of a right ventricle that is "protected" by a mechanical tricuspid valve prosthesis, direct right ventricular puncture represents a reasonable alternative for obtaining accurate hemodynamic information.

The Björk-Shiley 70 degree convexo-concave prosthesis strut fracture problem (present state of information).

PubMed

Ostermeyer, J; Horstkotte, D; Bennett, J; Huysmans, H; Lindblom, D; Olin, C; Orinius, E; Semb, G

1987-04-01

Between June 1980 and June 1983 4028 Björk-Shiley 70 degree convexo-concave prosthetic heart valves were distributed and implanted in Australia, Canada, Europe and South Africa. As of March 1986, a total of 52 outlet strut fractures (1.29%; 70% CL: 1.1%-1.5%) have been reported from 29 implant institutions in 12 countries. The majority (82.7%) occurred in Europe. Intervals between implantation and fracture were 13 days to 45.3 months (mean: 18.4 months; 70% CL: 16.6 months-20.1 months). The mortality rate after strut fracture was 78.7% (70% CL: 72.5%-84.9%). Upon stratification of the fracture by valve sizes and types it becomes evident that 75% (70% CL: 68.8%-81.2%) of all fractures are related to the sizes 29 mm to 33 mm (which virtually represent the same valve size) and predominantly to mitral valves (p less than 0.01). The large valves again have been stratified into two subsets, namely those fabricated from flanges originally machined as Björk-Shiley 60 degree convexo-concave valves (group I) and later produced valves machined initially to 70 degree specifications (group II). In group I the fracture rate was 5.2% (70% CL: 4.2%-6.2%) versus 1.6% (70% CL: 1.1%-2.1%) in group II (p less than 0.01), which identifies the group I 29 mm-33 mm Björk-Shiley 70 degree convexo-concave valves as the highest risk group for strut fracture. The rates are based upon all available information as of March 16, 1986.(ABSTRACT TRUNCATED AT 250 WORDS)

Identification of critical zones in the flow through prosthetic heart valves

NASA Astrophysics Data System (ADS)

Lopez, A.; Ledesma, R.; Zenit, R.; Pulos, G.

2008-11-01

The hemodynamic properties of prosthetic heart valves can cause blood damage and platelet activation due to the non- physiological flow patterns. Blood recirculation and elevated shear stresses are believed to be responsible for these complications. The objective of this study is to identify and quantify the conditions for which recirculation and high stress zones appear. We have performed a comparative study between a mechanical monoleaflet and biological valve. In order to generate the flow conditions to test the prosthesis, we have built a hydraulic circuit which reproduces the human systemic circulation, on the basis of the Windkessel model. This model is based on an electrical analogy which consists of an arterial resistance and compliance. Using PIV 3D- Stereo measurements, taken downstream from the prosthetic heart valves, we have reconstructed the full phase-averaged tridimensional velocity field. Preliminary results show that critical zones are more prominent in mechanical prosthesis, indicating that valves made with bio-materials are less likely to produce blood trauma. This is in accordance with what is generally found in the literature.

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.

Adapting to living with a mechanical aortic heart valve: a phenomenographic study.

PubMed

Oterhals, Kjersti; Fridlund, Bengt; Nordrehaug, Jan Erik; Haaverstad, Rune; Norekvål, Tone M

2013-09-01

To describe how patients adapt to living with a mechanical aortic heart valve. Aortic valve replacement with a mechanical prosthesis is preferred for patients with life expectancy of more than 10 years as they are more durable than bioprosthetic valves. Mechanical valves have some disadvantages, such as higher risk of thrombosis and embolism, increased risk of bleeding related to lifelong oral anticoagulation treatment and noise from the valve. An explorative design with a phenomenographic approach was employed. An explorative design with a phenomenographic approach was applied. Interviews were conducted over 4 months during 2010-2011 with 20 strategically sampled patients, aged 24-74 years having undergone aortic valve replacement with mechanical prosthesis during the last 10 years. Patients adapted to living with a mechanical aortic heart valve in four ways: 'The competent patient' wanted to stay in control of his/her life. 'The adjusted patient' considered the implications of having a mechanical aortic valve as part of his/her daily life. 'The unaware patient' was not aware of warfarin-diet-medication interactions. 'The worried patient' was bothered with the oral anticoagulation and annoyed by the sound of the valve. Patients moved between the different ways of adapting. The oral anticoagulation therapy was considered the most troublesome consequence, but also the sound of the valve was difficult to accept. Patient counselling and adequate follow-up can make patients with mechanical aortic heart valves more confident and competent to manage their own health. We recommend that patients should participate in a rehabilitation programme following cardiac surgery. © 2013 Blackwell Publishing Ltd.

A 29-Year-Old Harken Disk Mitral Valve

PubMed Central

Hsi, David H.; Ryan, Gerald F.; Taft, Janice; Arnone, Thomas J.

2003-01-01

An 81-year-old woman was evaluated for prosthetic mitral valve function. She had received a Harken disk mitral valve 29 years earlier due to severe mitral valve disease. This particular valve prosthesis is known for premature disk edge wear and erosion. The patient's 2-dimensional Doppler echocardiogram showed the distinctive appearance of a disk mitral valve prosthesis. Color Doppler in diastole showed a unique crown appearance, with initial flow acceleration around the disk followed by convergence to laminar flow in the left ventricle. Cineradiographic imaging revealed normal valve function and minimal disk erosion. We believe this to be the longest reported follow-up of a surviving patient with a rare Harken disk valve. We present images with unique echocardiographic and cineangiographic features. (Tex Heart Inst J 2003;30:319–21) PMID:14677746

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.

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.

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

Do CTA measurements of annular diameter, perimeter and area result in different TAVI prosthesis sizes?

PubMed

Horehledova, Barbora; Mihl, Casper; Hendriks, Babs M F; Eijsvoogel, Nienke G; Vainer, Jindrich; Veenstra, Leo F; Wildberger, Joachim E; Das, Marco

2018-06-16

Incorrect prosthesis size has direct impact on patient outcome after transcatheter aortic valve implantation (TAVI) procedure. Currently, annular diameter, area or perimeter may be used for prosthesis size selection. The aim was to evaluate whether the use different annular dimensions would result in the selection of different prosthesis sizes, when assessed in the same TAVI-candidate during the same phase of a cardiac cycle. Fifty consecutive TAVI-candidates underwent retrospectively ECG-gated computed tomography angiography (CTA). Aortic root dimensions were assessed in the 20% phase of the R-R interval. Annular short diameter, perimeter and area were used to select the prosthesis size, based on the industry recommendations for a self-expandable (Medtronic CoreValve; MCV) and balloon-expandable (Edwards Sapien XT Valve; ESV) valve. Complete agreement on selected prosthesis size amongst all three annular dimensions was observed in 62% (31/50; ESV) and 30% (15/50; MCV). Short aortic annulus measurement resulted in a smaller prosthesis size in 20% (10/50; ESV) and in 60% of cases (30/50; MCV) compared to the size suggested by both annular perimeter and area. In 18% (9/50; ESV) and 10% of cases (5/50; MCV) a larger prosthesis would have been selected based on annular perimeter compared to annular diameter and area. Prosthesis size derived from area was always in agreement with at least one other parameter in all cases. Aortic annulus area appears to be the most robust parameter for TAVI-prosthesis size selection, regardless of the specific prosthesis size. Short aortic annulus diameter may underestimate the prosthesis size, while use of annular perimeter may lead to size overestimation in some cases.

Pannus Formation Leads to Valve Malfunction in the Tricuspid Position 19 Years after Triple Valve Replacement.

PubMed

Alskaf, Ebraham; McConkey, Hannah; Laskar, Nabila; Kardos, Attila

2016-06-20

The Medtronic ATS Open Pivot mechanical valve has been successfully used in heart valve surgery for more than two decades. We present the case of a patient who, 19 years following a tricuspid valve replacement with an ATS prosthesis as part of a triple valve operation following infective endocarditis, developed severe tricuspid regurgitation due to pannus formation.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

PubMed

Seiffert, Moritz; Bader, Ralf; Kappert, Utz; Rastan, Ardawan; Krapf, Stephan; Bleiziffer, Sabine; Hofmann, Steffen; Arnold, Martin; Kallenbach, Klaus; Conradi, Lenard; Schlingloff, Friederike; Wilbring, Manuel; Schäfer, Ulrich; Diemert, Patrick; Treede, Hendrik

2014-10-01

This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

Total Artificial Heart Implantation After Undifferentiated High-Grade Sarcoma Excision

PubMed Central

Kremer, Jamila; Farag, Mina; Arif, Rawa; Brcic, Andreas; Sabashnikov, Anton; Schmack, Bastian; Popov, Aron-Frederik; Karck, Matthias; Dohmen, Pascal M.; Ruhparwar, Arjang; Weymann, Alexander

2016-01-01

Background Total artificial heart (TAH) implantation in patients with aggressive tumor infiltration of the heart can be challenging. Case Report We report on a patient with a rare primary undifferentiated high-grade spindle cell sarcoma of the mitral valve and in the left atrium, first diagnosed in 2014. The referring center did a first resection in 2014. In the course of 17 months, computer tomography (CT) scan again showed massive invasion of the mitral valve and left atrium. Partial resection and mitral valve replacement was not an option. We did a subtotal heart excision with total artificial heart implantation. In this report we discuss complications, risk factors, and perioperative management of this patient. Conclusions Patients with aggressive tumors of the heart can be considered for TAH implantation. PMID:27803495

Total Artificial Heart Implantation After Undifferentiated High-Grade Sarcoma Excision.

PubMed

Kremer, Jamila; Farag, Mina; Arif, Rawa; Brcic, Andreas; Sabashnikov, Anton; Schmack, Bastian; Popov, Aron-Frederik; Karck, Matthias; Dohmen, Pascal M; Ruhparwar, Arjang; Weymann, Alexander

2016-11-02

BACKGROUND Total artificial heart (TAH) implantation in patients with aggressive tumor infiltration of the heart can be challenging. CASE REPORT We report on a patient with a rare primary undifferentiated high-grade spindle cell sarcoma of the mitral valve and in the left atrium, first diagnosed in 2014. The referring center did a first resection in 2014. In the course of 17 months, computer tomography (CT) scan again showed massive invasion of the mitral valve and left atrium. Partial resection and mitral valve replacement was not an option. We did a subtotal heart excision with total artificial heart implantation. In this report we discuss complications, risk factors, and perioperative management of this patient. CONCLUSIONS Patients with aggressive tumors of the heart can be considered for TAH implantation.

Patient Management with Metallic Valve Prosthesis during Pregnancy and Postpartum Period.

PubMed

Garcez, Juliane Dantas Seabra; Rosa, Vitor Emer Egypto; Lopes, Antonio Sergio de Santis Andrade; Accorsi, Tarso Augusto Duenhas; Fernandes, João Ricardo Cordeiro; Pomerantzeff, Pablo Maria; Avila, Walkiria Samuel; Tarasoutchi, Flavio

2015-10-01

Prosthetic thrombosis is a rare complication, but it has high mortality and morbidity. Young women of childbearing age that have prosthetic heart valves are at increased risk of thrombosis during pregnancy due to changes in coagulation factors. Anticoagulation with adequate control and frequent follow-up if pregnancy occurs must be performed in order to prevent complications related to anticoagulant use. Surgery remains the treatment of choice for prosthetic heart valve thrombosis in most clinical conditions. Patients with metallic prosthetic valves have an estimated 5% risk of thrombosis during pregnancy and maternal mortality of 1.5% related to the event. Anticoagulation with vitamin K antagonists during pregnancy is related to varying degrees of complications at each stage of the pregnancy and postpartum periods. Warfarin sodium crosses the placental barrier and when used in the first trimester of pregnancy is a teratogenic agent, causing 1-3% of malformations characterized by fetal warfarin syndrome and also constitutes a major cause of miscarriage in 10-30% of cases. In the third trimester and at delivery, the use of warfarin is associated with maternal and neonatal bleeding in approximately 5 to 15% of cases, respectively. On the other hand, inadequate anticoagulation, including the suspension of the oral anticoagulants aiming at fetal protection, carries a maternal risk of about 25% of metallic prosthesis thrombosis, particularly in the mitral valve. This fact is also due to the state of maternal hypercoagulability with activation of coagulation factors V, VI, VII, IX, X, platelet activity and fibrinogen synthesis, and decrease in protein S levels. The Registry of Pregnancy and Cardiac Disease (ROPAC), assessing 212 pregnant women with metal prosthesis, showed that prosthesis thrombosis occurred in 10 (4.7%) patients and maternal hemorrhage in 23.1%, concluding that only 58% of patients with metallic prosthesis had a complication-free pregnancy.

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, Inc.

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 Wiley Blackwell.

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.

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.

Failing stentless Bioprostheses in patients with carcinoid heart valve disease.

PubMed

Schaefer, Andreas; Sill, Bjoern; Schoenebeck, Jeannette; Schneeberger, Yvonne; Reichenspurner, Hermann; Gulbins, Helmut

2015-03-27

Carcinoid tumor with consecutive endocardial fibroelastosis of the right heart, known as carcinoid heart valve disease (CHVD) or Hedinger's syndrome, is accompanied by combined right-sided valvular dysfunction with regurgitation and stenosis of the affected valves. Cardiac surgery with replacement of the tricuspid and/or pulmonary valve is an established therapeutic option for patients with Hedinger's syndrome. Little is known about the long term outcome and the choice of prosthesis for the pulmonal position is still a matter of debate. The authors report three cases of pulmonary valve replacement with stentless bioprostheses (Medtronic Freestyle, Medtronic PLC, Minneapolis, MN, USA) due to severe pulmonary valve degeneration in consequence of Hedinger's syndrome. All patients presented with re-stenosis of the pulmonal valve conduit at the height of the anastomoses in a premature fashion. Due to the increased risk for repeat surgical valve replacement, two patients were treated by transcatheter heart valves. We do not recommend the replacement of the pulmonary valve with stentless bioprostheses in patients with CHVD. These valves presented with an extreme premature degeneration and consecutive re-stenosis and heart failure.

Asymptomatic strut fracture in DeBakey-Surgitool aortic valves: incidence, management, and metallurgic aspects.

PubMed

Von Der Emde J, J; Eberlein, U; Breme J, J

1990-01-01

From August 1971 through November 1972, we implanted 62 Model 2 DeBakey-Surgitool aortic valve prostheses in 62 patients, 4 of whom later had clinically asymptomatic strut fractures. In 1 case, the patient died suddenly, and autopsy revealed detachment of the ball-cage; in each of the other 3 cases, fractures of 2 struts close to the base of the prosthesis were diagnosed fluoroscopically, and the patients underwent successful reoperation. The interval between implantation and reoperation ranged from 11 months to 16 years, 9 months. In 1 patient, retrospective study of chest radiographs revealed that the fracture had been present for 2(1/2) years. Larger valves (>/= A6) were affected significantly more often than smaller ones. We performed metallurgic analysis of 1 prosthesis: results revealed strut wear from fatigue cracking and secondary abrasion. Strut fracture was also promoted by suspension of the cage at right angles to the prosthetic ring and by use of a pyrolytic carbon ball in a titanium cage (i.e., an occluder harder than its holder). Patients with DeBakey-Surgitool aortic valve prostheses should undergo annual radiologic examinations to enable early detection of strut fractures. Prophylactic valve replacement is not indicated.

Comparison of mechanical and biological prostheses when used to replace heart valves in children and adolescents with rheumatic fever.

PubMed

Travancas, Paulo R; Dorigo, Ana H; Simões, Luiz C; Fonseca, Sandra C; Bloch, Kátia V; Herdy, Gesmar V

2009-04-01

To assess the outcomes in children and adolescents with rheumatic fever of the implantation of mechanical as opposed to biological heart valves. We assessed 73 patients with rheumatic heart disease under the age of 18 years, who underwent replacement of heart valves between January, 1996, and December, 2005, at the National Institute of Cardiology in Rio de Janeiro, Brazil. Of the group, 71 patients survived, and were divided into a group of 52 receiving mechanical prostheses, and 19 with biological prostheses. We compared endpoints between the groups in terms of mortality, reoperation, haemorrhage, and stroke. Survival curves were estimated using the Kaplan-Meier method and were compared by the Mantel (log-rank) test. Overall mortality was 8.2%. In those receiving mechanical prostheses, 2 (3.8%) patients died, 5 (9.6%) underwent reoperation, 2 (3.8%) suffered severe haemorrhage, and 3 (5.8%) had strokes. In those receiving biological valves, 2 (10.5%) patients died, and 4 (21%) underwent reoperation. After 2, 4, and 8 years, overall survival was 96%, 93% and 86%, respectively, with a borderline difference between the groups (p = 0.06). The probabilities of remaining free from reoperation (p = 0.13), and from combined endpoints, showed no statistically significant difference between the groups (p = 0.28). Patients with mechanical prostheses had lower mortality and required fewer reoperations, but when all combined endpoints were considered, the groups did not differ. The biological prosthesis proved to be a good option for cardiac surgery in children and adolescents with difficulties or risks of anticoagulation.

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.

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

Leaflet escape in a new bileaflet mechanical valve: TRI technologies.

PubMed

Bottio, Tomaso; Casarotto, Dino; Thiene, Gaetano; Caprili, Luca; Angelini, Annalisa; Gerosa, Gino

2003-05-13

Leaflet escape is a mode of structural valve failure for mechanical prostheses. This complication previously has been reported for both monoleaflet and bileaflet valve models. We report 2 leaflet escape occurrences observed in 2 patients who underwent valve replacement with a TRI Technologies valve prosthesis. At the University of Padua, between November 2000 and February 2002, 36 TRI Technologies valve prostheses (26 aortic and 10 mitral) were implanted in 34 patients (12 women and 22 men) with a mean age of 59.9+/-10.3 years (range, 30 to 75 years). There were 5 deaths: 3 in hospital, 1 early after discharge, and 1 late. Two patients experienced a catastrophic prosthetic leaflet escape; the first patient was a 52-year-old man who died 10 days after aortic valve and ascending aorta replacement, and the second was a 58-year-old man who underwent a successful emergency reoperation 20 months after mitral valve replacement. Examination of the explanted prostheses showed in both cases a leaflet escape caused by a leaflet's pivoting system fracture. Prophylactic replacement was then successfully accomplished so far in 12 patients, without evidence of structural valve failure in any of them. Among other significant postoperative complications, we observed 3 major thromboembolisms, 1 hemorrhage, and 1 paravalvular leak. These catastrophes prompted us to interrupt the implantation program, and they cast a shadow on the durability of the TRI Technologies valve prosthesis because of its high risk of structural failure.

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.

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

Tackling the Issue of High Postoperative Pacemaker Implantation Rates in Sutureless Aortic Valve Replacement: Should Balloon Inflation be Removed from the Implantation Method of the Perceval Prosthesis?

PubMed

Charles Blouin, Mathieu; Bouhout, Ismail; Demers, Philippe; Carrier, Michel; Perrault, Louis; Lamarche, Yoan; El-Hamamsy, Ismail; Bouchard, Denis

2017-05-01

Sutureless aortic valve replacement (AVR) is an emerging alternative to standard AVR in elderly and high-risk patients. This procedure is associated with a high rate of postoperative permanent pacemaker implantation (PPI). The study aim was to assess the impact on the rate of PPI of implanting the Perceval prosthesis without using balloon inflation. A total of 159 patients who underwent sutureless AVR using the Perceval prosthesis was included. Balloon inflation was used in 132 patients (Balloon group) and not used in the remaining 27 (No-Balloon group). Clinical, echocardiographic and electrocardiographic outcomes were assessed. There was no significant difference in PPI rate between the two groups (26% for Balloon group versus 22% in No-Balloon group; p = 0.700). Balloon inflation had no significant impact on the incidence of paravalvular leaks (p = 0.839), or on the need to return to cardiopulmonary bypass (CPB) intraoperatively due to paravalvular leak or unsatisfactory deployment (p >0.999). Mean and peak transaortic pressure gradients were similar between the two groups (p = 0.417 and p = 0.522, respectively). Cross-clamp and CPB times were shorter in the No-Balloon group (49.6 ± 15.9 min versus 61.1 ± 25.6 min and 64.1 ± 26.3 min versus 79.6 ± 35.4 min, respectively; p = 0.027 and p = 0.012, respectively). The two groups had similar postoperative PPI rates. Implanting the Perceval prosthesis without balloon inflation is safe and had no impact on paravalvular leaks, intraoperative complications or hemodynamic results. Reductions in aortic cross-clamp time and CPB time were observed when the balloon was not used.

Midterm Follow-Up of the Stentless Freedom Solo Bioprosthesis in 350 Patients.

PubMed

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

2016-07-01

The stentless Freedom Solo aortic bioprosthesis is implanted supraannularly using one running suture line in the sinuses of Valsalva. We report our 9-year experience with this bioprosthesis. From April 2005 to July 2014, 350 consecutive patients at our institution underwent aortic valve replacement with the Freedom Solo bioprosthesis. Follow-up and echocardiographic data were collected retrospectively from referring cardiology centers. The mean age was 76 ± 6 years, 48% were male, and 46% underwent a concomitant procedure. Median EuroSCORE II was 3.0 (interquartile range, 1.9 to 4.9). Operative mortality was 5.1% for all procedures and 2.1% for isolated aortic valve replacement. The 1-, 5-, and 9-year overall survival was 92%, 74%, and 47%, respectively. At 6 years, freedom from structural valve deterioration and freedom from aortic valve reoperation were 98% and 96%, respectively. Prosthetic valve endocarditis occurred at a rate of 0.8% per patient-year. Permanent pacemaker implantation was necessary in 2.3% (n = 8), and moderate and severe prosthesis-patient mismatch occurred in 30 patients overall (9.6%). Postoperative maximum and mean valvular gradients were 17 mm Hg and 10 mm Hg, respectively, and remained stable during follow-up. Aortic valve replacement with the Freedom Solo is safe and has a low rate of permanent pacemaker implantations and prosthesis-patient mismatch. Survival is comparable to that with other aortic bioprostheses, and structural valve deterioration and aortic valve reoperation are infrequent during midterm follow-up. Hemodynamic performance is excellent, with low valvular gradients that remain stable during follow-up. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Description and Validation of TAVIApp: A Novel Mobile Application for Support of Physicians in the Management of Aortic Stenosis—Management of Aortic Stenosis with TAVIApp

PubMed Central

Sabatino, Jolanda; Mongiardo, Annalisa; Ricci, Pietrantonio; Spaccarotella, Carmen

2017-01-01

Background Aortic stenosis (AS) is the most common heart valve disease in developed countries. The advent of transcatheter aortic valve implantation (TAVI) significantly improved patients' outcome but made clinical management more complex. The aim of the present study was to describe TAVIApp, a mobile app we developed to guide the management of AS, and test its efficacy. Methods and Results Clinical cases comprising 42 patients with AS were blindly evaluated by (A) an interventional cardiologist, assisted by the Heart Team (EXPERT), (B) young residents in cardiology, and (C) a young resident supported by TAVIApp. There was poor concordance between Group A and Group B with low performance by young residents (k = 0.52; p < 0.001). However, concordance increased to an optimal value when young residents were supported by TAVIApp (k = 1.0; p < 0.001) for the diagnosis of severe AS and eligibility assessment. Furthermore, regarding the selection of the most appropriate prosthesis size, concordance to Group A was poor without TAVIApp support (Group B) (k = 0.78; p = 0.430), but excellent with TAVIApp (k = 1.0; p < 0.001). Conclusions This study is the first describing and validating a new mobile application to support the management of AS. TAVIApp supports cardiologists in the evaluation of stenosis severity, eligibility for TAVI or AVR, and selection of the most appropriate prosthesis size in individual patients. PMID:29270437

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.

Results of Contemporary Valve Surgery in Patients with Carcinoid Heart Disease.

PubMed

Kuntze, Thomas; Owais, Tamer; Secknus, Maria-Anna; Kaemmerer, Daniel; Baum, Richard; Girdauskas, Evaldas

2016-05-01

Carcinoid tumor is a slow-growing type of neuroendocrine tumor, originating from enterochromaffin cells and secreting mainly serotonin. The diagnosis is based on clinical symptoms, hormone blood levels, radiological and nuclear imaging, and histological confirmation. However, most patients have metastases at the time of diagnosis because the clinical signs often remain unnoticed or are attributed to other abdominal conditions. In up to 50% of patients the endocardium is affected due to a hormonally active tumor profile. The study aim was to report the outcome of surgical treatment in patients with carcinoid heart disease, including the data of radiological and nuclear imaging, histological diagnosis, and follow up information. Between 2008 and 2014, a total of 39 consecutive patients (28 males, 11 females; mean age 66 years; range: 28-84 years) with carcinoid heart syndrome were operated on at the authors' institution. Valvular heart disease was diagnosed with two-dimensional echocardiography. The study population included 26 patients (67%) with severe metastatic disease, who underwent radiotherapy preoperatively, and 13 patients (33%) who were metastasis-free and did not receive preoperative systemic therapy. Follow up was available for all hospital survivors, all of whom underwent serial echocardiographic follow up postoperatively. Adverse cardiac events were defined as cardiac-related death, a need for valvular reintervention, the occurrence of valve prosthesis-related complications, or echocardiographic evidence of new, high-degree valvular dysfunction during follow up. The majority of patients (n = 34; 87%) underwent isolated tricuspid valve replacement, while simultaneous pulmonary valve replacement was performed in five patients (13%). Postoperative complications included reoperation for bleeding in five patients (13%) and new heart block requiring pacemaker implantation in 10 (25%). The in-hospital mortality was 5% (n = 2). The overall survival was 43% at six years postoperatively. At the latest follow up, 12 of the 17 survivors were in NYHA class I, and five in NYHA class II. The adverse cardiac event rate was 71%. Echocardiographically, 46% of patients (6/13) showed at least stationary or mild improvement in the right ventricular ejection fraction at follow up, with no evidence of paravalvular leak, infective endocarditis, or progressive other native valvular carcinoid affection. Postoperatively, the right atrial dimensions were preserved as normal in 23 patients (59%), mildly dilated in six (15%), moderately dilated in three (8%), and severely dilated in seven (18%). Valve-in-valve transcatheter aortic valve implantation was performed in two patients (12%) due to structural degeneration of the valve bioprosthesis and native valve disease progression. Despite advanced systemic disease, the surgical treatment of patients with carcinoid heart syndrome is associated with an acceptable perioperative risk and satisfactory mid-term survival. Those patients who survived valve surgery benefited from a significant improvement in their functional capacity. Percutaneous procedures may represent a useful tool to reduce the risk of late valvular reinterventions.

Sickle cell anemia and mitral valve replacement. Case report.

PubMed

Bomfim, V; Ribeiro, A; Gouvea, F; Pereira, J; Björk, V

1989-01-01

An 8-year-old black boy with sickle cell disease and severe hemolytic anemia crisis (95% hemoglobin S) also had mitral incompetence due to rheumatic valve disease. A 27 mm monostrut Björk-Shiley valve prosthesis was implanted after partial exchange transfusions had reduced the hemoglobin S to less than 40%. High-flow normothermic perfusion was used during extracorporeal circulation, with care taken to avoid hypoxia and acidosis. Postoperative recovery was uneventful.

Fracture and embolization of a Björk-Shiley disc. Fatal failure of a prosthetic mitral valve.

PubMed

Norenberg, D D; Evans, R W; Gundersen, A E; Abellera, R M

1977-12-01

A case of fracture of the disc occluder of a Bjork-Shiley mitral prosthesis with embolization of the disc fragments to distal aorta is presented. The possibility of valve dysfunction and the diagnostic value of echocardiography should be considered whenever acute heart failure occurs in a patient with an artificial valve.

Five-year results after valve replacement with the Björk-Shiley 70 degrees convexo-concave prosthesis.

PubMed

Koldsland, S; Svennevig, J L; Abdelnoor, M; Aas, H; Semb, G

1992-01-01

In the 18 months up to July 1983, 120 Björk-Shiley convexo-concave prostheses with 70 degrees opening angle were implanted in 47 women and 61 men aged 19-78 (mean 58.6) years. The prosthetic valves were aortic in 65 cases, mitral in 23 and both aortic and mitral in 20 cases. Emergency operation was required in ten cases, and concomitant surgery was performed in 43 (39.8%). The early mortality was 5.5%. A follow-up study, comprising 498 patient years, revealed 73.1% 5-year survival. There were three mechanical failures of prosthesis, in one of which re-replacement was successful. Elective prosthesis replacement was performed in four other cases judged to be at high risk of strut fracture.

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.

'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.

Visualizing anatomical evidences on atrioventricular conduction system for TAVI.

PubMed

Kawashima, Tomokazu; Sato, Fumi

2014-06-01

Visualizing the anatomy of the atrioventricular (AV) conduction axis substantiates that there is remarkable inter-individual variation at the macro- and microscopic levels, and that the atrioventricular bundle and left bundle branch are located more anteriorly, distally, and cranially and much closer to the aortic root complex than previously thought. The AV conduction system may therefore be compromised during implantation of a transcatheter aortic valve prosthesis, which may account for the relatively high incidence of new cardiac conduction abnormalities when conventional prosthetic valves are used. The design of the newer JenaValve® may afford advantages over more conventional valves by avoiding the high-risk implantation area and the potential for coronary ostia obstruction. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Aortic root replacement using a biovalsalva prosthesis in comparison to a "handsewn" composite bioprosthesis.

PubMed

Moorjani, Narain; Modi, Amit; Mattam, Kavita; Barlow, Clifford; Tsang, Geoffrey; Haw, Marcus; Livesey, Steven; Ohri, Sunil

2010-05-01

The Biovalsalva aortic root prosthesis incorporates an Elan porcine stentless biological aortic valve suspended within a triple-layered vascular conduit with preformed aortic sinuses of Valsalva. This study compared implantation of the Biovalsalva prosthesis with a "handsewn" composite bioprosthetic graft (CE Perimount bovine bioprosthesis anastomosed to a gelatin-impregnated gelweave Dacron graft). Between December 2004 and January 2009, 39 patients underwent elective or urgent aortic root replacement (modified Bentall procedure with coronary button reimplantation) using a Biovalsalva (n = 21) or a handsewn bioprosthesis (n = 18) for aortic root dilatation. There was no significant difference in the preoperative variables between the two study groups including age (70.7 +/- 1.7 vs. 67.6 +/- 2.9 years, p > 0.05). There was no in-hospital mortality. Three patients in each group underwent concomitant aortic hemi-arch replacement. Patients who underwent Biovalsalva implantation had a reduced need for transfusion of blood (1.25 +/- 0.32 vs. 3.17 +/- 0.71 units, p < 0.05) and fresh frozen plasma (2.78 +/- 0.39 vs. 1.85 +/- 0.31, p < 0.05), and reduced mediastinal blood loss (416 +/- 52 vs. 583 +/- 74 mL, p < 0.05) compared to those with a handsewn bioprosthesis. Cardiopulmonary bypass time (141 +/- 6 vs. 170 +/- 17 minutes, p = NS) and aortic cross-clamp time (113 +/- 6 vs. 115 +/- 7 minutes, p = NS) were similar. Postoperative echocardiography demonstrated excellent hemodynamic function of the Biovalsalva prosthesis (mean size 25.1 +/- 0.4 mm valved conduit) with a peak pressure gradient of 26.2 +/- 1.9 mmHg and no or trivial valvular regurgitation. The Biovalsalva prosthesis should be considered for patients requiring a biological aortic root replacement. It offers an "off-the-shelf" preassembled composite biological valve conduit with excellent hemostatic and hemodynamic properties.

Banking cryopreserved heart valves in Europe: assessment of a 5-year operation in an international tissue bank in Brussels.

PubMed

Goffin, Y; Grandmougin, D; Van Hoeck, B

1996-01-01

The heart valve bank of the European Homograft Bank has been set up in 1988 to meet the growing demand of cardiac surgeons for various sized and quality controlled cryopreserved homografts. Heart valve donors less than 60 years of age were classified in 3 categories: multiorgan donors with non transplantable hearts, recipients of cardiac transplantation and non beating heart cadavers with a warm ischemic time of less than 6 hours. Past history and biology were checked for transmissible diseases. Preparation, progressive freezing and storage in liquid nitrogen vapors, and quality control were according to the standards of the Belgian Ministry of Health. From end January 1989 to end May 1994, 989 homograft valves were cryopreserved (514 pulmonary, 475 aortic and 3 mitral) whereas 962 valves were discarded. The first cause of rejection being a major macroscopic lesion (41.48%). 138 hearts accepted at inspection were contaminated and 43 cases remained so after antibiotics. 38 cases were positive for hepatitis B or C. Complication at distribution and thawing included 10 instances of bag rupture and 15 of transversal fracture through the wall of the conduit. 477 aortic, 474 pulmonary valves as well as one mitral were implanted between May 1989 and May 1994, either for left or right ventricular outflow tract reconstruction. In the left ventricular outflow tract series 111 aortic and 23 pulmonary homograft valves were used in cases of native endocarditis, prosthetic endocarditis or recurrent endocarditis after homograft implantation. 9.6% of the requests could no be satisfied. Regular follow up information was available from 382 implants-40.1% only. The assessment of 5 years operation of the heart valve bank indicates: 1) the efficiency of selecting, cryopreserving and allocating quality controlled homograft valves from a large pool of donor hearts provided by a network of hospitals; 2) the difficulty of obtaining regular follow up information on the implants.

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.

Banking of cryopreserved heart valves in Europe: assessment of a 10-year operation in the European Homograft Bank (EHB).

PubMed

Goffin, Y A; Van Hoeck, B; Jashari, R; Soots, G; Kalmar, P

2000-03-01

The preparation, banking and distribution of cryopreserved heart valves has been carried out at the European Homograft Bank (EHB) in Brussels without interruption since January 1989. We present an assessment of the Bank's activities during this 10-year period. Heart valve donors aged <62 years form three categories: multiorgan donors with non-transplantable hearts; recipients of cardiac transplantation; and non-beating heart cadavers with a warm ischemia time of less than 6 h. Past history and biology are checked for transmissible diseases. Dissection, incubation in antibiotics and cryopreservation in 10% dimethylsulfoxide with storage in liquid nitrogen vapors (about -150 degrees C), and quality control are according to the standards of the Belgian Ministry of Health. Cryopreserved valves are shipped to the implantation centers in a dry shipper at about -150 degrees C. Between January 30th 1989 and December 31st 1998, 1,817 non-transplantable hearts and 12 excised semilunar valves were obtained. In total, 2,077 valves (1,032 pulmonary, 931 aortic and 13 mitral) were decontaminated, cryopreserved and stored in liquid nitrogen vapor (six more valves were refrigerated). In total, 1,515 valves were discarded at different stages of the protocol, the main causes of rejection being significant macroscopic lesions (68.2% aortic and 26.67% pulmonary). Inadequate excision at procurement (10.37% pulmonary), persistent contamination after antibiotics (5.6%) and positive serology for hepatitis B and C and Q fever (5.4%) were other frequent causes for rejection. Among the 2,117 accepted valves, 1,398 were graded first and 719 second choice, mainly on the basis of morphology. In total, 2,090 cryopreserved valves and one refrigerated valve were implanted in 39 institutions between May 1989 and December 1998. Of requests, 10.02% could not be satisfied. In total, 967 pulmonary valves were implanted in the right ventricular outflow tract (RVOT); 424 during a Ross procedure, and 76 in the left ventricular outflow tract (LVOT). Of the aortic valves, 732 were implanted in the LVOT and 266 in the RVOT. Mitral homografts were used for tricuspid valve replacement in two cases, and in the mitral position in seven. Complications at distribution and thawing included 10 bag ruptures and 16 transversal conduit wall fractures. Of the valves shipped, 317 (13.16%) were not used and were returned safely in the dry shipper. Comparison of distribution rates in the first 5.5 and last 4.5 years of EHB activity shows: (i) a significant increase in pulmonary valve implantations in the RVOT (from 71.95% to 81.95%); and (ii) a marked increase (265%) in pulmonary homograft implantations as part of a Ross operation, and a significant decrease (28%) in aortic homograft implantation in the LVOT. While macroscopic lesions of procured aortic valves remain the most frequent and unavoidable cause of homograft rejection during quality control, the high percentage of inadequate surgical heart valve excision should be corrected. The rates of bacterial contamination and positive serology seem acceptable. Storage and shipping of cryopreserved homografts in liquid nitrogen vapor permits them to be spared very efficiently. The increasing use of pulmonary valves for RVOT reconstruction either in congenital heart disease or as part of the Ross procedure compensates for the limited availability of good quality aortic valves.

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.

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 prosthesis. Georg Thieme Verlag KG Stuttgart · New York.

Q Fever: Statistics and Epidemiology

MedlinePlus

... severe with complications requiring hospitalization that may include endocarditis (infection of the heart tissue), encephalitis (inflammation of ... people with a history of heart valve defects, endocarditis, or heart valve implants may increase the risk ...

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

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.

Urgent splenectomy in the course of prosthetic valve endocarditis.

PubMed

Marcinkiewicz, Anna; Ostrowski, Stanisław; Pawłowski, Witold; Palczak, Artur; Adamek-Kośmider, Anna; Jaszewski, Ryszard

2014-06-01

We present a case of a 51-year-old male patient hospitalized due to acute coronary syndrome requiring stent implantation to the left main stem. Double antiplatelet therapy was commenced. After 2-3 days, the patient presented with high fever, dyspnea on exertion, pain in the chest, myalgia, and general weakness. Transthoracic (TTE) and transesophageal (TEE) echocardiography revealed abnormal, turbulent flow across the aortic prosthesis, which was probably caused by the presence of a pathological smooth and mobile structure (10 × 9 × 5 mm) in front of the aortic annulus. Blood cultures were positive and staphylococcal prosthetic valve endocarditis (PVE) was diagnosed. Despite antibiotic treatment, the patient's condition deteriorated, and he was referred for prosthesis reimplantation. After being transferred to the Cardiac Surgery Clinic, he presented with nausea, vomiting, and abdominal pain. The results of imaging examinations suggested spleen hematoma. The patient underwent an urgent splenectomy. Histopathological examination revealed a spleen infarction consequent to an embolic event and subscapular hematoma. On the 10(th) day after the laparotomy, cardiac surgery was performed. No large vegetations were found on the aortic prosthesis. The mechanical valve, implanted 20 years earlier, was functioning properly; it was intact and well healed. Several fragments of a thrombus and fibrous tissue, resembling a pannus and covered with minor calcifications, were removed from the ventricular surface of the discs. A decision was reached to leave the aortic prosthesis in situ. The valvular material culture revealed the presence of Streptococcus anginosus, and the antibiotic scheme was modified. The postoperative period was uneventful.

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.

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.

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 replacement was good (81% at 10 years). Thromboembolic and hemorrhagic events were of minor significance. Atrio-ventricular valve replacement carried the highest risk of valve thrombosis and we now give warfarin and an antiplatelet drug to children undergoing mechanical valve implantation in this position.

Prosthetic valve sparing aortic root replacement: an improved technique.

PubMed

Leacche, Marzia; Balaguer, Jorge M; Umakanthan, Ramanan; Byrne, John G

2008-10-01

We describe a modified surgical technique to treat patients with a previous history of isolated aortic valve replacement who now require aortic root replacement for an aneurysmal or dissected aorta. This technique consists of replacing the aortic root with a Dacron conduit, leaving intact the previously implanted prosthesis, and re-implanting the coronary arteries in the Dacron graft. Our technique differs from other techniques in that we do not leave behind any aortic tissue remnant and also in that we use a felt strip to obliterate any gap between the old sewing ring and the newly implanted graft. In our opinion, this promotes better hemostasis. We demonstrate that this technique is safe, feasible, and results in acceptable outcomes.

[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.

Long-term follow-up of stentless prosthesis.

PubMed

Sansone, Fabrizio; Dato, Guglielmo Mario Actis; Zingarelli, Edoardo; Ferrero, Emanuele; Prot, Sara; Ceresa, Fabrizio; Patanè, Francesco; Casabona, Riccardo

2014-05-01

Stentless prostheses have an interesting hemodynamic performance when compared to stented prostheses and are recommended in cases of small aortic annulus. From January 1996 to January 2004, 138 patients suffering from aortic disease, underwent aortic valve replacement. • Group A: 93 patients underwent stentless aortic valve implantation [stentless Biocor (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil) and stentless Sorin (Sorin Group, Saluggia, Italy)]. • Group B: 45 patients underwent stented aortic valve implantation (stented Biocor). Patients were assessed by clinical evaluation and echocardiography after a mean follow up of 124.5 ± 58.2 months. There was a significant difference in terms of time of extracorporeal circulation and aortic cross clamp. The actuarial survival at 4, 8, 12, and 15 years is 77%, 50%, 21%, and 18%, respectively. Freedom from reoperation at 4, 8, 12, and 14 years was 92%, 83%, 73%, and 63%, respectively. Freedom from all events, death, and reoperation at 4, 8, 12, and 14 years was 70%, 39%, 13%, and 8%, respectively. There is no statistical difference among the two groups in terms of actuarial survival, freedom from reoperation, and freedom from re-hospitalization for prosthesis-related causes. There was a significantly higher incidence of pacemaker implantation in Group A and the causes are not known. The rate of freedom from reoperation is high in both groups for the patients who remained alive. There was no statistical difference about prosthesis dysfunction between the two groups. The higher incidence of death in Group A cannot be explained by causes related to the prosthesis because there is no difference in terms of causes of death. Rates of reoperation did not differ between the two groups. The results obtained with stentless prostheses are encouraging even in long-term follow-up. Copyright © 2013 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

CT predictors of post-procedural aortic regurgitation in patients referred for transcatheter aortic valve implantation: an analysis of 105 patients.

PubMed

Marwan, Mohamed; Achenbach, Stephan; Ensminger, Stefan M; Pflederer, Tobias; Ropers, Dieter; Ludwig, Josef; Weyand, Michael; Daniel, Werner G; Arnold, Martin

2013-06-01

Cardiac computed tomography (CT) allows accurate and detailed analysis of the anatomy of the aortic root and valve, including quantification of calcium. We evaluated the correlation between different CT parameters and the degree of post-procedural aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) using the balloon-expandable Edwards Sapien prosthesis. Pre-intervention contrast-enhanced dual source CT data sets of 105 consecutive patients (48 males, mean age 81 ± 6 years, mean logEuroSCORE 34 ± 13%) with symptomatic severe aortic valve stenosis referred for TAVI using the Edwards Sapien prosthesis (Edwards lifesciences, Inc., CA, USA) were analysed. The degrees of aortic valve commissural calcification and annular calcification were visually assessed on a scale from 0 to 3. Furthermore, the degree of aortic valve calcification as quantified by the Agatston score, aortic annulus eccentricity, aortic diameter at the level of the sinus of valsalva and at the sinotubular junction were assessed. Early post-procedural AR was assessed using aortography. Significant AR was defined as angiographic AR of at least moderate degree (AR ≥ 2). Visual assessment of the degree of aortic annular calcification as well as the Agatston score of aortic valve calcium correlated weakly, yet significantly with the degree of post-procedural AR (r = 0.31 and 0.24, p = 0.001 and 0.013, respectively). Compared to patients with AR < 2, patients with AR ≥ 2 showed more severe calcification of the aortic annulus (mean visual scores 1.9 ± 0.6 vs. 1.5 ± 0.6, p = 0.003) as well as higher aortic valve Agatston scores (1,517 ± 861 vs. 1,062 ± 688, p = 0.005). Visual score for commissural calcification did not differ significantly between both groups (mean scores 2.4 ± 0.5 vs. 2.5 ± 0.5, respectively, p = 0.117). No significant correlation was observed between the degree of AR and commissural calcification, aortic annulus eccentricity index or aortic diameters. The extent of aortic valve annular calcification, but not of commissural calcification, predicts significant post-procedural AR in patients referred for TAVI using the balloon-expandable Edwards Sapiens prosthesis.

Short-term and mid-term results with the Sorin Freedom Solo aortic valve.

PubMed

Ustunsoy, Hasim; Yasim, Alptekin; Deniz, Hayati; Gokaslan, Gokhan; Ozcaliskan, Ozerdem

2013-03-01

The study aim was to present the short- and mid-term results for patients who underwent aortic valve replacement (AVR) with the Sorin Freedom Solo third-generation stentless prosthetic valve. AVR with a Sorin Freedom Solo valve was performed in 14 patients between March 2006 and March 2011. Patients aged > or = 60 years (male:female ratio 6:8; mean age 73.28 +/- 5.42 years) who required AVR with the Sorin Freedom Solo valve according to the surgeon's choice were included in the study. The valvular prosthesis was implanted in the supra-annular position, using a single suture line. Eight patients underwent an isolated AVR; combined interventions were carried out in the other patients due to concomitant cardiac disease. One patient died during the immediate perioperative period, and two more during the follow up, from non-cardiac causes. The mean maximum transvalvular gradient of patients with aortic stenosis was 88.1 +/- 20.2 mmHg, and this fell to 26.4 +/- 7.6 mmHg during the early postoperative period. The mean gradient at one year of follow up was further decreased to 19.4 +/- 5.3 mmHg. The left ventricular end-diastolic and end-systolic diameters were also significantly reduced, from 4.8 +/- 0.9 to 4.3 +/- 0.6 cm and from 3.2 +/- 0.6 to 2.8 +/- 5.3 cm, respectively. The average left ventricular ejection fraction was 60.2 +/- 4.9% preoperatively, and 63.2 +/- 2.1% at one year after surgery (p = NS). No paravalvular leakage, endocarditis, prosthesis failure or neurologic events were reported among patients. The Sorin Freedom Solo stentless valve has provided good early and intermediate-term results. Implantation of the prosthesis is straightforward, with low rates of morbidity and mortality. However, these data require further support from larger patient series and long-term follow up.

Strut fracture and disc embolization of a Björk-Shiley mitral valve prosthesis: localization of embolized disc by computerized axial tomography.

PubMed

Larrieu, A J; Puglia, E; Allen, P

1982-08-01

The case of a patient who survived strut fracture and embolization of a Björk-Shiley mitral prosthetic disc is presented. Prompt surgical treatment was directly responsible for survival. In addition, computerized axial tomography of the abdomen aided in localizing and retrieving the embolized disc, which was lodged at the origin of the superior mesenteric artery. A review of similar case reports from the literature supports our conclusions that the development of acute heart failure and absent or muffled prosthetic heart sounds in a patient with a Björk-Shiley prosthetic heart valve inserted prior to 1978 should raise the possibility of valve dysfunction and lead to early reoperation.

[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.

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 algorithms do not exist today and their development should be a major research priority. For CFD to further gain the confidence of valve designers and medical practitioners it must also undergo comprehensive validation with experimental data. Such validation requires the use of high-resolution flow measuring tools and techniques and the integration of experimental studies with CFD modeling.

Late outcome analysis of the Braile Biomédica® pericardial valve in the aortic position

PubMed Central

Azeredo, Lisandro Gonçalves; Veronese, Elinthon Tavares; Santiago, José Augusto Duncan; Brandão, Carlos Manuel de Almeida; Pomerantzeff, Pablo Maria Alberto; Jatene, Fabio Biscegli

2014-01-01

Objective Aortic valve replacement with Braile bovine pericardial prosthesis has been routinely done at the Heart Institute of the Universidade de São Paulo Medical School since 2006. The objective of this study is to analyze the results of Braile Biomédica® aortic bioprosthesis in patients with aortic valve disease. Methods We retrospectively evaluated 196 patients with aortic valve disease submitted to aortic valve replacement with Braile Biomédica® bovine pericardial prosthesis, between 2006 and 2010. Mean age was 59.41±16.34 years and 67.3% were male. Before surgery, 73.4% of patients were in NYHA functional class III or IV. Results Hospital mortality was 8.16% (16 patients). Linearized rates of mortality, endocarditis, reintervention, and structural dysfunction were 1.065%, 0.91%, 0.68% and 0.075% patients/year, respectively. Actuarial survival was 90.59±2.56% in 88 months. Freedom from reintervention, endocarditis and structural dysfunction was respectively 91.38±2.79%, 89.84±2.92% and 98.57±0.72% in 88 months. Conclusion The Braile Biomédica® pericardial aortic valve prosthesis demonstrated actuarial survival and durability similar to that described in the literature, but further follow up is required to assess the incidence of prosthetic valve endocarditis and structural dysfunction in the future. PMID:25372903

Alternative causes of bioreaction to prosthetic heart valves: three cases with pannus formation.

PubMed

Karakoyun, Süleyman; Gürsoy, Ozan Mustafa; Kalçık, Macit; Coban Kökten, Sermin; Ozkan, Mehmet

2014-01-01

Pannus formation is an infrequent but serious complication of prosthetic heart valve surgery. The cause of pannus is recognized as a bioreaction to the prostheses; histological investigations have shown that pannus comprises collagen and elastic tissues containing endothelial cells, chronic inflammatory cells, and myofibroblasts. However, the detailed mechanism of its formation has not been fully demonstrated. We aimed to evaluate the potential role of vascular endothelial growth factor (VEGF) and matrix metalloproteinase-2 (MMP-2) in the pathogenesis of pannus formation in three patients with mechanical prosthetic heart valves. Pannus specimens removed from the prostheses were fixed in 10% neutral-buffered formalin for 24 hours after surgical removal and paraffin-embedded using standard procedures. Serial sections were cut at 4 µm for immunohistochemistry analysis. Hematoxylin and eosin (HE) was used in the histological analysis. VEGF and MMP-2 were studied in the immunohistochemistry analysis. Three patients with mechanical prosthetic obstruction due to pannus overgrowth underwent redo valve surgery. In the first and second patients, the mitral prosthesis was explanted along with the pannus overgrowth. The third patient had both aortic and mitral prostheses; the aortic prosthesis was explanted with obstructive pannus formation, whereas the mitral valve was spared with excision of the nonobstructive pannus. The immunohistochemical study demonstrated the expressions of MMP-2 and VEGF in all of the pannus specimens acquired from these cases. VEGF and MMP-2 may play a role in the mechanism of pannus formation as the elements of the chronic active inflammatory process.

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.

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.

A review of state-of-the-art numerical methods for simulating flow through mechanical heart valves.

PubMed

Sotiropoulos, Fotis; Borazjani, Iman

2009-03-01

In nearly half of the heart valve replacement surgeries performed annually, surgeons prefer to implant bileaflet mechanical heart valves (BMHV) because of their durability and long life span. All current BMHV designs, however, are prone to thromboembolic complications and implant recipients need to be on a life-long anticoagulant medication regiment. Non-physiologic flow patterns and turbulence generated by the valve leaflets are believed to be the major culprit for the increased risk of thromboembolism in BMHV implant recipients. In this paper, we review recent advances in developing predictive fluid-structure interaction (FSI) algorithms that can simulate BMHV flows at physiologic conditions and at resolution sufficiently fine to start probing the links between hemodynamics and blood-cell damage. Numerical simulations have provided the first glimpse into the complex hemodynamic environment experienced by blood cells downstream of the valve leaflets and successfully resolved for the first time the experimentally observed explosive transition to a turbulent-like state at the start of the decelerating flow phase. The simulations have also resolved a number of subtle features of experimentally observed valve kinematics, such as the asymmetric opening and closing of the leaflets and the leaflet rebound during closing. The paper also discusses a future research agenda toward developing a powerful patient-specific computational framework for optimizing valve design and implantation in a virtual surgery environment.

A review of state-of-the-art numerical methods for simulating flow through mechanical heart valves

PubMed Central

Borazjani, Iman

2009-01-01

In nearly half of the heart valve replacement surgeries performed annually, surgeons prefer to implant bileaflet mechanical heart valves (BMHV) because of their durability and long life span. All current BMHV designs, however, are prone to thromboembolic complications and implant recipients need to be on a life-long anticoagulant medication regiment. Non-physiologic flow patterns and turbulence generated by the valve leaflets are believed to be the major culprit for the increased risk of thromboembolism in BMHV implant recipients. In this paper, we review recent advances in developing predictive fluid–structure interaction (FSI) algorithms that can simulate BMHV flows at physiologic conditions and at resolution sufficiently fine to start probing the links between hemodynamics and blood-cell damage. Numerical simulations have provided the first glimpse into the complex hemodynamic environment experienced by blood cells downstream of the valve leaflets and successfully resolved for the first time the experimentally observed explosive transition to a turbulent-like state at the start of the decelerating flow phase. The simulations have also resolved a number of subtle features of experimentally observed valve kinematics, such as the asymmetric opening and closing of the leaflets and the leaflet rebound during closing. The paper also discusses a future research agenda toward developing a powerful patient-specific computational framework for optimizing valve design and implantation in a virtual surgery environment. PMID:19194734

Pseudo-malfunction of the Coloplast Titan Inflatable Penile Prosthesis One-Touch Release Pump.

PubMed

Garber, Bruce B; Khurgin, Jacob L; Stember, Doron S; Perito, Paul E

2014-10-01

To define and describe a type of pseudo-malfunction of the Coloplast Titan Inflatable Penile Prosthesis (IPP) One-Touch Release (OTR) pump (Coloplast Corp, Minneapolis, MN). We retrospectively reviewed a consecutive series of 550 patients with refractory organic erectile dysfunction who were implanted with a Coloplast Titan IPP with the OTR pump during a period of approximately 4 years. All patients were implanted using standard techniques through an infrapubic or penoscrotal approach. Twenty-nine patients (5.3%) complained that their IPP would not inflate and that the pump bulb felt "hard." Examination revealed that their IPP was working normally; however, the inflate/deflate valve disc had become stuck in the deflate position. Very firm pressure had to be applied to the pump bulb to move the valve disc into the inflate position. Once this was accomplished, the device inflated and deflated normally. Another 14 patients (2.5%) reported this phenomenon to us but were able to apply enough pressure on the pump bulb to rectify it. The inflate/deflate valve disc in the Coloplast Titan OTR pump can occasionally become stuck in the deflate position (7.8% of patients in our experience). Patients may be unable to inflate the device and return for evaluation. In all cases we have encountered, firm pressure on the pump bulb caused the valve to shift into the inflate position, and the device worked properly thereafter. Patients and implanting urologists should be aware of this issue and of the way in which it can be rectified. Copyright © 2014 Elsevier Inc. All rights reserved.

Assessment of trans-aortic pressure gradient using a coronary pressure wire in patients with mechanical aortic and mitral valve prostheses.

PubMed

Kherada, Nisharahmed; Brenes, Juan Carlos; Kini, Annapoorna S; Dangas, George D

2017-03-15

Accurate evaluation of trans-aortic valvular pressure gradients is challenging in cases where dual mechanical aortic and mitral valve prostheses are present. Non-invasive Doppler echocardiographic imaging has its limitations due to multiple geometric assumptions. Invasive measurement of trans-valvular gradients with cardiac catheterization can provide further information in patients with two mechanical valves, where simultaneous pressure measurements in the left ventricle and ascending aorta must be obtained. Obtaining access to the left ventricle via the mitral valve after a trans-septal puncture is not feasible in the case of a concomitant mechanical mitral valve, whereas left ventricular apical puncture technique is associated with high procedural risks. Retrograde crossing of a bileaflet mechanical aortic prosthesis with standard catheters is associated with the risk of catheter entrapment and acute valvular regurgitation. In these cases, the assessment of trans-valvular gradients using a 0.014˝ diameter coronary pressure wire technique has been described in a few case reports. We present the case of a 76-year-old female with rheumatic valvular heart disease who underwent mechanical aortic and mitral valve replacement in the past. She presented with decompensated heart failure and echocardiographic findings suggestive of elevated pressure gradient across the mechanical aortic valve prosthesis. The use of a high-fidelity 0.014˝ diameter coronary pressure guidewire resulted in the detection of a normal trans-valvular pressure gradient across the mechanical aortic valve. This avoided a high-risk third redo valve surgery in our patient. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Risks of fracture of Björk-Shiley 60 degree convexo-concave prosthetic heart valves: long-term cohort follow up in the UK, Netherlands and USA.

PubMed

Blot, W J; Omar, R Z; Kallewaard, M; Morton, L S; Fryzek, J P; Ibrahim, M A; Acheson, D; Taylor, K M; van der Graaf, Y

2001-03-01

Approximately 82,000 Björk-Shiley convexo-concave (BSCC) 60 degree prosthetic heart valves were implanted in patients worldwide between 1979 and 1986. Outlet strut fractures (OSF) of some of the valves were first reported shortly after their introduction. Here, the determinants of OSF are examined, and the between-country variation and long-term risk are assessed. Cohorts of patients in the UK, Netherlands and USA with 15,770 BSCC 60 degree heart valves were followed up to 18 years for the occurrence of OSF. Crude rates of OSF were highest in the UK (0.18% per year), intermediate in the Netherlands (0.13%), and lowest in the USA (0.06%), although risk factor adjustment reduced the inter-country differences. Furthermore, in the UK and Netherlands, OSF rates (particularly for mitral valves) declined with time since implantation, and between-country differences were considerably diminished 10 or more years post implantation. The risk of OSF decreased steadily with advancing patient age. Fracture rates were lower among women than men, and also varied significantly with valve size and position and OSF status of other valves in the same shoporder. This long-term follow up of BSCC 60 degree heart valve patients indicates that risk factors for valve fracture are generally similar in the UK, Netherlands and USA. It also identifies a strong association between fracture risk and age, newly reveals gender-related differences, and shows that the risk of valve fracture persisted, albeit at a reduced rate, into the 1990s.

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

Beating heart mitral valve replacement with a bovine pericardial bioprosthesis for treatment of mitral valve dysplasia in a Bull Terrier.

PubMed

Behr, Luc; Chetboul, Valérie; Sampedrano, Carolina Carlos; Vassiliki, Gouni; Pouchelon, Jean-Louis; Laborde, François; Borenstein, Nicolas

2007-04-01

To describe an open, beating heart surgical technique and use of a bovine pericardial prosthetic valve for mitral valve replacement (MVR) in the dog. Clinical case report. Male Bull Terrier (17-month-old, 26 kg) with mitral valve dysplasia and severe regurgitation. A bovine pericardial bioprosthesis was used to replace the mitral valve using an open beating heart surgical technique and cardiopulmonary bypass. Successful MVR was achieved using a beating heart technique. Mitral regurgitation resolved and cardiac performances improved (left ventricular end-diastolic diameter decreased from 57.6 to 48.7 mm, and left atrium/aorta ratio returned to almost normal, from 1.62 to 1.19). Cardiopulmonary by-pass time and total surgical duration were decreased compared with standard cardioplegic techniques. Surgical recovery was uneventful and on echocardiography 6 months later valve function was excellent. Considering the technique advantages (no cardiac arrest, ischemic reperfusion injury, and hypothermia, or the need for aortic dissection and cannulation for administration of cardioplegic solution), short-term mortality and morbidity may be reduced compared with standard cardioplegic techniques. Based on experience in this dog, beating heart mitral valvular replacement is a seemingly safe and viable option for the dog and bovine pericardial prosthesis may provide better long-term survival than mechanical prostheses.

Long-term results of heart valve replacement with the Edwards Duromedics bileaflet prosthesis: a prospective ten-year clinical follow-up.

PubMed

Podesser, B K; Khuenl-Brady, G; Eigenbauer, E; Roedler, S; Schmiedberger, A; Wolner, E; Moritz, A

1998-05-01

The Edwards Duromedics valve (Baxter Healthcare Corp., Edwards Division, Santa Ana, Calif.) was designed with a self-irrigating hinge mechanism to reduce thromboembolic complications. After good initial clinical results, distribution was suspended in 1988 after reports of valve fracture after 20,000 valves had been implanted. The manufacturer conducted extensive studies to improve the Edwards Duromedics and reintroduced a modified version, which is available as Edwards Tekna. The purpose of the study was the evaluation of long-term results of the original Edwards Duromedics that might be important for the current version, the Edwards Tekna valve. A prospective clinical 10-year follow-up was performed of 508 patients who underwent valve replacement with the Edwards Duromedics valve in the aortic (n = 268), mitral (n = 183), and aortic and mitral (n = 56) position. The perioperative mortality rate was 6.9%; follow-up was 98% complete, comprising 3648 patient-years for a mean follow-up of 86 months (range: 33 to 144 months). The actuarial freedom from complications at the 10-year follow-up and the incidence rate (percent per patient-year) were as follows: late mortality rate, 69.2% +/- 2.4% (3.5% per patient-year); thromboembolism, 90.7% +/- 1.6% (0.96% per patient-year); anticoagulation-related hemorrhage, 87.7% +/- 1.7% (1.34% per patient-year); prosthetic valve endocarditis, 96.7% +/- 0.09% (0.38% per patient-year); valve-related mortality rate, 89.3% +/- 1.6% (1.21% per patient-year); valve failure, 86.2% +/- 1.85% (1.54% per patient-year); and valve-related morbidity and mortality rate, 71.1% +/- 2.3% (3.2% per patient-year). Three leaflet escapes were observed (one lethal, two successful reoperations; 99.1% +/- 0.05% freedom, 0.08% per patient-year). All patients functionally improved (86% in New York Heart Association classes I and II), and incidence of anemia was insignificant. These results confirm that the Edwards Duromedics valve shows excellent performance concerning thromboembolism, hemolysis, and functional improvement and will serve as a reference for the last version, the Edwards Tekna valve, where comparable long-term data are currently not available.

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.

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

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 of the in vivo remodeling on the functionality of the tube-in-stent valve remains to be tested. PMID:25380414

Micro and nanotechnologies in heart valve tissue engineering.

PubMed

Hasan, Anwarul; Saliba, John; Pezeshgi Modarres, Hassan; Bakhaty, Ahmed; Nasajpour, Amir; Mofrad, Mohammad R K; Sanati-Nezhad, Amir

2016-10-01

Due to the increased morbidity and mortality resulting from heart valve diseases, there is a growing demand for off-the-shelf implantable tissue engineered heart valves (TEHVs). Despite the significant progress in recent years in improving the design and performance of TEHV constructs, viable and functional human implantable TEHV constructs have remained elusive. The recent advances in micro and nanoscale technologies including the microfabrication, nano-microfiber based scaffolds preparation, 3D cell encapsulated hydrogels preparation, microfluidic, micro-bioreactors, nano-microscale biosensors as well as the computational methods and models for simulation of biological tissues have increased the potential for realizing viable, functional and implantable TEHV constructs. In this review, we aim to present an overview of the importance and recent advances in micro and nano-scale technologies for the development of TEHV constructs. Copyright © 2016 Elsevier Ltd. All rights reserved.

A cost-utility analysis of transcatheter versus surgical aortic valve replacement for the treatment of aortic stenosis in the population with intermediate surgical risk.

PubMed

Tam, Derrick Y; Hughes, Avery; Fremes, Stephen E; Youn, Saerom; Hancock-Howard, Rebecca L; Coyte, Peter C; Wijeysundera, Harindra C

2018-05-01

Although transcatheter aortic valve implantation has been shown to be noninferior to surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk, the cost-effectiveness of this strategy in this population is unknown. Our objective was to conduct a cost-utility analysis comparing transcatheter aortic valve implantation with surgical aortic valve replacement in the population with intermediate risk severe aortic stenosis. A fully probabilistic Markov model with 30-day cycles was constructed from the Canadian third-party payer's perspective to estimate the difference in cost and effectiveness (measured as quality-adjusted life years) of transcatheter aortic valve implantation versus surgical aortic valve replacement for intermediate-risk patients over a lifetime time horizon, discounted at 1.5% per annum. Clinical trial data from The Placement of Aortic Transcatheter Valve 2 informed the efficacy inputs. Costs (adjusted to 2016 Canadian dollars) were obtained from the Canadian Institute of Health Information and the Ontario Schedule of Benefits. Incremental cost-effectiveness ratios were calculated. In the base-case analysis, total lifetime costs for transcatheter aortic valve implantation were $10,548 higher than surgical aortic valve replacement but added 0.23 quality-adjusted life years, for an incremental cost-effectiveness ratio of $46,083/quality-adjusted life-years gained. Deterministic 1-way analyses showed that the incremental cost-effectiveness ratio was sensitive to rates of complications and cost of the transcatheter aortic valve implantation prosthesis. There was moderate-to-high parameter uncertainty; transcatheter aortic valve implantation was the preferred option in only 52.7% and 55.4% of the simulations at a $50,000 and $100,000 per quality-adjusted life years willingness-to-pay thresholds, respectively. On the basis of current evidence, transcatheter aortic valve implantation may be cost-effective for the treatment of severe aortic stenosis in patients with intermediate surgical risk. There remains moderate-to-high uncertainty surrounding the base-case incremental cost-effectiveness ratio. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Modification of the Smeloff mitral prosthesis.

PubMed

Smeloff, E A; Davey, T B; Riemenschneider, T A; Epstein, M L; Janos, G; Marshall, R

1982-07-01

The simplicity of the ball valve with its random seating capabilities coupled with its durability, reliability, and predictability has made it the attractive choice of many surgeons. A low incidence of embolic phenomena with the Smeloff full-orifice, double-caged, bare-strutted ball valve has made us reluctant to alter the design over 17 years. Recent evaluation of the reasons for reoperation on the Smeloff mitral valve implantation in 376 cases revealed 16 cases in which development of fibrous subvalvular pannus with signs and symptoms of mitral stenosis occurred. The mean occurrence time was 7.5 years for adults and 4.6 years for children under age 8 years. No such problem has been encountered with the valve in the aortic position. Many of these patients are maintained on aspirin and Persantine alone. Valve design was explored as a possible cause of mitral subvalvular stenosis. Alterations of the design were examined in the engineering laboratory and in dog implantations by catheterization, electrophysiologic evaluation, and echocardiography. The results were encouraging.

The future of heart valve banking and of homografts: perspective from the Deutsches Herzzentrum Berlin.

PubMed

Delmo Walter, E M; de By, T M M H; Meyer, R; Hetzer, R

2012-01-01

Ever since the early days of homograft implantation in 1956, and the introduction into clinical practice by Ross and Barrat Boyes, homograft heart valves have proven to have many advantages. Its disadvantages became evident during long-term follow up. Factors, such as donor and recipient morbidity, tissue banking techniques, and the often complex surgical technique required to implant, are of great influence on the long term results. Because of European Directives, legally binding quality assurance regulations have been introduced in homograft banks. However, still not all processing methods have been scientifically sub-structured on their effects on the final product and its durability. The donor shortage has stimulated researchers and industries to develop and improve mechanical and biological valve substitutes such as the stentless bioprostheses. In general, candidates for homograft valve implantation include patients with: endocarditis, congenital defects and women who wish to become pregnant. For each category of patients different implantation techniques are required. The results of homograft banking and homograft transplantation in the German Heart Institute Berlin are satisfactory. Freedom of re-infection rate after homograft implantation is 91.9% +/- 3.6% after 15 years. Current developments show an increased interest in tissue engineered as well as in de- and re-cellularization of heart valve homografts. The advantages and disadvantages of the several processing techniques have not yet been proven in long term clinical results. For homograft bankers these developments pose as a challenge to join forces and to initiate cooperate projects aimed at scientific and organizational development.

Echocardiographic Assessment of Heart Valve Prostheses

PubMed Central

Sordelli, Chiara; Severino, Sergio; Ascione, Luigi; Coppolino, Pasquale; Caso, Pio

2014-01-01

Patients submitted to valve replacement with mechanical or biological prosthesis, may present symptoms related either to valvular malfunction or ventricular dysfunction from other causes. Because a clinical examination is not sufficient to evaluate a prosthetic valve, several diagnostic methods have been proposed to assess the functional status of a prosthetic valve. This review provides an overview of echocardiographic and Doppler techniques useful in evaluation of prosthetic heart valves. Compared to native valves, echocardiographic evaluation of prosthetic valves is certainly more complex, both for the examination and the interpretation. Echocardiography also allows discriminating between intra- and/or peri-prosthetic regurgitation, present in the majority of mechanical valves. Transthoracic echocardiography (TTE) requires different angles of the probe with unconventional views. Transesophageal echocardiography (TEE) is the method of choice in presence of technical difficulties. Three-dimensional (3D)-TEE seems to be superior to 2D-TEE, especially in the assessment of paravalvular leak regurgitation (PVL) that it provides improved localization and analysis of the PVL size and shape. PMID:28465917

Leaflet embolisation from Duromedics valves: a report of two cases.

PubMed

Kumar, N; Balasundaram, S; Rickard, M; al Halees, Z; Duran, C M

1991-12-01

Embolization of parts of mechanical valves has been reported since the inception of prosthetic valve implantation. We report here two cases of embolization of one hemileaflet of a Duromedic bileaflet prosthesis in the mitral position due to a pivot fracture. Both presented with moderately severe mitral regurgitation and pulmonary edema and were successfully managed by replacement of the malfunctioning prostheses. The embolised disc was located in the left common iliac artery by abdominal ultrasound and removed by an inguinal, retroperitoneal approach with low morbidity. Both patients left hospital and are doing well to-date.

Artificial aortic valve dysfunction due to pannus and thrombus – different methods of cardiac surgical management

PubMed Central

Marcinkiewicz, Anna; Kośmider, Anna; Walczak, Andrzej; Zwoliński, Radosław; Jaszewski, Ryszard

2015-01-01

Introduction Approximately 60 000 prosthetic valves are implanted annually in the USA. The risk of prosthesis dysfunction ranges from 0.1% to 4% per year. Prosthesis valve dysfunction is usually caused by a thrombus obstructing the prosthetic discs. However, 10% of prosthetic valves are dysfunctional due to pannus formation, and 12% of prostheses are damaged by both fibrinous and thrombotic components. The authors present two patients with dysfunctional aortic prostheses who were referred for cardiac surgery. Different surgical solutions were used in the treatment of each case. Case study 1 The first patient was a 71-year-old woman whose medical history included arterial hypertension, stable coronary artery disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), and hypercholesterolemia; she had previously undergone left-sided mastectomy and radiotherapy. The patient was admitted to the Cardiac Surgery Department due to aortic prosthesis dysfunction. Transthoracic echocardiography revealed complete obstruction of one disc and a severe reduction in the mobility of the second. The mean transvalvular gradient was very high. During the operation, pannus covering the discs’ surface was found. A biological aortic prosthesis was reimplanted without complications. Case study 2 The second patient was an 87-year-old woman with arterial hypertension, persistent atrial fibrillation, and COPD, whose past medical history included gastric ulcer disease and ischemic stroke. As in the case of the first patient, she was admitted due to valvular prosthesis dysfunction. Preoperative transthoracic echocardiography revealed an obstruction of the posterior prosthetic disc and significant aortic regurgitation. Transesophageal echocardiography and fluoroscopy confirmed the prosthetic dysfunction. During the operation, a thrombus growing around a minor pannus was found. The thrombus and pannus were removed, and normal functionality of the prosthetic valve was restored. Conclusions Precise and modern diagnostic methods facilitated selection of the treatment method. However, the intraoperative view also seems to be crucial in individualizing the surgical approach. PMID:26702274

Artificial aortic valve dysfunction due to pannus and thrombus - different methods of cardiac surgical management.

PubMed

Ostrowski, Stanisław; Marcinkiewicz, Anna; Kośmider, Anna; Walczak, Andrzej; Zwoliński, Radosław; Jaszewski, Ryszard

2015-09-01

Approximately 60 000 prosthetic valves are implanted annually in the USA. The risk of prosthesis dysfunction ranges from 0.1% to 4% per year. Prosthesis valve dysfunction is usually caused by a thrombus obstructing the prosthetic discs. However, 10% of prosthetic valves are dysfunctional due to pannus formation, and 12% of prostheses are damaged by both fibrinous and thrombotic components. The authors present two patients with dysfunctional aortic prostheses who were referred for cardiac surgery. Different surgical solutions were used in the treatment of each case. The first patient was a 71-year-old woman whose medical history included arterial hypertension, stable coronary artery disease, diabetes mellitus, chronic obstructive pulmonary disease (COPD), and hypercholesterolemia; she had previously undergone left-sided mastectomy and radiotherapy. The patient was admitted to the Cardiac Surgery Department due to aortic prosthesis dysfunction. Transthoracic echocardiography revealed complete obstruction of one disc and a severe reduction in the mobility of the second. The mean transvalvular gradient was very high. During the operation, pannus covering the discs' surface was found. A biological aortic prosthesis was reimplanted without complications. The second patient was an 87-year-old woman with arterial hypertension, persistent atrial fibrillation, and COPD, whose past medical history included gastric ulcer disease and ischemic stroke. As in the case of the first patient, she was admitted due to valvular prosthesis dysfunction. Preoperative transthoracic echocardiography revealed an obstruction of the posterior prosthetic disc and significant aortic regurgitation. Transesophageal echocardiography and fluoroscopy confirmed the prosthetic dysfunction. During the operation, a thrombus growing around a minor pannus was found. The thrombus and pannus were removed, and normal functionality of the prosthetic valve was restored. Precise and modern diagnostic methods facilitated selection of the treatment method. However, the intraoperative view also seems to be crucial in individualizing the surgical approach.

Graphene nanoplatelet-reinforced silicone for the valvular prosthesis application.

PubMed

Lordeus, Makensley; Estrada, Angie; Stewart, Danique; Dua, Rupak; Zhang, Cheng; Agarwal, Arvind; Ramaswamy, Sharan

2015-01-01

Newly developed elastomer heart valves have been shown to better re-create the flow physics of native heart valves, resulting in preferable hemodynamic responses. This emergence has been motivated in part by the recent introduction of percutaneous valve approaches in the clinic. Unfortunately, elastomers such as silicone are prone to structural failure, which drastically limits their applicability the development of a valve prosthesis. To produce a mechanically more robust silicone substrate, we reinforced it with graphene nanoplatelets (GNPs). The nanoplatelets were introduced into a two-part silicone mixture and allowed to cure. Cytotoxicity and hemocompatibility tests revealed that the incorporation of GNPs did not adversely affect cell proliferation or augment adhesion of platelets on the surface of the composite materials. Static mechanical characterization by loading in the tensile direction subsequently showed no observable effect when graphene was utilized. However, cyclic tensile testing (0.05 Hz) demonstrated that silicone samples containing 250 mg graphene/L of uncured silicone significantly improved (p<0.05) material fatigue properties compared with silicone-only controls. This finding suggests that for the silicone-graphene composite, static loads were principally transferred onto the matrix. On the other hand, in cyclic loading conditions, the GNPs were recruited effectively to delay failure of the bulk material. We conclude that application of GNPs to extend silicone durability is useful and warrants further evaluation at the trileaflet valve configuration.

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.

Microstructured Nickel-Titanium Thin Film Leaflets for Hybrid Tissue Engineered Heart Valves Fabricated by Magnetron Sputter Deposition.

PubMed

Loger, K; Engel, A; Haupt, J; Lima de Miranda, R; Lutter, G; Quandt, E

2016-03-01

Heart valves are constantly exposed to high dynamic loading and are prone to degeneration. Therefore, it is a challenge to develop a durable heart valve substitute. A promising approach in heart valve engineering is the development of hybrid scaffolds which are composed of a mechanically strong inorganic mesh enclosed by valvular tissue. In order to engineer an efficient, durable and very thin heart valve for transcatheter implantations, we developed a fabrication process for microstructured heart valve leaflets made from a nickel-titanium (NiTi) thin film shape memory alloy. To examine the capability of microstructured NiTi thin film as a matrix scaffold for tissue engineered hybrid heart valves, leaflets were successfully seeded with smooth muscle cells (SMCs). In vitro pulsatile hydrodynamic testing of the NiTi thin film valve leaflets demonstrated that the SMC layer significantly improved the diastolic sufficiency of the microstructured leaflets, without affecting the systolic efficiency. Compared to an established porcine reference valve model, magnetron sputtered NiTi thin film material demonstrated its suitability for hybrid tissue engineered heart valves.

Hemodynamic Evaluation of a Biological and Mechanical Aortic Valve Prosthesis Using Patient-Specific MRI-Based CFD.

PubMed

Hellmeier, Florian; Nordmeyer, Sarah; Yevtushenko, Pavlo; Bruening, Jan; Berger, Felix; Kuehne, Titus; Goubergrits, Leonid; Kelm, Marcus

2018-01-01

Modeling different treatment options before a procedure is performed is a promising approach for surgical decision making and patient care in heart valve disease. This study investigated the hemodynamic impact of different prostheses through patient-specific MRI-based CFD simulations. Ten time-resolved MRI data sets with and without velocity encoding were obtained to reconstruct the aorta and set hemodynamic boundary conditions for simulations. Aortic hemodynamics after virtual valve replacement with a biological and mechanical valve prosthesis were investigated. Wall shear stress (WSS), secondary flow degree (SFD), transvalvular pressure drop (TPD), turbulent kinetic energy (TKE), and normalized flow displacement (NFD) were evaluated to characterize valve-induced hemodynamics. The biological prostheses induced significantly higher WSS (medians: 9.3 vs. 8.6 Pa, P = 0.027) and SFD (means: 0.78 vs. 0.49, P = 0.002) in the ascending aorta, TPD (medians: 11.4 vs. 2.7 mm Hg, P = 0.002), TKE (means: 400 vs. 283 cm 2 /s 2 , P = 0.037), and NFD (means: 0.0994 vs. 0.0607, P = 0.020) than the mechanical prostheses. The differences between the prosthesis types showed great inter-patient variability, however. Given this variability, a patient-specific evaluation is warranted. In conclusion, MRI-based CFD offers an opportunity to assess the interactions between prosthesis and patient-specific boundary conditions, which may help in optimizing surgical decision making and providing additional guidance to clinicians. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Mitral valve stenosis caused by abnormal pannus extension over the prosthetic ring and leaflets after Duran ring mitral annuloplasty.

PubMed

Yunoki, Junji; Minato, Naoki; Katayama, Yuji; Sato, Hisashi

2009-01-01

We treated a 61-year-old woman with mitral stenosis caused by pannus formation after Duran ring annuloplasty. Pannus overgrowth on the ring with extension onto both leaflets narrowed the mitral orifice and severely restricted the mobility of the valve leaflets. Mitral valve replacement with a St. Jude Medical mechanical heart valve prosthesis was successfully performed, and the postoperative course was uneventful. Patients undergoing Duran ring annuloplasty should be followed up with the consideration of possible mitral stenosis caused by pannus extension, as the cause for pannus formation remains unclear.

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.

In Vitro Evaluation of a Novel Hemodynamically Optimized Trileaflet Polymeric Prosthetic Heart Valve

PubMed Central

Claiborne, Thomas E.; Sheriff, Jawaad; Kuetting, Maximilian; Steinseifer, Ulrich; Slepian, Marvin J.; Bluestein, Danny

2013-01-01

Calcific aortic valve disease is the most common and life threatening form of valvular heart disease, characterized by stenosis and regurgitation, which is currently treated at the symptomatic end-stages via open-heart surgical replacement of the diseased valve with, typically, either a xenograft tissue valve or a pyrolytic carbon mechanical heart valve. These options offer the clinician a choice between structural valve deterioration and chronic anticoagulant therapy, respectively, effectively replacing one disease with another. Polymeric prosthetic heart valves (PHV) offer the promise of reducing or eliminating these complications, and they may be better suited for the new transcatheter aortic valve replacement (TAVR) procedure, which currently utilizes tissue valves. New evidence indicates that the latter may incur damage during implantation. Polymer PHVs may also be incorporated into pulsatile circulatory support devices such as total artificial heart and ventricular assist devices that currently employ mechanical PHVs. Development of polymer PHVs, however, has been slow due to the lack of sufficiently durable and biocompatible polymers. We have designed a new trileaflet polymer PHV for surgical implantation employing a novel polymer—xSIBS—that offers superior bio-stability and durability. The design of this polymer PHV was optimized for reduced stresses, improved hemodynamic performance, and reduced thrombogenicity using our device thrombogenicity emulation (DTE) methodology, the results of which have been published separately. Here we present our new design, prototype fabrication methods, hydrodynamics performance testing, and platelet activation measurements performed in the optimized valve prototype and compare it to the performance of a gold standard tissue valve. The hydrodynamic performance of the two valves was comparable in all measures, with a certain advantage to our valve during regurgitation. There was no significant difference between the platelet activation rates of our polymer valve and the tissue valve, indicating that similar to the latter, its recipients may not require anticoagulation. This work proves the feasibility of our optimized polymer PHV design and brings polymeric valves closer to clinical viability. PMID:23445066

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.

One-year outcome following biological or mechanical valve replacement for infective endocarditis.

PubMed

Delahaye, F; Chu, V H; Altclas, J; Barsic, B; Delahaye, A; Freiberger, T; Gordon, D L; Hannan, M M; Hoen, B; Kanj, S S; Lejko-Zupanc, T; Mestres, C A; Pachirat, O; Pappas, P; Lamas, C; Selton-Suty, C; Tan, R; Tattevin, P; Wang, A

2015-01-15

Nearly half of patients require cardiac surgery during the acute phase of infective endocarditis (IE). We describe the characteristics of patients according to the type of valve replacement (mechanical or biological), and examine whether the type of prosthesis was associated with in-hospital and 1-year mortality. Among 5591 patients included in the International Collaboration on Endocarditis Prospective Cohort Study, 1467 patients with definite IE were operated on during the active phase and had a biological (37%) or mechanical (63%) valve replacement. Patients who received bioprostheses were older (62 vs 54years), more often had a history of cancer (9% vs 6%), and had moderate or severe renal disease (9% vs 4%); proportion of health care-associated IE was higher (26% vs 17%); intracardiac abscesses were more frequent (30% vs 23%). In-hospital and 1-year death rates were higher in the bioprosthesis group, 20.5% vs 14.0% (p=0.0009) and 25.3% vs 16.6% (p<.0001), respectively. In multivariable analysis, mechanical prostheses were less commonly implanted in older patients (odds ratio: 0.64 for every 10years), and in patients with a history of cancer (0.72), but were more commonly implanted in mitral position (1.60). Bioprosthesis was independently associated with 1-year mortality (hazard ratio: 1.298). Patients with IE who receive a biological valve replacement have significant differences in clinical characteristics compared to patients who receive a mechanical prosthesis. Biological valve replacement is independently associated with a higher in-hospital and 1-year mortality, a result which is possibly related to patient characteristics rather than valve dysfunction. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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.

Back table outflow graft anastomosis technique for HeartWare HVAD implantation.

PubMed

Basher, S; Bick, J; Maltais, S

2015-12-01

The management of concomitant aortic and aortic valve disease with left ventricular assist device (LVAD) implantation for patients with severe cardiomyopathy is challenging, and has not been established given the complexity of LVAD surgery with concomitant aortic interventions. A 45-year-old patient presented to our institution with end-stage heart failure symptoms and non-ischemic cardiomyopathy. The patient was found to have a bicuspid aortic valve, severe native aortic regurgitation, a significant ascending aortic aneurysm, and severely depressed left ventricular (LV) function requiring two inotropes. He underwent a successful hemiarch repair of the ascending aortic aneurysm using a back table outflow graft anastomosis technique, and subsequent placement of a HeartWare Ventricular Assist Device (HVAD) with concomitant aortic valve closure with a modified Park's stitch. The patient did well postoperatively and is currently listed for heart transplantation.

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.

Tissue-Engineered Fibrin-Based Heart Valve with a Tubular Leaflet Design

PubMed Central

Weber, Miriam; Heta, Eriona; Moreira, Ricardo; Gesche, Valentine N.; Schermer, Thomas; Frese, Julia

2014-01-01

The general approach in heart valve tissue engineering is to mimic the shape of the native valve in the attempt to recreate the natural haemodynamics. In this article, we report the fabrication of the first tissue-engineered heart valve (TEHV) based on a tubular leaflet design, where the function of the leaflets of semilunar heart valves is performed by a simple tubular construct sutured along a circumferential line at the root and at three single points at the sinotubular junction. The tubular design is a recent development in pericardial (nonviable) bioprostheses, which has attracted interest because of the simplicity of the construction and the reliability of the implantation technique. Here we push the potential of the concept further from the fabrication and material point of view to realize the tube-in-tube valve: an autologous, living HV with remodelling and growing capability, physiological haemocompatibility, simple to construct and fast to implant. We developed two different fabrication/conditioning procedures and produced fibrin-based constructs embedding cells from the ovine umbilical cord artery according to the two different approaches. Tissue formation was confirmed by histology and immunohistology. The design of the tube-in-tube foresees the possibility of using a textile coscaffold (here demonstrated with a warp-knitted mesh) to achieve enhanced mechanical properties in vision of implantation in the aortic position. The tube-in-tube represents an attractive alternative to the conventional design of TEHVs aiming at reproducing the valvular geometry. PMID:23829551

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.

Tricuspid valve replacement: postoperative and long-term results.

PubMed

Van Nooten, G J; Caes, F; Taeymans, Y; Van Belleghem, Y; François, K; De Bacquer, D; Deuvaert, F E; Wellens, F; Primo, G

1995-09-01

A series of 146 consecutive patients who underwent tricuspid valve replacement at the University Brugmann Hospital between 1967 and 1987 was reviewed. Mean age at operation was 51.4 years (+/- 12.1 years). Different types of prostheses were implanted including porcine and bovine pericardial bioprostheses and older and bileaflet mechanical valves. Most patients were severely disabled by their cardiac disease before operation, with 30.1% in New York Heart Association functional class III and 69.9% in class IV. Operative mortality and hospital mortality rates (30 days) were high (16.4%). Incremental risk factors for hospital death included icterus (p < 0.005), preoperative hepatomegaly (p = 0.012), and New York Heart Association functional class IV (p = 0.013). Multivariate analysis only selected preoperative icterus (p < 0.01) as being independently significantly related to hospital mortality. The hospital survivors were followed up for a median of 94 months. A complete follow-up was available for all patients except two for 30 months or more. At 30 months the only two significant parameters were the type of myocardial protection (p = 0.024) and the year of operation (before 1977 or after [precardioplegia era or after], p = 0.011). There were 70 late deaths during the entire follow-up period. The univariate (log-rank statistics) incremental risk factor for late death was the type of tricuspid prosthesis (Smeloff-Cutter and Kay-Shiley versus St. Jude Medical versus bioprosthesis) (p = 0.04). A trend was observed for the type of operative myocardial protection (normothermia and coronary perfusion) (p = 0.06) and preoperative New York Heart Association functional class IV (p = 0.055). Actuarial survival was 74% at 60 months and 23.4% at 180 months. Cumulative follow-up added up to 1015 patient-years. In a more detailed analysis of the effect on survival of the type of tricuspid prosthesis, a significant difference was observed between the bioprostheses and some older mechanical prostheses (Smeloff-Cutter and Kay-Shiley) (p = 0.04) but not between the bioprostheses and the bileaflet valves (p = 0.15). When the follow-up period was stratified according to less than 7 years and more than 7 years of follow-up, no difference was observed for the first period, but for the late follow-up the new mechanical prostheses did better than the bioprostheses (p = 0.05), suggesting a degradation of the bioprostheses after 7 years and favoring mechanical prostheses for those patients with a good long-term prognosis.

[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.

Non-cardiac surgery in patients with prosthetic heart valves: a 12 years experience.

PubMed

Akhtar, Raja Parvez; Abid, Abdul Rehman; Zafar, Hasnain; Gardezi, Syed Javed Raza; Waheed, Abdul; Khan, Jawad Sajid

2007-10-01

To study patients with mechanical heart valves undergoing non-cardiac surgery and their anticoagulation management during these procedures. It was a cohort study. The study was conducted at the Department of Cardiac Surgery, Punjab Institute of Cardiology, Lahore and Department of Surgery, Services Institute of Medical Sciences, Lahore, from September 1994 to June 2006. Patients with mechanical heart valves undergoing non-cardiac surgical operation during this period, were included. Their anticoagulation was monitored and anticoagulation related complications were recorded. In this study, 507 consecutive patients with a mechanical heart valve replacement were followed-up. Forty two (8.28%) patients underwent non-cardiac surgical operations of which 24 (57.1%) were for abdominal and non-abdominal surgeries, 5 (20.8%) were emergency and 19 (79.2%) were planned. There were 18 (42.9%) caesarean sections for pregnancies. Among the 24 procedures, there were 7(29.1%) laparotomies, 7(29.1%) hernia repairs, 2 (8.3%) cholecystectomies, 2 (8.3%) hysterectomies, 1(4.1%) craniotomy, 1(4.1%) spinal surgery for neuroblastoma, 1(4.1%) ankle fracture and 1(4.1%) carbuncle. No untoward valve or anticoagulation related complication was seen during this period. Patients with mechanical valve prosthesis on life-long anticoagulation, if managed properly, can undergo any type of non-cardiac surgical operation with minimal risk.

Heart valve replacement with the Sorin tilting-disc prosthesis. A 10-year experience.

PubMed

Milano, A; Bortolotti, U; Mazzucco, A; Mossuto, E; Testolin, L; Thiene, G; Gallucci, V

1992-02-01

From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and aortic valve replacement, 92% +/- 4% after mitral valve replacement, and 89% +/- 3% after aortic valve replacement, with no cases of mechanical fracture. The Sorin valve has shown a satisfactory long-term overall performance, comparable with other mechanical prostheses, and an excellent durability that renders it a reliable heart valve substitute for the mitral and aortic positions.

Bundle-branch reentry ventricular tachycardia after transcatheter aortic valve replacement

PubMed Central

de la Rosa Riestra, Adriana; Rubio Caballero, José Amador; Freites Estévez, Alfonso; Alonso Belló, Javier; Botas Rodríguez, Javier

2016-01-01

An 83-year-old male suffering from severe symptomatic aortic valve stenosis received an implant of a biological aortic prosthesis through the femoral artery without complications. Seven days after dischargement he experienced a syncope. The patient was wearing an ECG holter monitor that day, which showed a wide QRS complex tachycardia of 300 beats per minute. The electrophysiological study revealed a bundle-branch reentry ventricular tachycardia as the cause of the syncope. Radio-frequency was applied on the right-bundle branch. Twelve months later, the patient has remained asymptomatic. PMID:27134443

Single-center experience and short-term outcome with the JenaValve: a second-generation transapical transcatheter aortic valve implantation device.

PubMed

Reuthebuch, Oliver; Inderbitzin, Devdas Thomas; Rüter, Florian; Jeger, Raban; Kaiser, Christoph; Buser, Peter; Fassl, Jens; Eckstein, Friedrich S

2014-01-01

We present the post-CE(Conformité Européenne)-mark single-center implantation experience and short-term outcome with the second-generation transapical JenaValve transcatheter aortic valve implantation system. Patients [N = 27; 9 women; mean (SD) age, 80.3 (5.5) years] were operated on between November 2011 and August 2012. Via a transapical approach, the valve was positioned, in some cases, repositioned, and finally implanted. All data were collected during the hospital stay. The implantation success rate was 100%; the mean (SD) operation time was 124.7 (43.2) minutes; and the size of the implanted prosthesis was 23 mm (n = 6), 25 mm (n = 14), and 27 mm (n = 7). The in-hospital major adverse cardiac and cerebrovascular events were as follows: intraoperative resuscitation with subsequent aortic rupture (n = 1), postoperative hemorrhage needing revision (n = 1), myocardial infarction (n = 1), atrioventricular block needing a definitive pacemaker (n = 1), new-onset renal failure needing hemodialysis (n = 1), and stroke (n = 1). The 30-day mortality was 11.1% (n = 3). The mean (SD) intensive care unit/total stay was 2.2 (1.7)/11.7 (7.9) days. Postoperative echocardiography [day 6.7 (4.8)] revealed residual paravalvular leakage of trace to grade 1 in 12 patients (44.5%) and no leakage in 15 patients, with a mean (SD) transvalvular pressure gradient of 11.6 (5.6) mm Hg with significant reduction by 36.0 (17.7) mm Hg (P = 0.0001, Wilcoxon signed rank test). This second-generation repositionable transcatheter aortic valve implantation device could safely and successfully be implanted with a fast learning curve, significant reduction in pressure gradients, overall clinical improvement at discharge, as well as an acceptable morbidity and mortality rate in this highest-risk patient cohort.

Impact of concomitant mitral valve repair for severe mitral regurgitation at the time of continuous-flow left ventricular assist device insertion.

PubMed

Sandoval, Elena; Singh, Steve K; Carillo, Julius A; Baldwin, Andrew C W; Ono, Masahiro; Anand, Jatin; Frazier, O H; Mallidi, Hari R

2017-10-01

Mitral regurgitation (MR) is common in patients with end-stage heart failure. We assessed the effect of performing concomitant mitral valve repair during continuous-flow left ventricular assist device (CF-LVAD) implantation in patients with severe preoperative MR. We performed a single-centre, retrospective review of all patients who underwent CF-LVAD implantation between December 1999 and December 2013 (n = 469). Patients with severe preoperative MR (n = 78) were identified and then stratified according to whether they underwent concomitant valve repair. Univariate and survival analyses were performed, and multivariable regression was used to determine predictors of survival. Of the 78 patients with severe MR, 21 underwent valve repair at the time of CF-LVAD implantation (repair group) and 57 did not (non-repair group). A comparison of the 2 groups showed significant differences between groups: INTERMACS I 16.985 vs 9.52%, (P = 0.039), cardiopulmonary bypass time 82.09 vs 109.4 min (P = 0.0042) and the use of HeartMate II 63.16 vs 100% (P = 0.001). Survival analysis suggested trends towards improved survival and a lower incidence of heart failure-related readmissions in the repair group. Multivariable regression analysis showed no significant independent predictors of survival (mitral valve repair: odds ratio 0.4, 95% confidence interval 0.8-1.5; P = 0.2). Despite the lack of statistical significance, trends towards improved survival and a lower incidence of heart failure events suggest that mitral valve repair may be beneficial in patients undergoing CF-LVAD implantation. Given the known relationship between severe MR and mortality, further study is encouraged to confirm the value of mitral valve repair in these patients. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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.

Prevention, identification, and management of post-operative penile implant complications of infection, hematoma, and device malfunction

PubMed Central

O’Rourke, Timothy K.; Erbella, Alexander; Zhang, Yu

2017-01-01

Penile prosthesis implant surgery is an effective management approach for a number of urological conditions, including medication refractory erectile dysfunction (ED). Complications encountered post-operatively include infection, bleeding/hematoma, and device malfunction. Since the 1970s, modifications to these devices have reduced complication rates through improvement in antisepsis and design using antibiotic coatings, kink-resistant tubing, lock-out valves to prevent autoinflation, and modified reservoir shapes. Device survival and complication rates have been investigated predominately by retrospective database-derived studies. This review article focuses on the identification and management of post-operative complications following penile prosthetic and implant surgery. Etiology for ED, surgical technique, and prosthesis type are variable among studies. The most common post-operative complications of infection, bleeding, and device malfunction may be minimized by adherence to consistent technique and standard protocol. Novel antibiotic coatings and standard antibiotic regimen may reduce infection rates. Meticulous hemostasis and intraoperative testing of devices may further reduce need for revision surgery. Additional prospective studies with consistent reporting of outcomes and comparison of surgical approach and prosthesis type in patients with variable ED etiology would be beneficial. PMID:29238663

Current surgical management of mitral regurgitation.

PubMed

Calvinho, Paulo; Antunes, Manuel

2008-04-01

From Walton Lillehei, who performed the first successful open mitral valve surgery in 1956, until the advent of robotic surgery in the 21st Century, only 50 years have passed. The introduction of the first heart valve prosthesis, in 1960, was the next major step forward. However, correction of mitral disease by valvuloplasty results in better survival and ventricular performance than mitral valve replacement. However, the European Heart Survey demonstrated that only 40% of the valves are repaired. The standard procedures (Carpentier's techniques and Alfieri's edge-to-edge suture) are the surgical basis for the new technical approaches. Minimally invasive surgery led to the development of video-assisted and robotic surgery and interventional cardiology is already making the first steps on endovascular procedures, using the classical concepts in highly differentiated approaches. Correction of mitral regurgitation is a complex field that is still growing, whereas classic surgery is still under debate as the new era arises.

Tomographic PIV behind a prosthetic heart valve

NASA Astrophysics Data System (ADS)

Hasler, D.; Landolt, A.; Obrist, D.

2016-05-01

The instantaneous three-dimensional velocity field past a bioprosthetic heart valve was measured using tomographic particle image velocimetry. Two digital cameras were used together with a mirror setup to record PIV images from four different angles. Measurements were conducted in a transparent silicone phantom with a simplified geometry of the aortic root. The refraction indices of the silicone phantom and the working fluid were matched to minimize optical distortion from the flow field to the cameras. The silicone phantom of the aorta was integrated in a flow loop driven by a piston pump. Measurements were conducted for steady and pulsatile flow conditions. Results of the instantaneous, ensemble and phase-averaged flow field are presented. The three-dimensional velocity field reveals a flow topology, which can be related to features of the aortic valve prosthesis.

Transcatheter Aortic Valve Replacement for Native Aortic Valve Regurgitation

PubMed Central

Spina, Roberto; Anthony, Chris; Muller, David WM

2015-01-01

Transcatheter aortic valve replacement with either the balloon-expandable Edwards SAPIEN XT valve, or the self-expandable CoreValve prosthesis has become the established therapeutic modality for severe aortic valve stenosis in patients who are not deemed suitable for surgical intervention due to excessively high operative risk. Native aortic valve regurgitation, defined as primary aortic incompetence not associated with aortic stenosis or failed valve replacement, on the other hand, is still considered a relative contraindication for transcatheter aortic valve therapies, because of the absence of annular or leaflet calcification required for secure anchoring of the transcatheter heart valve. In addition, severe aortic regurgitation often coexists with aortic root or ascending aorta dilatation, the treatment of which mandates operative intervention. For these reasons, transcatheter aortic valve replacement has been only sporadically used to treat pure aortic incompetence, typically on a compassionate basis and in surgically inoperable patients. More recently, however, transcatheter aortic valve replacement for native aortic valve regurgitation has been trialled with newer-generation heart valves, with encouraging results, and new ancillary devices have emerged that are designed to stabilize the annulus–root complex. In this paper we review the clinical context, technical characteristics and outcomes associated with transcatheter treatment of native aortic valve regurgitation. PMID:29588674

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 macroscopically. Conclusions This design of the novel ePTFE transcatheter pulmonary valve is safe and effective to deploy in sheep by hybrid approach, and the early valvular functionality is good. PMID:24926892

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.

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 single-leaflet prolapse was detected in two, which was primarily related to the leaflet design. No stent dislocation, migration or affection of the mitral valve was observed. For the first time, we demonstrate the technical feasibility of a transapical TEHV delivery into the aortic valve position using a commercially available and clinically applied transapical implantation system that allows for exact anatomical positioning. Our data indicate that the combination of TEHV and a state-of-the-art transapical delivery system is feasible, representing an important step towards translational, transcatheter-based TEHV concepts.

[Directions for reoperation of patients with Björk-Shiley convexo-concave valve prosthesis, based on long-term experience].

PubMed

Yamaki, F; Nakano, K; Endo, M; Hashimoto, A; Koyanagi, H

1994-02-01

Although a high incidence of strut fracture of the Björk-Shiley convexo-concave (C-C) valve prosthesis has been reported, it is still controversial whether the prosthesis functioning normally should be replaced electively. To clarify our policy for this issue, we reviewed 28 patients who had undergone mitral valve replacement with a C-C valve prosthesis, and evaluated long-term results according to STS guidelines. The incidence of valve-related complications expressed as % patient-year were; structural deterioration 0.30, nonstructural dysfunction 0.30, thromboembolism 1.20. There were no thrombosed valves, anticoagulant-related hemorrhage or prosthetic valve endocarditis. The actuarial free rate after valve replacement with the C-C at 10 years, constructed by the Kaplan-Meier method, were compared with those with St. Jude Medical (SJM) valve prosthesis. (1) Actuarial survival: 77.9 vs 87.3 (NS), (2) Reoperation-free: 91.6 vs 98.0 (p < 0.05), (3) thromboembolism-free: 83.7 vs 83.9 (NS), (4) Event-free (hospital death+reoperation+valve-related complications: 71.2 vs 77.7 (NS). The long-term results with the C-C were compatible to those with a SJM valve prosthesis. However, if a strut fracture occurs, it is very difficult to save the patient's life. The hospital mortality of re-replacement of valve prosthesis during the last 10 years, at our institute, was 2.6%, which is almost equal to the cumulative risk of strut fracture of the C-C valve after 10 years (3.0%).(ABSTRACT TRUNCATED AT 250 WORDS)

Observation of cavitation in a mechanical heart valve in a total artificial heart.

PubMed

Lee, Hwansung; Tsukiya, Tomonori; Homma, Akihiko; Kamimura, Tadayuki; Takewa, Yoshiaki; Nishinaka, Tomohiro; Tatsumi, Eisuke; Taenaka, Yoshiyuki; Takano, Hisateru; Kitamura, Soichiro

2004-01-01

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valves was investigated using the 25 mm Medtronic Hall valve and the 23 mm Omnicarbon valve. Closing of these valves in the mitral position was simulated in an electrohydraulic totally artificial heart. Tests were conducted under physiologic pressures at heart rates from 60 to 100 beats per minute with cardiac outputs from 4.8 to 7.7 L/min. The disk closing motion was measured by a laser displacement sensor. A high-speed video camera was used to observe the cavitation bubbles in the mechanical heart valves. The maximum closing velocity of the Omnicarbon valve was faster than that of the Medtronic Hall valve. In both valves, the closing velocity of the leaflet, used as the cavitation threshold, was approximately 1.3-1.5 m/s. In the case of the Medtronic Hall valve, cavitation bubbles were generated by the squeeze flow and by the effects of the venturi and the water hammer. With the Omnicarbon valve, the cavitation bubbles were generated by the squeeze flow and the water hammer. The mechanism leading to the development of cavitation bubbles depended on the valve closing velocity and the valve stop geometry. Most of the cavitation bubbles were observed around the valve stop and were generated by the squeeze flow.

Effects of bileaflet mechanical heart valve orientation on coronary flow

NASA Astrophysics Data System (ADS)

Haya, Laura; Tavoularis, Stavros

2015-11-01

The aortic sinus is approximately tri-radially symmetric, but bileaflet mechanical heart valves (BMHVs), which are commonly used to replace diseased aortic valves, are bilaterally symmetric. This mismatch in symmetry suggests that the orientation in which a BMHV is implanted within the aortic sinus affects the flow characteristics downstream of it. This study examines the effect of BMHV orientation on the flow in the coronary arteries, which originate in the aortic sinus and supply the heart tissue with blood. Planar particle image velocimetry measurements were made past a BMHV mounted at the inlet of an anatomical aorta model under physiological flow conditions. The complex interactions between the valve jets, the sinus vortex and the flow in the right coronary artery were elucidated for three valve orientations. The coronary flow rate was directly affected by the size, orientation, and time evolution of the vortex in the sinus, all of which were sensitive to the valve's orientation. The total flow through the artery was highest when the valve was oriented with its axis of symmetry intersecting the artery's opening. The findings of this research may assist surgeons in choosing the best orientation for BMHV implantation. The bileaflet valve was donated by St. Jude Medical. Financial support was provided by the Natural Sciences and Engineering Research Council of Canada.

Decellularized heart valve as a scaffold for in vivo recellularization: deleterious effects of granulocyte colony-stimulating factor.

PubMed

Juthier, Francis; Vincentelli, André; Gaudric, Julien; Corseaux, Delphine; Fouquet, Olivier; Calet, Christine; Le Tourneau, Thierry; Soenen, Valérie; Zawadzki, Christophe; Fabre, Olivier; Susen, Sophie; Prat, Alain; Jude, Brigitte

2006-04-01

Autologous recellularization of decellularized heart valve scaffolds is a promising challenge in the field of tissue-engineered heart valves and could be boosted by bone marrow progenitor cell mobilization. The aim of this study was to examine the spontaneous in vivo recolonization potential of xenogeneic decellularized heart valves in a lamb model and the effects of granulocyte colony-stimulating factor mobilization of bone marrow cells on this process. Decellularized porcine aortic valves were implanted in 12 lambs. Six lambs received granulocyte colony-stimulating factor (10 microg x kg(-1) x d(-1) for 7 days, granulocyte colony-stimulating factor group), and 6 received no granulocyte colony-stimulating factor (control group). Additionally, nondecellularized porcine valves were implanted in 5 lambs (xenograft group). Angiographic and histologic evaluation was performed at 3, 6, 8, and 16 weeks. Few macroscopic modifications of leaflets and the aortic wall were observed in the control group, whereas progressive shrinkage and thickening of the leaflets appeared in the granulocyte colony-stimulating factor and xenograft groups. In the 3 groups progressive ovine cell infiltration (fluorescence in situ hybridization) was observed in the leaflets and in the adventitia and the intima of the aortic wall but not in the media. Neointimal proliferation of alpha-actin-positive cells, inflammatory infiltration, adventitial neovascularization, and calcifications were more important in the xenograft and the granulocyte colony-stimulating factor groups than in the control group. Continuous re-endothelialization appeared only in the control group. Decellularized xenogeneic heart valve scaffolds allowed partial autologous recellularization. Granulocyte colony-stimulating factor led to accelerated heart valve deterioration similar to that observed in nondecellularized xenogeneic cardiac bioprostheses.

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices.

PubMed

Maltais, Simon; Topilsky, Yan; Tchantchaleishvili, Vakhtang; McKellar, Stephen H; Durham, Lucian A; Joyce, Lyle D; Daly, Richard C; Park, Soon J

2012-06-01

The HeartMate II (Thoratec Corp, Pleasanton, Calif) continuous-flow left ventricular assist device has emerged as the standard of care for patients with advanced heart failure. The objective of this study was to assess the safety and early effectiveness of concomitant tricuspid valve procedures in patients undergoing implantation of a HeartMate II device. From February 2007 to April 2010, 83 patients underwent HeartMate II left ventricular assist device implantation. Of these, 37 patients had concomitant tricuspid valve procedures (32 repairs, 5 replacements) for severe tricuspid regurgitation. The effects of a tricuspid valve procedure on tricuspid regurgitation and right ventricular remodeling were assessed comparing echocardiographic findings at baseline and 30 days after left ventricular assist device implantation. Overall survival was also compared. Patients undergoing a concomitant tricuspid valve procedure had more tricuspid regurgitation (vena contracta, 5.6 ± 2.1 mm vs 2.9 ± 2.0 mm; P < .001), worse right ventricular dysfunction (right ventricular end-diastolic area, 33.6 ± 6.2 mm vs 31.6 ± 8.5 mm; P = .05), higher mean right atrial pressure (17.4 ± 7.1 mm Hg vs 14.9 ± 5.1 mm Hg; P = .03), and a higher Kormos score (2.6 ± 2.1 vs 1.2 ± 1.4; P = .0008) preoperatively. One month after surgery, tricuspid regurgitation was worse in patients who underwent left ventricular assist device implantation alone (+18.6%), whereas it improved significantly in patients undergoing a concomitant tricuspid valve procedure (-50.2%) (P = .005). A corresponding significant reduction in right ventricular end-diastolic area (33.6% ± 6.2% vs 30.1% ± 9.7%; P = .03) and a trend toward better right ventricular function (55.5% ± 79.7% vs 35.7% ± 60.5%; P = .28) were noted in patients undergoing a concomitant tricuspid valve procedure. Survival was comparable between the 2 groups. In patients with severe tricuspid regurgitation undergoing left ventricular assist device implantation, a concomitant tricuspid valve procedure effectively reduces tricuspid regurgitation and promotes reverse remodeling of the right ventricle. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.211 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that...) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

A D-Shaped Bileaflet Bioprosthesis which Replicates Physiological Left Ventricular Flow Patterns

PubMed Central

Tan, Sean Guo-Dong; Kim, Sangho; Hon, Jimmy Kim Fatt; Leo, Hwa Liang

2016-01-01

Prior studies have shown that in a healthy heart, there exist a large asymmetric vortex structure that aids in establishing a steady flow field in the left ventricle. However, the implantation of existing artificial heart valves at the mitral position is found to have a negative effect on this physiological flow pattern. In light of this, a novel D-shaped bileaflet porcine bioprosthesis (GD valve) has been designed based on the native geometry mitral valve, with the hypothesis that biomimicry in valve design can restore physiological left ventricle flow patterns after valve implantation. An in-vitro experiment using two dimensional particle velocimetry imaging was carried out to determine the hemodynamic performance of the new bileaflet design and then compared to that of the well-established St. Jude Epic valve which functioned as a control in the experiment. Although both valves were found to have similar Reynolds shear stress and Turbulent Kinetic Energy levels, the novel D-shape valve was found to have lower turbulence intensity and greater mean kinetic energy conservation. PMID:27258099

SUBCOMMISSURAL IMPLANTATION OF AORTIC PROSTHESES WITH THE USE OF THE NONCORONARY SINUS AND THE FIBROUS TRIGONES

PubMed Central

Liotta, Domingo; Haller, Jordan D.; Pisanu, Amadeo; Bracco, Daniel; Bertolozzi, Enrique

1979-01-01

The technique described here permits insertion of a large prosthesis into a small aortic annulus and avoids the necessity of additional procedures for enlarging the aortic ring. Inspection of the fibrous skeleton of the heart reveals that the large intervalvular trigone and the noncoronary sinus of Valsalva are remarkably elastic. Full advantage of this natural elasticity is achieved by suturing the prosthesis to the base of these structures from outside the aorta. Sutures are placed in the sinuses of the right and left cusps in the usual manner. Judicious application of this procedure allows the implantation of a No. 23 or No. 24 prosthesis in cases that would require a No. 19 or No. 21 with the use of conventional methods. Images PMID:15216322

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.

Sinus MRI scan

MedlinePlus

... your body: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Recently placed artificial joints Certain types of vascular stents Pain pumps ...

The effect of X-ray beam distortion on the Edwards Sapien XT(™) trans-catheter aortic valve replacement prosthesis.

PubMed

Crowhurst, James A; Poon, Karl K; Murdoch, Dale; Incani, Alexander; Raffel, Owen C; Liddicoat, Annelise; Walters, Darren

2015-12-01

Profiling the Aortic root perpendicular to the fluoroscopic image plane will achieve a more successful implant position for trans-catheter aortic valve replacement (TAVR). This study aimed to investigate whether the divergent nature of the X-ray beam from the C-arm altered the appearance of the TAVR device. Under bench-top testing, a 23, 26 and 29 mm Edwards Sapien XT valve was positioned coaxially at the bottom of a fluoroscopic image utilising 22 and 32 cm fields of view (FOV). The table was then moved so that the valve was positioned at the top of the image. The valve's appearance was scored using a previously published three tier classification tool (excellent, satisfactory and poor) and quantified with measurements. The number of degrees of C-arm rotation that were required to bring the valve back to a coaxial appearance was recorded. When using the 32 cm FOV, the valve's appearance changes from excellent to satisfactory. When a 22 cm FOV was used, the change is less marked. More C-arm rotation is required to bring the appearance back to coaxial with the 32 cm FOV. Not maintaining the valve in the centre of the image can distort the valves appearance. This has the potential to affect the final implantation depth.

Reoperation for composite valve graft failure: Operative results and midterm survival.

PubMed

Maroto, Luis C; Carnero, Manuel; Cobiella, Javier; García, Mónica; Vilacosta, Isidre; Reguillo, Fernando; Villagrán, Enrique; Olmos, Carmen

2018-06-01

The replacement of a failed composite valve graft is technically more demanding and is associated with increased morbidity and mortality. We present our technique and outcomes for reoperations for composite graft failures. Between September 2011 and June 2017, 14 patients underwent a redo composite graft replacement. Twelve patients (85.7%) were male, and mean age was 58.4 years ± 12 standard deviation (SD). One patient had two previous root replacements. Indications for reoperation were endocarditis (8), aortic pseudoaneurysm (3), and aortic prosthesis thrombosis (3). Mean logistic EuroSCORE and EuroSCORE II were 30.8% and 14.7%, respectively. A mechanical composite graft was used in 12 patients and biological composite grafts were used in two patients. Hospital mortality was 14.3% (n = 2). One patient (7.1%) required reoperation for bleeding, One patient (7.1%) had mechanical ventilation >24 h, and four patients (28.6%) required implantation of a permanent pacemaker. Median intensive care unit and hospital stays were 3 days (interquartile range [IQR] 1-5) and 10 days (IQR 6.5-38.5). One patient experienced recurrent prosthetic valve endocarditis 14 months after operation. On follow-up, 11 of 12 survivors were in New York Heart Association class I or II. Survival at 3 years was 85.7% ± 9.4% SD. Composite valve graft replacement can be performed with acceptable morbidity and mortality with good mid-term survival. © 2018 Wiley Periodicals, Inc.

Effects of a 3D segmental prosthetic system for tricuspid valve annulus remodelling on the right coronary artery: a human cadaveric coronary angiography study.

PubMed

Riki-Marishani, Mohsen; Gholoobi, Arash; Sazegar, Ghasem; Aazami, Mathias H; Hedjazi, Aria; Sajjadian, Maryam; Ebrahimi, Mahmoud; Aghaii-Zade Torabi, Ahmad

2017-09-01

A prosthetic system to repair secondary tricuspid valve regurgitation was developed. The conceptual engineering of the current device is based on 3D segmental remodelling of the tricuspid valve annulus in lieu of reductive annuloplasty. This study was designed to investigate the operational safety of the current prosthetic system with regard to the anatomical integrity of the right coronary artery (RCA) in fresh cadaveric human hearts. During the study period, from January to April 2016, the current prosthetic system was implanted on the tricuspid valve annulus in fresh cadaveric human hearts that met the study's inclusion criteria. The prepared specimens were investigated via selective coronary angiography of the RCA in the catheterization laboratory. The RCA angiographic anatomies were categorized as normal, distorted, kinked or occluded. Sixteen specimens underwent implantation of the current prosthetic system. The mean age of the cadaveric human hearts was 43.24 ± 15.79 years, with vehicle accident being the primary cause of death (59%). A dominant RCA was noticed in 62.5% of the specimens. None of the specimens displayed any injury, distortion, kinking or occlusion in the RCA due to the implantation of the prostheses. In light of the results of the present study, undertaken on fresh cadaveric human heart specimens, the current segmental prosthetic system for 3D remodelling of the tricuspid valve annulus seems to be safe vis-à-vis the anatomical integrity of the RCA. Further in vivo studies are needed to investigate the functional features of the current prosthetic system with a view to addressing the complex pathophysiology of secondary tricuspid valve regurgitation. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Re-do aortic root replacement after an allograft aortic root replacement.

PubMed

Vrtik, Marian; Tesar, Peter J

2009-10-01

Structural degeneration of allograft aortic root is a global process. In addition to valvular degeneration, the allograft wall calcification poses a risk of systemic calcific embolization and late phase anastomotic aneurysm formation and rupture (anecdotal). Furthermore, the valve annulus is often small, and the tissues are rigid making the implantation of an adequately sized prosthesis within the allograft wall difficult. To avoid these issues, we routinely perform re-do aortic root replacement with either a mechanical valve conduit or bio-root composite graft. The technique has been successfully used in 22 consecutive patients with no operative mortality and minimal morbidity.

Changes in turbulence with rotation of the omnicarbon prosthesis.

PubMed

Travis, Brandon R; Nyboe, Camilla; Christensen, Thomas D; Smerup, Morten; Johansen, Peter; Nygaard, Hans; Hasenkam, J Michael

2007-01-01

This study was performed to determine whether annular plane orientation of the Omnicarbon aortic valve influences forward flow turbulence. The Omnicarbon prostheses was modified to allow in situ manual rotation of the valve when implanted in the aortic position of eight 90 kg pigs. Pulsed Doppler ultrasound was used to acquire velocity measurements at 17 locations within the cross-sectional area of the ascending aorta. In each animal, 12 valve rotations were tested in this manner. Reynolds normal stresses were estimated from the velocity measurements. High Reynolds normal stresses were concentrated between left and posterior-right sides of the aortic wall for all orientations studied. No trends in mean or maximum Reynolds normal stresses with respect to valve rotation were consistent in the experiments. Unlike previous experiments with the Medtronic-Hall tilting disc valve, these experiments showed no notable changes in Reynolds normal stress with respect to orientation of the Omnicarbon valve. This suggests that the tendency of turbulent stresses to change with tilting disc valve orientation may be dependent on valve design.

Numerical Model of Full Cardiac Cycle Hemodynamics in a Total Artificial Heart and the Effect of Its Size on Platelet Activation

PubMed Central

Marom, Gil; Chiu, Wei-Che; Crosby, Jessica R.; DeCook, Katrina J.; Prabhakar, Saurabh; Horner, Marc; Slepian, Marvin J.; Bluestein, Danny

2014-01-01

The SynCardia total artificial heart (TAH) is the only FDA approved device for replacing hearts in patients with congestive heart failure. It pumps blood via pneumatically driven diaphragms and controls the flow with mechanical valves. While it has been successfully implanted in more than 1,300 patients, its size precludes implantation in smaller patients. This study’s aim was to evaluate the viability of scaled-down TAHs by quantifying thrombogenic potentials from flow patterns. Simulations of systole were first conducted with stationary valves, followed by an advanced full-cardiac-cycle model with moving valves. All the models included deforming diaphragms and platelet suspension in the blood flow. Flow stress-accumulations were computed for the platelet trajectories and thrombogenic potentials were assessed. The simulations successfully captured complex flow patterns during various phases of the cardiac-cycle. Increased stress-accumulations, but within the safety margin of acceptable thrombogenicity, were found in smaller TAHs, indicating that they are clinically viable. PMID:25354999

Early Results of Rheumatic Mitral Valve Repair.

PubMed

Petrone, Giuseppe; Theodoropoulos, Panagiotis; Punjabi, Prakash P

2016-11-01

Mitral valve repair (MVr) in rheumatic heart disease (RHD) remains challenging. The present authors' surgical experience of MVr in 56 patients with RHD operated in between January 2011 and September 2014 is reported. Among the patients (mean age 32 ± 11 years), 11 were in NYHA functional class II, 32 in class III, and seven in class IV. An adequate or oversized autologous pericardial patch was sutured to extend the coaptating edge of both the anterior leaflet (in 18 patients) and the posterior leaflet (in 30 patients). Neochordae were implanted as needed (n = 43), and leaflet thinning (n = 13), commissurotomy (n = 15) and chordal splitting (n = 9) were also performed. A rigid annuloplasty ring was implanted in 32 patients, and in 24 patients a complete flexible annuloplasty ring made from pericardium, 4 mm Gore-Tex tube graft or a Dacron patch was constructed. Repair was not attempted in 16 patients, with replacement using a mechanical bileaflet prosthesis being considered the only option. Intraoperative post-repair transesophageal echocardiography demonstrated competency, with trivial mitral regurgitation (MR) up to grade I in all patients and a minimum coaptation depth ≥5 mm. There were no intraoperative or in-hospital deaths. Clinical and echocardiographic evaluations were performed up to six weeks after surgery, at which time 51 patients were in NYHA classes I-II and five were in class III. Residual mild MR up to grade I was identified in six patients. No recurrence of MR was observed in any of the patients, and no patients were reoperated on. The lack of adequate access to anticoagulation medication and monitoring, in addition to religious/cultural bias to the type of prosthetic valve used in low-income countries, necessitates an increase in the numbers of rheumatic MVr.

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.

Severe bioprosthetic mitral valve stenosis in pregnancy.

PubMed

Munoz-Mendoza, Jerson; Pinto Miranda, Veronica; Tanawuttiwat, Tanyanan; Badiye, Amit; Chaparro, Sandra V

2016-01-01

A 21-year-old woman in the 16th week of pregnancy was admitted due to acute presentation of severe exertional dyspnea. She had undergone mitral valve replacement (MVR) with bioprosthetic valve for infective endocarditis 2 years ago. She developed congestive heart failure from mitral bioprosthetic valve stenosis due to early structural valve deterioration. She also had severe pulmonary hypertension and underwent a redo MVR using a mechanical valve prosthesis with good maternal outcome but fetal demise. This report brings up the debate about what type of valve should be used in women in reproductive age, and discusses the management of severe mitral stenosis and stenosis of a bioprosthetic valve during pregnancy. Surgical options can almost always be delayed until fetal maturity is achieved and a simultaneous cesarean section can be performed. However, under certain circumstances when the maternal welfare is in jeopardy the surgical intervention is mandatory even before the fetus reaches viability.

A whole-heart motion-correction algorithm: Effects on CT image quality and diagnostic accuracy of mechanical valve prosthesis abnormalities.

PubMed

Suh, Young Joo; Kim, Young Jin; Kim, Jin Young; Chang, Suyon; Im, Dong Jin; Hong, Yoo Jin; Choi, Byoung Wook

2017-11-01

We aimed to determine the effect of a whole-heart motion-correction algorithm (new-generation snapshot freeze, NG SSF) on the image quality of cardiac computed tomography (CT) images in patients with mechanical valve prostheses compared to standard images without motion correction and to compare the diagnostic accuracy of NG SSF and standard CT image sets for the detection of prosthetic valve abnormalities. A total of 20 patients with 32 mechanical valves who underwent wide-coverage detector cardiac CT with single-heartbeat acquisition were included. The CT image quality for subvalvular (below the prosthesis) and valvular regions (valve leaflets) of mechanical valves was assessed by two observers on a four-point scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent). Paired t-tests or Wilcoxon signed rank tests were used to compare image quality scores and the number of diagnostic phases (image quality score≥3) between the standard image sets and NG SSF image sets. Diagnostic performance for detection of prosthetic valve abnormalities was compared between two image sets with the final diagnosis set by re-operation or clinical findings as the standard reference. NG SSF image sets had better image quality scores than standard image sets for both valvular and subvalvular regions (P < 0.05 for both). The number of phases that were of diagnostic image quality per patient was significantly greater in the NG SSF image set than standard image set for both valvular and subvalvular regions (P < 0.0001). Diagnostic performance of NG SSF image sets for the detection of prosthetic abnormalities (20 pannus and two paravalvular leaks) was greater than that of standard image sets (P < 0.05). Application of NG SSF can improve CT image quality and diagnostic accuracy in patients with mechanical valves compared to standard images. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

A new concept in the surgical treatment of gastroesophageal reflux.

PubMed Central

Samelson, S L; Weiser, H F; Bombeck, C T; Siewert, J R; Ludtke, F E; Hoelscher, A H; Abuabara, S F; Nyhus, L M

1983-01-01

Surgical treatment of gastroesophageal reflux has been thought to depend on the construction of a valve mechanism at the gastroesophageal junction (GEJ). Recently, a silicone prosthesis that does not construct a valve has been introduced, and in preliminary studies in the human, shown to be effective in the treatment of reflux. A precise mode of action has not been demonstrated for the prosthesis. This study was undertaken to investigate the mechanics of the prosthesis and determine its effectiveness in an animal model. Six canine gastroesophageal specimens were excised and the lower esophageal sphincter (LES) simulated by a rubber band placed around the GEJ at a tension calibrated to give 25 mmHg "sphincter" pressure. Circumferential silk ligatures of varying length were then placed on the stomach 3.0 cm distal to the GEJ. With no ligature, the LES opening pressure (LESOP) was 8.0 mmHg, varying to 17.0 mmHg with an 8.0 cm ligature. Further, 24 adult mongrel dogs were randomly divided into four equal groups: controls, circular myomectomy of the LES alone, myomectomy combined with fundoplication, and myomectomy combined with implantation of the silicone antireflux prosthesis. Evaluation included manometry, endoscopy, and histology. Although only the normal sphincter and fundoplication responded physiologically, the prosthesis was just as effective in preventing reflux, as evidenced by reducing acid exposure time of myomectomized dogs from 35.4% to 1.8%, and by preventing endoscopic esophagitis. It was concluded that the silicone antireflux prosthesis acts in the same fashion as the ligature in the model, by interrupting distraction of the LES by gastric wall tension. This concept is an effective method for raising LESOP, treating experimental gastroesophageal reflux, and eliminating the sequelae of reflux. Long-term evaluations of the prosthesis are required. PMID:6830333

A new concept in the surgical treatment of gastroesophageal reflux.

PubMed

Samelson, S L; Weiser, H F; Bombeck, C T; Siewert, J R; Ludtke, F E; Hoelscher, A H; Abuabara, S F; Nyhus, L M

1983-03-01

Surgical treatment of gastroesophageal reflux has been thought to depend on the construction of a valve mechanism at the gastroesophageal junction (GEJ). Recently, a silicone prosthesis that does not construct a valve has been introduced, and in preliminary studies in the human, shown to be effective in the treatment of reflux. A precise mode of action has not been demonstrated for the prosthesis. This study was undertaken to investigate the mechanics of the prosthesis and determine its effectiveness in an animal model. Six canine gastroesophageal specimens were excised and the lower esophageal sphincter (LES) simulated by a rubber band placed around the GEJ at a tension calibrated to give 25 mmHg "sphincter" pressure. Circumferential silk ligatures of varying length were then placed on the stomach 3.0 cm distal to the GEJ. With no ligature, the LES opening pressure (LESOP) was 8.0 mmHg, varying to 17.0 mmHg with an 8.0 cm ligature. Further, 24 adult mongrel dogs were randomly divided into four equal groups: controls, circular myomectomy of the LES alone, myomectomy combined with fundoplication, and myomectomy combined with implantation of the silicone antireflux prosthesis. Evaluation included manometry, endoscopy, and histology. Although only the normal sphincter and fundoplication responded physiologically, the prosthesis was just as effective in preventing reflux, as evidenced by reducing acid exposure time of myomectomized dogs from 35.4% to 1.8%, and by preventing endoscopic esophagitis. It was concluded that the silicone antireflux prosthesis acts in the same fashion as the ligature in the model, by interrupting distraction of the LES by gastric wall tension. This concept is an effective method for raising LESOP, treating experimental gastroesophageal reflux, and eliminating the sequelae of reflux. Long-term evaluations of the prosthesis are required.

Prosthesis-patient mismatch after transcatheter aortic valve implantation: impact of 2D-transthoracic echocardiography versus 3D-transesophageal echocardiography.

PubMed

da Silva, Cristina; Sahlen, Anders; Winter, Reidar; Bäck, Magnus; Rück, Andreas; Settergren, Magnus; Manouras, Aristomenis; Shahgaldi, Kambiz

2014-12-01

To investigate the role of 2D-transthoracic echocardiography (2D-TTE) and 3D-transesophageal echocardiography (3D-TEE) in the determination of aortic annulus size prior transcatheter aortic valve implantation (TAVI) and its' impact on the prevalence of patient prosthesis mismatch (PPM). Echocardiography plays an important role in measuring aortic annulus dimension in patients undergoing TAVI. This has great importance since it determines both eligibility for TAVI and selection of prosthesis type and size, and can be potentially important in preventing an inadequate ratio between the prosthetic valvular orifice and the patient's body surface area, concept known as prosthesis-patient mismatch (PPM). A total of 45 patients were studied pre-TAVI: 20 underwent 3D-TEE (men/women 12/8, age 84.8 ± 5.6) and 25 2D-TTE (men/women 9/16, age 84.4 ± 5.4) in order to measure aortic annulus diameter. The presence of PPM was assessed before hospital discharge and after a mean period of 3 months. Moderate PPM was defined as indexed aortic valve area (AVAi) ≤ 0.85 cm(2)/m(2) and severe PPM as AVAi < 0.65 cm(2)/m(2). Immediately post-TAVI, moderate PPM was present in 25 and 28 % of patients worked up using 3D-TEE and 2D-TTE respectively p value = n.s) and severe PPM occurred in 10 % of the patients who underwent 3D-TEE and in 20 % in those with 2D-TTE (p value = n.s). The echocardiographic evaluation 3 months post-TAVI showed 25 % moderate PPM in the 3D-TEE group compared with 24 % in the 2D-TTE group (p value = n.s) and no cases of severe PPM in the 3DTEE group comparing to 20 % in the 2D-TTE group (p = 0.032). Our results indicate a higher incidence of severe PPM in patients who performed 2DTTE compared to those performing 3DTEE prior TAVI. This suggests that the 3D technique should replace the 2DTTE analysis when investigating the aortic annulus diameter in patients undergoing TAVI.

Chest MRI

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... heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or are on dialysis (you ... Diagnose abnormal growths in the chest Evaluate blood flow Show lymph nodes and blood vessels Show the ...

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 replace diseased valves. Being amenable to relatively inexpensive mass production techniques, the attainment of this goal could benefit very large numbers of patients in developing and emerging countries who currently have no access to treatment for rheumatic heart disease that is so prevalent in these areas. This review discusses the evolution and current status of polymeric valves in wide-ranging circumstances.

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

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.

Breast MRI scan

MedlinePlus

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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.

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.

Dissection of the atrial wall after mitral valve replacement.

PubMed Central

Lukács, L; Kassai, I; Lengyel, M

1996-01-01

We describe an unusual sequela of mitral valve replacement in a 50-year-old woman who had undergone a closed mitral commissurotomy in 1975. She was admitted to our hospital because of mitral restenosis in November 1993, at which time her mitral valve was replaced with a mechanical prosthesis. On the 8th postoperative day, the patient developed symptoms of heart failure; transesophageal echocardiography revealed dissection and rupture of the left atrial wall. At prompt reoperation, we found an interlayer dissection and rupture of the atrial wall into the left atrium. We repaired the ruptured atrial wall with a prosthetic patch. The postoperative course was uneventful, and postoperative transesophageal echocardiography showed normal prosthetic valve function and no dissection. Images PMID:8680278

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.

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.

Effects of combined cryopreservation and decellularization on the biomechanical, structural and biochemical properties of porcine pulmonary heart valves.

PubMed

Theodoridis, Karolina; Müller, Janina; Ramm, Robert; Findeisen, Katja; Andrée, Birgit; Korossis, Sotirios; Haverich, Axel; Hilfiker, Andres

2016-10-01

Non-fixed, decellularized allogeneic heart valve scaffolds seem to be the best choice for heart valve replacement, their availability, however, is quite limited. Cryopreservation could prolong their shelf-life, allowing for their ideal match to a recipient. In this study, porcine pulmonary valves were decellularized using detergents, either prior or after cryopreservation, and analyzed. Mechanical integrity was analyzed by uniaxial tensile testing, histoarchitecture by histological staining, and composition by DNA, collagen (hydroxyproline) and GAG (chondroitin sulfate) quantification. Residual sodium dodecyl sulfate (SDS) in the scaffold was quantified by applying a methylene blue activation assay (MBAS). Cryopreserved decellularized scaffolds (DC) and scaffolds that were decellularized after cryopreservation (CD) were compared to fresh valves (F), cryopreserved native valves (C), and decellularized only scaffolds (D). The E-modulus and tensile strength of decellularized (D) tissue showed no significant difference compared to DC and CD. The decellularization resulted in an overall reduction of DNA and GAG, with DC containing the lowest amount of GAGs. The DNA content in the valvular wall of the CD group was higher than in the D and DC groups. CD valves showed slightly more residual SDS than DC valves, which might be harmful to recipient cells. In conclusion, cryopreservation after decellularization was shown to be preferable over cryopreservation before decellularization. However, in vivo testing would be necessary to determine whether these differences are significant in biocompatibility or immunogenicity of the scaffolds. Absence of adverse effects on biomechanical stability of acellular heart valve grafts by cryopreservation, neither before nor after decellularization, allows the identification of best matching patients in a less time pressure dictated process, and therefore to an optimized use of a very limited, but best-suited heart valve prosthesis. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

MRI

MedlinePlus

... the test, tell your provider if you have: Artificial heart valves Brain aneurysm clips Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not ... artificial joints Vascular stents Worked with sheet metal in ...

Magnetic resonance angiography

MedlinePlus

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Towards real-time cardiovascular magnetic resonance guided transarterial CoreValve implantation: in vivo evaluation in swine

PubMed Central

2012-01-01

Background Real-time cardiovascular magnetic resonance (rtCMR) is considered attractive for guiding TAVI. Owing to an unlimited scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, rtCMR is presumed to allow safe device navigation and to offer optimal orientation for precise axial positioning. We sought to evaluate the preclinical feasibility of rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis. Methods rtCMR-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in 8 swine using the original CoreValve prosthesis and a modified, CMR-compatible delivery catheter without ferromagnetic components. Results rtCMR using TrueFISP sequences provided reliable imaging guidance during TAVI, which was successful in 6 swine. One transfemoral attempt failed due to unsuccessful aortic arch passage and one pericardial tamponade with subsequent death occurred as a result of ventricular perforation by the device tip due to an operating error, this complication being detected without delay by rtCMR. rtCMR allowed for a detailed, simultaneous visualization of the delivery system with the mounted stent-valve and the surrounding anatomy, resulting in improved visualization during navigation through the vasculature, passage of the aortic valve, and during placement and deployment of the stent-valve. Post-interventional success could be confirmed using ECG-triggered time-resolved cine-TrueFISP and flow-sensitive phase-contrast sequences. Intended valve position was confirmed by ex-vivo histology. Conclusions Our study shows that rtCMR-guided TAVI using the commercial CoreValve prosthesis in conjunction with a modified delivery system is feasible in swine, allowing improved procedural guidance including immediate detection of complications and direct functional assessment with reduction of radiation and omission of contrast media. PMID:22453050

Towards real-time cardiovascular magnetic resonance guided transarterial CoreValve implantation: in vivo evaluation in swine.

PubMed

Kahlert, Philipp; Parohl, Nina; Albert, Juliane; Schäfer, Lena; Reinhardt, Renate; Kaiser, Gernot M; McDougall, Ian; Decker, Brad; Plicht, Björn; Erbel, Raimund; Eggebrecht, Holger; Ladd, Mark E; Quick, Harald H

2012-03-27

Real-time cardiovascular magnetic resonance (rtCMR) is considered attractive for guiding TAVI. Owing to an unlimited scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, rtCMR is presumed to allow safe device navigation and to offer optimal orientation for precise axial positioning. We sought to evaluate the preclinical feasibility of rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis. rtCMR-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in 8 swine using the original CoreValve prosthesis and a modified, CMR-compatible delivery catheter without ferromagnetic components. rtCMR using TrueFISP sequences provided reliable imaging guidance during TAVI, which was successful in 6 swine. One transfemoral attempt failed due to unsuccessful aortic arch passage and one pericardial tamponade with subsequent death occurred as a result of ventricular perforation by the device tip due to an operating error, this complication being detected without delay by rtCMR. rtCMR allowed for a detailed, simultaneous visualization of the delivery system with the mounted stent-valve and the surrounding anatomy, resulting in improved visualization during navigation through the vasculature, passage of the aortic valve, and during placement and deployment of the stent-valve. Post-interventional success could be confirmed using ECG-triggered time-resolved cine-TrueFISP and flow-sensitive phase-contrast sequences. Intended valve position was confirmed by ex-vivo histology. Our study shows that rtCMR-guided TAVI using the commercial CoreValve prosthesis in conjunction with a modified delivery system is feasible in swine, allowing improved procedural guidance including immediate detection of complications and direct functional assessment with reduction of radiation and omission of contrast media.

Perioperative Results and Complications in 15,964 Transcatheter Aortic Valve Replacements: Prospective Data From the GARY Registry.

PubMed

Walther, Thomas; Hamm, Christian W; Schuler, Gerhard; Berkowitsch, Alexander; Kötting, Joachim; Mangner, Norman; Mudra, Harald; Beckmann, Andreas; Cremer, Jochen; Welz, Armin; Lange, Rüdiger; Kuck, Karl-Heinz; Mohr, Friedrich W; Möllmann, Helge

2015-05-26

Transcatheter aortic valve replacement (TAVR) has evolved into a routine procedure with good outcomes in high-risk patients. TAVR complication rates were evaluated based on prospective data from the German Aortic Valve Registry (GARY). From 2011 to 2013, a total of 15,964 TAVR procedures were registered. We evaluated the total cohort for severe vital complications (SVCs), including the following: death on the day of intervention, conversion to sternotomy, low cardiac output that required mechanical support, aortic dissection, and annular rupture; technical complications of the procedures (TCOs), such as repositioning or retrieval of the valve prosthesis and embolization of the prosthesis; and other complications. Mean patient age was 81 ± 6 years, 54% of the patients were women, the median logistic Euroscore I was 18.3, the German aortic valve score was 5.6, and the Society of Thoracic Surgeons score was 5.0. Overall in-hospital mortality was 5.2%, whereas SVCs occurred in 5.0% of the population. Independent predictors for SVCs were female sex, pre-operative New York Heart Association functional class IV, ejection fraction <30%, pre-operative intravenous inotropes, arterial vascular disease, and higher degree of calcifications. TCOs occurred in 4.7% of patients and decreased significantly from 2011 to 2013. An emergency sternotomy was performed in 1.3% of the patients; however, multivariate analysis did not identify any predictors for conversion to sternotomy. The all-comers GARY registry revealed good outcomes after TAVR and a regression in complications. Survival of approximately 60% of patients who experienced SVCs or who required sternotomy underlines the need for heart team-led indication, intervention, and follow-up care of TAVR patients. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Reoperation for non-structural valvular dysfunction caused by pannus ingrowth in aortic valve prosthesis.

PubMed

Oh, Se Jin; Park, Samina; Kim, Jun Sung; Kim, Kyung-Hwan; Kim, Ki Bong; Ahn, Hyuk

2013-07-01

The authors' clinical experience is presented of non-structural valvular dysfunction of the prosthetic aortic valve caused by pannus ingrowth during the late postoperative period after previous heart valve surgery. Between January 1999 and April 2012, at the authors' institution, a total of 33 patients underwent reoperation for increased mean pressure gradient of the prosthetic aortic valve. All patients were shown to have pannus ingrowth. The mean interval from the previous operation was 16.7 +/- 4.3 years, and the most common etiology for the previous aortic valve replacement (AVR) was rheumatic valve disease. The mean effective orifice area index (EOAI) of the previous prosthetic valve was 0.97 +/- 0.11 cm2/m2, and the mean pressure gradient on the aortic prosthesis before reoperation was 39.1 +/- 10.7 mmHg. Two patients (6.1%) died in-hospital, and late death occurred in six patients (18.2%). At the first operation, 30 patients underwent mitral or tricuspid valve surgery as a concomitant procedure. Among these operations, mitral valve replacement (MVR) was combined in 24 of all 26 patients with rheumatic valve disease. Four patients underwent pannus removal only while the prosthetic aortic valve was left in place. The mean EOAI after reoperation was significantly increased to 1.16 +/- 0.16 cm2/m2 (p < 0.001), and the mean pressure gradient was decreased to 11.9 +/- 1.9 mmHg (p < 0.001). Non-structural valvular dysfunction caused by pannus ingrowth was shown in patients with a small EOAI of the prosthetic aortic valve and combined MVR for rheumatic disease. As reoperation for pannus overgrowth showed good clinical outcomes, an aggressive resection of pannus and repeated AVR should be considered in symptomatic patients to avoid the complications of other cardiac diseases.

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.

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 with increased risk of PPI. The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors, may be needed to reduce the risk of PPI.

Long-term performance of the Hancock bioprosthetic valved conduit in the aortic root position.

PubMed

Badiu, Catalin C; Bleiziffer, Sabine; Eichinger, Walter B; Hettich, Ina; Krane, Markus; Bauernschmitt, Robert; Lange, Rüdiger

2011-03-01

The study aim was to assess long-term morbidity and mortality with special regard to prosthesis durability after aortic root replacement with the Hancock bioprosthetic porcine conduit. Between 1975 and 2004, a total of 81 patients (55 males, 26 females; mean age 58 +/- 18 years) underwent aortic root replacement with the Hancock conduit for aortic dissection (n = 22; 27%), ascending aortic aneurysm (n = 57; 70%), or porcelain aorta (n = 2; 3%). Twenty-five patients (31%) underwent an emergency operation, 12 (15%) presented with Marfan syndrome, and eight (10%) had undergone previous cardiac surgery. Concomitant procedures were performed in 26 cases (32%). The follow up was 98% complete; the mean follow up was 4.8 +/- 4.0 years (range: 1 day to 16.7 years), and the cumulative follow up was 403 patient-years. Actuarial event-free rates were calculated, and valve-related complications classified according to guidelines for reporting morbidity and mortality after cardiac valvular operations. There were seven (9%) operative deaths and four (5%) in-hospital deaths. Actuarial survival rates at five and 10 years (excluding operative deaths) were 77.0 +/- 5.3% and 54.0 +/- 7.5%, respectively. Actuarial freedom from aortic valve reoperation at five and 10 years was 98 +/- 1.6% and 64 +/- 10.2%, from structural valve deterioration 88.1 +/- 4.7% and 49.9 +/- 9.6%, from thromboembolic events 87.4 +/- 4.6% and 75.1 +/- 9.5%, and from major bleeding events 90.2 +/- 3.9% and 75.4 +/- 8.1%, respectively. Among redo procedures, the stentless Hancock valve could be excised without separating the synthetic graft from the left ventricular outflow tract, and a stented valve prosthesis thus implanted. Hence, it was possible to avoid a second Bentall operation. The long-term survival rates after aortic root replacement with the bioprosthetic Hancock conduit were reasonable for this demanding patient cohort. However, the durability of the prosthesis was inferior to that reported for the stented Hancock valve substitute. The key benefit of this bioprosthetic valved conduit was the simplified redo procedure.

Influence of the Quantity of Aortic Valve Calcium on the Agreement Between Automated 3-Dimensional Transesophageal Echocardiography and Multidetector Row Computed Tomography for Aortic Annulus Sizing.

PubMed

Podlesnikar, Tomaz; Prihadi, Edgard A; van Rosendael, Philippe J; Vollema, E Mara; van der Kley, Frank; de Weger, Arend; Ajmone Marsan, Nina; Naji, Franjo; Fras, Zlatko; Bax, Jeroen J; Delgado, Victoria

2018-01-01

Accurate aortic annulus sizing is key for selection of appropriate transcatheter aortic valve implantation (TAVI) prosthesis size. The present study compared novel automated 3-dimensional (3D) transesophageal echocardiography (TEE) software and multidetector row computed tomography (MDCT) for aortic annulus sizing and investigated the influence of the quantity of aortic valve calcium (AVC) on the selection of TAVI prosthesis size. A total of 83 patients with severe aortic stenosis undergoing TAVI were evaluated. Maximal and minimal aortic annulus diameter, perimeter, and area were measured. AVC was assessed with computed tomography. The low and high AVC burden groups were defined according to the median AVC score. Overall, 3D TEE measurements slightly underestimated the aortic annulus dimensions as compared with MDCT (mean differences between maximum, minimum diameter, perimeter, and area: -1.7 mm, 0.5 mm, -2.7 mm, and -13 mm 2 , respectively). The agreement between 3D TEE and MDCT on aortic annulus dimensions was superior among patients with low AVC burden (<3,025 arbitrary units) compared with patients with high AVC burden (≥3,025 arbitrary units). The interobserver variability was excellent for both methods. 3D TEE and MDCT led to the same prosthesis size selection in 88%, 95%, and 81% of patients in the total population, the low, and the high AVC burden group, respectively. In conclusion, the novel automated 3D TEE imaging software allows accurate and highly reproducible measurements of the aortic annulus dimensions and shows excellent agreement with MDCT to determine the TAVI prosthesis size, particularly in patients with low AVC burden. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Quality of Life and Anxiety in Younger Patients after Biological versus Mechanical Aortic Valve Replacement.

PubMed

Kottmaier, Marc; Hettich, Ina; Deutsch, Marcus-André; Badiu, Catalin; Krane, Markus; Lange, Ruediger; Bleiziffer, Sabine

2017-04-01

Background  Since biological valve recipients are likely to need a redo procedure in the future for valve deterioration, we hypothesized patients might be more fearful about the progression of their disease than patients after aortic valve replacement (AVR) with a mechanical valve. The aim of this study is to compare the quality of life (QOL) and anxiety in patients who have undergone biological versus mechanical AVR. Method  A total of 56 patients after mechanical AVR (mean age: 64.4 ± 8.17 years) and 66 patients after biological AVR (mean age: 64.8 ± 11.05 years) received three questionnaires 5.66 (± 2.68) years after surgery, including: The short form-36 (SF-36) to assess QOL, the fear of progression questionnaire (FOP), and the cardiac anxiety questionnaire (CAQ) to assess general anxiety, anxiety related to cardiac symptoms, and anxiety about progression of heart disease and valve and anticoagulation-specific questions. Results  No significant differences were found for all categories of the SF-36. The FOP showed significantly favorable values for the biological AVR group. The CAQ showed a tendency in the subscale "avoidance" (i.e., avoidance of pulse increase) and "attention" towards more favorable values for the biological AVR group. Conclusions  In contrast to our hypothesis, patients after mechanical AVR show significantly higher anxiety values for the FOP, and a tendency toward higher values for "avoidance" (i.e., avoidance of pulse increase). Partnership concerns, especially in terms of sexuality can be explained by factors that are recognizable for the partner, such as valve sound. These data provide evidence that factors that are continuously present after mechanical AVR, such as valve sound or anticoagulation might affect wellbeing stronger than the certainty of reoperation in the future after biological AVR. We conclude that implantation of a biological prosthesis can be justified in younger patients with regards to QOL. Georg Thieme Verlag KG Stuttgart · New York.

Pulsatile flow in the aorta of the LVAD supported heart studied using particle image velocimetry

NASA Astrophysics Data System (ADS)

Moyedi, Zahra

Currently many patients die because of the end-stage heart failure, mainly due to the reduced number of donor heart transplant organs. Studies show that a permanent left ventricular assist device (LVAD), a battery driven pump which is surgically implanted, increased the survival rate of patients with end-stage heart failure and improved considerably their quality of life. The inlet conduit of the LVAD is attached to the left ventricle and the outflow conduit anastomosed to the ascending aorta. The purpose of LVAD support is to help a weakened heart to pump blood to the rest of the body. However LVAD can cause some alterations of the natural blood flow. When your blood comes in contact with something that isn't a natural part of your body blood clots can occur and disrupt blood flow. Aortic valve integrity is vital for optimal support of left ventricular assist LVAD. Due to the existence of high continuous transvalvular pressure on the aortic valve, the opening frequency of the valve is reduced. To prevent the development of aortic insufficiency, aortic valve closure during LVAD implantation has been performed. However, the closed aortic valve reduces wash out of the aortic root, which causes blood stagnation and potential thrombus formation. So for this reason, there is a need to minimize the risks of occurring blood clot, by having more knowledge about the flow structure in the aorta during LVAD use. The current study focuses on measuring the flow field in the aorta of the LVAD assisted heart with two different types of aortic valve (Flat and Finned) using the SDSU cardiac simulator. The pulsatile pump that mimics the natural pulsing action of the heart also added to the system. The flow field is visualized using Particle Image Velocimetry (PIV). Furthermore, The fluid mechanics of aorta has been studied when LVAD conduit attached to two different locations (proximal and distal to the aortic valve) with pump speeds of 8,000 to 10,000 revolutions per minute (RPM). As LVAD speed increases, the velocity of the defined area (close to the proximal anastomosis) increases linearly but inversely the stagnation index decreases. We observed that with Finned valve attachment, the stagnation value is lower than the flat valve so the results suggest that D1 valve has lower risk of thrombosis close to the aortic valve.

Late leaflet fracture and embolization of a Duromedics mitral prosthesis.

PubMed

Sudo, K; Sasagawa, N; Ide, H; Nunokawa, M; Fujiki, T; Tonari, K

2000-08-01

A case of leaflet fracture and embolization of a mitral prosthetic valve is described. A 54-year-old man had received mitral valve replacement with an Edwards-Duromedics 29M prosthetic valve, at 10 years ago. Emergency mitral valve replacement was performed because the patient had severe congestive left heart failure with severe acute mitral regurgitation caused by a fracture in one of the mitral valve leaflets. The leaflet, which was fractured into 2 pieces, was removed from the right common iliac artery at 3 months after valve replacement. Visual inspection revealed that the leaflet contained a midline fracture. The fracture originated within a cavitary erosion pit near the major radius of the leaflet. The patient recovered from acute renal failure, requiring hemodialysis for 80 days, and is currently without complaints. We have used a Duromedics mitral valve in 11 patients, from April 1987 to April 1988. No subsequent valve failure has occurred. The diagnosis, treatment and cause of a mechanical valve fracture are discussed.

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.

Challenges of coronary angiography and intervention in patients previously treated by TAVI.

PubMed

Blumenstein, Johannes; Kim, Won-Keun; Liebetrau, Christoph; Gaede, Luise; Kempfert, Joerg; Walther, Thomas; Hamm, Christian; Möllmann, Helge

2015-08-01

Since the beginning of the transcatheter aortic valve implantation (TAVI) era, many prosthetic valves have entered clinical practice. TAVI prostheses differ regarding stent design and some may potentially interfere with diagnostic or interventional catheters. The aim of our analysis was to evaluate the feasibility of coronary angiography (CA) or percutaneous coronary intervention (PCI) in patients with prior TAVI. From 2011 to 2014, 1,000 patients were treated by TAVI at our center using eight different valve prostheses (Symetis ACURATE TA and ACURATE TF; Medtronic CoreValve and Engager; JenaValve, SJM Portico; Edwards Lifesciences SAPIEN and SAPIEN XT). In this analysis, all patients were included who underwent either CA or PCI after TAVI. CA or PCI were rated as fully feasible when coronary ostia could be fully intubated, partially feasible when coronary arteries could be displayed only unselectively or unfeasible when coronary arteries could not be displayed. A total of 35 patients underwent CA/PCI after TAVI at our hospital. In all patients with valves implanted in a subcoronary position (SAPIEN n = 19; JenaValve n = 1), selective intubation was feasible using standard catheters. Out of 15 patients with valve types that are placed over the coronary ostia (CoreValve n = 10, ACURATE n = 4, Portico n = 1), selective intubation of coronary arteries was not possible in 9 cases, even with the use of different diagnostic catheters. Full accessibility was possible only in 3 cases. In 2 cases, display of the right CA was only feasible using unselective aortography. In 1 case, coronary arteries could not be displayed at all immediately after a valve-in-valve procedure. CA or PCI after TAVI is usually feasible. Devices that are placed in a partially supracoronary position, however, can interfere with diagnostic or guiding catheters and impede straightforward intervention, especially when the prosthesis is not implanted in the correct position.

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.

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.

Reynolds Shear Stress for Textile Prosthetic Heart Valves in Relation to Fabric Design

PubMed Central

Bark, David L.; Koupei, Atieh Yousefi; Forleo, Marcio; Vaesken, Antoine; Heim, Frederic; Dasi, Lakshmi P.

2016-01-01

The most widely implanted prosthetic heart valves are either mechanical or bioprosthetic. While the former suffers from thrombotic risks, the latter suffers from a lack of durability. Textile valves, alternatively, can be designed with durability and to exhibit hemodynamics similar to the native valve, lowering the risk for thrombosis. Deviations from native valve hemodynamics can result in an increased Reynolds Shear Stress (RSS), which has the potential to instigate hemolysis or shear-induced thrombosis. This study is aimed at characterizing flow in multiple textile valve designs with an aim of developing a low profile valve. Valves were created using a shaping process based on heating a textile membrane and placed within a left heart simulator. Turbulence and bulk hemodynamics were assessed through particle imaging velocimetry (PIV), along with flow and pressure measurements. Overall, RSS was reduced for low profile valves relative to high profile valves, but was otherwise similar among low profile valves. However, leakage was found in 3 of the 4 low profile valve designs driving the fabric design for low profile valves. Through textile design, low profile valves can be created with favorable hemodynamics. PMID:26919564

Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study.

PubMed

Lauten, Alexander; Figulla, Hans R; Unbehaun, Axel; Fam, Neil; Schofer, Joachim; Doenst, Torsten; Hausleiter, Joerg; Franz, Marcus; Jung, Christian; Dreger, Henryk; Leistner, David; Alushi, Brunilda; Stundl, Anja; Landmesser, Ulf; Falk, Volkmar; Stangl, Karl; Laule, Michael

2018-02-01

Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days). Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive-risk cohort. The study demonstrates hemodynamic efficacy with consistent elimination of TR-associated venous backflow and initial clinical improvement. These results encourage further trials to determine which patients benefit most from this interventional approach. © 2018 American Heart Association, Inc.

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 encouraging with improvements in surgical techniques and myocardial preservation methods.

Cervical MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Lumbar MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Shoulder MRI scan

MedlinePlus

... you have: Brain aneurysm clips Certain types of artificial heart valves Heart defibrillator or pacemaker Inner ear (cochlear) implants Kidney disease or dialysis (you may not be able to receive contrast) Recently placed artificial joints Certain types of vascular stents Worked with ...

Establishing human heart chromium, cobalt and vanadium concentrations by inductively coupled plasma mass spectrometry.

PubMed

Day, Patrick L; Eckdahl, Steven J; Maleszewski, Joseph J; Wright, Thomas C; Murray, David L

2017-05-01

Chromium, cobalt, and vanadium are used in metallic joint prosthesis. Case studies have associated elevated heart tissue cobalt concentrations with myocardial injury. To document the long term heart metal ion concentrations, a validated inductively coupled plasma mass spectroscopy (ICP-MS) method was needed. The method utilized a closed-vessel microwave digestion system to digest the samples. An ICP-MS method utilizing Universal Cell Technology was used to determine our target analyte concentrations. Accuracy was verified using reference materials. Precision, sensitivity, recovery and linearity studies were performed. This method was used to establish a reference range for a non-implant containing cohort of 80 autopsy human heart tissues RESULTS: This method demonstrated an analytic measurement range of 0.5-100ng/mL for each element. Accuracy was within ±10% of target value for each element. Within-run precision for each element was below 20% CV. The chromium, vanadium and cobalt concentrations (mean±SD) were 0.1523±0.2157μg/g, 0.0094±0.0211μg/g and 0.1039±0.1305μg/g respectively in 80 non-implant containing human heart tissue samples. This method provides acceptable recovery of the chromium, cobalt and vanadium in heart tissue; allowing assessment of the effects of metallic joint prosthesis on myocardial health. Copyright © 2017 Elsevier GmbH. All rights reserved.

The role of TTE in assessment of the patient before and following TAVI for AS

PubMed Central

Edwards, Nicola C; Doshi, Sagar N; Steeds, Richard P

2016-01-01

Transcatheter aortic valve implantation is now accepted as a standard mode of treatment for an increasingly large population of patients with severe aortic stenosis. With the availability of this technique, echocardiographers need to be familiar with the imaging characteristics that can help to identify which patients are best suited to conventional surgery or transcatheter aortic valve implantation, and what parameters need to be measured. This review highlights the major features that should be assessed during transthoracic echocardiography before presentation of the patient to the ‘Heart Team’. In addition, this review summarises the aspects to be considered on echocardiography during follow-up assessment after successful implantation of a transcatheter aortic valve. PMID:27249549

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.

Design Studies of Cardiac Valve Prostheses

PubMed Central

Liotta, Domingo

1985-01-01

This paper indicates the vital importance of considering prosthesis articulation in the design of cardiac valves. The prosthesis articulation interrelates with the fixed and the movable prosthetic components. Two basic physiological hemodynamic principles are reviewed: [List: see text] A bileaflet, free-tilting, swivelling prosthesis with a central articular mechanism is undergoing investigation. The four articulations have their own perennial preserving mechanisms to prevent potential failure mode by collecting blood elements in the valve tilting design. PMID:15227041

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.

[Late outlet strut fracture of an aortic Björk-Shiley and embolization of the prosthetic disc].

PubMed

Brochet, E; Bougis de Brux, M A; Assayag, P; Benacin, Y; Gamerman, G; Guerot, C; Valère, P E

1988-09-01

A new case of late fracture of an outlet strut in a convexo-concave Björk-Shiley valve is reported. The fracture occurred 6 years after aortic implantation of the valve and was responsible for aorto-iliac embolization by the prosthetic disc and death of the patient from cardiogenic shock. This not uncommon complication of the Björk-Shiley valve prosthesis is usually ascribed to the relative fragility of its outlet strut welded to the metallic ring and subjected to strong pressures. Although most cases were observed within the first two years of prosthetic valve insertion, and mainly with valves manufactured in 1981 and 1982, our case and a few others demonstrate the possibility of late rupture. Cardiologists must be aware of this possible complication, since in some favourable cases it can be diagnosed at an early stage and the patient's life can be saved by an emergency operation.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades.

PubMed

Chung, Eric

2017-02-01

Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades.

Penile prosthesis implant: scientific advances and technological innovations over the last four decades

PubMed Central

2017-01-01

Despite introduction of oral phosphodiesterase type 5 inhibitors and intracavernosal vasoactive agents, penile prosthesis implant remains a relevant and desired option with sales of penile prostheses continue to stay high, as many men became refractory to medical therapy and/or seeking a more effective and permanent therapy. There are two types of penile prosthesis implants: inflatable and non-inflatable types, and the inflatable penile implants can be subdivided into single-, two- and three-piece devices. Non-inflatable penile prosthesis (non-IPP) may be referred to as semi-rigid rod or malleable prosthesis. IPP is considered a superior option to malleable prosthesis as it produces penile rigidity and flaccidity that closely replicates a normal penile erectile function. Since the introduction of IPP by Scott in 1973, surgical landscape for penile prosthesis implantation has changed dramatically. Advances in prosthesis design, device technologies and surgical techniques have made penile prosthesis implant a more natural, durable and reliable device. The following article reviews the scientific advances and technological innovation in modern penile prosthesis implants over the last four decades. PMID:28217449

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

Total artificial heart implantation in a young Marfan syndrome patient.

PubMed

Rao, Prashant; Keenan, Jack B; Rajab, Taufiek K; Kim, Samuel; Smith, Richard; Amabile, Orazio; Khalpey, Zain

2018-03-01

Cardiovascular complications represent the leading cause of morbidity and mortality in patients with Marfan syndrome. Here, we describe a unique case where a total artificial heart was implanted in a young Marfan syndrome woman. A 22-year-old postpartum African American female with Marfan syndrome developed multiple severe valve dysfunction and biventricular failure that was refractory to medical management. She previously had a Bentall procedure for Type A aortic dissection and repair of a Type B dissection. We implanted a total artificial heart with a good outcome. Total artificial heart is a durable option for severe biventricular failure and multiple valvular dysfunction as a bridge to transplant in a young patient with Marfan syndrome.

The current status of fluoroscopy and echocardiography in the diagnosis of prosthetic valve thrombosis-a review article.

PubMed

Gürsoy, Mustafa Ozan; Kalçik, Macit; Karakoyun, Süleyman; Özkan, Mehmet

2015-01-01

Prosthetic valve thrombosis (PVT) is a potentially life-threatening complication of heart valve replacement. Early diagnosis is crucial for the prevention of significantly morbid and lethal complications. Cinefluoroscopy (CF) and echocardiography have been widely used for diagnosing PVT. In recent years, the role of CF has declined since the introduction of transesophageal echocardiography and the great improvements in ultrasound technology including real time three-dimensional imaging. Nevertheless, both echocardiography and CF provide different kinds of information on prosthesis function, and therefore they are considered as complementary and not alternative. In this review, we aimed to summarize the current status of CF and echocardiography in the diagnosis of PVT. © 2014, Wiley Periodicals, Inc.

One-year outcomes after rapid-deployment aortic valve replacement.

PubMed

Young, Christopher; Laufer, Günther; Kocher, Alfred; Solinas, Marco; Alamanni, Francesco; Polvani, Gianluca; Podesser, Bruno K; Aramendi, Jose Ignacio; Arribas, Jose; Bouchot, Olivier; Livi, Ugolino; Massetti, Massimo; Terp, Kim; Giot, Christophe; Glauber, Mattia

2018-02-01

The goals of rapid-deployment aortic valve replacement include facilitation of minimally invasive surgery and reduced aortic crossclamp time. We report the short-term outcomes of a series of 493 patients undergoing rapid-deployment aortic valve replacement with the EDWARDS INTUITY valve system (Edwards Lifesciences, LLC, Irvine, Calif). Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study was a prospective, multicenter (n = 26) European registry designed to evaluate the safety and performance of the valve system. During rapid-deployment aortic valve replacement, device technical success and crossclamp time were assessed. Procedural outcomes, hemodynamic performance, and various adverse events and clinical outcomes were evaluated up to 2 years. Between 2012 and 2014, 493 of 517 enrolled patients successfully received implants with the study valve (95.4% technical success). Mean crossclamp times for 163 full sternotomies, 128 mini-upper sternotomies, and 36 right anterior thoracotomies isolated aortic valve replacements were 47.3, 52.0, and 73.3 minutes, respectively. Mean follow-up was 1.8 years, with 870 total patient-years of follow-up. Mean effective orifice area increased from 0.72 (baseline) to 1.88 cm 2 , and mean pressure gradient decreased from 47.6 to 9.6 mm Hg (1 year). Mean effective orifice area index increased (0.39-1.01 cm 2 /m 2 ), and 28 of 287 patients (9.8%) exhibited severe prosthesis-patient mismatch at 1 year. After 1 year, 68.1% and 21.7% of patients were in New York Heart Association class I and II, respectively. Freedom from death, major bleeding, major perivalvular leak, reoperation, and device explant at 1 year were 0.935, 0.939, 0.976, 0.975, and 0.983, respectively. These results demonstrate commendable safety and performance of the test valve system over the short term in a broad European setting. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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.

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2014 CFR

2014-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2012 CFR

2012-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

14 CFR 67.111 - Cardiovascular.

Code of Federal Regulations, 2013 CFR

2013-01-01

... diagnosis of any of the following: (1) Myocardial infarction; (2) Angina pectoris; (3) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (4) Cardiac valve replacement; (5) Permanent cardiac pacemaker implantation; or (6) Heart replacement...

14 CFR 67.311 - Cardiovascular.

Code of Federal Regulations, 2011 CFR

2011-01-01

... diagnosis of any of the following: (a) Myocardial infarction; (b) Angina pectoris; (c) Coronary heart disease that has required treatment or, if untreated, that has been symptomatic or clinically significant; (d) Cardiac valve replacement; (e) Permanent cardiac pacemaker implantation; or (f) Heart replacement. ...

Percutaneous closure of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement.

PubMed

Nakamura, Kenta; Passeri, Jonathan J; Inglessis-Azuaje, Ignacio

2017-07-01

We report a case of acute aorto-right ventricular fistula following transcatheter bicuspid aortic valve replacement and subsequent percutaneous closure. The diagnosis and treatment of this rare complication is illustrated through multi-modality imaging. We hypothesize that the patient's heavily calcified bicuspid aortic valve anatomy led to asymmetric deployment of the transcatheter aortic valve replacement (TAVR) prosthesis, traumatizing the right sinus of Valsalva at the distal edge of the TAVR stent and ultimately fistulized to the right ventricle. The patient acutely decompensated with heart failure five days after TAVR and underwent emergent intervention. The aorto-right ventricular fistula was closed using an 18-mm septal occluder device with marked clinical recovery. Transcatheter closure is a viable treatment option for acute aorto-right ventricular fistula. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Cardiovascular tissue engineering: where we come from and where are we now?

PubMed

Smit, Francis E; Dohmen, Pascal M

2015-01-27

Abstract Tissue engineering was introduced by Vacanti and Langer in the 80's, exploring the potential of this new technology starting with the well-known "human ear on the mouse back". The goal is to create a substitute which supplies an individual therapy for patients with regeneration, remodeling and growth potential. The growth potential of these subjects is of special interest in congenital cardiac surgery, avoiding repeated interventions and surgery. Initial applications of tissue engineered created substitutes were relatively simple cardiovascular grafts seeded initially by end-differentiated autologous endothelial cells. Important data were collected from these initial clinical autologous endothelial cell seeded grafts in peripheral and coronary vessel disease. After these initial successfully implantation bone marrow cell were used to seed patches and pulmonary conduits were implanted in patients. Driven by the positive results of tissue engineered material implanted under low pressure circumstances, first tissue engineered patches were implanted in the systemic circulation followed by the implantation of tissue engineered aortic heart valves. Tissue engineering is an extreme dynamic technology with continuously modifications and improvements to optimize clinical products. New technologies are unified and so this has also be done with tissue engineering and new application features, so called transcatheter valve intervention. First studies are initiated to apply tissue engineered heart valves with this new transcatheter delivery system less invasive. Simultaneously studies have been started on tissue engineering of so-called whole organs since organ transplantation is restricted due to donor shortage and tissue engineering could overcome this problem. Initial studies of whole heart engineering in the rat model are promising and larger size models are initiated.

Potential biomedical applications of ion beam technology

NASA Technical Reports Server (NTRS)

Banks, B. A.; Weigand, A. J.; Babbush, C. A.; Vankampen, C. L.

1976-01-01

Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic pros-thesis fixtion, and dental implants.

Potential biomedical applications of ion beam technology

NASA Technical Reports Server (NTRS)

Banks, B. A.; Weigand, A. J.; Van Kampen, C. L.; Babbush, C. A.

1976-01-01

Electron bombardment ion thrusters used as ion sources have demonstrated a unique capability to vary the surface morphology of surgical implant materials. The microscopically rough surface texture produced by ion beam sputtering of these materials may result in improvements in the biological response and/or performance of implanted devices. Control of surface roughness may result in improved attachment of the implant to soft tissue, hard tissue, bone cement, or components deposited from blood. Potential biomedical applications of ion beam texturing discussed include: vascular prostheses, artificial heart pump diaphragms, pacemaker fixation, percutaneous connectors, orthopedic prosthesis fixation, and dental implants.

Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial.

PubMed

Muller, David W M; Farivar, Robert Saeid; Jansz, Paul; Bae, Richard; Walters, Darren; Clarke, Andrew; Grayburn, Paul A; Stoler, Robert C; Dahle, Gry; Rein, Kjell A; Shaw, Marty; Scalia, Gregory M; Guerrero, Mayra; Pearson, Paul; Kapadia, Samir; Gillinov, Marc; Pichard, Augusto; Corso, Paul; Popma, Jeffrey; Chuang, Michael; Blanke, Philipp; Leipsic, Jonathon; Sorajja, Paul

2017-01-31

Symptomatic mitral regurgitation (MR) is associated with high morbidity and mortality that can be ameliorated by surgical valve repair or replacement. Despite this, many patients with MR do not undergo surgery. Transcatheter mitral valve replacement (TMVR) may be an option for selected patients with severe MR. This study aimed to examine the effectiveness and safety of TMVR in a cohort of patients with native valve MR who were at high risk for cardiac surgery. Patients underwent transcatheter, transapical delivery of a self-expanding mitral valve prosthesis and were examined in a prospective registry for short-term and 30-day outcomes. Thirty patients (age 75.6 ± 9.2 years; 25 men) with grade 3 or 4 MR underwent TMVR. The MR etiology was secondary (n = 23), primary (n = 3), or mixed pathology (n = 4). The Society of Thoracic Surgeons Predicted Risk of Mortality was 7.3 ± 5.7%. Successful device implantation was achieved in 28 patients (93.3%). There were no acute deaths, strokes, or myocardial infarctions. One patient died 13 days after TMVR from hospital-acquired pneumonia. Prosthetic leaflet thrombosis was detected in 1 patient at follow-up and resolved after increased oral anticoagulation with warfarin. At 30 days, transthoracic echocardiography showed mild (1+) central MR in 1 patient, and no residual MR in the remaining 26 patients with valves in situ. The left ventricular end-diastolic volume index decreased (90.1 ± 28.2 ml/m 2 at baseline vs. 72.1 ± 19.3 ml/m 2 at follow-up; p = 0.0012), as did the left ventricular end-systolic volume index (48.4 ± 19.7 ml/m 2 vs. 43.1 ± 16.2 ml/m 2 ; p = 0.18). Seventy-five percent of the patients reported mild or no symptoms at follow-up (New York Heart Association functional class I or II). Successful device implantation free of cardiovascular mortality, stroke, and device malfunction at 30 days was 86.6%. TMVR is an effective and safe therapy for selected patients with symptomatic native MR. Further evaluation of TMVR using prostheses specifically designed for the mitral valve is warranted. This intervention may help address an unmet need in patients at high risk for surgery. (Early Feasibility Study of the Tendyne Mitral Valve System [Global Feasibility Study]; NCT02321514). Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Self-reported quality of life and health among Björk-Shiley convexo-concave prosthetic heart valve patients.

PubMed

Signorello, L B; Kennedy, J A; Richmond, R A; Sieu, K L; Blot, W J; Harrison, D C

2001-03-01

The risk of fracture of Björk-Shiley convexo-concave (BSCC) prosthetic heart valves has resulted in consideration of prophylactic explantation and replacement for patients with high-risk valves. Little information exists on perceived quality of life, health status, and serious morbidity among BSCC patients, including those who have undergone explantation. Self-administered questionnaires were completed by a cohort of 585 BSCC patients who participated in an X-ray imaging study to detect precursors to valve fracture up to seven years (average 3.9 years) previously. Responses from 31 explant patients were contrasted with those from 554 BSCC patients in whom explant surgery was not attempted. Perceived quality of life and health status and risk of hospitalization after participating in the imaging study varied considerably among patients, but on average tended not to differ significantly between those with and without explants. A slightly greater proportion of explantees tended to report both improved health status and high rates of heart attack and pacemaker implantation. The health status of these patients was, in general, considerably worse than previously reported among valve implant patients. Over half the cohort were hospitalized during follow up, and half were unable to walk up more than one flight of stairs without shortness of breath. The less than optimal health status of most BSCC patients and relatively high rates of morbidity should be taken into account when considering potential explantation of the valves.

In-body tissue-engineered aortic valve (Biovalve type VII) architecture based on 3D printer molding.

PubMed

Nakayama, Yasuhide; Takewa, Yoshiaki; Sumikura, Hirohito; Yamanami, Masashi; Matsui, Yuichi; Oie, Tomonori; Kishimoto, Yuichiro; Arakawa, Mamoru; Ohmuma, Kentaro; Tajikawa, Tsutomu; Kanda, Keiichi; Tatsumi, Eisuke

2015-01-01

In-body tissue architecture--a novel and practical regeneration medicine technology--can be used to prepare a completely autologous heart valve, based on the shape of a mold. In this study, a three-dimensional (3D) printer was used to produce the molds. A 3D printer can easily reproduce the 3D-shape and size of native heart valves within several processing hours. For a tri-leaflet, valved conduit with a sinus of Valsalva (Biovalve type VII), the mold was assembled using two conduit parts and three sinus parts produced by the 3D printer. Biovalves were generated from completely autologous connective tissue, containing collagen and fibroblasts, within 2 months following the subcutaneous embedding of the molds (success rate, 27/30). In vitro evaluation, using a pulsatile circulation circuit, showed excellent valvular function with a durability of at least 10 days. Interposed between two expanded polytetrafluoroethylene grafts, the Biovalves (N = 3) were implanted in goats through an apico-aortic bypass procedure. Postoperative echocardiography showed smooth movement of the leaflets with minimal regurgitation under systemic circulation. After 1 month of implantation, smooth white leaflets were observed with minimal thrombus formation. Functional, autologous, 3D-shaped heart valves with clinical application potential were formed following in-body embedding of specially designed molds that were created within several hours by 3D printer. © 2014 Wiley Periodicals, Inc.

Biofilm formation and design features of indwelling silicone rubber tracheoesophageal voice prostheses--an electron microscopical study.

PubMed

Leunisse, C; van Weissenbruch, R; Busscher, H J; van der Mei, H C; Dijk, F; Albers, F W

2001-01-01

After total laryngectomy, voice can be restored with a silicone rubber tracheoesophageal voice prosthesis. However, biofilm formation and subsequent deterioration of the silicone material of the prosthesis will limit device life by impairing valve function. To simulate the natural process of biofilm development under dynamic nutrient conditions, a modified Robbins device was used to evaluate the biofilm-related valve dysfunction of the Groningen, Provox2, Blom-Singer indwelling, and VoiceMaster voice prostheses. Obstruction of the semicircular slit-valved Groningen prosthesis leading to increased airway resistance was caused not only by a buildup of deposits on the esophageal flange and valve hat, but also by accumulation of deposits on the semicircular valve seating. The hinged flap valved Provox2 and indwelling Blom-Singer prostheses failed to close sufficiently because of biofilm formation on the valve seating. The esophageal flange of the VoiceMaster prosthesis was affected, but the tripod structure of the ball valve was fully colonized up to the titanium sleeve, which interfered with proper valve opening and closure. These findings on biofilm formation could be used for the further development and modification of critical design features of voice prostheses to facilitate tracheoesophageal speech. Copyright 2001 John Wiley & Sons, 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.

Single-centre experience with next-generation devices for transapical aortic valve implantation.

PubMed

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

2015-01-01

Transcatheter aortic valve implantation (TAVI) has become an established procedure in patients with aortic stenosis and high surgical risk. Experience with first-generation transcatheter heart valves (THVs) is broad but limitations, e.g. paravalvular regurgitation, have been demonstrated. Much hope rests on the recently Conformité Européenne mark approved next-generation devices to improve results in these patients. However, apart from the initial approval studies, clinical data with these new devices are still scarce. We aimed to assess short-term outcomes of 200 consecutive patients who underwent transapical TAVI with next-generation THV at our institution. Transapical TAVI was performed in 200 consecutive patients 80.5±6.7 years old (38.5% female) at high surgical risk (log EuroSCORE 20.2±16.5%). Devices implanted were the Engager (Medtronic, Inc., Minneapolis, MN, USA; n=50), JenaValve (JenaValve Technology, Munich, Germany; n=88) and Symetis Acurate (Symetis SA, Ecublens, Switzerland; n=62) THV that were selected by the heart team on an individual basis. Data at baseline, during the procedure and follow-up were analysed according to standardized Valve Academic Research Consortium end points. Median follow-up was 219 days. Implantation was successful in 96.5% of cases. Valve function improved significantly with an increase in effective orifice area from 0.8±0.4 to 1.8±0.3 cm2 and a reduction in mean transvalvalvular gradients from 34.0±17.0 to 11.2±5.4 mmHg. Paravalvular regurgitation was none or trace in 70.3% of patients, Grade 1 in 26.1%, and Grade 2 in 3.5%. No patients developed aortic regurgitation>Grade 2. Major access site complications occurred in 6.5%, major stroke in 1.5% and stage-3 kidney injury in 2.5% of patients. A permanent pacemaker was implanted in 20.5% of patients overall and in 8.0% for a complete heart block. At 30-day follow-up 72.8% of patients were in New York Heart Association class I or II (10.5% at baseline). Overall survival was 91.5% at 30 days and 73.9% at 1 year. In a real-world clinical setting, next-generation transapical THV yielded positive haemodynamic results. The incidence of relevant paravalvular regurgitation was scarce in this group and clinical outcomes were encouraging during short-term follow-up. Long-term follow-up is required to investigate the durability of these new devices. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Beating heart mitral valve repair with integrated ultrasound imaging

NASA Astrophysics Data System (ADS)

McLeod, A. Jonathan; Moore, John T.; Peters, Terry M.

2015-03-01

Beating heart valve therapies rely extensively on image guidance to treat patients who would be considered inoperable with conventional surgery. Mitral valve repair techniques including the MitrClip, NeoChord, and emerging transcatheter mitral valve replacement techniques rely on transesophageal echocardiography for guidance. These images are often difficult to interpret as the tool will cause shadowing artifacts that occlude tissue near the target site. Here, we integrate ultrasound imaging directly into the NeoChord device. This provides an unobstructed imaging plane that can visualize the valve lea ets as they are engaged by the device and can aid in achieving both a proper bite and spacing between the neochordae implants. A proof of concept user study in a phantom environment is performed to provide a proof of concept for this device.

Next-Generation Transcatheter Heart Valves: Current Trials in Europe and the USA

PubMed Central

Werner, Nikos; Nickenig, Georg

2012-01-01

Transcatheter aortic valve implantation (TAVI) has proven to be a viable alternative for patients with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement. At the same time, there is increasing evidence that moderate-to-severe periprosthetic aortic regurgitation after TAVI is associated with dramatically increased mortality and morbidity. The issue of proper positioning of the valve, including the ability to reposition and recapture the device, must be dealt with before the use of TAVI can be extended to younger, healthier patients. The next generation of transcatheter heart valves will most likely address repositionability to facilitate accurate placement with additional features that minimize paravalvular leakage. Upcoming devices promise to improve outcomes and usability of current TAVI systems. PMID:22891121

Impact of Clinically Relevant Elliptical Deformations on the Damage Patterns of Sagging and Stretched Leaflets in a Bioprosthetic Heart Valve.

PubMed

Sritharan, Deepa; Fathi, Parinaz; Weaver, Jason D; Retta, Stephen M; Wu, Changfu; Duraiswamy, Nandini

2018-06-12

After implantation of a transcatheter bioprosthetic heart valve its original circular circumference may become distorted, which can lead to changes in leaflet coaptation and leaflets that are stretched or sagging. This may lead to early structural deterioration of the valve as seen in some explanted transcatheter heart valves. Our in vitro study evaluates the effect of leaflet deformations seen in elliptical configurations on the damage patterns of the leaflets, with circular valve deformation as the control. Bovine pericardial tissue heart valves were subjected to accelerated wear testing under both circular (N = 2) and elliptical (N = 4) configurations. The elliptical configurations were created by placing the valve inside custom-made elliptical holders, which caused the leaflets to sag or stretch. The hydrodynamic performance of the valves was monitored and high resolution images were acquired to evaluate leaflet damage patterns over time. In the elliptically deformed valves, sagging leaflets experienced more damage from wear compared to stretched leaflets; the undistorted leaflets of the circular valves experienced the least leaflet damage. Free-edge thinning and tearing were the primary modes of damage in the sagging leaflets. Belly region thinning was seen in the undistorted and stretched leaflets. Leaflet and fabric tears at the commissures were seen in all valve configurations. Free-edge tearing and commissure tears were the leading cause of valve hydrodynamic incompetence. Our study shows that mechanical wear affects heart valve pericardial leaflets differently based on whether they are undistorted, stretched, or sagging in a valve configuration. Sagging leaflets are more likely to be subjected to free-edge tear than stretched or undistorted leaflets. Reducing leaflet stress at the free edge of non-circular valve configurations should be an important factor to consider in the design and/or deployment of transcatheter bioprosthetic heart valves to improve their long-term performance.

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.

Thirty-Seven-Year Durability of a Starr-Edwards Aortic Prosthesis

PubMed Central

Ozkokeli, Mehmet; Ates, Mehmet; Ekinci, Abdurrahman; Akcar, Murat

2005-01-01

We report the case of a patient who was diagnosed with prosthetic valve endocarditis caused by Staphylococcus aureus. He had undergone aortic valve replacement with a Starr-Edwards prosthesis 37 years earlier. Because of uncontrolled infection despite antibiotic treatment, the patient underwent successful surgical replacement of the prosthetic valve. PMID:15902834

Percutaneous Dual-valve Intervention in a High-risk Patient with Severe Aortic and Mitral Stenosis

PubMed Central

Mrevlje, Blaz; Aboukura, Mohamad; Nienaber, Christoph A.

2016-01-01

Aortic stenosis is the most frequent and mitral stenosis is the least frequent native single-sided valve disease in Europe. Patients with the combination of severe symptomatic degenerative aortic and mitral stenosis are very rare. Guidelines for the treatment of heart valve diseases are clear for single-valve situations. However, there is no common agreement or recommendation for the best treatment strategy in patients with multiple valve disease and severe concomitant comorbidities. A 76-year-old female patient with the combination of severe degenerative symptomatic aortic and mitral stenosis and several comorbidities including severe obesity, who was found unsuitable surgical candidate by the heart team and unsuitable for two-time general anesthesia in the case of two-step single-valve percutaneous approach by anesthesiologists, underwent successful percutaneous dual-valve single-intervention (transcatheter aortic valve implantation and percutaneous mitral balloon commissurotomy). Percutaneous dual-valve single-intervention is feasible in selected symptomatic high-risk patients. PMID:27867460

The effect of the sequential therapy in end-stage heart failure (ESHF)--from ECMO, through the use of implantable pump for a pneumatic heart assist system, Religa Heart EXT, as a bridge for orthotopic heart transplant (OHT). Case study.

PubMed

Religa, Grzegorz; Jasińska, Małgorzata; Czyżewski, Łukasz; Torba, Krzysztof; Różański, Jacek

2014-10-21

Modern Polish medicine offers patients various treatments for end-stage treatment-resistant heart failure. Methods applied at the right time before the occurrence of irreversible changes in organs give a chance for survival and prolong life. Here, we report on the safety and efficacy of the sequential use of the above treatments in a 58-year old patient with heart failure in dilatative cardiomyopathy (DCM). A 7-day mechanical blood circulatory support and extracorporeal membrane oxygenation of blood (ECMO), followed by a 13-day implantation of a left ventricular assist device, Religa Heart EXT, was used as a bridge to a successful orthotopic heart transplant (OHT). On Day 40 after OHT, the patient was discharged home with stable function of the circulatory system. We describe our experiences with the qualification, preparation, and procedure of sequential ECMO, Religa Heart EXT, and OHT. Application of short-term ECMO as a bridge-to-bridge helped save the patient from severe cardiogenic shock caused by increased left ventricular afterload. The experimental implantation of an innovative Religa Heart EXT prosthesis was a safe and efficacious bridge to transplantation. Too short time of Religa Heart EXT implantation in the discussed patient prevented the possibility to evaluate the occurrence of thromboembolic complications and infections compared to the documented complications of POLVAD implanted until now. OHT is a safe and efficacious method of treatment of patients previously supported by ECMO and Religa Heart EXT.

Calfplasty.

PubMed

Felício, Y

2000-01-01

The author describes a method of calf augmentation by a silicone prosthesis implant for correction of asymmetrical legs or aesthetic problems. Preference is given to the placement of soft silicone implants (Glitzentein implants); they are more natural looking than hard implants. The implants are placed over both heads of the gastrocnemius muscle or beneath the fascia cruris superficialis. Operations were performed from November 1985 to August 1999. One hundred patients were studied: 95 female and 5 male. Two hundred calf implants were performed: 188 soft implants (Glitzenstein), 6 hard implants (Aiache), and 6 together on the same leg (Glitzenstein and Aiache implants). No infection problems, prosthesis rupture, or hematomas occurred. There were four seromas, but they disappeared in 15 days. Four prostheses were removed in two patients who did not like the final result. One prosthesis changed place, to the upper part of the calf. The operation is performed under sedative and local anesthesia, with an incision of approximately 4 to 5 cm in the popliteal pleat, at the same height as the fascia cruris. To date, no functional problem or muscular dysfunction has been provoked by silicone prosthesis implants. The patient walks 8 h after the surgery. We selected 500 patients who received implants in the legs with calf prostheses, fat implants, and prosthesis and fat implant together, during 14 years of follow-up, but the focus of this paper is a calf implant with prosthesis in 100 patients with 200 calf prosthesis implants.

Expandable right ventricular-to-pulmonary artery conduit: an animal study.

PubMed

Boudjemline, Younes; Laborde, François; Pineau, Emmanuelle; Mollet, Alix; Abadir, Sylvia; Borenstein, Nicolas; Behr, Luc; Bonhoeffer, Philipp

2006-06-01

This study was performed to assess a new vascular stent graft as an expandable valved conduit for right ventricular outflow tract (RVOT) reconstruction in sheep. Conduits were constructed by sewing an 18-mm valved conduit inside a stent. Crimped to 16 mm, they were implanted either under or without extracorporeal circulation in seven (group A) and in five (group B) sheep, respectively. Six weeks and 3 mo after their insertion, conduits were dilated intraluminally. A valved stent was implanted percutaneously into conduits before they were killed. Two animals from group A recovered normally, whereas five animals had a complicated postoperative course. In group B, one died acutely due to kinking of the conduit. Balloon dilatations were performed in all surviving animals. First dilatations had a slight impact on valvular function in all animals but one, whereas second dilatations led to significant PR in all. Transcatheter valve implantation was performed successfully. When animals were killed, no bleeding was found around the surgically implanted device. In conclusion, we designed a biologic valved conduit for RVOT reconstruction that can be dilated sequentially to follow animal growth. This new device can have tremendous applications in children with congenital heart diseases involving the RVOT.

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 who underwent transcatheter aortic valve implantation. Thus, classification of CKD stages before transcatheter aortic valve implantation is important for appropriate risk stratification. PMID:28289067

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 before transcatheter aortic valve implantation is important for appropriate risk stratification. Copyright © 2017 by the American Society of Nephrology.

The dynamic cardiac biosimulator: A method for training physicians in beating-heart mitral valve repair procedures.

PubMed

Leopaldi, Alberto M; Wrobel, Krzysztof; Speziali, Giovanni; van Tuijl, Sjoerd; Drasutiene, Agne; Chitwood, W Randolph

2018-01-01

Previously, cardiac surgeons and cardiologists learned to operate new clinical devices for the first time in the operating room or catheterization laboratory. We describe a biosimulator that recapitulates normal heart valve physiology with associated real-time hemodynamic performance. To highlight the advantages of this simulation platform, transventricular extruded polytetrafluoroethylene artificial chordae were attached to repair flail or prolapsing mitral valve leaflets. Guidance for key repair steps was by 2-dimensional/3-dimensional echocardiography and simultaneous intracardiac videoscopy. Multiple surgeons have assessed the use of this biosimulator during artificial chordae implantations. This simulation platform recapitulates normal and pathologic mitral valve function with associated hemodynamic changes. Clinical situations were replicated in the simulator and echocardiography was used for navigation, followed by videoscopic confirmation. This beating heart biosimulator reproduces prolapsing mitral leaflet pathology. It may be the ideal platform for surgeon and cardiologist training on many transcatheter and beating heart procedures. Copyright © 2017 The American Association for Thoracic Surgery. All rights reserved.

Superhydrophobicity to minimize thrombogenic risk on mechanical heart valves

NASA Astrophysics Data System (ADS)

Bark, David; Vahabi, Hamed; Movafaghi, Sanli; Popat, Ketul; Kota, Arun K.; Dasi, Lakshmi Prasad

2017-11-01

A large number of prosthetic heart valves are implanted each year to treat heart valve disease, where half of the surgically replaced valves are mechanical heart valves (MHV)s. MHVs are at high risk for thrombosis and therefore require lifelong antithrombotic therapies, causing an increased bleeding risk that can lead to death. To alleviate this need, we investigate the potential of superhydrophobic surfaces in reducing the thrombotic risk. Particle imaging velocimetry and computational fluid dynamics are used to quantify shear stress in the presence of potential slip on the surface. Coagulation and cell adhesion are quantified by incubating blood under static conditions. We further evaluate a dynamic blood response in polydimethylsiloxane channels under complex shear conditions that mimic the hinge region of bileaflet mechanical heart valves, a region known to exhibit thrombosis. Overall, Shear stress is not reduced on a superhydrophobic bileaflet MHV. However, superhydrophobic surfaces significantly reduce the potential for platelet responses under static and dynamic blood flow conditions, a counterintuitive result when considering that hydrophobic surfaces are prone to protein and cell adhesion. The authors gratefully acknowledge funding from National Institutes of Health (NIH) under Award Number R01HL119824 and F32HL129730. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

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 with normal aortic root geometry.

The Best Anticoagulation Therapy in Multiple-Trauma Patients with Mechanical Heart Valves: Evaluation of Latest Guidelines and Studies.

PubMed

Moeinipour, Aliasghar; Zarifian, Ahmadreza; Sheikh Andalibi, Mohammad Sobhan; Shamloo, Alireza Sepehri; Ahmadabadi, Ali; Amouzeshi, Ahmad; Hoseinikhah, Hamid

2015-12-22

It is common practice for patients with prosthetic cardiac devices, especially heart valve prosthesis, arterial stents, defibrillators, and pacemaker devices, to use anticoagulation treatment. When these patients suffer from multiple trauma after motor vehicle accidents, the best medical management for this challenging position is mandatory. This strategy should include a rapid diagnosis of all possible multiple organ injuries, with special attention to anticoagulation therapy so as to minimize the risk of thromboembolism complication in prosthetic devices. In this review, we describe the best medical management for patients with multiple trauma who use anticoagulants after heart valve replacement. We searched electronic databases PubMed/Medline, Scopus, Embase, and Google Scholar using the following terms: anticoagulant, warfarin, heparin, and multiple trauma. Also, similar studies suggested by the databases were included. Non-English articles were excluded from the review. For patients who use anticoagulation therapy, teamwork between cardiac surgeons, general surgeons, anesthesiologists, and cardiologists is essential. For optimal medical management, multiple consults between members of this team is mandatory for rapid diagnosis of all possible damaged organs, with special attention to the central nervous system, chest, and abdominal traumas. With this strategy, it is important to take note of anticoagulation drugs to minimize the risk of thromboembolism complications in cardiac devices. The best anticoagulant agents for emergency operations in patients with multiple trauma who are using an anticoagulant after heart valve replacement are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC).

Effect of Framework in an Implant-Supported Full-Arch Fixed Prosthesis: 3D Finite Element Analysis.

PubMed

Menini, Maria; Pesce, Paolo; Bevilacqua, Marco; Pera, Francesco; Tealdo, Tiziano; Barberis, Fabrizio; Pera, Paolo

2015-01-01

The aim of this study was to analyze through a three-dimensional finite element analysis (3D-FEA) stress distribution on four implants supporting a full-arch implant-supported fixed prosthesis (FFP) using different prosthesis designs. A 3D edentulous maxillary model was created and four implants were virtually placed into the maxilla and splinted, simulating an FFP without framework, with a cast metal framework, and with a carbon fiber framework. An occlusal load of 150 N was applied, stresses were transmitted into peri-implant bone, and prosthodontic components were recorded. 3D-FEA revealed higher stresses on the implants (up to +55.16%), on peri-implant bone (up to +56.93%), and in the prosthesis (up to +70.71%) when the full-acrylic prosthesis was simulated. The prosthesis with a carbon fiber framework showed an intermediate behavior between that of the other two configurations. This study suggests that the presence of a rigid framework in full-arch fixed prostheses provides a better load distribution that decreases the maximum values of stress at the levels of implants, prosthesis, and maxillary bone.

Influence of type of aortic valve prosthesis on coronary blood flow velocity.

PubMed

Jelenc, Matija; Juvan, Katja Ažman; Medvešček, Nadja Tatjana Ružič; Geršak, Borut

2013-02-01

Severe aortic valve stenosis is associated with high resting and reduced hyperemic coronary blood flow. Coronary blood flow increases after aortic valve replacement (AVR); however, the increase depends on the type of prosthesis used. The present study investigates the influence of type of aortic valve prosthesis on coronary blood flow velocity. The blood flow velocity in the left anterior descending coronary artery (LAD) and the right coronary artery (RCA) was measured intraoperatively before and after AVR with a stentless bioprosthesis (Sorin Freedom Solo; n = 11) or a bileaflet mechanical prosthesis (St. Jude Medical Regent; n = 11). Measurements were made with an X-Plore epicardial Doppler probe (Medistim, Oslo, Norway) following induction of hyperemia with an adenosine infusion. Preoperative and postoperative echocardiography evaluations were used to assess valvular and ventricular function. Velocity time integrals (VTI) were measured from the Doppler signals and used to calculate the proportion of systolic VTI (SF), diastolic VTI (DF), and normalized systolic coronary blood flow velocities (NSF) and normalized diastolic coronary blood flow velocities (NDF). The systolic proportion of the LAD VTI increased after AVR with the St. Jude Medical Regent prosthesis, which produced higher LAD SF and NSF values than the Sorin Freedom Solo prosthesis (SF, 0.41 ± 0.09 versus 0.29 ± 0.13 [P = .04]; NSF, 0.88 ± 0.24 versus 0.55 ± 0.17 [P = .01]). No significant changes in the LAD velocity profile were noted after valve replacement with the Sorin Freedom Solo, despite a significant reduction in transvalvular gradient and an increase in the effective orifice area. AVR had no effect on the RCA flow velocity profile. The coronary flow velocity profile in the LAD was significantly influenced by the type of aortic valve prosthesis used. The differences in the LAD velocity profile probably reflect differences in valve design and the systolic transvalvular flow pattern.

Which is the best antiaggregant or anticoagulant therapy after TAVI? A propensity-matched analysis from the ITER registry. The management of DAPT after TAVI.

PubMed

D'Ascenzo, Fabrizio; Benedetto, Umberto; Bianco, Matteo; Conrotto, Federico; Moretti, Claudio; D'Onofrio, Augusto; Agrifoglio, Marco; Colombo, Antonio; Ribichini, Flavio; Tarantini, Giuseppe; D'Amico, Maurizio; Salizzoni, Stefano; Rinaldi, Mauro

2017-12-08

The safety and efficacy of single vs. dual antiplatelet therapy (DAPT) in patients undergoing TAVI remain to be addressed. The aim of our study was to evaluate the usefulness of a DAPT compared to a single platelet therapy in patients undergoing TAVI with a balloon-expandable prosthesis. All consecutive patients enrolled in the ITER registry were included. Patients undergoing TAVI discharged with aspirin alone were compared to those taking DAPT before and after selection using propensity score with matching. Subgroup analysis was performed for those on OAT. Prosthetic heart valve dysfunction at follow-up was the primary endpoint, whereas all-cause death, cardiovascular death, bleedings, vascular complications and cerebrovascular accidents were the secondary ones. From 1,364 patients, after propensity score with matching, 605 were selected for each group (aspirin alone vs. DAPT). At 30 days, rates of VARC mortality were lower in patients with aspirin alone (1.5% vs. 4.1%, p=0.003), mainly driven by a reduction of major vascular complications (5.3% vs. 10.7%, p<0.001) and of major bleedings (6.6% vs. 11.5%, p<0.001), without a difference in prosthetic heart valve dysfunction after 45±14 months (2.8% vs. 3.0%, p=0.50). These results were confirmed on multivariable analysis. After TAVI with a balloon-expandable prosthesis, aspirin alone does not increase the risk of prosthetic valve dysfunction, and reduces the risk of periprocedural complications and of 30-day all-cause death.

Application of color Doppler flow mapping to calculate orifice area of St Jude mitral valve

NASA Technical Reports Server (NTRS)

Leung, D. Y.; Wong, J.; Rodriguez, L.; Pu, M.; Vandervoort, P. M.; Thomas, J. D.

1998-01-01

BACKGROUND: The effective orifice area (EOA) of a prosthetic valve is superior to transvalvular gradients as a measure of valve function, but measurement of mitral prosthesis EOA has not been reliable. METHODS AND RESULTS: In vitro flow across St Jude valves was calculated by hemispheric proximal isovelocity surface area (PISA) and segment-of-spheroid (SOS) methods. For steady and pulsatile conditions, PISA and SOS flows correlated with true flow, but SOS and not PISA underestimated flow. These principles were then used intraoperatively to calculate cardiac output and EOA of newly implanted St Jude mitral valves in 36 patients. Cardiac output by PISA agreed closely with thermodilution (r=0.91, Delta=-0.05+/-0.55 L/min), but SOS underestimated it (r=0.82, Delta=-1.33+/-0.73 L/min). Doppler EOAs correlated with Gorlin equation estimates (r=0.75 for PISA and r=0.68 for SOS, P<0.001) but were smaller than corresponding in vitro EOA estimates. CONCLUSIONS: Proximal flow convergence methods can calculate forward flow and estimate EOA of St Jude mitral valves, which may improve noninvasive assessment of prosthetic mitral valve obstruction.

Heart valve scaffold fabrication: Bioinspired control of macro-scale morphology, mechanics and micro-structure.

PubMed

D'Amore, Antonio; Luketich, Samuel K; Raffa, Giuseppe M; Olia, Salim; Menallo, Giorgio; Mazzola, Antonino; D'Accardi, Flavio; Grunberg, Tamir; Gu, Xinzhu; Pilato, Michele; Kameneva, Marina V; Badhwar, Vinay; Wagner, William R

2018-01-01

Valvular heart disease is currently treated with mechanical valves, which benefit from longevity, but are burdened by chronic anticoagulation therapy, or with bioprosthetic valves, which have reduced thromboembolic risk, but limited durability. Tissue engineered heart valves have been proposed to resolve these issues by implanting a scaffold that is replaced by endogenous growth, leaving autologous, functional leaflets that would putatively eliminate the need for anticoagulation and avoid calcification. Despite the diversity in fabrication strategies and encouraging results in large animal models, control over engineered valve structure-function remains at best partial. This study aimed to overcome these limitations by introducing double component deposition (DCD), an electrodeposition technique that employs multi-phase electrodes to dictate valve macro and microstructure and resultant function. Results in this report demonstrate the capacity of the DCD method to simultaneously control scaffold macro-scale morphology, mechanics and microstructure while producing fully assembled stent-less multi-leaflet valves composed of microscopic fibers. DCD engineered valve characterization included: leaflet thickness, biaxial properties, bending properties, and quantitative structural analysis of multi-photon and scanning electron micrographs. Quasi-static ex-vivo valve coaptation testing and dynamic organ level functional assessment in a pressure pulse duplicating device demonstrated appropriate acute valve functionality. Copyright © 2017. Published by Elsevier Ltd.

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 obstruction, annular rupture or with limited aortic valve calcification, the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-expanding stent. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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

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.

21 CFR 870.3800 - Annuloplasty ring.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency. (b) Classification. Class II (special...

Stroke prevention strategies in patients with atrial fibrillation and heart valve abnormalities: perceptions of 'valvular' atrial fibrillation: results of the European Heart Rhythm Association Survey.

PubMed

Potpara, Tatjana S; Lip, Gregory Y H; Larsen, Torben B; Madrid, Antonio; Dobreanu, Dan; Jędrzejczyk-Patej, Ewa; Dagres, Nikolaos

2016-10-01

The purpose of this European Heart Rhythm Association (EHRA) Survey was to assess the perceptions of 'valvular' atrial fibrillation (AF) and management of AF patients with various heart valve abnormalities in daily clinical practice in European electrophysiology (EP) centres. Questionnaire survey was sent via the Internet to the EHRA-EP Research Network Centres. Of the 52 responding centres, 42 (80.8%) were university hospitals. Choosing the most comprehensive definition of valvular AF, a total of 49 centres (94.2%) encountered a mechanical prosthetic heart valve and significant rheumatic mitral stenosis, 35 centres (67.3%) also considered bioprosthetic valves, and 25 centres (48.1%) included any significant valvular heart disease, requiring surgical repair in the definition of valvular AF. Only three centres (5.8%) would define valvular AF as the presence of any (even mild) valvular abnormality. None of the centres would use non-vitamin K antagonist oral anticoagulants (NOACs) in AF patients with mechanical prosthetic valves, only 5 centres (9.8%) would use NOACs in patients with significant mitral stenosis, 17 centres (32.7%) would consider the use of NOACs in patients with bioprosthetic valves, and 21 centres (41.2%) would use NOACs in patients with a non-recent transcatheter valve replacement/implantation, while 13 centres (25.5%) would never consider the use of NOACs in AF patients with even mild native heart valve abnormality. Our survey showed marked heterogeneity in the definition of valvular AF and thromboprophylactic treatments, with the use of variable NOACs in patients with valvular heart disease other than prosthetic heart valves or significant mitral stenosis, indicating that this term may be misleading and should not be used. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Implant and prosthesis movement after enucleation: a randomized controlled trial.

PubMed

Shome, Debraj; Honavar, Santosh G; Raizada, Kuldeep; Raizada, Deepa

2010-08-01

To evaluate implant and prosthesis movement after myoconjunctival enucleation and subsequent polymethyl methacrylate (PMMA) implantation, compared with the traditional enucleation with muscle imbrication using a PMMA implant and with enucleation accompanied by porous polyethylene implantation. Randomized, controlled, observer-masked, interventional study. One hundred fifty patients, equally and randomly allocated to the 3 groups. Group 1 consisted of patients in whom a PMMA implant was used after enucleation with muscle imbrication (traditional PMMA group). Group 2 consisted of patients in whom a PMMA implant was used after enucleation with a myoconjunctival technique (myoconjunctival PMMA group). Group 3 consisted of patients in whom a porous polyethylene implant was used after enucleation by the scleral cap technique (porous polyethylene group). Fifty patients were included in each group. Patients were allocated to 1 of the 3 groups using stratified randomization. Informed consent was obtained. Acrylic prostheses custom made by a trained ocularist were fitted 6 weeks after surgery in all patients. A masked observer measured implant and prosthesis movement 6 weeks after surgery using a slit-lamp device with real-time video and still photographic documentation. Analysis of implant and prosthesis movement was carried out using the Mann-Whitney U test, and a P value of < or =0.03 was considered significant. Complications including implant displacement and exposure also were noted. Implant and prosthesis movement. Myoconjunctival PMMA implant movement was better than the traditional PMMA implant (P = 0.001), but was similar to that of the porous polyethylene implant. Prosthesis movement with the myoconjunctival PMMA implant was better than that of either the traditional PMMA (P = 0.001) or porous polyethylene (P = 0.002) implants. Myoconjunctival enucleation technique with a PMMA implant provides statistically and clinically significantly better implant and prosthesis movement than the traditional PMMA implant and better prosthesis movement than the porous polyethylene implant. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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.

Pathology in patients with ventricular assist devices: a study of 21 autopsies, 24 ventricular apical core biopsies and 24 explanted hearts.

PubMed

Rose, Alan G; Park, Soon J

2005-01-01

Ventricular assist devices (VADs) are used as a bridge to cardiac transplantation or as a permanent or sometimes temporary treatment for end stage heart failure. Our autopsy and surgical pathology experience with VADs prior to August 2002 was reviewed. Noted were patient's age, sex, underlying (UCOD) and proximate causes of death (PCOD), duration of VAD implantation, presence of native or prosthetic valvar disease and organ complications. Myocardium from biopsies and explanted hearts were blindly assessed for coagulative necrosis (CN), contraction bands (CB), myocytolysis (MC), increased eosinophilia (IE), myocyte waviness (MW) and fibrosis (F). Each was graded as either mild (score 1), moderate (score 2) or severe (score 3). Autopsy patients: Twenty-one patients, with mean age 55 years (range 10-73), comprised 10 women and 11 men. UCOD was ischemic disease in 16 patients, dilated cardiomyopathy in 4 and aortic valve disease in 1. The mean duration of VAD implantation was 125.7 days (range 1-1095 days, S.D.=253.6). Five patients had biventricular VADs, and 16 had LVAD only. Acquired aortic valve fusion was noted in three patients. PCOD was VAD related in six, donor heart problem in four, cerebrovascular accident in four, miscellaneous in three, pulmonary hypertension in two and aortic disease in two patients. Morbidity: local liver necrosis in seven, acquired aortic valve disease in four, gut infarction in three, abdominal aortic aneurysm in two and host cell assault against VAD porcine aortic valves in one case. Biopsies and explanted hearts: Twenty-four patients had a mean age of 53 years (range 38-68, S.D.=8.6). VADs were implanted for 177.8 days (range 7-593 days, S.D.=151.1). Comparison of histologic scores of biopsies with explanted hearts showed the following: CN 1.33 (S.D.=1.4)/0.21 (S.D.=0.66; P<.001); CB: 2.1 (S.D.=0.93)/0.83 (S.D.=0.28; NS); MC: 0.88 (S.D.=1.19)/0.13 (S.D.=0.34; P<.01); IE: 1.71 (S.D.=1.27)/0.38 (S.D.=0.65; NS); fibrosis: 1.08 (S.D.=1.35)/1.75 (S.D.=1.26; NS); and MW: 1.50 (S.D.=1.22)/0.59 (S.D.=0.73; P<.01). Acquired aortic stenosis developed in six hearts, and one heart showed thrombotic occlusion of the left ventricular outflow tract below an aortic bioprosthesis. VAD significantly reduced the amount of CN, MC and MW in the left ventricle but may lead to acquired aortic stenosis of native aortic valves or total occlusive thrombosis of aortic prosthetic valves. Proximate cause of death was, most often, VAD related.

A novel open-tray impression technique for fabrication of a provisional prosthesis on immediate load implants in a completely edentulous arch.

PubMed

Kaneko, Takahiro; Yamagishi, Kiyoshi; Horie, Norio; Shimoyama, Tetsuo

2013-01-01

To evaluate the clinical outcome of a novel open-tray impression technique for fabrication of a provisional prosthesis supported by immediately loaded implants in a completely edentulous arch. An open-tray impression technique was evaluated in this retrospective study that included patients treated between March 2006 and October 2009. Preoperatively, a diagnostic prosthesis was delivered, and a novel open tray was fabricated based on this prosthesis. After implant placement, the impression and interocclusal record were taken simultaneously using the novel open tray. Laboratory-fabricated, screw-retained, all-acrylic resin provisional restorations were delivered on the same day of surgery. The prosthesis was assessed from the day of surgery until replacement with a definitive prosthesis. The study included 21 patients (mean age, 64.5 years) and a total of 125 implants. Of these, 104 implants were immediately loaded. In all patients, well-fitting provisional restorations supported by a minimum of four implants were delivered. Fracture of the first molar cusp was observed in one case after 30 days. However, there was no extensive fracture in the framework or functional disorder of the prosthesis. No implant failed during the follow-up after implant surgery. This protocol enabled fabrication of a well-fitting acrylic resin provisional prosthesis supported by immediately loaded implants because the impression was taken while in centric occlusion and an occlusion identical to the diagnostic prosthesis could be reconstructed.

Modelling and numerical simulation of the in vivo mechanical response of the ascending aortic aneurysm in Marfan syndrome.

PubMed

García-Herrera, Claudio M; Celentano, Diego J; Herrera, Emilio A

2017-03-01

Marfan syndrome (MFS) is a genetic disorder that affects connective tissue, impairing cardiovascular structures and function, such as heart valves and aorta. Thus, patients with Marfan disease have a higher risk of developing circulatory problems associated with mitral and aortic valves prolapse, manifested as dilated aorta and aortic aneurysm. However, little is known about the biomechanical characteristics of these structures affected with MFS. This study presents the modelling and simulation of the mechanical response of human ascending aortic aneurysms in MFS under in vivo conditions with intraluminal pressures within normotensive and hypertensive ranges. We obtained ascending aortic segments from five adults with MFS subjected to a vascular prosthesis implantation replacing an aortic aneurysm. We characterised the arterial samples via ex vivo tensile test measurements that enable fitting the material parameters of a hyperelastic isotropic constitutive model. Then, these material parameters were used in a numerical simulation of an ascending aortic aneurysm subjected to in vivo normotensive and hypertensive conditions. In addition, we assessed different constraints related to the movement of the aortic root. Overall, our results provide not only a realistic description of the mechanical behaviour of the vessel, but also useful data about stress/stretch-based criteria to predict vascular rupture. This knowledge may be included in the clinical assessment to determine risk and indicate surgical intervention.

From tricuspid to double orifice Morphology: Percutaneous tricuspid regurgitation repair with the MitraClip device in congenitally corrected-transposition of great arteries.

PubMed

Picard, Fabien; Tadros, Victor-Xavier; Asgar, Anita W

2017-09-01

Edge to edge transcatheter mitral valve repair with MitraClip (Abbott Vascular, Menlo Park, CA) is increasing for high-risk surgical patients with significant mitral regurgitation. Patients with congenitally corrected transposition of the great arteries (CCTGA) presenting with tricuspid valve regurgitation of a systemic right ventricle may represent particularly challenging candidates for MitraClip given their anatomy. We report the case of a 67-year-old gentleman with CCTGA and severe tricuspid regurgitation who was referred for MitraClip implantation after heart team consensus. Successful implantation of one clip was performed, achieving a significant reduction of the regurgitation. Similarly, favorable findings were confirmed at 6 months, 1 and 2 years follow-up and the patient had no recurrent heart failure admissions after 2-year follow-up. We describe the technical considerations and the importance of 3D-transoesophageal echocardiography for performing the MitraClip of a trileaflet systemic atrioventricular valve. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Elective removal of convexo-concave Björk-Shiley valves.

PubMed

Rajesh, P B; Smith, G H; Lawford, P V; Black, M M

1994-08-01

Replacement has been an accepted method for treating advanced cardiac valvular disease for more than 25 years. However, the perfect prosthesis has yet to be developed, judging by the number of devices available. A prosthesis that initially appears promising may cause problems in due course, and indeed some devices have been modified or withdrawn from clinical use. A notable example of a prosthetic valve that has give problems is the Björk-Shiley convexo-concave prosthesis, some models of which have undergone mechanical failure due to strut fracture. We report the elective removal of such a valve and the subsequent examination of the prosthesis. The results of this examination suggest that a policy of elective removal is justified.

Pediatric Tubular Pulmonary Heart Valve from Decellularized Engineered Tissue Tubes

PubMed Central

Reimer, Jay M.; Syedain, Zeeshan H.; Haynie, Bee H.T.; Tranquillo, Robert T.

2015-01-01

Pediatric patients account for a small portion of the heart valve replacements performed, but a pediatric pulmonary valve replacement with growth potential remains an unmet clinical need. Herein we report the first tubular heart valve made from two decellularized, engineered tissue tubes attached with absorbable sutures, which can meet this need, in principle. Engineered tissue tubes were fabricated by allowing ovine dermal fibroblasts to replace a sacrificial fibrin gel with an aligned, cell-produced collagenous matrix, which was subsequently decellularized. Previously, these engineered tubes became extensively recellularized following implantation into the sheep femoral artery. Thus, a tubular valve made from these tubes may be amenable to recellularization and, ideally, somatic growth. The suture line pattern generated three equi-spaced “leaflets” in the inner tube, which collapsed inward when exposed to back pressure, per tubular valve design. Valve testing was performed in a pulse duplicator system equipped with a secondary flow loop to allow for root distention. All tissue-engineered valves exhibited full leaflet opening and closing, minimal regurgitation (< 5%), and low systolic pressure gradients (< 2.5 mmHg) under pulmonary conditions. Valve performance was maintained under various trans-root pressure gradients and no tissue damage was evident after 2 million cycles of fatigue testing. PMID:26036175

Comparative experimental re-evaluation of the two implanting methods of silicone gel testicular prostheses in beagle dogs

PubMed Central

2011-01-01

Background Testicular prosthesis has been applied clinically for decades, and implantation of testis prosthesis under the tunica albuginea has been considered to be the standard method in the most of the reports. However, postoperative scrotal appearance, the mobilization and the palpitation of the prosthesis are not always satisfactory to all the patients. Modifications in surgical techniques might be necessary to bring improvements to the clinical outcomes in testicular prosthesis implantation. Findings In a group of 9 beagle dogs in this study, an orchiectomy succeeded with a testicular prosthesis implantation under the tunica vaginalis, and a complete mechanical denudation of the testicular parenchyma succeeded with an implantation under the tunica albuginea were performed, respectively. Histopathological evaluations of the scrotal tissues and the implants, which were made at the end of the follow-up, showed that all the tested animals lived uneventful lives during the follow-up period, and no rejections or infections were found. Prostheses implanted under the tunica vaginalis showed a more satisfying mobilization and palpation than those implanted under the tunica albuginea. Chronic inflammation in the para-prosthesis tissues with vascular proliferation and fibrinogenesis were more common in the "under tunica albuginea" group than that in the "under tunica vaginalis" group, although differences in fibrinogenesis between the two groups were found to be statistically insignificant. Conclusions In this comparative study, we have re-evaluated the two most popular implantation methods of testicular prosthesis, the "under the tunica albuginea" and the "under the tunica vaginalis" pathways, in animal models. We found that the testicular prosthesis were all well tolerated, but the prosthesis implanted under the tunica vaginalis showed a more satisfying result concerning appearance, palpability, and histopathological findings than that of the "under the tunica albuginea" group. The "under the tunica vaginalis" method might become a more practical method for future testicular prosthesis implantation. PMID:21457571

Exertional Angina Due To Fused Aortic Bioprosthesis During Left Ventricular Assist Device Support: Two Cases and Review of the Literature.

PubMed

Bonios, Michael J; Selzman, Craig H; Gilbert, Edward M; McKellar, Stephen H; Koliopoulou, Antigoni; Strege, Jennifer L; Nativi, Jose N; Fang, James C; Stehlik, Josef; Drakos, Stavros G

We present the case of two patients with idiopathic dilated cardiomyopathy and moderate aortic valve regurgitation that were treated with a bioprosthetic valve at the time of the left ventricular assist device (LVAD) implantation. A few months later, patients revealed partial recovery in the left ventricle systolic function. Both patients, during the LVAD turndown protocol, reported the onset of chest pain. The transthoracic echocardiography revealed the presence of a new transaortic pressure gradient. We confirmed the presence of a fused bioprosthetic valve by further performing a transesophageal echocardiogram and a left and right heart catheterization. Replacement of aortic valve at the time of an LVAD implantation constitutes a challenging case. Although a mechanical valve is contraindicated due to the increased thromboembolic risk, selecting a bioprosthetic valve increases the risk of valve leaflets fusion. The consequences of this phenomenon should be acknowledged in LVAD patients undergoing aortic valve replacement with a bioprosthetic, especially under the view of LVAD explantation for those revealing myocardial recovery under mechanical unloading.

Tricuspid valve regurgitation after heart transplantation.

PubMed

Kwon, Murray H; Shemin, Richard J

2017-05-01

Tricuspid valve regurgitation (TVR) in the orthotopic heart transplant (OHT) recipient is quite common and has varied clinical sequelae. In its severest forms, it can lead to right-sided failure symptoms indistinguishable from that seen in native heart TVR disease. While certain implantation techniques are widely recognized to reduce the risk of TVR in the cardiac allograft, concomitant tricuspid annuloplasty, while having advocates, is not currently accepted as a routinely established adjunct. Decisions to surgically correct TVR in the OHT recipient must be made carefully, as certain clinical scenarios have high risk of failure. Like in the native heart, anatomic etiologies typically have the greatest chances for success compared to functional etiologies. While repair options have been utilized, there is emerging data to support replacement as the more durable option. While mechanical prostheses are impractical in the heart transplant recipient, biologic valves offer the advantage of continued access to the right ventricle for biopsies in addition to acceptable durability in the low pressure system of the right side.

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

2013 update on congenital heart disease, clinical cardiology, heart failure, and heart transplant.

PubMed

Subirana, M Teresa; Barón-Esquivias, Gonzalo; Manito, Nicolás; Oliver, José M; Ripoll, Tomás; Lambert, Jose Luis; Zunzunegui, José L; Bover, Ramon; García-Pinilla, José Manuel

2014-03-01

This article presents the most relevant developments in 2013 in 3 key areas of cardiology: congenital heart disease, clinical cardiology, and heart failure and transplant. Within the area of congenital heart disease, we reviewed contributions related to sudden death in adult congenital heart disease, the importance of specific echocardiographic parameters in assessing the systemic right ventricle, problems in patients with repaired tetralogy of Fallot and indication for pulmonary valve replacement, and confirmation of the role of specific factors in the selection of candidates for Fontan surgery. The most recent publications in clinical cardiology include a study by a European working group on correct diagnostic work-up in cardiomyopathies, studies on the cost-effectiveness of percutaneous aortic valve implantation, a consensus document on the management of type B aortic dissection, and guidelines on aortic valve and ascending aortic disease. The most noteworthy developments in heart failure and transplantation include new American guidelines on heart failure, therapeutic advances in acute heart failure (serelaxin), the management of comorbidities such as iron deficiency, risk assessment using new biomarkers, and advances in ventricular assist devices. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Collagen Matrix Remodeling in Stented Pulmonary Arteries after Transapical Heart Valve Replacement.

PubMed

Ghazanfari, Samaneh; Driessen-Mol, Anita; Hoerstrup, Simon P; Baaijens, Frank P T; Bouten, Carlijn V C

2016-01-01

The use of valved stents for minimally invasive replacement of semilunar heart valves is expected to change the extracellular matrix and mechanical function of the native artery and may thus impair long-term functionality of the implant. Here we investigate the impact of the stent on matrix remodeling of the pulmonary artery in a sheep model, focusing on matrix composition and collagen (re)orientation of the host tissue. Ovine native pulmonary arteries were harvested 8 (n = 2), 16 (n = 4) and 24 (n = 2) weeks after transapical implantation of self-expandable stented heart valves. Second harmonic generation (SHG) microscopy was used to assess the collagen (re)orientation of fresh tissue samples. The collagen and elastin content was quantified using biochemical assays. SHG microscopy revealed regional differences in collagen organization in all explants. In the adventitial layer of the arterial wall far distal to the stent (considered as the control tissue), we observed wavy collagen fibers oriented in the circumferential direction. These circumferential fibers were more straightened in the adventitial layer located behind the stent. On the luminal side of the wall behind the stent, collagen fibers were aligned along the stent struts and randomly oriented between the struts. Immediately distal to the stent, however, fibers on both the luminal and the adventitial side of the wall were oriented in the axial direction, demonstrating the stent impact on the collagen structure of surrounding arterial tissues. Collagen orientation patterns did not change with implantation time, and biochemical analyses showed no changes in the trend of collagen and elastin content with implantation time or location of the vascular wall. We hypothesize that the collagen fibers on the adventitial side of the arterial wall and behind the stent straighten in response to the arterial stretch caused by oversizing of the stent. However, the collagen organization on the luminal side suggests that stent-induced remodeling is dominated by contact guidance. © 2016 S. Karger AG, Basel.

[Initial experience of transcatheter implantation with a new aortic valve in sheep].

PubMed

Wang, Jian-ming; Yang, Jian; Yang, Li-fang; Zhang, Xue-xin; Hu, Yun; Liu, Jin-cheng; Yu, Shi-qiang; Yi, Ding-hua

2011-11-01

To evaluate the feasibility and short-term results of transcatheter aortic valve implantation (TAVI) using a new transcatheter valve. Twenty healthy adult sheep received general anesthesia. Under the guidance of X-ray and transthoracic echocardiography (TTE), the new anti-calcification transcatheter valve was released from delivery system and implanted at the level of native aortic annulus via left common carotid artery. Position and function of the new anti-calcification transcatheter valve were evaluated by angiography and TTE immediately after intervention. Thirty day survival rate of animals was obtained. New transcatheter valves were implanted in all sheep. Fifteen sheep (75%) survived up to 30 days and post-operative examination showed that the transcatheter valve was in optimal position without migration and mitral valve impingement. The native coronary artery was patent in these animals. There was a slight paravalvular leak in 5 sheep. Postoperative echocardiography showed reflux percentage was significantly increased (P < 0.05) compared pre-intervention. Effective orifice area, aortic systolic pressure, diastolic aortic pressure, mean aortic pressure, left ventricular systolic pressure, left ventricular end diastolic pressure and heart rate were similar between post and pre-intervention (all P < 0.05). Five sheep died after TAVI within 30 days, including one fatal ventricular fibrillation occurred immediately after releasing the transcatheter valve and another sheep died of acute myocardial infarction due to left main coronary artery occlusion evidenced by angiography. Two sheep died of severe mitral regurgitation at 8 and 12 hours post-operation and one died of infective endocarditis at 26 days after intervention. Our favorable preliminary results showed that it was feasible to perform TAVI using the new transcatheter valve.

The valve choice in tricuspid valve replacement: 25 years of experience.

PubMed

Van Nooten, G J; Caes, F L; François, K J; Taeymans, Y; Primo, G; Wellens, F; Leclerq, J L; Deuvaert, F E

1995-01-01

This study reviews 146 consecutive patients who underwent tricuspid valve replacement (TVR) with 69 bioprostheses (porcine and bovine pericardial) and 77 mechanical ball, disc or bileaflet valves between 1967 and 1987. The mean age was 51.4 +/- 12.1 years. Preoperatively, 97% were in New York Heart Association (NYHA) functional class III or more and over 40% had undergone previous cardiac surgery. Hospital mortality was high (16.1%). Incremental risk factors for hospital death were preoperative icterus (P < 0.01), hepatomegaly (P = 0.02), NYHA functional class IV (P = 0.02) and male sex (P = 0.04) (univariate analysis). Ninety-eight percent of the hospital survivors were followed up for a mean of 92 months. Cumulative follow-up added up to 955 patient-years. There were 70 late deaths. The actuarial survival rate was 74% at 60 months and less than 25% at 14 years. Incremental risk factors for late death indicated by univariate analysis were the type of tricuspid prosthesis (Smel-off-Cutter and Kay-Shiley prostheses) (P = 0.04), the type of operative myocardial protection (normothermia and coronary perfusion) (P = 0.05) and preoperative NYHA functional class IV (P = 0.05). We conclude that TVR carries a high operative risk and poor long-term survival, both influenced by preoperative and perioperative variables. Bearing in mind the poor prognosis for TVR, we prefer a large-sized bioprosthesis, in view of its initial good durability and low risk of valve-related events. However, in patients with good life expectancy, a bileaflet mechanical prosthesis may be an acceptable alternative.

Development and marketing of a prosthetic urinary control valve system

NASA Technical Reports Server (NTRS)

Tenney, J. B., Jr.; Rabinowitz, R.; Rogers, D. W.; Harrison, H. N.

1983-01-01

An implantable prosthetic for the control of urinary incontinence was developed and marketed. Three phases are presented: bench development studies, animal trials, and human clinical trials. This work was performed under the direction of a Research Team at Rochester General Hospital (RGH). Bench trials were completed on prototype hardware and provided early verification of the device's ability to withstand repeated cyclic testing. Configurational variants were evaluated and a preferred design concept was established. Silicone rubber (medical grade) was selected as the preferred material for the prosthesis.

CardiaMed mechanical valve: mid-term results of a multicenter clinical trial.

PubMed

Nazarov, Vladimir M; Zheleznev, Sergey I; Bogachev-Prokophiev, Alexandr V; Afanasyev, Alexandr V; Nemchenko, Eugene V; Jeltovskiy, Yuri V; Lavinyukov, Sergey O

2014-01-01

Prosthesis choice is a major concern in valvular surgery. A multicenter clinical trial was performed to assess the efficacy and safety of the CardiaMed prosthetic heart valve. The study enrolled 420 patients who underwent mitral (209) or aortic (211) valve replacement from 2003 to 2004 at 7 institutions in Russia, and who were followed up from 2006 to 2011. The mean age was 52.2 ± 10.2 years (range, 12-78 years), 47.4% were female, and 99.05% completed the study. The maximum observation term was 7.5 years (2188.5 patient-years); 1081.6 patient-years for aortic and 1106.9 patient-years for mitral valve replacement. The overall 7-year survival rate was 85.1%  ± 3.7%; 86.1%  ± 4.8% and 84.4%  ± 5.4% for aortic and mitral valve replacement, respectively. The 7-year freedom from valve-related death was 93.9%  ± 3.7% and 94.5%  ± 3.2% for aortic and mitral valve replacement, respectively. When early mortality (<30 days) was excluded, these rates were 94.8%  ± 3.1% and 93.8%  ± 3.82%, respectively. Linearized valve-dependent complication rates were determined for structural valve failure (0%/patient-year overall), thrombosis (0.63%/patient-year, all for mitral valve replacement), thromboembolic complications including transient neurologic deficits (0.13%/patient-year overall, 0.5%/patient-year for aortic valve replacement, 0.8%/patient-year for mitral valve replacement), hemorrhagic bleeding (0.64%/patient-year overall, 0.55%/patient-year for aortic valve replacement, 0.09%/patient-year for mitral valve replacement), prosthetic endocarditis (0.28%/patient-year overall, 0.28%/patient-year for aortic valve replacement, 0%/patient-year for mitral valve replacement), and hemolysis (0%/patient-year overall). The CardiaMed mechanical heart valve prostheses meets world standards of safety and efficacy.

[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.

[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 fraction in abnormal tricuspid group was lower than that in normal tricuspid group during the follow-up. Abnormal TR after PPI during a long-term follow-up is quite common. The related factors include the time interval from the first pacemaker implantation, number of transtricuspid lead, right atrial size, mild TR and MR pre-implantation.

Mitral Transcatheter Technologies

PubMed Central

Maisano, Francesco; Buzzatti, Nicola; Taramasso, Maurizio; Alfieri, Ottavio

2013-01-01

Mitral valve regurgitation (MR) is often diagnosed in patients with heart failure and is associated with worsening of symptoms and reduced survival. While surgery remains the gold standard treatment in low-risk patients with degenerative MR, in high-risk patients and in those with functional MR, transcatheter procedures are emerging as an alternative therapeutic option. MitraClip® is the device with which the largest clinical experience has been gained to date, as it offers sustained clinical benefit in selected patients. Further to MitraClip implantation, several additional approaches are developing, to better match with the extreme variability of mitral valve disease. Not only repair is evolving, initial steps towards percutaneous mitral valve implantation have already been undertaken, and initial clinical experience has just started. PMID:23908865

Conservative Management of Retained Cardiac Missiles: Case Report and Literature Review

DTIC Science & Technology

2009-08-01

al87 implanted metal foreign bodies in the heart and pericardium of dogs and showed that by 8 weeks, the metal was completely encapsulated by fibrous...wound involving the heart. Int J Cardiol. 2006; 108:408-409. 78. Aubert S, Neto OS, Pawale A, et al. Late mitral valve regurgitation after bullet

Fungal Endocarditis Due to Aspergillus oryzae: The First Case Reported in the Literature.

PubMed

Mazza, Andrea; Luciani, Nicola; Luciani, Marco; Cammertoni, Federico; Giaquinto, Alessia; Pavone, Natalia; Bruno, Piergiorgio; Massetti, Massimo

2017-03-01

Infective endocarditis (IE) is a severe disease with high mortality and morbidity. Prosthetic valve endocarditis is a life-threatening complication which can occur in less than 10% of patients with valve prosthesis. A fungal etiology of IE is rare and accounts for only 2-4% of all case of endocarditis, but is associated with a higher mortality and morbidity. Herein is reported the first case of fungal endocarditis of aortic valve prosthesis due to Aspergillus oryzae in a 67-year-old caucasian man who nine years previously underwent mitral and aortic valve replacement with mechanical prostheses, and tricuspid annuloplasty for acute IE due to Enterococcus spp. Seven months previously, the patient also underwent a redo cardiac procedure to replace a mitral valve prosthesis with a new mechanical device due to a leakage. Aspergillus oryzae showed impressive growth with strong and unexpected virulence in both local and systemic settings.

Single leg separation prevalence among explanted Björk-Shiley prosthetic heart valves.

PubMed

Blot, William J; Signorello, Lisa B; Cohen, Sarah S; Ibrahim, Michel A

2007-11-01

Björk-Shiley convexo-concave (BSCC) prosthetic heart valves are believed to have been implanted in over 86,000 patients worldwide. Limited data are available on the prevalence of single leg separations (SLS) of the valves' outlet struts, a potential precursor to complete valve fracture. Data maintained by the manufacturer, including results of examinations for SLS in explanted valves, were merged with available information on the characteristics of the valve. The prevalence of SLS in the examined valves was calculated according to valve angle, size, position, and study. Among 343 examined valves, the overall prevalence of SLS was 8.2%, but this varied significantly by valve size, being three-fold higher among 29+ mm valves than among smaller valves, with statistically non-significantly higher prevalences among mitral than aortic, and among 70 degrees than 60 degrees valves. By applying the size, position and angle-specific SLS prevalences to the worldwide valve distribution, it is estimated that SLS may be present in 6.8% (95% confidence limits 4.1-9.4%) of all BSCC valves. These findings suggest that SLS may affect between 820 and 1,880 of the almost 20,000 BSCC valves among surviving patients worldwide. Such estimates help frame the context for potential patient screenings, should imaging and acoustic techniques to detect SLS become available.

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.

The marvel of percutaneous cardiovascular devices in the elderly.

PubMed

Guidoin, Robert; Douville, Yvan; Clavel, Marie-Annick; Zhang, Ze; Nutley, Mark; Pîbarot, Philippe; Dionne, Guy

2010-06-01

Thanks to minimally invasive procedures, frail and elderly patients can also benefit from innovative technologies. More than 14 million implanted pacemakers deliver impulses to the heart muscle to regulate the heart rate (treating bradycardias and blocks). The first human implantation of defibrillators was performed in early 2000. The defibrillator detects cardiac arrhythmias and corrects them by delivering electric shocks. The ongoing development of minimally invasive technologies has also broadened the scope of treatment for elderly patients with vascular stenosis and aneurysmal disease as well as other complex vascular pathologies. The nonsurgical cardiac valve replacement represents one of the most recent and exciting developments, demonstrating the feasibility of replacing a heart valve by way of placement through an intra-arterial or trans-ventricular sheath. Percutaneous devices are particularly well suited for the elderly as the surgical risks of minimally invasive surgery are considerably less as compared to open surgery, leading to a shorter hospital stay, a faster recovery, and improved quality of life.

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.

Design considerations and quantitative assessment for the development of percutaneous mitral valve stent.

PubMed

Kumar, Gideon Praveen; Cui, Fangsen; Phang, Hui Qun; Su, Boyang; Leo, Hwa Liang; Hon, Jimmy Kim Fatt

2014-07-01

Percutaneous heart valve replacement is gaining popularity, as more positive reports of satisfactory early clinical experiences are published. However this technique is mostly used for the replacement of pulmonary and aortic valves and less often for the repair and replacement of atrioventricular valves mainly due to their anatomical complexity. While the challenges posed by the complexity of the mitral annulus anatomy cannot be mitigated, it is possible to design mitral stents that could offer good anchorage and support to the valve prosthesis. This paper describes four new Nitinol based mitral valve designs with specific features intended to address migration and paravalvular leaks associated with mitral valve designs. The paper also describes maximum possible crimpability assessment of these mitral stent designs using a crimpability index formulation based on the various stent design parameters. The actual crimpability of the designs was further evaluated using finite element analysis (FEA). Furthermore, fatigue modeling and analysis was also done on these designs. One of the models was then coated with polytetrafluoroethylene (PTFE) with leaflets sutured and put to: (i) leaflet functional tests to check for proper coaptation of the leaflet and regurgitation leakages on a phantom model and (ii) anchorage test where the stented valve was deployed in an explanted pig heart. Simulations results showed that all the stents designs could be crimped to 18F without mechanical failure. Leaflet functional test results showed that the valve leaflets in the fabricated stented valve coapted properly and the regurgitation leakage being within acceptable limits. Deployment of the stented valve in the explanted heart showed that it anchors well in the mitral annulus. Based on these promising results of the one design tested, the other stent models proposed here were also considered to be promising for percutaneous replacement of mitral valves for the treatment of mitral regurgitation, by virtue of their key features as well as effective crimping. These models will be fabricated and put to all the aforementioned tests before being taken for animal trials. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

Transition from a fixed implant dental prosthesis to an implant overdenture in an edentulous patient: a clinical report.

PubMed

Ali, Bolouri; Bhavani, Venkatachalam

2014-09-01

The lack of planning before implant placement and restoration in edentulous patients can lead to a number of problems. Prosthodontists are often faced with the challenge of re-treating patients who have only recently been treated. Although many reports discuss retreatment by fabricating all new prosthetic components, few discuss salvaging parts of the patient's existing prosthesis. This report details the treatment of an edentulous patient who presented with an implant-retained fixed dental prosthesis in the maxillary arch and no opposing prosthesis. The transition from an implant-retained fixed dental prosthesis to a removable implant- and tissue-supported overdenture that uses the patient's existing computer-aided design/computer-aided manufacturing milled titanium substructure is described. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Characterizing the Collagen Fiber Orientation in Pericardial Leaflets Under Mechanical Loading Conditions

PubMed Central

Alavi, S. Hamed; Ruiz, Victor; Krasieva, Tatiana; Botvinick, Elliot L.; Kheradvar, Arash

2014-01-01

When implanted inside the body, bioprosthetic heart valve leaflets experience a variety of cyclic mechanical stresses such as shear stress due to blood flow when the valve is open, flexural stress due to cyclic opening and closure of the valve, and tensile stress when the valve is closed. These types of stress lead to a variety of failure modes. In either a natural valve leaflet or a processed pericardial tissue leaflet, collagen fibers reinforce the tissue and provide structural integrity such that the very thin leaflet can stand enormous loads related to cyclic pressure changes. The mechanical response of the leaflet tissue greatly depends on collagen fiber concentration, characteristics, and orientation. Thus, understating the microstructure of pericardial tissue and its response to dynamic loading is crucial for the development of more durable heart valve, and computational models to predict heart valves’ behavior. In this work, we have characterized the 3D collagen fiber arrangement of bovine pericardial tissue leaflets in response to a variety of different loading conditions under Second-Harmonic Generation Microscopy. This real-time visualization method assists in better understanding of the effect of cyclic load on collagen fiber orientation in time and space. PMID:23180029

Timing of anticoagulant re-initiation following intracerebral hemorrhage in mechanical heart valves: Survey of neurosurgeons and thrombosis experts.

PubMed

AlKherayf, Fahad; Xu, Yan; Westwick, Harrison; Moldovan, Ioana Doina; Wells, Philip S

2017-03-01

While oral anticoagulation (OAC) is universally indicated for patients with mechanical heart valves (MHVs), OAC resumption following anticoagulant-associated intracerebral hemorrhage (ICH) is an area of uncertainty. We sought to determine the practice preferences of North American neurosurgeons and thrombosis experts on optimal timing of OAC re-initiation. A cross-sectional survey was disseminated to North American members of the American Association of Neurological Surgeons and the International Society for Thrombosis and Haemostasis. Demographic factors, as well as a clinical scenario with 14 modifiable clinical risk factors were included in the survey. 504 physicians completed our survey (response rate 34.3%). Majority of participants were affiliated with academic centres, and managed≤10 ICH patients with MHV per year. There was wide distribution in response in optimal timing for OAC resumption following an ICH: 59% and 60% preferred to re-start OAC between 3 and 14 days following the hemorrhagic event (median of 6-7 days). Smaller hemorrhages (<30cm 2 ). CHADS 2 score ≥2, concomitant venous thromboembolism, mitral valve prosthesis, caged-ball valves and multiple valves prompted earlier OAC resumption. Wide variation in the current practice of neurosurgeons and thrombosis specialists exist when they encounter patients with ICH and MHV, though decisions were influenced by patient- and valve-related factors. As our observed variation likely reflects the immense gap in current evidence, prospective randomized trials in this population are therefore urgently needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Penile Prosthesis Implantation in Patients with a History of Total Phallic Construction.

PubMed

Zuckerman, Jack M; Smentkowski, Katherine; Gilbert, David; Storme, Oscar; Jordan, Gerald; Virasoro, Ramon; Tonkin, Jeremy; McCammon, Kurt

2015-12-01

Outcomes following penile prosthesis implantation in patients with a history of total phallic construction are not well described. The aim of this study was to evaluate outcomes following neophallus penile prosthesis placement. Retrospective review penile prosthesis placement in patients with prior total phallic construction. GORE-TEX® (Gore Medical, Flagstaff, AZ) sleeve neotunica construction was utilized in all patients. Success defined as patient sexual activity with a functioning prosthesis. Thirty-one patients underwent neophallic prosthesis implantation at a mean 35.6 years of age. Prosthesis placement occurred at an average 56.3 months following phallic construction and follow-up was a mean of 59.7 months. Malleable prostheses were placed in 21 patients and inflatable in 10; implants were bilateral in 94%. Six percent experienced operative complications including a bladder injury (1) and phallic flap arterial injury (1). Postoperative complications occurred in 23% at a median 5.5 months following placement. Five prostheses were explanted secondary to infection or erosion and two additional required revisions. Of the explanted prosthesis two were later replaced without further complication. Eighty-one percent of patients were sexually active following prosthesis placement. Penile prosthesis placement is possible in patients with prior penile reconstruction/phallic construction. Although complications rates appear to be elevated in this population compared with historic controls of normal anatomic men, the majority of patients in this series were sexually active following prosthesis placement. This demonstrates the utility of prosthesis implantation in these difficult patients. © 2015 International Society for Sexual Medicine.

TexMi: Development of Tissue-Engineered Textile-Reinforced Mitral Valve Prosthesis

PubMed Central

Moreira, Ricardo; Gesche, Valentine N.; Hurtado-Aguilar, Luis G.; Schmitz-Rode, Thomas; Frese, Julia

2014-01-01

Mitral valve regurgitation together with aortic stenosis is the most common valvular heart disease in Europe and North America. Mechanical and biological prostheses available for mitral valve replacement have significant limitations such as the need of a long-term anticoagulation therapy and failure by calcifications. Both types are unable to remodel, self-repair, and adapt to the changing hemodynamic conditions. Moreover, they are mostly designed for the aortic position and do not reproduce the native annular-ventricular continuity, resulting in suboptimal hemodynamics, limited durability, and gradually decreasing ventricular pumping efficiency. A tissue-engineered heart valve specifically designed for the mitral position has the potential to overcome the limitations of the commercially available substitutes. For this purpose, we developed the TexMi, a living textile-reinforced mitral valve, which recapitulates the key elements of the native one: annulus, asymmetric leaflets (anterior and posterior), and chordae tendineae to maintain the native annular-ventricular continuity. The tissue-engineered valve is based on a composite scaffold consisting of the fibrin gel as a cell carrier and a textile tubular structure with the twofold task of defining the gross three-dimensional (3D) geometry of the valve and conferring mechanical stability. The TexMi valves were molded with ovine umbilical vein cells and stimulated under dynamic conditions for 21 days in a custom-made bioreactor. Histological and immunohistological stainings showed remarkable tissue development with abundant aligned collagen fibers and elastin deposition. No cell-mediated tissue contraction occurred. This study presents the proof-of-principle for the realization of a tissue-engineered mitral valve with a simple and reliable injection molding process readily adaptable to the patient's anatomy and pathological situation by producing a patient-specific rapid prototyped mold. PMID:24665896

Development and clinical application of a new testicular prosthesis

PubMed Central

Ning, Ye; Cai, Zhikang; Chen, Huixing; Ping, Ping; Li, Peng; Wang, Zhong; Li, Zheng

2011-01-01

A new type of testicular prosthesis made of silastic with an elliptical shape to mimic a normal testis was developed by our team and submitted for patenting in China. The prosthesis was produced in different sizes to imitate the normal testis of the patient. To investigate the effects and safety of the testicular prosthesis, 20 patients receiving testicular prosthesis implantation were recruited for this study. Follow-up after 6 months revealed no complications in the patients. All the patients answered that they were satisfied with their body image and the position of the implants, 19 patients were satisfied with the size and 16 patients were satisfied with the weight. These results show that the testicular prosthesis used in this study can meet patient's expectations. Patients undergoing orchiectomy should be offered the option to receive a testicular prosthesis implantation. The dimensions and weight of the available prosthetic implants should be further addressed to improve patient satisfaction. PMID:21927041

Total prosthetic replacement of atrioventricular valves in the dog

PubMed Central

Den Otter, G.

1968-01-01

The free-floating cone and cage valve, described in a previous study as being successful as a substitute for the right atrioventricular valve, does not perform well when it is inserted in the mitral ostium. A tilting cone or disc was constructed and tested in a series of 15 dogs. This prosthesis gave excellent results in 12 animals. The reasons for its failure in the remaining three is discussed. The prosthesis presented has advantages over any ball and cage valve, mainly because of its smaller volume. Images PMID:5654076

Role of modern 3D echocardiography in valvular heart disease

PubMed Central

2014-01-01

Three-dimensional (3D) echocardiography has been conceived as one of the most promising methods for the diagnosis of valvular heart disease, and recently has become an integral clinical tool thanks to the development of high quality real-time transesophageal echocardiography (TEE). In particular, for mitral valve diseases, this new approach has proven to be the most unique, powerful, and convincing method for understanding the complicated anatomy of the mitral valve and its dynamism. The method has been useful for surgical management, including robotic mitral valve repair. Moreover, this method has become indispensable for nonsurgical mitral procedures such as edge to edge mitral repair and transcatheter closure of paravaluvular leaks. In addition, color Doppler 3D echo has been valuable to identify the location of the regurgitant orifice and the severity of the mitral regurgitation. For aortic and tricuspid valve diseases, this method may not be quite as valuable as for the mitral valve. However, the necessity of 3D echo is recognized for certain situations even for these valves, such as for evaluating the aortic annulus for transcatheter aortic valve implantation. It is now clear that this method, especially with the continued development of real-time 3D TEE technology, will enhance the diagnosis and management of patients with these valvular heart diseases. PMID:25378966

Rehabilitation of a missing ear with an implant retained auricular prosthesis

PubMed Central

Guttal, Satyabodh Sheshraj; Shanbhag, Shruti; Kulkarni, Sudhindra S.; Thakur, Srinath L.

2015-01-01

Burns can leave a patient with a severely debilitating disability even after treatment. The objectives of burn rehabilitation are to minimize the adverse effects caused by the injury while rehabilitating the patient's physical and psychological well-being, maximizing social integration. Long-term success of maxillofacial prostheses mainly depends on the retention. Extra oral implant retained prostheses have proved to be a predictable treatment option for maxillofacial rehabilitation. Replacement of a severely deformed external ear with burned tissues may be satisfactorily accomplished by a cosmetic prosthesis anchored by implants integrated in the skull. The use of such implants is now a well-recognized method for creating a stable result in maxillofacial rehabilitation. This case report describes a safe, simple and economical method for the rehabilitation of a patient with missing right auricle using an implant supported silicone prosthesis. The implant was placed in the mastoid region of the temporal bone. Reconstruction of the ear was done with auricular silicone prosthesis, retained using magnets incorporated in an autopolymerizing resin shim to decrease the weight of the prosthesis on a single implant. This method eliminates the need of tedious laboratory procedures and exact casting and fitting requirements of a metal substructure while minimizing the overall weight and cost of the prosthesis while maintaining adequate support, esthetics and retention of the prosthesis. PMID:26929490

Prosthetic valve implantation with preservation of the entire valvular and subvalvular apparatus of the tricuspid valve in congenitally corrected transposition of the great arteries.

PubMed

Ergenoglu, Mehmet U; Yerebakan, Halit; Ozveren, Olcay; Koner, Ozge; Kalangos, Afksendiyos; Demirsoy, Ergun

2011-10-01

Congenitally corrected transposition of the great arteries, which is characterized by atrioventricular and ventriculoarterial discordance, is a rare congenital heart disease. Most of the cases are diagnosed in childhood, owing to associated cardiac anomalies, such as ventricular septal defect, pulmonary stenosis or pulmonary atresia, and Ebstein-like malformation of the tricuspid valve. We present a patient with congenitally corrected transposition of the great arteries who underwent surgical replacement of the tricuspid valve with a bioprosthesis and reconstruction of the left ventricular outflow tract with bovine conduit.

Afebrile Pannus-Induced Blood Culture-Negative Mechanical Valve Endocarditis.

PubMed

Matsukuma, Seiji; Eishi, Kiyoyuki; Tanigawa, Kazuyoshi; Miura, Takashi; Matsumaru, Ichiro; Hisatomi, Kazuki; Tsuneto, Akira

2016-12-01

The diagnosis of prosthetic valve endocarditis may be challenging in patients with an atypical clinical presentation. Virtually all infections associated with mechanical prosthetic valves are localized to the prosthesis-tissue junction at the sewing ring and are accompanied by tissue destruction around the prosthesis. Because the orifice of the mechanical prosthetic valve is made of metal and pyrolytic carbon, which do not enable the adherence of microorganisms, any vegetation originating from the interior of the valve orifice is usually rare. Here we present a rare case of pannus-induced mechanical prosthetic valve endocarditis that was difficult to diagnose. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Understanding the requirements of self-expandable stents for heart valve replacement: Radial force, hoop force and equilibrium.

PubMed

Cabrera, María Sol; Oomens, Cees W J; Baaijens, Frank P T

2017-04-01

A proper interpretation of the forces developed during stent crimping and deployment is of paramount importance for a better understanding of the requirements for successful heart valve replacement. The present study combines experimental and computational methods to assess the performance of a nitinol stent for tissue-engineered heart valve implantation. To validate the stent model, the mechanical response to parallel plate compression and radial crimping was evaluated experimentally. Finite element simulations showed good agreement with the experimental findings. The computational models were further used to determine the hoop force on the stent and radial force on a rigid tool during crimping and self-expansion. In addition, stent deployment against ovine and human pulmonary arteries was simulated to determine the hoop force on the stent-artery system and the equilibrium diameter for different degrees of oversizing. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

A 29-year-old Harken disk mitral valve: long-term follow-up by echocardiographic and cineradiographic imaging.

PubMed

Hsi, David H; Ryan, Gerald F; Taft, Janice; Arnone, Thomas J

2003-01-01

An 81-year-old woman was evaluated for prosthetic mitral valve function. She had received a Harken disk mitral valve 29 years earlier due to severe mitral valve disease. This particular valve prosthesis is known for premature disk edge wear and erosion. The patients 2-dimensional Doppler echocardiogram showed the distinctive appearance of a disk mitral valve prosthesis. Color Doppler in diastole showed a unique crown appearance, with initial flow acceleration around the disk followed by convergence to laminar flow in the left ventricle. Cineradiographic imaging revealed normal valve function and minimal disk erosion. We believe this to be the longest reported follow-up of a surviving patient with a rare Harken disk valve. We present images with unique echocardiographic and cineangiographic features.

Infective endocarditis: outcome in surviving patients with intracardiac complications.

PubMed

Mocchegiani, Roberto; Pergolini, Martina; Nataloni, Maura

2007-03-01

The purpose of this study was to assess the outcome of 15 patients who survived infective endocarditis with abscesses and other intracardiac complications. Abscesses were associated with native valve endocarditis in seven patients and prosthetic valve endocarditis in eight patients; fistulas were observed in three patients, and subaortic perforation in three patients. Sensitivity for the detection of abscesses was 42.8% and 92.8% using transthoracic and transoesophageal echocardiography, respectively. Eleven patients underwent surgical treatment with no operative mortality, whereas four patients were only medically treated. During follow-up (mean 8.26 years), two patients died (13%) and six recurrences (five early and one late prosthetic valve endocarditis) required re-intervention for prosthesis dysfunction (40%); an improvement in New York Heart Association class in survivors and no changes in echocardiographic lesions were observed. Infective intracardiac complications do not seem to significantly reduce the overall survival (87%) of patients at long-term follow-up.

The Mosaic bioprosthesis in the aortic position: 17 years' results.

PubMed

Gansera, Brigitte; Hapfelmeier, Alexander; Brandl, Kristina; Spiliopoulos, Kyriakos; Gundling, Felix; Eichinger, Walter

2014-02-01

The Mosaic bioprosthesis (Medtronic Inc., Minneapolis, Minnesota, United States), a stented porcine aortic valve, combines glutaraldehyde fixation with zero-pressure, root-pressure techniques and antimineralization treatment with amino-oleic acid for improved hemodynamics and tissue durability. The first device has been implanted worldwide at the authors' institution in September 1993. The aim of the present study was to collect mid- to long-term data of the prosthesis. A total of 272 patients (124 males and 148 females) underwent isolated aortic valve replacement with the Mosaic bioprosthesis between September 1993 and August 2007. Median age at implant was 76.8 years (range, 31.3 to 90.7). Median follow-up was 12.0 years (range, 0 to 17.2 years); follow-up was complete for 223 (82%) patients. Early mortality (30 days) was 4% (12 patients). Overall survival at 5, 10, 15, and 17 years was 68.6% ± 3.1%, 36.4% ± 3.3%, 17.1% ± 3.6%, and 10.7% ± 4.3%, respectively. Eleven late deaths (5%) were cardiac related. There were 24 thromboembolic events, 1 hemorrhagic, and 6 reoperations/explants. At a median follow-up of 12 years, freedom from any cause of death was 27.0% ± 3.2% acting as a competing risk for the incidence of thromboembolic events (16.4% ± 3.5%), hemorrhage (0.5% ± 0.5%), and reoperation/explant (4.1% ± 1.8%). Two redos were due to structural valve deterioration (SVD), two for nonstructural dysfunction (paravalvular leakage), one for thrombosed prosthesis, and one for endocarditis. Performance and late outcome of the Mosaic bioprosthesis was satisfactory during 17 years after clinical introduction. The Mosaic bioprosthesis showed low incidence of SVD or need for reoperation in the long term. Georg Thieme Verlag KG Stuttgart · New York.

An animal model to evaluate skin-implant-bone integration and gait with a prosthesis directly attached to the residual limb

PubMed Central

Farrell, Brad J; Prilutsky, Boris I; Kistenberg, Robert S; Dalton, John F; Pitkin, Mark

2014-01-01

Background Despite the number of advantages of bone-anchored prostheses, their use in patients is limited due to the lack of complete skin-implant integration. The objective of the present study was to develop an animal model that would permit both detailed investigations of gait with a bone-anchored limb prosthesis and histological analysis of the skin-implant-bone interface after physiological loading of the implant during standing and walking. Methods Full-body mechanics of walking in two cats was recorded and analyzed before and after implantation of a percutaneous porous titanium pylon into the right tibia and attachment of a prosthesis. The rehabilitation procedures included initial limb casting, progressively increasing loading of implant, and standing and locomotor training. Detailed histological analysis of bone and skin ingrowth into implant was performed at the end of the study. Findings The two animals adopted the bone-anchored prosthesis for standing and locomotion, although loads on the prosthetic limb during walking decreased by 22% and 62%, respectively, 4 months after implantation. The animals shifted body weight to the contralateral side and increased propulsion forces by the contralateral hindlimb. Histological analysis of the limb implants demonstrated bone and skin ingrowth. Interpretation The developed animal model to study prosthetic gait and tissue integration with the implant demonstrated that porous titanium implants may permit bone and skin integration and prosthetic gait with a prosthesis. Future studies with this model will help optimize the implant and prosthesis properties. PMID:24405567

Heart valves from polyester fibers: a preliminary 6-month in vivo study.

PubMed

Vaesken, Antoine; Pelle, Anne; Pavon-Djavid, Graciela; Rancic, Jeanne; Chakfe, Nabil; Heim, Frederic

2018-06-27

Transcatheter aortic valve implantation (TAVI) has become a popular alternative technique to surgical valve replacement for critical patients. Biological valve tissue has been used in TAVI procedures for over a decade, with over 150,000 implantations to date. However, with only 6 years of follow up, little is known about the long-term durability of biological tissue. Moreover, the high cost of tissue harvesting and chemical treatment procedures favor the development of alternative synthetic valve leaflet materials. In that context, textile polyester [polyethylene terephthalate (PET)] could be considered as an interesting candidate to replace the biological valve leaflets in TAVI procedures. However, no result is available in the literature about the behavior of textile once in contact with biological tissue in the valve position. The interaction of synthetic textile material with living tissues should be comparable to biological tissue. The purpose of this preliminary work is to compare the in vivo performances of various woven textile PET valves over a 6-month period in order to identify favorable textile construction features. In vivo results indicate that fibrosis as well as calcium deposit can be limited with an appropriate material design.

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 Association for Cardio-Thoracic Surgery. All rights reserved.

Apixaban Versus Warfarin for Mechanical Heart Valve Thromboprophylaxis in a Swine Aortic Heterotopic Valve Model.

PubMed

Lester, Patrick A; Coleman, Dawn M; Diaz, Jose A; Jackson, Tatum O; Hawley, Angela E; Mathues, Angela R; Grant, Brandon T; Knabb, Robert M; Ramacciotti, Eduardo; Frost, Charles E; Song, Yan; Wakefield, Thomas W; Myers, Daniel D

2017-05-01

Warfarin is the current standard for oral anticoagulation therapy in patients with mechanical heart valves, yet optimal therapy to maximize anticoagulation and minimize bleeding complications requires routine coagulation monitoring, possible dietary restrictions, and drug interaction monitoring. As alternatives to warfarin, oral direct acting factor Xa inhibitors are currently approved for the prophylaxis and treatment of venous thromboembolism and reduction of stroke and systemic embolization. However, no in vivo preclinical or clinical studies have been performed directly comparing oral factor Xa inhibitors such as apixaban to warfarin, the current standard of therapy. A well-documented heterotopic aortic valve porcine model was used to test the hypothesis that apixaban has comparable efficacy to warfarin for thromboprophylaxis of mechanical heart valves. Sixteen swine were implanted with a bileaflet mechanical aortic valve that bypassed the ligated descending thoracic aorta. Animals were randomized to 4 groups: control (no anticoagulation; n=4), apixaban oral 1 mg/kg twice a day (n=5), warfarin oral 0.04 to 0.08 mg/kg daily (international normalized ratio 2-3; n=3), and apixaban infusion (n=4). Postmortem valve thrombus was measured 30 days post-surgery for control-oral groups and 14 days post-surgery for the apixaban infusion group. Control thrombus weight (mean) was significantly different (1422.9 mg) compared with apixaban oral (357.5 mg), warfarin (247.1 mg), and apixiban 14-day infusion (61.1 mg; P <0.05). Apixaban is a promising candidate and may be a useful alternative to warfarin for thromboprophylaxis of mechanical heart valves. Unlike warfarin, no adverse bleeding events were observed in any apixaban groups. © 2017 American Heart Association, Inc.

Effect of joining the sectioned implant-supported prosthesis on the peri-implant strain generated in simulated mandibular model.

PubMed

Singh, Ipsha; Nair, K Chandrasekharan; Shetty, Jayakar

2017-01-01

The aim of this study is to evaluate the strain developed in simulated mandibular model before and after the joining of an implant-supported screw-retained prosthesis by different joining techniques, namely, arc welding, laser welding, and soldering. A specimen simulating a mandibular edentulous ridge was fabricated in heat-cured acrylic resin. 4-mm holes were drilled in the following tooth positions; 36, 33, 43, 46. Implant analogs were placed in the holes. University of California, Los Angeles, abutment was attached to the implant fixture. Eight strain gauges were attached to the acrylic resin model. Six similar models were made. Implant-supported screw-retained fixed prosthesis was fabricated in nickel-chromium alloy. A load of 400 N was applied on the prosthesis using universal testing machine. Resultant strain was measured in each strain gauge. All the prostheses were sectioned at the area between 36 and 33, 33 and 43, and 43 and 46 using 35 micrometer carborundum disc, and strain was measured in each strain gauge after applying a load of 400 N on the prosthesis. Specimens were joined by arc welding, soldering, and laser welding. After joining, a load of 400 N was applied on each prosthesis and the resultant strain was measured in each strain gauge. Highest mean strain values were recorded before sectioning of the prostheses (889.9 microstrains). Lowest mean strain values were recorded after sectioning the prosthesis and before reuniting it (225.0 microstrains). Sectioning and reuniting the long-span implant prosthesis was found to be a significant factor in influencing the peri-implant strain.

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.

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.

21 CFR 872.3960 - Mandibular condyle prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3960 Mandibular condyle prosthesis. (a) Identification. A mandibular condyle prosthesis is a device that is intended to be implanted in the human jaw to... requirement for premarket approval for any mandibular condyle prosthesis intended to be implanted in the human...

In vivo canine studies of a Sinkhole valve and vascular graft coated with biocompatible PU-PEO-SO3.

PubMed

Han, D K; Lee, K B; Park, K D; Kim, C S; Jeong, S Y; Kim, Y H; Kim, H M; Min, B G

1993-01-01

PU-PEO-SO3 was applied as a coating material over a newly designed Sinkhole bileaflet PU heart valve and a porous PU vascular graft. Performance and biocompatibility were evaluated using an in vivo canine shunt system between the right ventricle and pulmonary artery. The survival periods in three implantations were 14, 24, and 39 days, during which no mechanical failure occurred in any Sinkhole valve or vascular graft. Scanning electron microscopy (SEM) studies demonstrated much less platelet adhesion and thrombus formation on PU-PEO-SO3 grafts than on PU vascular grafts. Cracks in the valve leaflet were occasionally observed on PU surfaces, but not on PU-PEO-SO3. After a 39 day implantation, calcium deposition on vascular grafts was decreased as compared with valve leaflets, and calcification on PU-PEO-SO3 was much lower than on PU. These results suggest that Sinkhole valves and vascular grafts are promising, and PU-PEO-SO3 as a coating material is more blood compatible, biostable, and calcification resistant in vivo than in untreated PU.

Actinobacillus endocarditis associated with hypertrophic cardiomyopathy

PubMed Central

Jorge, Vanda Cristina; Araújo, Ana Carolina; Grilo, Ana; Noronha, Carla; Panarra, António; Riso, Nuno; Vaz Riscado, Manuel

2012-01-01

Infective endocarditis can be associated with complex clinical presentations, sometimes with a difficult multi-disciplinary management. Actinobacillus actinomycetemcomitans belongs to the Haemophilus species, Actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens and Kingella species group, responsible for 5% to 10% of infective endocarditis in native heart valves. These organisms have slow fastidious growth pattern, often associated with negative cultures, and cause systemic embolism with abscess formation. The authors present the case of a 59-year-old man, admitted due to fever of unknown origin, with a personal history of obstructive hypertrophic cardiomyopathy and recent dental manipulation. The diagnosis of mitral valve’s endocarditis was established after a transoesophageal ecocardiography, with a late isolation of A actinomycetemcomitans in blood culture. Despite the institution of antibiotic therapy, the patient suffered from multiple episodes of septic embolism: skin, mucosae, cerebral abscesses, spondylodiscitis and uveitis. He was submitted to heart surgery with miectomy and replacement of the native mitral valve by a mechanical prosthesis, while on antibiotics. PMID:22891010

Fixation of Bovine Pericardium-Based Tissue Biomaterial with Irreversible Chemistry Improves Biochemical and Biomechanical Properties

PubMed Central

Tam, H.; Zhang, W.; Infante, D.; Parchment, N.; Sacks, M.

2018-01-01

Bioprosthetic heart valves (BHVs), derived from glutaraldehyde crosslinked (GLUT) porcine aortic valve leaflets or bovine pericardium (BP), are used to replace defective heart valves. However, valve failure can occur within 12–15 years due to calcification and/or progressive structural degeneration. We present a novel fabrication method that utilizes carbodiimide, neomycin trisulfate, and pentagalloyl glucose crosslinking chemistry (TRI) to better stabilize the extracellular matrix of BP. We demonstrate that TRI-treated BP is more compliant than GLUT-treated BP. GLUT-treated BP exhibited permanent geometric deformation and complete alteration of apparent mechanical properties when subjected to induced static strain. TRI BP, on the other hand, did not exhibit such permanent geometric deformations or significant alterations of apparent mechanical properties. TRI BP also exhibited better resistance to enzymatic degradation in vitro and calcification in vivo when implanted subcutaneously in juvenile rats for up to 30 days. PMID:28213846

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.

Conceptual model for early health technology assessment of current and novel heart valve interventions

PubMed Central

Huygens, Simone A; Rutten-van Mölken, Maureen P M H; Bekkers, Jos A; Bogers, Ad J J C; Bouten, Carlijn V C; Chamuleau, Steven A J; de Jaegere, Peter P T; Kappetein, Arie Pieter; Kluin, Jolanda; van Mieghem, Nicolas M D A; Versteegh, Michel I M; Witsenburg, Maarten; Takkenberg, Johanna J M

2016-01-01

Objective The future promises many technological advances in the field of heart valve interventions, like tissue-engineered heart valves (TEHV). Prior to introduction in clinical practice, it is essential to perform early health technology assessment. We aim to develop a conceptual model (CM) that can be used to investigate the performance and costs requirements for TEHV to become cost-effective. Methods After scoping the decision problem, a workgroup developed the draft CM based on clinical guidelines. This model was compared with existing models for cost-effectiveness of heart valve interventions, identified by systematic literature search. Next, it was discussed with a Delphi panel of cardiothoracic surgeons, cardiologists and a biomedical scientist (n=10). Results The CM starts with the valve implantation. If patients survive the intervention, they can remain alive without complications, die from non-valve-related causes or experience a valve-related event. The events are separated in early and late events. After surviving an event, patients can experience another event or die due to non-valve-related causes. Predictors will include age, gender, NYHA class, left ventricular function and diabetes. Costs and quality adjusted life years are to be attached to health conditions to estimate long-term costs and health outcomes. Conclusions We developed a CM that will serve as foundation of a decision-analytic model that can estimate the potential cost-effectiveness of TEHV in early development stages. This supports developers in deciding about further development of TEHV and identifies promising interventions that may result in faster take-up in clinical practice by clinicians and reimbursement by payers. PMID:27843569

Complications with the MICRA TPS Pacemaker System: Persistent Complete Heart Block and Late Capture Failure.

PubMed

Holm, Niels; Müller, Andreas; Zbinden, Rainer

2017-04-01

A Medtronic MICRA transcatheter pacing system (Medtronic, Minneapolis, MN, USA) was implanted in an 86-year-old patient with sick sinus syndrome and left bundle branch block after transfemoral aortic valve implantation. During implantation she developed a persistent complete heart block due to manipulation with the large-bore delivery catheter. Two weeks later, acute pacemaker dysfunction occurred due to massive increase of pacing threshold and impedance without obvious pacemaker dislocation or myocardial perforation. Recurrent capture failure was seen with pacing output set at 5 V/1.0 ms. Hence, microdislocation or fixation of the tines in the right ventricular trabeculae has to be assumed. © 2016 Wiley Periodicals, Inc.

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.

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.

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.

Prevalence of pannus formation after aortic valve replacement: clinical aspects and surgical management.

PubMed

Sakamoto, Yoshimasa; Hashimoto, Kazuhiro; Okuyama, Hiroshi; Ishii, Shinichi; Shingo, Taguchi; Kagawa, Hiroshi

2006-01-01

Pannus formation after aortic valve replacement is not common, but obstruction due to chronic pannus is one of the most serious complications of valve replacement. The causes of pannus formation are still unknown and effective preventive methods have not been fully elucidated. We reviewed our clinical experience of all patients who underwent reoperation for prosthetic aortic valve obstruction due to pannus formation between 1973 and 2004. We compared the initial 18-year period of surgery, when the Björk-Shiley tilting-disk valve was used, and the subsequent 13-year period of surgery, when the St. Jude Medical valve was used. Seven of a total of 390 patients (1.8%) required reoperation for prosthetic aortic valve obstruction due to pannus formation. All seven patients were women; four patients underwent resection of the pannus and three patients needed replacement of the valve. The frequency of pannus formation in the early group was 2.4% (6/253), whereas it was 0.73% (1/137) in the late group (P < 0.05). Pannus was localized at the minor orifice of the Björk-Shiley valve in the early group and turbulent transvalvular blood flow was considered to be one of the important factors triggering its growth. We also consider that small bileaflet valves have the possibility of promoting pannus formation and that the implantation of a larger prosthesis can contribute to reducing the occurrence of pannus.

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

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

Nose, Y.

The goal of the present program is to define the spatial constraints of the body for a totally implantable radioisotope-powered cardiac prosthesis. The design is such that the prosthesis is compatib1e with both the human and the experimental animal, the calf. Most recent efforts were directed to the definition of the size and shape of the human thorax for implanting the blood pump. This was done by formulating a mathematical shape model from dimensions obtained from plastic molds made in the chest cavity of human cadavers. The shape model was used in conjunction with dimensions obtained from 100 chest radiographsmore » of living humans to arrive at a statistical distribution of chest dimensions. The results are presented as scale drawings of the walls of the thorax as a iunction of the percent of the population having sizes smaller than the given curves. An effort is underway to define the natural heart boundaries in the chest to define soft tissue and vascular connections in the thorax. A parallel effort was to determine the anatomical and physiological tolerance of calves to implanted models of the thermal conventer. Five calves were implanted with models, four have been sacrificed at 8 to 12 months after implantation, and one remains under observation. All calves were in good physical condition with the retroperitoneal infrarenal space appearing to be most feasible for implantation. (auth)« less

Splinter haemorrhages, Osler's nodes, Janeway lesions and Roth spots: the peripheral stigmata of endocarditis.

PubMed

Sethi, Karishma; Buckley, Jim; de Wolff, Jacob

2013-09-01

Infective endocarditis is a serious endo-vascular infection, potentially affecting not only native heart valves, but also intra-vascularly implanted foreign materials such as valvular prostheses and pacemaker electrodes (Westphal et al, 2009).

A new self-expandable aortic valved stent deployed above native leaflets for aortic insufficiency: an in vitro study.

PubMed

Huang, H; Zhou, Y; Shao, J; Cai, J; Mei, Y; Wang, Y

2012-12-01

The aim of this paper was to develop a new self-expandable aortic valved stent following the shape of the sinus of Valsalva, which can be deployed above native leaflets for aortic regurgitation, and study it's effect on coronary artery flow when orthotopic implantation in and above native leaflets. New self-expandable aortic valved stent consist of nitinol stent and bovine pericardium, and was designed following the shape of the sinus of Valsalva, the bovine pericardium was tailed as native leaflet. Thirty-six swine hearts were divided into three equal groups of twelve. In Group A (N.=12), the new self-expandable aortic valved stents deployed in native leaflets. In Group B (N.=12), the new self-expandable aortic valved stents deployed above native leaflets. In Group C (N.=12), the cylinder-like valved stents deployed only in native leaflets. The measurements of each coronary flow rate and endoscopic inspections were repeated post-implantation. In Group A and C, valve implantation in native leaflets resulted in a significant decrease in both left and right coronary flows. In Group B, no significant change in either right or left coronary flow was found after new self-expandable aortic valved stent placement. Endoscopic inspections showed that in group A and C the native leaflets sandwiched between valved stent and aortic wall, whereas, in group B the native leaflets were under the artificial leaflets. Two kinds of stents deployed in native leaflets affect left and right coronary flows significantly. No significant effect was found when the new self-expandable aortic valved stent deployed above native leaflets. This new self-expandable aortic valved stent can be deployed above the native leaflets, which avoids the obstruction of native leaflets on coronary flow.

Biomaterial-host interactions: consequences, determined by implant retrieval analysis.

PubMed

Kaplan, S S

1994-01-01

Prosthetic biomaterials have had a profound impact on reconstructive surgery but complete biocompatability remains illusive. This review considers the retrieval analysis of four common prosthetic structures: the hip, the knee, heart valves, and blood vessels. We show that despite a fine record of early success, deterioration due to mechanical failure or deleterious host responses to the implant may compromise long term function. The eventual retrieval and detailed analysis of implanted structures provides an invaluable opportunity to determine the characteristics of implant success or failure and to provoke the development of still better materials.

Adjuvant Maneuvers for Residual Curvature Correction During Penile Prosthesis Implantation in Men with Peyronie's Disease.

PubMed

Berookhim, Boback M; Karpman, Edward; Carrion, Rafael

2015-11-01

The surgical treatment of comorbid erectile dysfunction and Peyronie's disease has long included the implantation of an inflatable penile prosthesis as well as a number of adjuvant maneuvers to address residual curvature after prosthesis placement. To review the various surgical options for addressing curvature after prosthesis placement, with specific attention paid to an original article by Wilson et al. reporting on modeling over a penile prosthesis for the management of Peyronie's disease. A literature review was performed analyzing articles reporting the management of penile curvature in patients undergoing implantation of an inflatable penile prosthesis. Reported improvement in Peyronie's deformity as well as the complication rate associated with the various surgical techniques described. Modeling is a well-established treatment modality among patients with Peyronie's disease undergoing penile prosthesis implantation. A variety of other adjuvant maneuvers to address residual curvature when modeling alone is insufficient has been presented in the literature. Over 20 years of experience with modeling over a penile prosthesis have proven the efficacy and safety of this treatment option, providing the surgeon a simple initial step for the management of residual curvature after penile implantation which allows for the use of additional adjuvant maneuvers in those with significant deformities. © 2015 International Society for Sexual Medicine.

A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis.

PubMed

Thalmann, Markus; Grubitzsch, Herko; Matschke, Klaus; Glauber, Mattia; Tan, Erwin; Francois, Katrien; Amorim, Mario J; Hensens, Ab G; Cesari, Francesco; Feyrer, Richard; Diegeler, Anno; Veit, Franz; Repossini, Alberto

2016-01-01

The purpose of this study was to evaluate the safety and performance of the Freedom Solo valve in aortic valve replacement by clinical and hemodynamic outcomes. Six hundred sixteen patients underwent aortic valve replacement in 18 European centers; mean age was 74.5 ± 5.9 years, 54.1% of the patients were male, and concomitant procedures were performed in 43.2% of the patients. The majority (69%) of the implanted sizes were 23 mm and 25 mm. At 1 year, overall survival was 94.0%, whereas freedom from valve-related death was 98.6%. There were 9 (1.5%) early (≤ 30 days) and 27 (4.4%) late (>30 days) deaths. Early and late valve-related mortality was 0.3% (n = 2) and 1.1% (n = 7), respectively. Freedom from explant was 97.6%; 10 valves were explanted for endocarditis and 4 for paravalvular leak. There were 10 (1.6%) early and 5 (0.8%) late strokes. Atrioventricular block requiring pacemaker implant occurred in 8 (1.3%) and 1 (0.2%) patients in the early and late postoperative period, respectively. Thrombocytopenia was seen in 27 cases (4.4%) in the early postoperative period. Preoperatively, 93.8% of patients were in New York Heart Association functional classes II through IV, whereas at 1 year 96.9% of patients were in New York Heart Association functional classes I and II. At 1-year follow-up, mean and peak pressure gradients were 7.2 and 14.6 mm Hg, respectively. Indexed left ventricular mass decreased by 12% from 138 g/m(2) at discharge to 122 g/m(2) at 1 year. At 1-year follow-up after Freedom Solo implantation, we found acceptable clinical results with low mortality and morbidity and good hemodynamic performance, confirming safety and effectiveness in this multicenter experience. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Influence of the tilt angle of Percutaneous Aortic Prosthesis on Velocity and Shear Stress Fields

PubMed Central

Gomes, Bruno Alvares de Azevedo; Camargo, Gabriel Cordeiro; dos Santos, Jorge Roberto Lopes; Azevedo, Luis Fernando Alzuguir; Nieckele, Ângela Ourivio; Siqueira-Filho, Aristarco Gonçalves; de Oliveira, Glaucia Maria Moraes

2017-01-01

Background Due to the nature of the percutaneous prosthesis deployment process, a variation in its final position is expected. Prosthetic valve placement will define the spatial location of its effective orifice in relation to the aortic annulus. The blood flow pattern in the ascending aorta is related to the aortic remodeling process, and depends on the spatial location of the effective orifice. The hemodynamic effect of small variations in the angle of inclination of the effective orifice has not been studied in detail. Objective To implement an in vitro simulation to characterize the hydrodynamic blood flow pattern associated with small variations in the effective orifice inclination. Methods A three-dimensional aortic phantom was constructed, reproducing the anatomy of one patient submitted to percutaneous aortic valve implantation. Flow analysis was performed by use of the Particle Image Velocimetry technique. The flow pattern in the ascending aorta was characterized for six flow rate levels. In addition, six angles of inclination of the effective orifice were assessed. Results The effective orifice at the -4º and -2º angles directed the main flow towards the anterior wall of the aortic model, inducing asymmetric and high shear stress in that region. However, the effective orifice at the +3º and +5º angles mimics the physiological pattern, centralizing the main flow and promoting a symmetric distribution of shear stress. Conclusion The measurements performed suggest that small changes in the angle of inclination of the percutaneous prosthesis aid in the generation of a physiological hemodynamic pattern, and can contribute to reduce aortic remodeling. PMID:28793046

Acquired tricuspid valve stenosis associated with two ventricular endocardial pacing leads in a dog.

PubMed

Tompkins, Emily; Dulake, Michelle I; Ghaffari, Shadie; Nakamura, Reid K

2015-01-01

Acquired tricuspid valve stenosis (TVS) is a rare complication of endocardial pacing lead implantation in humans that has only been described once previously in the veterinary literature in a dog with excessive lead redundancy. A 12 yr old terrier presented with right-sided congestive heart failure 6 mo after implantation of a second ventricular endocardial pacing lead. The second lead was placed due to malfunction of the first lead, which demonstrated abnormally low impedance. Transthoracic echocardiography identified hyperechoic tissue associated with the pacing leads as they crossed the tricuspid valve annulus as well as a stenotic tricuspid inflow pattern via spectral Doppler interrogation. Medical management was ultimately unsuccessful and the dog was euthanized 6 wk after TVS was diagnosed. The authors report the first canine case of acquired TVS associated with two ventricular endocardial pacing leads.

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.

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.

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.

Post-traumatic tricuspid insufficiency: a case report.

PubMed

Tütün, Ufuk; Aksöyek, Ayşen; Parlar, Ali Ihsan; Cobanoğlu, Adnan

2011-11-01

Post-traumatic tricuspid insufficiency is a rare complication of chest trauma. An 18-year-old male patient was injured in a bicycle accident from his abdominal and anterior chest wall. The tear on the inferior diaphragmatic surface of the heart was repaired with primary sutures by the attending surgeon. Eighteen years later, he was admitted to the hospital with severe tricuspid regurgitation (3+/4+). During the operation, the valve was determined unsuitable for repair and was replaced with a bioprosthesis. The hemodynamic aberrations relevant to an isolated tricuspid valve injury are very often well-tolerated. Reconstructive surgery may be possible in the early period. In the late cases, repair is sometimes not feasible due to degeneration of the valvular apparatus. Replacement with a biological prosthesis may give the best long-term results in longstanding cases.

Mitral valve surgery using right anterolateral thoracotomy: is the aortic cannulation a safety procedure?

PubMed

Guedes, Marco Antonio Vieira; Pomerantzeff, Pablo Maria Alberto; Brandão, Carlos Manuel de Almeida; Vieira, Marcelo Luiz Campos; Grinberg, Max; Stolf, Noedir Antonio Groppo

2010-01-01

The right anterolateral thoracotomy is an alternative technique for surgical approach of mitral valve. In these cases, femoral-femoral bypass still has been used, rising occurrence of complications related to femoral cannulation. Describe the technique and results of mitral valve treatment by right anterolateral thoracotomy using aortic cannulation for cardiac pulmonary bypass (CPB). From 1983 e 2008, 100 consecutive female patients, with average age 35 ±13 years, 96 (96%) underwent mitral valve surgical treatment in the Heart Institute of São Paulo. A right anterolateral thoracotomy approach associated with aortic cannulation was used for CPB. Eighty (80%) patients had rheumatic disease and 84 (84%) patients presented functional class III or IV. Were performed 45 (45%) comissurotomies, 38 (38%) valve repairs, 7(7%) mitral valve replacements, seven (7%) recomissurotomies and three (3%) prosthesis replacement. Sparing surgery was performed in 90 (90%) patients. The average CPB and clamp time were 57 ± 27 min e 39 ± 19 min, respectively. There were no in-hospital death, reoperation due to bleeding and convertion to sternotomy. Introperative complications were related to heart harvest (5%), especially in reoperations (3%). The most important complications in postoperative period were related to pulmonary system (11%), followed by atrial fibrilation (10%) but without major systemic repercussions. The mean inhospital length of stay was 8 ± 3 days. Follow-up was 6.038 patients/month. Actuarial survival was 98.0 ± 1.9% and freedom from reoperation was 81.4 ± 7.8% in 180 months. The right anterolateral thoracotomy associated with aortic cannulation in mitral valve surgery is a simple technique, reproducible and safety.

Patterns and determinants of functional and absolute iron deficiency in patients undergoing cardiac rehabilitation following heart surgery.

PubMed

Tramarin, Roberto; Pistuddi, Valeria; Maresca, Luigi; Pavesi, Marco; Castelvecchio, Serenella; Menicanti, Lorenzo; de Vincentiis, Carlo; Ranucci, Marco

2017-05-01

Background Anaemia and iron deficiency are frequent following major surgery. The present study aims to identify the iron deficiency patterns in cardiac surgery patients at their admission to a cardiac rehabilitation programme, and to determine which perioperative risk factor(s) may be associated with functional and absolute iron deficiency. Design This was a retrospective study on prospectively collected data. Methods The patient population included 339 patients. Functional iron deficiency was defined in the presence of transferrin saturation <20% and serum ferritin ≥100 µg/l. Absolute iron deficiency was defined in the presence of serum ferritin values <100 µg/l. Results Functional iron deficiency was found in 62.9% of patients and absolute iron deficiency in 10% of the patients. At a multivariable analysis, absolute iron deficiency was significantly ( p = 0.001) associated with mechanical prosthesis mitral valve replacement (odds ratio 5.4, 95% confidence interval 1.9-15) and tissue valve aortic valve replacement (odds ratio 4.5, 95% confidence interval 1.9-11). In mitral valve surgery, mitral repair carried a significant ( p = 0.013) lower risk of absolute iron deficiency (4.4%) than mitral valve replacement with tissue valves (8.3%) or mechanical prostheses (22.5%). Postoperative outcome did not differ between patients with functional iron deficiency and patients without iron deficiency; patients with absolute iron deficiency had a significantly ( p = 0.017) longer postoperative hospital stay (median 11 days) than patients without iron deficiency (median nine days) or with functional iron deficiency (median eight days). Conclusions Absolute iron deficiency following cardiac surgery is more frequent in heart valve surgery and is associated with a prolonged hospital stay. Routine screening for iron deficiency at admission in the cardiac rehabilitation unit is suggested.

Bioprosthetic Valve Fracture Improves the Hemodynamic Results of Valve-in-Valve Transcatheter Aortic Valve Replacement.

PubMed

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

2017-07-01

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) may be less effective in small surgical valves because of patient/prosthesis mismatch. Bioprosthetic valve fracture (BVF) using a high-pressure balloon can be performed to facilitate VIV TAVR. We report data from 20 consecutive clinical cases in which BVF was successfully performed before or after VIV TAVR by inflation of a high-pressure balloon positioned across the valve ring during rapid ventricular pacing. Hemodynamic measurements and calculation of the valve effective orifice area were performed at baseline, immediately after VIV TAVR, and after BVF. BVF was successfully performed in 20 patients undergoing VIV TAVR with balloon-expandable (n=8) or self-expanding (n=12) transcatheter valves in Mitroflow, Carpentier-Edwards Perimount, Magna and Magna Ease, Biocor Epic and Biocor Epic Supra, and Mosaic surgical valves. Successful fracture was noted fluoroscopically when the waist of the balloon released and by a sudden drop in inflation pressure, often accompanied by an audible snap. BVF resulted in a reduction in the mean transvalvular gradient (from 20.5±7.4 to 6.7±3.7 mm Hg, P <0.001) and an increase in valve effective orifice area (from 1.0±0.4 to 1.8±0.6 cm 2 , P <0.001). No procedural complications were reported. BVF can be performed safely in small surgical valves to facilitate VIV TAVR with either balloon-expandable or self-expanding transcatheter valves and results in reduced residual transvalvular gradients and increased valve effective orifice area. © 2017 American Heart Association, Inc.

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 confirms that this procedure is feasible and safe, and provides good results with low incidence of postoperative renal disorders. 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

A review of clinical and technical considerations for fixed and removable implant prostheses in the edentulous mandible.

PubMed

Zitzmann, Nicola Ursula; Marinello, Carlo Paolo

2002-01-01

The aim of the present article is to review some of the technical treatment options for implant prostheses restoring the edentulous mandible, mainly based on the Brånemark system. Clinical and technical aspects are discussed for the three established concepts: (1) implant-supported fixed prosthesis, (2) removable implant-supported overdenture, and (3) combined implant-retained and soft tissue-supported overdenture prosthesis. The framework of an implant-supported fixed screw-retained prosthesis can be processed in gold, Co-Cr alloy, or titanium with casting, laser-welding, or milling techniques. To improve the stability and retention of a conventional complete denture, one to four implants are indicated, and unsplinted (single attachments) or splinted designs (bar systems) can be applied. The design of the overdenture prosthesis must be carefully planned according to the requirements to ensure adequate stability and optimal form, contour, and esthetics, and the patient's best comfort. A large variety of different treatment modalities exist for both the fixed and removable mandibular implant prosthesis. Clinical and technical aspects should be considered at the beginning of the treatment to: (1) select the optimal implant position, (2) establish an adequate number of functional units, (3) select the appropriate retainers, and (4) apply the best technique for framework processing and veneering.

International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes

PubMed Central

Albrecht, Helmi; Lim, Yeong Phang; Manning, Linda

2013-01-01

A survey of 24 international heart valve banks was conducted to acquire information on heart valve processing techniques used and outcomes achieved. The objective was to provide an overview of heart valve banking activities for tissue bankers, tissue banking associations, and regulatory bodies worldwide. Despite similarities found for basic manufacturing processes, distinct differences in procedural details were also identified. The similarities included (1) use of sterile culture media for procedures, (2) antibiotic decontamination, (3) use of dimethyl sulfoxide (DMSO) as a cryoprotectant, (4) controlled rate freezing for cryopreservation, and (5) storage at ultralow temperatures of below −135°C. Differences in procedures included (1) type of sterile media used, (2) antibiotics combination, (3) temperature and duration used for bioburden reduction, (4) concentration of DMSO used for cryopreservation, and (5) storage duration for released allografts. For most banks, the primary reasons why allografts failed to meet release criteria were positive microbiological culture and abnormal morphology. On average, 85% of allografts meeting release criteria were implanted, with valve size and type being the main reasons why released allografts were not used clinically. The wide variation in percentage of allografts meeting release requirements, despite undergoing validated manufacturing procedures, justifies the need for regular review of important outcomes as cited in this paper, in order to encourage comparison and improvements in the HVBs' processes. PMID:24163756

Biological and mechanical evaluation of a Bio-Hybrid scaffold for autologous valve tissue engineering.

PubMed

Jahnavi, S; Saravanan, U; Arthi, N; Bhuvaneshwar, G S; Kumary, T V; Rajan, S; Verma, R S

2017-04-01

Major challenge in heart valve tissue engineering for paediatric patients is the development of an autologous valve with regenerative capacity. Hybrid tissue engineering approach is recently gaining popularity to design scaffolds with desired biological and mechanical properties that can remodel post implantation. In this study, we fabricated aligned nanofibrous Bio-Hybrid scaffold made of decellularized bovine pericardium: polycaprolactone-chitosan with optimized polymer thickness to yield the desired biological and mechanical properties. CD44 + , αSMA + , Vimentin + and CD105 - human valve interstitial cells were isolated and seeded on these Bio-Hybrid scaffolds. Subsequent biological evaluation revealed interstitial cell proliferation with dense extra cellular matrix deposition that indicated the viability for growth and proliferation of seeded cells on the scaffolds. Uniaxial mechanical tests along axial direction showed that the Bio-Hybrid scaffolds has at least 20 times the strength of the native valves and its stiffness is nearly 3 times more than that of native valves. Biaxial and uniaxial mechanical studies on valve interstitial cells cultured Bio-Hybrid scaffolds revealed that the response along the axial and circumferential direction was different, similar to native valves. Overall, our findings suggest that Bio-Hybrid scaffold is a promising material for future development of regenerative heart valve constructs in children. Copyright © 2016 Elsevier B.V. All rights reserved.

Consequence of patient substitution of nattokinase for warfarin after aortic valve replacement with a mechanical prosthesis.

PubMed

Elahi, Maqsood M; Choi, Charles H; Konda, Subbareddy; Shake, Jay G

2015-01-01

This report describes a patient's self-substitution of nattokinase for the vitamin K antagonist warfarin after aortic valve replacement with a mechanical prosthesis. Nattokinase is an enzyme derived from a popular fermented soybean preparation in Japan (natto), which has fibrinolytic properties and is gaining popularity in nontraditional health journals and nonmedical health websites as an over-the-counter thrombolytic. After nearly a year of use of nattokinase without warfarin, the patient developed thrombus on the mechanical valve and underwent successful repeat valve replacement. We believe this is the first documented case of nattokinase being used as a substitute for warfarin after valve replacement, and we strongly discourage its use for this purpose.

Consequence of patient substitution of nattokinase for warfarin after aortic valve replacement with a mechanical prosthesis

PubMed Central

Elahi, Maqsood M.; Choi, Charles H.; Konda, Subbareddy

2015-01-01

This report describes a patient's self-substitution of nattokinase for the vitamin K antagonist warfarin after aortic valve replacement with a mechanical prosthesis. Nattokinase is an enzyme derived from a popular fermented soybean preparation in Japan (natto), which has fibrinolytic properties and is gaining popularity in nontraditional health journals and nonmedical health websites as an over-the-counter thrombolytic. After nearly a year of use of nattokinase without warfarin, the patient developed thrombus on the mechanical valve and underwent successful repeat valve replacement. We believe this is the first documented case of nattokinase being used as a substitute for warfarin after valve replacement, and we strongly discourage its use for this purpose. PMID:25552810

Maxillary implant-retained partial overdenture with Dolder bar attachment: a clinical report.

PubMed

Kim, Hyeongil; Buhite, Robert J; Monaco, Edward A

2015-03-01

This article describes a technique for maintaining a maxillary Kennedy III partial removable dental prosthesis design in a patient who had non-restorable failing abutments by replacing the abutments with dental implants. Two implants were placed immediately after extraction of the abutment teeth in the anterior maxilla. After the implants were fully integrated, a Dolder bar attachment was fitted onto the implants. A new maxillary partial removable dental prosthesis was fabricated using the implants and the remaining natural teeth as abutments to restore function and esthetics. With the aid of dental implants, this Kennedy III maxillary removable dental prosthesis design could provide additional retention and support by promoting cross-arch stability and tissue, implant and tooth support. The patient's satisfaction was significantly increased.

Manufacturer-provided effective orifice area index charts and the prevention of prosthesis-patient mismatch.

PubMed

House, Chad M; Nelson, William B; Kroshus, Timothy J; Dahiya, Ranjan; Pibarot, Philippe

2012-01-01

Prosthesis-patient mismatch (PPM) occurs when an implanted prosthesis is too small relative to the patient's body surface area (BSA). However, mismatch can often be prevented by indexing the expected effective orifice area (EOA) of a prosthesis to the patient's BSA and then selecting the largest implantable prosthesis to avoid mismatch. Previously, prosthesis manufacturers have attempted to simplify this process by providing charts that include the expected EOA for their prosthesis, already indexed into an array of BSA values. One caveat with these charts is that the expected EOA data must truly be reliable, or the charts will misguide the implanting surgeon. Manufacturer-provided charts could be improved by standardizing the EOA data, with one potential source being the hemodynamic data submitted to the United States Food and Drug Administration. This review discusses PPM, manufacturer-provided EOA charts, and the regulation of EOA data.

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.

Patient selection for transcatheter aortic valve replacement: A combined clinical and multimodality imaging approach

PubMed Central

Cocchia, Rosangela; D’Andrea, Antonello; Conte, Marianna; Cavallaro, Massimo; Riegler, Lucia; Citro, Rodolfo; Sirignano, Cesare; Imbriaco, Massimo; Cappelli, Maurizio; Gregorio, Giovanni; Calabrò, Raffaele; Bossone, Eduardo

2017-01-01

Transcatheter aortic valve replacement (TAVR) has been validated as a new therapy for patients affected by severe symptomatic aortic stenosis who are not eligible for surgical intervention because of major contraindication or high operative risk. Patient selection for TAVR should be based not only on accurate assessment of aortic stenosis morphology, but also on several clinical and functional data. Multi-Imaging modalities should be preferred for assessing the anatomy and the dimensions of the aortic valve and annulus before TAVR. Ultrasounds represent the first line tool in evaluation of this patients giving detailed anatomic description of aortic valve complex and allowing estimating with enough reliability the hemodynamic entity of valvular stenosis. Angiography should be used to assess coronary involvement and plan a revascularization strategy before the implant. Multislice computed tomography play a central role as it can give anatomical details in order to choice the best fitting prosthesis, evaluate the morphology of the access path and detect other relevant comorbidities. Cardiovascular magnetic resonance and positron emission tomography are emergent modality helpful in aortic stenosis evaluation. The aim of this review is to give an overview on TAVR clinical and technical aspects essential for adequate selection. PMID:28400918

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

PubMed

Steffen, Robert J; Blackstone, Eugene H; Smedira, Nicholas G; Soltesz, Edward G; Hoercher, Katherine J; Thuita, Lucy; Starling, Randall C; Mountis, Maria; Moazami, Nader

2017-11-01

Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant. Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival. Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Biocor No- React stentless aortic valve--short-term results.

PubMed

Von Oppell, U O; Stemmet, F; Levetan, B; Heijke, S A; Brink, J

2001-01-01

Short-term results of the bioprosthetic Biocor No-React composite porcine stentless aortic valve (Biocor Industria e Pesquisas LTDA, Belo Horizonte, Brazil) implanted in patients in whom anticoagulation was thought to be contraindicated or expected to be non-compliant. Retrospective review of 52 consecutive prospective patients in whom this valve was implanted, between September 1994 and May 1998. Average age was 44 +/- 17 years; 75% of patients were operated on for rheumatic heart disease and combined procedures were done in 40% of cases. Early mortality was 5.8%, and related to pre-operative ejection fraction ( P < 0.03), New York Heart Association (NYHA) class (P < 0.01), and bacterial endocarditis (P < 0.04). On discharge, 84% of survivors were in NYHA class I and 16% in class II. The average postoperative prosthetic valve peak gradient on echocardiography was 19.9 +/- 11 mmHg and was related to pre-operative ejection fraction and smaller valve sizes. Postoperative residual trivial or mild aortic regurgitation was seen in 19 patients (36.6%), resolved on follow-up in 10 cases, and did not correlate with structural deterioration, re-operation, mortality, or widening of the non-coronary sinus. The non-coronary aortic sinus was widened on closure, because of perceived crowding of the adjacent stentless valve commisures, in 52% of cases. This was thought to be related to the use of an oblique as opposed to transverse aortotomy. Patient survival, inclusive of operative deaths, was 88.5%, and event-free survival was 80.0% at 4 years. The short-term results of this stentless aortic valve in a young predominantly third-world population group are acceptable, and appear to be superior to the results for mechanical valves in a similar patient group. We would recommend a transverse aortotomy above the sinotubular ridge to be the more appropriate aortotomy incision when using stentless aortic valves.

Atrioventricular and intraventricular block after transcatheter aortic valve implantation.

PubMed

Lee, Jane J; Goldschlager, Nora; Mahadevan, Vaikom S

2018-06-24

Aortic stenosis is the most common valvular heart disease in industrialized countries and the most common cause of left ventricular outflow tract (LVOT) obstruction. Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for intermediate to high-risk surgical candidates with symptomatic severe aortic stenosis. Conduction system abnormalities, including atrioventricular (AV) and intraventricular (IV) block, are the most common complication of TAVR. In this review, we aim to explore the anatomical issues relevant to atrioventricular block, the relevant clinical and procedural aspects, and the management and long-term implications of AV and IV block.

An implantable myoelectric sensor based prosthesis control system.

PubMed

DeMichele, Glenn A; Troyk, Philip R; Kerns, Douglas A; Weir, Richard

2006-01-01

We present progress on the design and testing of an upper-extremity prosthesis control system based on implantable myoelectric sensors. The implant consists of a single silicon chip packaged with transmit and receive coils. Forward control telemetry to, and reverse EMG data telemetry from multiple implants has been demonstrated.

Development of the transtibial prosthesis controlled pneumatically and electrically by microcomputer system.

PubMed

Shimada, Youichi; Terayama, Yukio

2006-01-01

This report represents the development of the prototype transtibial prosthesis to assist a smooth and comfortable walking for an unilateral amputee. This prosthesis is composed of two air cylinders, solenoid valves, portable and small air tank for compressed air storage, a multiple sensor system and a microprocessor. Two air cylinders are located around the rods to act as antagonistic and agonistic muscles. The system causes flexion and extension of the foot plate jointed at the ankle with compressed air, injected -or discharged via a solenoid or electromagnetic valves. The valves or solenoids are controlled with a microprocessor (Microchip Technology Inc., PIC16F876), the microprocessor generates control signals to the interface circuits for valve opening and closing consistent with the foot position during the walking phase. The control patterns generated in the microprocessor are modified with feedback from the touch sensor, ankle joint angle sensor and the two dimensional acceleration sensor. The primary walking pattern for an individual amputee should be developed through the gait analysis with video.

Heart Transplant in Patients with Predominantly Rheumatic Valvular Heart Disease.

PubMed

Rosa, Vitor E E; Lopes, Antonio S S A; Accorsi, Tarso A D; Fernandes, Joao Ricardo C; Spina, Guilherme S; Sampaio, Roney O; Bacal, Fernando; Tarasoutchi, Flavio

2015-09-01

International records indicate that only 2.6% of patients with heart transplants have valvular heart disease. The study aim was to evaluate the epidemiological and clinical profile of patients with valvular heart disease undergoing heart transplantation. Between 1985 and 2013, a total of 569 heart transplants was performed at the authors' institution. Twenty patients (13 men, seven women; mean age 39.5 +/- 15.2 years) underwent heart transplant due to structural (primary) valvular disease. Analyses were made of the patients' clinical profile, laboratory data, echocardiographic and histopathological data, and mortality and rejection. Of the patients, 18 (90%) had a rheumatic etiology, with 85% having undergone previous valve surgery (45% had one or more operations), and 95% with a normal functioning valve prosthesis at the time of transplantation. Atrial fibrillation was present in seven patients (35%), while nine (45%) were in NYHA functional class IV and eight (40%) in class III. The indication for cardiac transplantation was refractory heart failure in seven patients (35%) and persistent NYHA class III/IV in ten (50%). The mean left ventricular ejection fraction (LVEF) was 26.6 +/- 7.9%. The one-year mortality was 20%. Histological examination of the recipients' hearts showed five (27.7%) to have reactivated rheumatic myocarditis without prior diagnosis at the time of transplantation. Univariate analysis showed that age, gender, LVEF, rheumatic activity and rejection were not associated with mortality at one year. Among the present patient cohort, rheumatic heart disease was the leading cause of heart transplantation, and a significant proportion of these patients had reactivated myocarditis diagnosed in the histological analyses. Thus, it appears valid to investigate the existence of rheumatic activity, especially in valvular cardiomyopathy with severe systolic dysfunction before transplantation.

Intermediate results of isolated mitral valve replacement with a Biocor porcine valve.

PubMed

Rizzoli, Giulio; Bottio, Tomaso; Vida, Vladimiro; Nesseris, Georgios; Caprili, Luca; Thiene, Gaetano; Gerosa, Gino

2005-02-01

We analyzed the intermediate experience, survival, and prosthetic complications of patients who received the Biocor valve, a new-generation porcine valve, in the mitral position. At the University of Padua, between May 1992 and January 2004, 154 consecutive patients (102 female and 52 male patients; mean age, 72.3 +/- 6 years; age range, 37-86 years) received 158 mitral Biocor prostheses (Biocor Industria e Pesguisa Ltda, Belo Horizonte, Brazil). Thirty-five percent of the patients had previous mitral operations, 24% had coronary artery bypass grafting, and 34.6% had other procedures. Median preoperative New York Heart Association class was III. Echocardiography was performed in 75% of the long-term survivors. Follow-up included 609.4 patient-years and was 100% complete, with a median time of 4 patient-years (range, 0.02-11.3 years). At 8 years, 20 (14%) of 142 operative survivors were still at risk. Early mortality was 13.6%. According to univariate analysis, New York Heart Association class III to IV, ejection fraction of less than 40%, urgency, male sex, and coronary artery bypass grafting were significant perioperative risk factors. Eight- and 10-year actuarial survival was 51.1% +/- 5.6% (40 deaths). Eight-year actuarial freedom from valve-related death, thromboembolism, anticoagulant-related hemorrhage, endocarditis, paravalvular leak, and valve-related complications were 85.2% +/- 5%, 85.7% +/- 4.4%, 92.6% +/- 3.7%, 94.1% +/- 3%, 91.8% +/- 3%, and 70.2% +/- 5.7%, respectively. Freedom from structural valve deterioration was 100%. Actual freedom from reoperation was 93.2% +/- 2.2%. By Doppler echocardiography, the peak and mean transprosthetic gradients were 15 +/- 5 mm Hg and 6.3 +/- 3 mm Hg, respectively (mean follow-up, 4.2 +/- 2.7 years). At intermediate follow-up, the Biocor prosthesis in the mitral position showed excellent results in terms of valve durability when compared with other second-generation tissue valves.

Ureaplasma parvum causing life-threatening disease in a susceptible patient.

PubMed

Korytny, Alexander; Nasser, Roni; Geffen, Yuval; Friedman, Tom; Paul, Mical; Ghanem-Zoubi, Nesrin

2017-08-16

A 56-year-old man with lymphoma developed orchitis followed by septic arthritis of his right glenohumeral joint. Synovial fluid cultures were negative but PCR amplification test was positive for Ureaplasmaparvum. The patient was treated with doxycycline. Two and a half years later, the patient presented with shortness of breath and grade III/IV diastolic murmur on auscultation. Echocardiography revealed severely dilated left heart chambers, severe aortic regurgitation and several mobile masses on the aortic valve cusps suspected to be vegetations. He underwent valve replacement; valve tissue culture was negative but the 16S rRNA gene amplification test was positive for U. parvum He was treated again with doxycycline. In an outpatient follow-up 1 year and 3 months later, the patient was doing well. Repeated echocardiography showed normal aortic prosthesis function. © BMJ Publishing Group Ltd (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Mechanisms of Cochlear Stimulation Through the Round Window

NASA Astrophysics Data System (ADS)

Lukashkin, Andrei N.; Weddell, Thomas; Russell, Ian J.

2011-11-01

The round window membrane (RW) functions as a pressure relief valve in conventional hearing allowing structures of the middle ear to move. Investigations in recent years have shown that middle ear implants can be used to stimulate the cochlea via the RW. Isolated clinical uses of this technique have been applied but more thorough theoretical and empirical studies are required. Using guinea pigs as test subjects we have investigated physiological effects of RW stimulation using a simulation of active middle ear prosthesis, a cylindrical neodymium iron boron disk magnet placed upon the RW which can be stimulated by an electromagnetic coil positioned in close proximity to the magnet.

Self-expanding Portico Valve Versus Balloon-expandable SAPIEN XT Valve in Patients With Small Aortic Annuli: Comparison of Hemodynamic Performance.

PubMed

Del Trigo, María; Dahou, Abdellaziz; Webb, John G; Dvir, Danny; Puri, Rishi; Abdul-Jawad Altisent, Omar; Campelo-Parada, Francisco; Thompson, Chris; Leipsic, Jonathon; Stub, Dion; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Doyle, Daniel; Mohammadi, Siamak; Pasian, Sergio; Côté, Melanie; Pibarot, Philippe; Rodés-Cabau, Josep

2016-05-01

The self-expanding Portico valve is a new transcatheter aortic valve system yielding promising preliminary results, yet there are no comparative data against earlier generation transcatheter aortic valve systems. The aim of this study was to compare the hemodynamic performance of the Portico and balloon-expandable SAPIEN XT valves in a case-matched study with echocardiographic core laboratory analysis. Twenty-two patients underwent transcatheter aortic valve implantation with the Portico 23-mm valve and were matched for aortic annulus area and mean diameter measured by multidetector computed tomography, left ventricular ejection fraction, body surface area, and body mass index with 40 patients treated with the 23-mm SAPIEN XT. Mean aortic annulus diameters were 19.6±1.3mm by transthoracic echocardiography and 21.4±1.2mm by computed tomography, with no significant between-group differences. Doppler echocardiographic images were collected at baseline and at 1-month of follow-up and were analyzed in a central echocardiography core laboratory. There were no significant between-group differences in residual mean transaortic gradients (SAPIEN XT: 10.4±3.7mmHg; Portico: 9.8±1.1mmHg; P=.49) and effective orifice areas (SAPIEN XT: 1.36±0.27cm(2); Portico, 1.37±.29cm(2); P=.54). Rates of severe prosthesis-patient mismatch (effective orifice area<0.65cm(2)/m(2)) were similar (SAPIEN XT: 13.5%; Portico: 10.0%; P=.56). No between-group differences were found in the occurrence of moderate-severe paravalvular leaks (5.0% vs 4.8% of SAPIEN XT and Portico respectively; P=.90). Transcatheter aortic valve implantation with the self-expanding Portico system yielded similar short-term hemodynamic performance compared with the balloon-expandable SAPIEN XT system for treating patients with severe aortic stenosis and small annuli. Further prospective studies with longer-term follow-up and in patients with larger aortic annuli are required. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Femtosecond laser-induced ripple patterns for homogenous nanostructuring of pyrolytic carbon heart valve implant

NASA Astrophysics Data System (ADS)

Stępak, Bogusz; Dzienny, Paulina; Franke, Volker; Kunicki, Piotr; Gotszalk, Teodor; Antończak, Arkadiusz

2018-04-01

Laser-induced periodic surface structures (LIPSS) are highly periodic wavy surface features which are frequently smaller than incident light wavelength that bring possibility of nanostructuring of many materials. In this paper the possibility of using them to homogeneously structure the surface of artificial heart valve made of PyC was examined. By changing laser irradiation parameters such like energy density and pulse separation the most suitable conditions were established for 1030 nm wavelength. A wide spectrum of periodicities and geometries was obtained. Interesting side effects like creating a thin shell-like layer were observed. Modified surfaces were examined using EDX and Raman spectroscopy to determine change in elemental composition of surface.

Concomitant Transapical Transcatheter Valve Implantations: Edwards Sapien Valve for Severe Mitral Regurgitation in a Patient with Failing Mitral Bioprostheses and JenaValve for the Treatment of Pure Aortic Regurgitation.

PubMed

Aydin, Unal; Gul, Mehmet; Aslan, Serkan; Akkaya, Emre; Yildirim, Aydin

2015-04-28

Transcatheter valve implantation is a novel interventional technique, which was developed as an  alternative therapy for surgical aortic valve replacement in inoperable patients with severe aortic stenosis. Despite limited experience in using transcatheter valve implantation for mitral and aortic regurgitation, transapical transcatheter aortic valve implantation and valve-in-valve implantation for degenerated mitral valve bioprosthesis can be performed in high-risk patients who are not candidates for conventional replacement surgery. In this case, we present the simultaneous transcatheter valve implantation via transapical approach for both degenerated bioprosthetic mitral valve with severe regurgitation and pure severe aortic regurgitation.

[The endo-exo femur prosthesis--a new concept of bone-guided, prosthetic rehabilitation following above-knee amputation].

PubMed

Aschoff, H H; Clausen, A; Hoffmeister, T

2009-01-01

The implantation of an intramedullary transcutaneously conducted femur prosthesis presents a rather new procedure for the rehabilitation of above-knee amputated patients. The aim of the so-called endo-exo prosthesis is to avoid the well-known problems at the interface between the sleeve of the prosthesis and the soft tissue coat of the femur stump which often impedes an inconspicuous and harmonic gait. The company ERSKA Implants in Lübeck/Germany has developed an intramedullary femur prosthesis with a spongiosa metal-configurated relief surface which, when implanted cementless, enables a secure osseointegration and allows a more direct transmission of muscle power to the lower leg prosthesis. A minimum length of 16-18 cm and a sufficient soft tissue coverage of the femur stump is needed. The problems at the perforation point of the implant through the soft tissue coat can be handled or even be avoided and they do not necessarily provoke an intramedullary infection. We report on 30 cases that were operated between 1999 and 2008. The design of the prosthesis, aspects of the operative procedure and latest results are presented.

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.

Surgical Treatment of Valvular Heart Disease: Overview of Mechanical and Tissue Prostheses, Advantages, Disadvantages, and Implications for Clinical Use.

PubMed

Fiedler, Amy G; Tolis, George

2018-02-05

Valvular heart disease (VHD) affects a large number of patients annually. From a surgical standpoint, there are two primary options for valve replacement: mechanical or bioprosthetic. While there are clear advantages and disadvantages to either option, and recent literature does challenge some of the prior dictums of valve choice, a handful of absolutes remain true. Mechanical valves provide superior durability and freedom from re-operation when compared to their bioprosthetic counterparts, at the expense of bleeding or thrombotic complications associated with the need for lifelong oral anticoagulation. Unless a clear contraindication to oral anticoagulation exists, we recommend implanting mechanical valves for patients less than 60 years old and those who are older than 65 but maintained on anticoagulation for reasons other than their valvular disease. Bioprosthetic valves should be placed in patients who are greater than 65 years old or those patients who have a postoperative life expectancy of less than 10 years. Valve choice in patients between the ages of 60 to 70 is not dictated by guidelines and is less clear, with patient preference playing a larger role than their age range.

Three-dimensional finite element analysis of vertical and angular misfit in implant-supported fixed prostheses.

PubMed

Assunção, Wirley Gonçalves; Gomes, Erica Alves; Rocha, Eduardo Passos; Delben, Juliana Aparecida

2011-01-01

Three-dimensional finite element analysis was used to evaluate the effect of vertical and angular misfit in three-piece implant-supported screw-retained fixed prostheses on the biomechanical response in the peri-implant bone, implants, and prosthetic components. Four three-dimensional models were fabricated to represent a right posterior mandibular section with one implant in the region of the second premolar (2PM) and another in the region of the second molar (2M). The implants were splinted by a three-piece implant-supported metal-ceramic prosthesis and differed according to the type of misfit, as represented by four different models: Control = prosthesis with complete fit to the implants; UAM (unilateral angular misfit) = prosthesis presenting unilateral angular misfit of 100 μm in the mesial region of the 2M; UVM (unilateral vertical misfit) = prosthesis presenting unilateral vertical misfit of 100 μm in the mesial region of the 2M; and TVM (total vertical misfit) = prosthesis presenting total vertical misfit of 100 μm in the platform of the framework in the 2M. A vertical load of 400 N was distributed and applied on 12 centric points by the software Ansys, ie, a vertical load of 150 N was applied to each molar in the prosthesis and a vertical load of 100 N was applied at the 2PM. The stress values and distribution in peri-implant bone tissue were similar for all groups. The models with misfit exhibited different distribution patterns and increased stress magnitude in comparison to the control. The highest stress values in group UAM were observed in the implant body and retention screw. The groups UVM and TVM exhibited high stress values in the platform of the framework and the implant hexagon, respectively. The three types of misfit influenced the magnitude and distribution of stresses. The influence of misfit on peri-implant bone tissue was modest. Each type of misfit increased the stress values in different regions of the system.

Comparative analysis of use of porous orbital implant with mucus membrane graft and dermis fat graft as a primary procedure in reconstruction of severely contracted socket

PubMed Central

Bhattacharjee, Kasturi; Bhattacharjee, Harsha; Kuri, Ganesh; Das, Jayanta Kr; Dey, Debleena

2014-01-01

Purpose: The purpose of our study is to present a surgical technique of primary porous orbital ball implantation with overlying mucus membrane graft (MMG) for reconstruction of severely contracted socket and to evaluate prosthesis retention and motility in comparison to dermis fat graft (DFG). Study Design: Prospective comparative study. Materials and Methods: A total of 24 patients of severe socket contracture (Grade 2-4 Krishna's classification) were subdivided into two groups, 12 patients in each group. In Group I, DFG have been used for reconstruction. In Group II, porous polyethylene implant with MMG has been used as a primary procedure for socket reconstruction. In Group I DFG was carried out in usual procedure. In case of Group II, vascularized scar tissues were separated 360° and were fashioned into four strips. A scleral capped porous polyethylene implant was placed in the intraconal space and four strips of scar tissue were secured to the scleral cap and extended part overlapped the implant to make a twofold barrier between the implant and MMG. Patients were followed-up as per prefixed proforma. Prosthesis motility and retention between the two groups were measured. Results: In Group I, four patients had recurrence of contracture with fall out of prosthesis. In Group II stable reconstruction was achieved in all the patients. In terms of prosthesis motility, maximum in Group I was 39.2% and Group II, was 59.3%. The difference in prosthesis retention (P = 0.001) and motility (P = 0.004) between the two groups was significant. Conclusion: Primary socket reconstruction with porous orbital implant and MMG for severe socket contracture is an effective method in terms of prosthesis motility and prosthesis retention. PMID:24618485

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.

In vitro investigation of a novel elastic vascular prosthesis for valve-sparing aortic root and ascending aorta replacement.

PubMed

Scharfschwerdt, Michael; Leonhard, Moritz; Lehmann, Judith; Richardt, Doreen; Goldmann, Helmut; Sievers, Hans-Hinrich

2016-05-01

Prosthetic replacement of the thoracic aorta with common Dacron prostheses impairs the aortic 'windkessel' and, in valve-sparing procedures, also aortic valve function. Elastic graft material may overcome these deficiencies. Fresh porcine aortas including the root were set up in a mock circulation before and after replacement of the ascending part with a novel vascular prosthesis providing elastic behaviours. In a first series (n = 14), haemodynamics and leaflet motions of the aortic valve were investigated and also cyclic changes of aortic dimensions at different levels of the root. In a second series (n = 7), intravascular pressure and dimensions of the proximal descending aorta were measured and the corresponding wall tension was calculated. Haemodynamics of the aortic valve remain comparable after replacement. Though the novel prosthesis does not feature such high distensibility as the native aorta, the dynamic of the root was significantly increased compared with common Dacron prostheses at the commissural level, preserving 'windkessel' function. Thus, wall tension of the residual aorta remained unchanged; nevertheless, maximum pressure-time differential dp/dt increased by 13%. The use of the novel elastic prosthesis for replacement of the ascending aorta seems to be beneficial, especially with regard to the preservation of the aortic windkessel. Further studies will be needed to clarify long-term utilization of the material in vivo. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Mini-implants: alternative for oral rehabilitation of a child with ectodermal dysplasia.

PubMed

Mello, Bianca Zeponi Fernandes; Silva, Thiago Cruvinel; Rios, Daniela; Machado, Maria Aparecida Andrade Moreira; Valarelli, Fabrício Pinelli; Oliveira, Thais Marchini

2015-01-01

Ectodermal dysplasia is a rare congenital disease that affects several structures of ectodermal origin. The most commonly related oral characteristics are hypodontia, malformed teeth and underdeveloped alveolar ridges. New alternative treatments are needed due to the failure of the conventional prosthesis retention. This case report outlines the oral rehabilitation treatment of a 9-year-old girl with ectodermal dysplasia. The treatment was performed with conventional prosthesis upon mini-implants. The mini-implants provided prosthetic retention. The patient reported a good adaptation of the dental prosthesis and satisfaction with the treatment. The increased self-esteem improved the socialization skills of the girl. In this case report, use of prosthesis with mini-implants was satisfactory for prosthetic retention. However, clinical studies with long-term follow-up are needed to test the mini-implants as an alternative for oral rehabilitation of children with ectodermal dysplasia.

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.

Diagnostic value of NobelGuide to minimize the need for reconstructive surgery of jaws before implant placement: a review.

PubMed

Scotti, Roberto; Pellegrino, Gerardo; Marchetti, Claudio; Corinaldesi, Guiseppe; Ciocca, Leonardo

2010-01-01

To test if using a CAD/CAM system might reduce the necessity of bone augmentation in patients with atrophic maxillary arches before implant therapy. Twenty male and female patients consecutively scheduled for bone augmentation of the jaw before implant surgery were included in this study, with a total of 29 jaws (maxillary and mandibular) to analyze for the implant-supported fixed prosthesis group and 19 maxillary arches for the implant-supported removable prosthesis group. NobelGuide System (Nobel Biocare), Autocad System (Autodesk), and routine manual CT measurements of available bone were used in this study. The total results of the mean values of the fixed prosthesis group plus the mean values of the removable prosthesis group showed a statistically significant difference between the NobelGuide intervention score and both manual (P = .004) and Autocad (P = .001) measurements. The NobelGuide System represents a viable diagnostic device to reduce the entity or avoid bone reconstructive surgery before implant placements in the atrophic maxilla and mandible.

Survival of various implant-supported prosthesis designs following 36 months of clinical function.

PubMed

Rodriguez, A M; Orenstein, I H; Morris, H F; Ochi, S

2000-12-01

The use of endosseous dental implants to replace natural teeth lost to trauma, dental caries, or periodontal disease has become a predictable form of prosthetic treatment since gaining popularity in the early 1980s. While numerous clinical studies have focused on the survival of implants, few address the survival of different prosthesis designs. Beginning in 1991, 882 prostheses supported by more than 2,900 implants (687 patients) were placed by the Department of Veterans Affairs Dental Implant Clinical Research Group (DICRG). These prostheses were divided into five research strata based on arch location. The recommended design for each stratum was: bar-supported overdenture (maxillary completely edentulous); screw-retained hybrid denture (mandibular completely edentulous); screw-retained fixed partial denture (mandibular and maxillary posterior partially edentulous); and cemented single crown (maxillary anterior single tooth). Alternative overdenture designs were utilized in the edentulous arches when the recommended prosthesis could not be fabricated. Prosthesis success rates for the research strata were calculated for an observation time of up to 36 months following prosthesis placement. Success rates for the maxillary edentulous stratum ranged from 94.6% for the bar-retained overdenture supported by five to six fixtures to 81.8% for the cap-retained overdenture. The mandibular edentulous strata produced success rates of 98.1% for the fixed hybrid prosthesis to 91.7% for the cap-retained prosthesis. Success rates for maxillary and mandibular posterior fixed partial dentures were 94.3% and 92.6%, respectively, while the maxillary anterior single-tooth prosthesis yielded a success rate of 98.1% for the 36-month observation period. The recommended prosthesis designs investigated in this study proved to be reliable, with encouraging success rates for an observation period of 36 months following placement.

European homograft bank: twenty years of cardiovascular tissue banking and collaboration with transplant coordination in Europe.

PubMed

Jashari, R; Goffin, Y; Vanderkelen, A; Van Hoeck, B; du Verger, A; Fan, Y; Holovska, V; Brahy, O

2010-01-01

Established in 1989 in Brussels as an international nonprofit association, the European Homograft Bank (EHB) has been collaborating closely with the transplant coordination of the different centers in Belgium and other European countries. Donor selection is made after discussion of exclusion criteria with the transplant coordinator of the procurement center. EHB collaborates with 15 Belgian, 11 German, 10 French, 10 Swiss, 3 Italian, 3 Dutch, and some other procurement and/or implantation centers. Donor ages range from newborn to 65 years. Tissue preparation, morphologic evaluation, and functional testing are performed under Class A laminar flow. After decontamination in a cocktail of 3 antibiotics (lincomycin, vancomycin, and polymixin B) during 20-48 hours, the tissues cryopreserved with liquid nitrogen to -100 degrees C are stored in vapors of liquid nitrogen below -150 degrees C for a maximum of 5 years. Systematic virologic examination of donor blood is performed for HIV, HTLV, hepatitis B/C, and syphilis, as well as for enteroviruses, Q fever, malaria, and West Nile virus by indication. Bacteriologic examination for anaerobic and aerobic contamination is performed at the different steps of processing. Histologic examination for malignant disease and infection is performed systematically. Indications for implantation are discussed with the requesting surgeon. Transport to the implantation center is carried out safely in a dry shipper at -150 degrees C or in dry ice at -76 degrees C. The EHB received 4,511 hearts and 1,169 batches of arteries from January 1989 to December 2008. The 5,133 heart valves (1,974 aortic, 3,106 pulmonary, and 53 mitral) and 2,066 arterial segments have been prepared and stored; 4,600 cryopreserved valvular (2,717 pulmonary, 1,835 aortic, and 48 mitral) and 1,937 arterial allografts have been distributed for implantation in various European Cardiovascular Centers. EHB is not always able to meet the increased demand for heart valves and arterial allografts. Collaboration between the EHB and the Transplant Coordination is satisfactory. Donor selection criteria are discussed with the transplant coordinator; whereas, implantation indication, with the implanting surgeon. Because the EHB is not always able to meet demands for the cryopreserved valves and arterial segments, there is a need to increase number of procurements. Cardiovascular surgeons need to play more active roles in the resolution of this problem.

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.

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.

Strut fracture with Björk-Shiley 70 degrees convexo-concave valve. An international multi-institutional follow-up study.

PubMed

Ericsson, A; Lindblom, D; Semb, G; Huysmans, H A; Thulin, L I; Scully, H E; Bennett, J G; Ostermeyer, J; Grunkemeier, G L

1992-01-01

Between 1980 and 1983, 831 Björk-Shiley 70 degrees convexo-concave prosthetic heart valves were implanted at five institutions in Sweden, Germany. The Netherlands, and Canada. As of January 1991, there were 34 outlet strut fractures occurring from 0.2 to 10.1 years (median = 4.6 years) after implantation. In addition, there were 28 sudden, unexplained deaths. The mortality after strut fracture was 84%. The mortality after emergency valve replacement for strut fracture was 50%. The 10-year actuarial fracture rate (standard error) was 10.5 (2.4)% for large (29-33 mm) valves vs. 3.3 (1.2)% for 21-27 mm valves (P less than 0.001). Within valve size groups, fracture rates for aortic and mitral valves were similar. Cox regression analysis found only valve size to be significantly associated with strut fracture. There is a further subgrouping of the valves according to the manufacturer: group I are the earlier large 29-33 mm) valves; group II are the later large valves; group III are the small size (21-27 mm) valves. The risk of strut fracture was highest in group I (12.3% at 10 years) with an approximatively constant hazard (1.4% per year). A comparison was made with a statistical model incorporating all cases reported to the manufacturer. This model estimates fracture rates approximately 63%-73% of those found in the present study. These findings lead us to recommend that group I patients should be considered for elective reoperation on an individual basis, giving careful attention to risk factors and contraindications.

Imaging of pannus formation in patients with mechanical heart valves.

PubMed

Gündüz, Sabahattin; Özkan, Mehmet; Yesin, Mahmut

2015-11-26

Patient-prosthesis mismatch (PPM) should be recognized in patients with elevated transprosthetic gradients but without leaflet immobility, since the treatment strategy may differ in either etiology. However, thrombus and/or pannus formation should be excluded before a diagnosis of PPM is made. Particularly, pannus formation may not be diagnosed with 2-dimensional transesophageal echocardiography. Electrocardiographically gated 64-section multidetector computed tomography (MDCT) may be a promising tool in diagnosing or excluding pannus formation. Our report underlines the utility of MDCT in this regard and also emphasizes the importance of recognition of PPM as a differential diagnosis in such patients.

Imaging of pannus formation in patients with mechanical heart valves

PubMed Central

Gündüz, Sabahattin; Özkan, Mehmet; Yesin, Mahmut

2015-01-01

Patient-prosthesis mismatch (PPM) should be recognized in patients with elevated transprosthetic gradients but without leaflet immobility, since the treatment strategy may differ in either etiology. However, thrombus and/or pannus formation should be excluded before a diagnosis of PPM is made. Particularly, pannus formation may not be diagnosed with 2-dimensional transesophageal echocardiography. Electrocardiographically gated 64-section multidetector computed tomography (MDCT) may be a promising tool in diagnosing or excluding pannus formation. Our report underlines the utility of MDCT in this regard and also emphasizes the importance of recognition of PPM as a differential diagnosis in such patients. PMID:26635931

Virtual Surgery for Conduit Reconstruction of the Right Ventricular Outflow Tract.

PubMed

Ong, Chin Siang; Loke, Yue-Hin; Opfermann, Justin; Olivieri, Laura; Vricella, Luca; Krieger, Axel; Hibino, Narutoshi

2017-05-01

Virtual surgery involves the planning and simulation of surgical reconstruction using three-dimensional (3D) modeling based upon individual patient data, augmented by simulation of planned surgical alterations including implantation of devices or grafts. Here we describe a case in which virtual cardiac surgery aided us in determining the optimal conduit size to use for the reconstruction of the right ventricular outflow tract. The patient is a young adolescent male with a history of tetralogy of Fallot with pulmonary atresia, requiring right ventricle-to-pulmonary artery (RV-PA) conduit replacement. Utilizing preoperative magnetic resonance imaging data, virtual surgery was undertaken to construct his heart in 3D and to simulate the implantation of three different sizes of RV-PA conduit (18, 20, and 22 mm). Virtual cardiac surgery allowed us to predict the ability to implant a conduit of a size that would likely remain adequate in the face of continued somatic growth and also allow for the possibility of transcatheter pulmonary valve implantation at some time in the future. Subsequently, the patient underwent uneventful conduit change surgery with implantation of a 22-mm Hancock valved conduit. As predicted, the intrathoracic space was sufficient to accommodate the relatively large conduit size without geometric distortion or sternal compression. Virtual cardiac surgery gives surgeons the ability to simulate the implantation of prostheses of different sizes in relation to the dimensions of a specific patient's own heart and thoracic cavity in 3D prior to surgery. This can be very helpful in predicting optimal conduit size, determining appropriate timing of surgery, and patient education.

[Simultaneous interventions on the ascending portion, arch of the aorta and cardiac valves in patients with Marfan's syndrome].

PubMed

Belov, Iu V; Stepanenko, A B; Gens, A P; Charchian, E R; Savichev, D D

2007-01-01

Simultaneous surgical interventions on the aorta and valvular system of the heart were performed in four patients presenting with aortic dissections and aneurysms conditioned by Marfan's syndrome. The following reconstructive operations were carried out: 1) prosthetic repair of the aortic valve and the ascending portion of the aorta by means of a valve-containing conduit with replantation of the openings of the coronary arteries into the side of the prosthesis according to the Benthall - De Bono technique, annuloplasty of the tricuspid valve according to the De Vega technique, valvuloplasty of the mitral valve by the Alferi technique; 2) grafting of the aortic valve and the ascending portion of the aorta by means of a valve-containing conduit with replantation of the openings of the coronary arteries according to the Kabrol's technique, plasty of the tricuspid valve by the De Vega technique; 3) prosthetic repair of the aortic arch with distal wedge-like excision of the membrane of the dissection and directing the blood flow along the both channels, plasty of the mitral valve, plasty of the aortic valve and the ascending portion of the aorta with a valve-containing conduit, accompanied by replantation of the openings of the coronary arteries into the side of the graft according to the Benthall - De Bono technique; (4) plasty of the mitral valve with a disk graft through the fibrous ring of the aortic valve, prosthetic repair of the aortic valve and the ascending portion of the aorta with a valve-containing conduit, accompanied by replantation of the openings of the coronary arteries into the side according to the Benthall-De Bono technique.

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

Debridement, antibiotics, irrigation, and retention (DAIR) of the prosthesis after hip hemiarthroplasty infections. Does it work?

PubMed

Kazimoglu, Cemal; Yalcin, Nadir; Onvural, Burak; Akcay, Serkan; Agus, Haluk

2015-08-01

Debridement, antibiotic, and implant retention (DAIR) is an attractive treatment modality after hip hemiarthroplasty (HA) infections. Data about the success of the procedure after acute onset infections is lacking. The aim of this study was to analyze the clinical outcome and associated risk factors. A multicenter, retrospective cohort study was designed, including 39 patients with acute onset prosthetic infection who had undergone debridement and irrigation with prosthesis retention. The primary outcome measure was infection eradication without prosthesis removal. We also analyzed how the success rate was influenced by the length of the interval between implantation of the prosthesis and the beginning of the treatment. The overall success rate was 41%. Sedimentation rate over 60 mm/h and the longer duration (2 weeks) after prosthesis implantation were found as factors negatively influencing the success rate. Our results indicated limited success to DAIR- treated patients with infected HA. The high failure rate of DAIR treatment after 2 weeks from the implantation should be taken into consideration.

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.

Implantation of personalized, biocompatible mitral annuloplasty rings: feasibility study in an animal model

PubMed Central

Sündermann, Simon H.; Gessat, Michael; Cesarovic, Nikola; Frauenfelder, Thomas; Biaggi, Patric; Bettex, Dominique; Falk, Volkmar; Jacobs, Stephan

2013-01-01

OBJECTIVES Implantation of an annuloplasty ring is an essential component of a durable mitral valve repair. Currently available off-the-shelf rings still do not cover all the variations in mitral annulus anatomy and pathology from subject to subject. Computed tomography (CT) and echo imaging allow for 3-D segmentation of the mitral valve and mitral annulus. The concept of tailored annuloplasty rings has been proposed although, to date, no surgically applicable implementation of patient-specific annuloplasty rings has been seen. The objective of this trial was to prove the concept of surgical implantation of a model-guided, personalized mitral annuloplasty ring, manufactured based on individual CT-scan models. METHODS ECG-gated CT angiography was performed in six healthy pigs under general anaesthesia. Based on the individual shape of the mitral annulus in systole, a customized solid ring with integrated suturing holes was designed and manufactured from a biocompatible titanium alloy by a rapid process using laser melting. The ring was implanted three days later and valve function was assessed by intraoperative echocardiography. The macroscopic annulus–annuloplasty match was assessed after heart explantation. RESULTS CT angiography provided good enough image quality in all animals to allow for segmentation of the mitral annulus. The individually tailored mitral rings were manufactured and successfully implanted in all pigs. In 50%, a perfect matching of the implanted ring and the mitral annulus was achieved. In one animal, a slight deviation of the ring shape from the circumference was seen postoperatively. The rings implanted in the first two animals were significantly oversized but the deviation did not affect valve competence. CONCLUSIONS CT image quality and accuracy of the dimensions of the mitral annulus were sufficient for digital modelling and rapid manufacturing of mitral rings. Implantation of individually tailored annuloplasty rings is feasible. PMID:23287589

21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Interarticular disc prosthesis (interpositional implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... (interpositional implant) is a device that is intended to be an interface between the natural articulating surface...

21 CFR 874.3695 - Mandibular implant facial prosthesis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is...

21 CFR 874.3695 - Mandibular implant facial prosthesis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Mandibular implant facial prosthesis. 874.3695 Section 874.3695 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... intended to be implanted for use in the functional reconstruction of mandibular deficits. The device is...

Pannus-related prosthetic valve dysfunction. Case report

PubMed Central

MOLDOVAN, MARIA-SÎNZIANA; BEDELEANU, DANIELA; KOVACS, EMESE; CIUMĂRNEAN, LORENA; MOLNAR, ADRIAN

2016-01-01

Pannus-related prosthetic valve dysfunction, a complication of mechanical prosthetic valve replacement, is rare, with a slowly progressive evolution, but it can be acute, severe, requiring surgical reintervention. We present the case of a patient with a mechanical single disc aortic prosthesis, with moderate prosthesis-patient mismatch, minor pannus found on previous ultrasound examinations, who presented to our service with angina pain with a duration of 1 hour, subsequently interpreted as non-ST segment elevation myocardial infarction (NSTEMI) syndrome. Coronarography showed normal epicardial coronary arteries, an ample movement of the prosthetic disc, without evidence of coronary thromboembolism, and Gated Single-Photon Emission Computerized Tomography (SPECT) with Technetium (Tc)-99m detected no perfusion defects. Transthoracic echocardiography (TTE) evidenced a dysfunctional prosthesis due to a subvalvular mass; transesophageal echocardiography (TOE) showed the interference of this mass, with a pannus appearance, with the closure of the prosthetic disc. Under conditions of repeated angina episodes, under anticoagulant treatment, surgery was performed, with the intraoperative confirmation of pannus and its removal. Postoperative evolution was favorable. This case reflects the diagnostic and therapeutic management problems of pannus-related prosthetic valve dysfunction. PMID:27004041

Pannus-related prosthetic valve dysfunction. Case report.

PubMed

Moldovan, Maria-Sînziana; Bedeleanu, Daniela; Kovacs, Emese; Ciumărnean, Lorena; Molnar, Adrian

2016-01-01

Pannus-related prosthetic valve dysfunction, a complication of mechanical prosthetic valve replacement, is rare, with a slowly progressive evolution, but it can be acute, severe, requiring surgical reintervention. We present the case of a patient with a mechanical single disc aortic prosthesis, with moderate prosthesis-patient mismatch, minor pannus found on previous ultrasound examinations, who presented to our service with angina pain with a duration of 1 hour, subsequently interpreted as non-ST segment elevation myocardial infarction (NSTEMI) syndrome. Coronarography showed normal epicardial coronary arteries, an ample movement of the prosthetic disc, without evidence of coronary thromboembolism, and Gated Single-Photon Emission Computerized Tomography (SPECT) with Technetium (Tc)-99m detected no perfusion defects. Transthoracic echocardiography (TTE) evidenced a dysfunctional prosthesis due to a subvalvular mass; transesophageal echocardiography (TOE) showed the interference of this mass, with a pannus appearance, with the closure of the prosthetic disc. Under conditions of repeated angina episodes, under anticoagulant treatment, surgery was performed, with the intraoperative confirmation of pannus and its removal. Postoperative evolution was favorable. This case reflects the diagnostic and therapeutic management problems of pannus-related prosthetic valve dysfunction.

Intracardiac Echocardiography for Structural Heart and Electrophysiological Interventions.

PubMed

Basman, Craig; Parmar, Yuvrajsinh J; Kronzon, Itzhak

2017-09-06

With an increasing number of interventional procedures performed for structural heart disease and cardiac arrhythmias each year, echocardiographic guidance is necessary for safe and efficient results. The purpose of this review article is to overview the principles of intracardiac echocardiography (ICE) and describes the peri-interventional role of ICE in a variety of structural heart disease and electrophysiological interventions. Both transthoracic (TTE) and transesophageal echocardiography have limitations. ICE provides the advantage of imaging from within the heart, providing shorter image distances and higher resolution. ICE may be performed without sedation and avoids esophageal intubation as with transesophageal echocardiography (TEE). Limitations of ICE include the need for additional venous access with possibility of vascular complications, potentially higher costs, and a learning curve for new operators. Data supports the use of ICE in guiding device closure of interatrial shunts, transseptal puncture, and electrophysiologic procedures. This paper reviews the more recent reports that ICE may be used for primary guidance or as a supplement to TEE in patients undergoing left atrial appendage (LAA) closure, interatrial shunt closure, transaortic valve implantation (TAVI), percutaneous mitral valve repair (PMVR), paravalvular leak (PVL) closure, aortic interventions, transcatheter pulmonary valve replacement (tPVR), ventricular septal defect (VSD), and patent ductus arteriosus (PDA) closure. ICE imaging technology will continue to expand and help improve structural heart and electrophysiology interventions.

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 effective and relatively safe procedure for the treatment of severe aortic stenosis in suitable patients. PMID:25061453

Surgical revision after percutaneous mitral valve repair by edge-to-edge device: when the strategy fails in the highest risk surgical population.

PubMed

Alozie, Anthony; Westphal, Bernd; Kische, Stephan; Kaminski, Alexander; Paranskaya, Liliya; Bozdag-Turan, Ilkay; Ortak, Jasmin; Schubert, Jochen; Steinhoff, Gustav; Ince, Hüseyin

2014-07-01

Percutaneous edge-to-edge devices for non-surgical repair of mitral valve regurgitation are under clinical evaluation in high-risk patients deemed not suitable for conventional surgery. To address guidelines for initial therapy decision, we here report on 13 cases of surgery after failed percutaneous edge-to-edge mitral valve repair or attempted repair, and discuss methodology and prognostic factors for operative outcome in this high-risk situation. Thirteen patients referred to our cardiothoracic unit after failed percutaneous mitral valve repair or attempted repair using the edge-to-edge technique, were treated surgically for mitral valve failure between June 2010 and December 2012. Pathology of mitral valve before and after interventional mitral valve repair (especially prevalent mode of failure) was evaluated and classified for each individual patient by echocardiography and intraoperative direct visualization. Number of implanted edge-to-edge devices were identified. Preoperative risk scores were matched with intraoperative observations and histopathological findings of valve tissue. Postoperative morbidity and mortality were analysed with respect to mitral valve and patient-related data. Three of 10 patients were referred with severe mitral valve regurgitation/stenosis after initially successful percutaneous edge-to-edge therapy or attempted therapy. In 3 patients, ≥ 2 edge-to-edge devices were implanted leading to very tight edge-to-edge leaflet connection and fibrosis. All patients underwent successful surgical mitral valve replacement and concomitant complete cardiac surgery (CABG, aortic or tricuspid valve surgery, ASD closure and pulmonary vein isolation for atrial fibrillation). The likelihood of repair was reduced with respect to multiple edge-to-edge technology. One device could not be harvested surgically because of embolization. One patient died on the second postoperative day due to sepsis with multiple organ failure. The remaining 12 patients were discharged with excellent valve prosthesis function and followed up to 2 years post-surgery. The current long-term survival rate is 77%. Our series demonstrate that highest risk patients can survive mitral valve surgery after failed multiple edge-to-edge interventional mitral valve repair. As long-term results of the MitraClip therapy are pending, we recommend close meshed follow-up of patients treated with the MitraClip device, especially within the first year of the index procedure as delays in salvage management, interventional or surgical, when the index procedure fails may increase morbidity and mortality. © The Author 2013. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

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.

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-coated polyurethane films investigated an abdominal aorta implant model in pigs using a button configuration that simulated the blood contacting environment of a vascular graft. One week explants of the collagen-coated polyurethane films demonstrated 14.3+/-2.5% of neointimal cells on the surface of the implant transduced with green fluorescent protein - adenovirus (AdGFP) vector loadings of 1 x 10(8) PFU. PCR studies demonstrated no detectable vector DNA in blood or distal organs. Similarly, polyurethane films with direct attachment of antivector antibodies to the surface were used in sheep pulmonary valve leaflet replacement studies, simulating the blood contacting environment of a prosthetic heart valve cusp. Polyurethane films with antibody tethered AdGFP vector (10(8) PFU) demonstrated 25.1+/-5.7% of attached cells transduced in these 1 week studies, with no detectable vector DNA in blood or distal organs. In vivo GFP expression was confirmed with immunohistochemistry. It is concluded that site-specific intravascular delivery of adenoviral vectors for gene therapy can be achieved with polyurethane implants utilizing the antivector antibody tethering mechanism.

Initial Clinical Experience with an Endoluminal Spiral Prosthesis for Treating Complicated Venous Thrombosis and Preventing Pulmonary Embolism

PubMed Central

Jakob, H.; Oelert, H.; Schmiedt, W.; Teusch, P.; Iversen, S.; Hake, U.; Schild, H.; Maass, D.

1989-01-01

Fourteen patients with complicated venous thrombosis or recurrent pulmonary embolism were treated by implantation of an endoluminal spiral prosthesis subsequent to balloon angioplasty, surgical thrombectomy or embolectomy, a combination of these, or, in 2 cases, no other treatment. The patients were divided into 2 groups, based on their primary diagnosis and the purpose of the prosthesis. Group I included 8 patients with extensive iliofemoral or caval thrombosis, caused by congenital caval stenosis (1 case) or extravascular compression or retraction (7 cases); 7 of these patients had had previous operations, and the remaining patient had undergone thrombolysis, which failed. The current treatment consisted of balloon angioplasty and surgical thrombectomy or embolectomy, and implantation of an endoluminal spiral stent to prevent elastic recoil of the vessel. In 4 cases, an arteriovenous fistula was constructed and was taken down 3 months later; in 1 additional patient, a bilateral arteriovenous fistula was created. Group II comprised 6 patients with recurrent pulmonary embolism (4 cases), massive pulmonary embolism (1 case), or paradoxical bilateral carotid artery embolism (1 case). Four of these patients underwent surgical thrombectomy or embolectomy, while 2 had no treatment other than filter implantation. All 6 underwent transluminal implantation of a helix caval filter (a modification of the endoluminal spiral stent). All but 1 implantation was accomplished by means of either a transfemoral or a transjugular cutdown; the remaining implantation was performed transatrially after a pulmonary embolectomy. The only device-related complication was a retroperitoneal hematoma in Group I, resulting from perforation of the inferior vena cava by the guidewire during device implantation. This complication necessitated an emergency laparotomy and takedown of the arteriovenous fistula, which resulted in rethrombosis of the left iliofemoral vein. The other 7 stented veins were patent at early phlebographic follow-up, as were all 5 of those studied later. One Group-I patient died 4 months after surgery, due to tumor progression and without signs of caval restenosis. Twelve months postoperatively, 1 Group-II patient died of urosepsis without a recurrence of pulmonary embolism. Four of the 6 Group-II patients were studied late postoperatively, and all of their stented vessels were patent. There was no operative mortality or postoperative embolism. On the basis of these results, we conclude that endoluminal stenting with an expandable spiral prosthesis is a promising method for remote venous reconstruction. Moreover, it appears that the modified stent, or helix caval filter, compares favorably with commercially available filters. (Texas Heart Institute Journal 1989;16:87-94) Images PMID:15227219

Outcomes Assessment of Treating Completely Edentulous Patients with a Fixed Implant-Supported Profile Prosthesis Utilizing a Graftless Approach. Part 1: Clinically Related Outcomes.

PubMed

Alzoubi, Fawaz; Bedrossian, Edmond; Wong, Allen; Farrell, Douglas; Park, Chan; Indresano, Thomas

To assess outcomes of treating completely edentulous patients with a fixed implant-supported profile prosthesis utilizing a graftless approach for the maxilla and for the mandible, with emphasis on clinically related outcomes, specifically implant and prosthesis survival. This was a retrospective study with the following inclusion criteria: completely edentulous patients rehabilitated with a fixed implant-supported profile denture utilizing a graftless approach. Patients fulfilling the inclusion criteria were asked to participate in the study during their follow-up visits, and hence a consecutive sampling strategy was used. Data regarding implant and prosthesis cumulative survival rates (CSRs) were gathered and calculated. Thirty-four patients were identified with a total of 220 implants placed. An overall CSR of 98.2% was recorded with an observation of up to 10 years. For tilted, axial, and zygomatic implants, CSRs of 96.9%, 98.0%, and 100%, respectively, were observed for up to 10 years. For provisional prostheses, CSRs of 92.3% at 1 year, and 84.6% at 2 years were observed. For final prostheses, a CSR of 93.8% was observed at 10 years. The results suggest that treating completely edentulous patients with a fixed profile prosthesis utilizing a graftless approach in the maxilla and the mandible can be a reliable treatment option.

Two Bilateral Zygomatic Implants Placed and Immediately Loaded: A Retrospective Chart Review with Up-to-54-Month Follow-up.

PubMed

Neugarten, Jay; Tuminelli, Frank J; Walter, Leora

To report on the outcome of placement of two bilateral zygomatic implants with an immediately loaded prosthesis. A retrospective chart review was conducted of all patients treated with zygomatic implants between August 1, 2011 and June 6, 2016. All patients had at least two zygomatic implants placed bilaterally and immediately loaded with a provisional prosthesis the same day of implant placement. The implants were Nobel Biocare TiUnite or machined surface with lengths of 30 to 52.5 mm. All patients were treated by a team consisting of one surgeon, a restorative dentist or prosthodontist, an anesthesiologist, and a laboratory technician. Implant success was defined as successful integration of the implant; prosthetic success was defined as retention of the prosthesis under normal function. One hundred five zygomatic implants were placed and immediately loaded in 28 patients over a period of 1 to 60 months. Ages ranged from 46 to 81 years, with 26 female and 2 male patients. All the implants were placed by one surgeon. The immediate load on the day of implant placement was completed by either one of 2 prosthodontists or 11 restorative dentists. Implant success was 96% (101/105). All four failed implants were in one patient and were TiUnite surface coated. This study demonstrated that two zygomatic implants bilaterally placed and immediately loaded with a full-arch splinted prosthesis will provide a predictable outcome.

TriGuard™ HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement.

PubMed

Samim, Mariam; van der Worp, Bart; Agostoni, Pierfrancesco; Hendrikse, Jeroen; Budde, Ricardo P J; Nijhoff, Freek; Ramjankhan, Faiz; Doevendans, Pieter A; Stella, Pieter R

2017-02-15

This study aims to evaluate the safety and performance of the new embolic deflection device TriGuard™HDH in patients undergoing TAVR. Transcatheter aortic valve replacement (TAVR) is associated with a high incidence of new cerebral ischemic lesions. The use of an embolic protection device may reduce the frequency of TAVR-related embolic events. This prospective, single arm feasibility pilot study included 14 patients with severe symptomatic aortic stenosis scheduled for TAVR. Cerebral diffusion weighted magnetic resonance imaging (DWI) was planned in all patients one day before and at day 4 (±2) after the procedure. Major adverse cerebral and cardiac events (MACCEs) were recorded for all patients. Primary endpoints of this study were I) device performance success defined as coverage of the aortic arch takeoffs throughout the entire TAVR procedure and II) MACCE occurrence. Secondary endpoints included the number and the volume of new cerebral ischemic lesions on DWI. Thirteen patients underwent transfemoral TAVR and one patient a transapical procedure. Edwards SAPIEN valve prosthesis was implanted in 8 (57%) patients and Medtronic CoreValve prosthesis in the remaining 6 (43%). Predefined performance success of the TriGuard™HDH device was achieved in 9 (64%) patients. The composite endpoint MACCE occurred in none of the patients. Post-procedural DWI was performed in 11 patients. Comparing the DWI of these patients to a historical control group showed no reduction in number [median 5.5 vs. 5.0, P = 0.857], however there was a significant reduction in mean lesion volume per patient [median 13.8 vs. 25.1, P = 0.049]. This study showed the feasibility and safety of using the TriGuard™HDH for cerebral protection during TAVR. This device did not decrease the number of post-procedural new cerebral DWI lesions, however its use showed decreased lesion volume as compared to unprotected TAVR. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Clinical evaluation of immediate loading of electroeroded screw-retained titanium fixed prostheses supported by tilted implant: a multicenter retrospective study.

PubMed

Acocella, Alessandro; Ercoli, Carlo; Geminiani, Alessandro; Feng, Changyong; Billi, Mauro; Acocella, Gabriele; Giannini, Domenico; Sacco, Roberto

2012-05-01

Immediate occlusal loading of dental implants in the edentulous mandible has proven to be an effective, reliable, and predictable treatment protocol. However, there is limited long-term data available in the literature, when an electroeroded definitive cast-titanium fixed prosthesis is used for this treatment protocol. The aim of this study was to evaluate the clinical effectiveness of dental implants (Astra Tech Dental, Mölndal, Sweden) in the edentulous mandible immediately loaded with an electroeroded cast-titanium screw-retained fixed prosthesis. Forty-five patients received five implants each in the interforaminal area. All the implants were inserted with torque up to 40 Ncm and the distal implants were distally tilted approximately 20 to 30 degrees to minimize the length of posterior cantilevers. Implants were loaded within 48 hours of placement with an acrylic resin-titanium screw-retained prosthesis fabricated by electroerosion. Two of the 225 inserted implants failed after 3 and 16 months of healing, respectively, with a cumulative survival rate of 99.1% and a prosthetic survival rate of 97.8%. Immediate loading of tilted dental implants inserted in the edentulous mandible with a screw-retained titanium definitive prosthesis fabricated with electrical discharge machining provide reliable and predictable results. © 2011 Wiley Periodicals, Inc.

Shortened penis post penile prosthesis implantation treated with subcutaneous soft silicone penile implant: case report.

PubMed

Shirvanian, V; Lemperle, G; Araujo Pinto, C; Elist, J J

2014-01-01

Penile prosthesis surgery for erectile dysfunction has the highest satisfaction rates among all treatment options but is often associated with subjective and objective loss of penile length and girth following surgery. To present a novel technique using a subcutaneous soft silicone implant for reversal of penile shortening and narrowing after prosthesis surgery, with additional gains in overall penile length and girth. Nine patients were treated with the insertion of a subcutaneous soft silicone penile implant. All patients had previously reported a loss in penile length (0.5-2 cm), and seven of nine patients also reported a loss in penile girth (0.5-2.6 cm) after penile prosthesis surgery. During a follow-up period of 4-24 months, penile length and girth measurements showed a mean increase in length of 2.4 cm (±0.75 cm) and a mean increase in girth of 3.4 cm (±0.94 cm). The additional insertion of a subcutaneous soft silicone implant in patients with decreased penile length and girth after penile prosthesis surgery is an effective treatment option that provides reversal of lost penile length and girth.

Frequency of technical complications in fixed implant prosthesis: the effect of prosthesis screw emergence correction by CAD-CAM.

PubMed

Anitua, Eduardo; Flores, Carlos; Piñas, Laura; Alkhraisat, Mohammad

2018-06-05

CAD-CAM technology permits the angular correction of screw emergence into the prosthesis, however there is lack of controlled clinical studies that assess the frequency of technical complications in angled screw channel restorations. This controlled clinical study was designed to assess technical incidences in angled screw channel restorations. Patients having implant prosthesis placed between November, 2014 and December, 2015 were screened. The patients were selected if they received prosthesis with up to 30º correction of the prosthesis screw emergence and had at least one non-angulated prosthesis (screw-retained). All the prostheses were located completely/partially in the posterior region. The frequency of technical complications was the principal variable. A total of 52 patients with a mean age of 62 ± 10 years participated with a total 110 prostheses (55 in the test group and 55 in the control group). A total of 11 technical complications occurred (7 in the test group and 4 in the control group). These differences were not statistically significant. All the prostheses in both groups survived the follow-up. The correction of the screw emergence into the prosthesis has not increased the risk of technical complications in CAD-CAM implant prostheses.

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.).

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review

PubMed Central

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-01-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed. PMID:28959744

Gingival Retraction Methods for Fabrication of Fixed Partial Denture: Literature Review.

PubMed

S, Safari; Ma, Vossoghi Sheshkalani; Mi, Vossoghi Sheshkalani; F, Hoseini Ghavam; M, Hamedi

2016-06-01

Fixed dental prosthesis success requires appropriate impression taking of the prepared finish line. This is critical in either tooth supported fixed prosthesis (crown and bridge) or implant supported fixed prosthesis (solid abutment). If the prepared finish line is adjacent to the gingival sulcus, gingival retraction techniques should be used to decrease the marginal discrepancy among the restoration and the prepared abutment. Accurate marginal positioning of the restoration in the prepared finish line of the abutment is required for therapeutic, preventive and aesthetic purposes. In this article, conventional and modern methods of gingival retraction in the fixed tooth supported prosthesis and fixed implant supported prosthesis are expressed. PubMed and Google Scholar databases were searched manually for studies on gingival tissue managements prior to impression making in fixed dental prosthesis since 1975. Conclusions were extracted and summarized. Keywords were impression making, gingival retraction, cordless retraction, and implant. Gingival retraction techniques can be classified as mechanical, chemical or surgical. In this article, different gingival management techniques are discussed.

The management of the acute ischemic priapism: A state of the art review.

PubMed

Falcone, M; Gillo, A; Capece, M; Raheem, A; Ralph, D; Garaffa, G

2017-12-01

To review the current literature on early penile prosthesis implantation in patients with refractory ischemic priapism (IP). A systematic search for the terms "penile prosthesis", "priapism", "impotence", "fibrosis", "downsized prosthesis cylinders", and "patient satisfaction" has been carried out in PubMed, EMBASE, Cochrane, SCOPUS and Science Citation Index databases. Cavernosal tissue damage in IP is time related. Conservative measures and aspiration with or without intracorporeal instillation of α-adrenergic agonists are usually successful in the early stages. Shunt surgery in patients remains debatable, as the lack of response to aspiration and instillation of α-adrenergic agonists indicates that irreversible changes in the cavernosal smooth muscle are likely to have already occurred. Immediate penile prosthesis implantation in patients with refractory IP settles the priapic episode, maintains the long term rigidity necessary to engage in penetrative sexual intercourse and prevents the otherwise inevitable penile shortening. Although complication rates after penile prosthesis implantation in acute priapism are higher than in virgin cases, they are still lower than after implantation in patients with severe corporal fibrosis due to chronic priapism. Regardless of the complication rates, penile prosthesis implantation in refractory IP should be preferred as it allows the preservation of penile length, which is one of the main factors influencing postoperative patient's satisfaction following surgery. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Effect of cement washout on loosening of abutment screws and vice versa in screw- and cement- retained implant-supported dental prosthesis

PubMed Central

Kim, Seok-Gyu; Son, Mee-Kyoung

2015-01-01

PURPOSE The purpose of this study was to examine the abutment screw stability of screw- and cement-retained implant-supported dental prosthesis (SCP) after simulated cement washout as well as the stability of SCP cements after complete loosening of abutment screws. MATERIALS AND METHODS Thirty-six titanium CAD/CAM-made implant prostheses were fabricated on two implants placed in the resin models. Each prosthesis is a two-unit SCP: one screw-retained and the other cemented. After evaluating the passive fit of each prosthesis, all implant prostheses were randomly divided into 3 groups: screwed and cemented SCP (Control), screwed and noncemented SCP (Group 1), unscrewed and cemented SCP (Group 2). Each prosthesis in Control and Group 1 was screwed and/or cemented, and the preloading reverse torque value (RTV) was evaluated. SCP in Group 2 was screwed and cemented, and then unscrewed (RTV=0) after the cement was set. After cyclic loading was applied, the postloading RTV was measured. RTV loss and decementation ratios were calculated for statistical analysis. RESULTS There was no significant difference in RTV loss ratio between Control and Group 1 (P=.16). No decemented prosthesis was found among Control and Group 2. CONCLUSION Within the limits of this in vitro study, the stabilities of SCP abutment screws and cement were not significantly changed after simulated cement washout or screw loosening. PMID:26140172

Natural tooth intrusion and reversal in implant-assisted prosthesis: evidence of and a hypothesis for the occurrence.

PubMed

Sheets, C G; Earthmann, J C

1993-12-01

Based on clinical observation, a hypothesis of the mechanism of intrusion of natural teeth in an implant-assisted prosthesis is suggested. Engineering principles are presented that establish an energy absorption model as it relates to the implant-assisted prosthesis. In addition, in the course of patient treatment it has been discovered that the intrusion of natural teeth can be reversed. Patient histories that demonstrate intrusion reversal are reviewed. The possible mechanisms for the intrusion/reversal phenomenon are presented and preventative recommendations are given.

Cardiovascular Collapse During Transcatheter Aortic Valve Replacement: Diagnosis and Treatment of the “Perilous Pentad”

PubMed Central

El-Gamel, Adam

2013-01-01

Transcatheter aortic valve replacement (TAVR) has, without a doubt, brought an unprecedented excitement to the field of interventional cardiology. The avoidance of a sternotomy by transfemoral or transapical aortic-valve implantation appears to come at the price of some serious complications, including an increased risk of embolic stroke and paravalvular leakage. The technical challenges of the procedure and the complex nature of the high-risk patient cohort make the learning curve for this procedure a steep one, with the potential for unexpected complications always looming. Although most commonly relating to vascular access, these complications can also result from prosthesis-related trauma or malposition, or from unanticipated trauma from the pacing wire or the super stiff wire. Sudden and unexplained hypotension is often the earliest indicator of major complication and must prompt an immediate and detailed exclusion of five major pathologies: retroperitoneal bleeding from access site rupture, aortic dissection or rupture, pericardial tamponade, coronary ostial obstruction, or acute severe aortic regurgitation. In most cases, these can be dealt with quickly, and by percutaneous means, although open surgery may occasionally be necessary. Increased operator and team experience should make prevention and recognition of these catastrophic complications more complete. For this reason, the importance of specific training, such as that provided by the valve manufacturers through workshops and proctorship, cannot be overemphasized. It is essential that all operators, and indeed all members of the implant team, exert extreme vigilance to the development of intraprocedural complications, which could have rapid and potentially lethal consequences. Greater experience with an improved understanding of these risks, along with the development of better devices, deliverable through smaller and less traumatic sheath technology, will undoubtedly improve the safety and, potentially, widen the applicability of TAVR in the future. Forthcoming innovations include a newer generation of the valves with operator-controlled steerability to facilitate negotiation of tortuous aortic anatomy, as well as fully retrievable and resheathable devices to accommodate the events of dislocation or embolization. The fact that Transcatheter aortic valve implantation (TAVI) is new implies learning from experience but also from mistakes. The TAVI team must be vigilant to recognize and diagnose intraprocedure severe hypotension. The “perilous pentad” of catastrophic causes must be constantly borne in mind: retroperitoneal bleeding from access site rupture, aortic dissection or rupture, pericardial tamponade, coronary ostial obstruction, and acute severe aortic insufficiency. PMID:26798706

Complicated rheumatic mitral stenosis presenting in an elderly patient and the challenges in its management.

PubMed

Ganeshpure, Swapnil; Vaidya, Gaurang Nandkishor; Gattani, Vipul

2012-12-05

A 76 -year-old lady with a recent diagnosis of rheumatic heart disease (RHD), and a history of repeated lower respiratory tract infections, came with symptoms of gastritis unrelated to the primary disease but further diagnostic study in the hospital revealed poorly controlled atrial fibrillation, grossly dilated left atrium with two large left atrial thrombi and mitral valve area<1 cm(2). It was decided that the best approach in our patient would be mitral valve replacement with mechanical prosthesis. Despite the usual trend of using bioprosthesis in the elderly, our decision was influenced by the fact that the patient would need chronic anticoagulation for atrial fibrillation in any case. The purpose of our case presentation is to illustrate a late-presenting case of RHD with unusual associations and the challenges to choose the best possible management.

Mechanics of cryopreserved aortic and pulmonary homografts.

PubMed

Vesely, I; Casarotto, D C; Gerosa, G

2000-01-01

The surgical placement of pulmonary valve grafts into the aortic position (the Ross procedure) has been performed for three decades. Cryopreserved pulmonary valves have had mixed clinical results, however. The objectives of this study were to compare the mechanics of cryopreserved human aortic and pulmonary valve cusps and roots to determine if the pulmonary root can withstand the greater pressures of the aortic position. Six aortic and six pulmonary valve roots were obtained from the Oxford Valve Bank. They were harvested during cardiac transplantation from hearts explanted for dilated cardiomyopathy (mean patient age 68 years). The whole roots were initially stored frozen at -186 degrees C, then shipped packed on dry ice. After complete thawing, the roots were pressurized whole; test strips were then cut from the valve cusps, roots and sinuses and tested for stress/strain, stress relaxation, and ultimate failure strength. The pulmonary roots were more distensible (30% versus 20% strain to lock-up) and less compliant when loaded to aortic pressures. The pulmonary valve cusp and root tissue also showed greater extensibility and greater stiffness (lower compliance) when subjected to the same loads. We conclude that mechanical differences between aortic and pulmonary valve tissues are minimal. The pulmonary root should withstand the forces imposed on it when placed in the aortic position. However, if implanted whole, the pulmonary root will distend about 30% more than the aortic root when subjected to aortic pressures. These geometric changes may affect valve function in the long term and should be appreciated when implanting a pulmonary valve graft.

Success and complications of implant-retained prostheses provided by the Post-Doctoral Prosthodontics Program, University of Puerto Rico: a cross-sectional study.

PubMed

Loza-Herrero, María A; Rivas-Tumanyan, Sona; Morou-Bermudez, Evangelia

2015-11-01

The success rate of implant-retained prostheses in a postdoctoral prosthodontics program was unknown and could not be related to any set of potential clinical issues or patient characteristics. The purpose of this study was to determine the success rate of implant-retained prostheses placed by prosthodontic residents between 1997 and 2012 and to evaluate the associations between patient classifications and specific restoration characteristics as related to prosthesis success or failure. A total of 272 prostheses in 119 patients were clinically evaluated. Success was defined as the absence of prosthetic complications or any implant-related complication that affected prosthesis survival. Logistic regression was used to evaluate associations between prosthesis success/failure and a wide array of study variables, adjusting for patient age, sex, and prosthesis longevity. The overall success rate was 71%, with a mean prosthesis age of 4.5 years (range: 4 months to 16.8 years). Implant single crowns were the most successful prosthesis type (81% success). The most common complications observed were porcelain fractures in fixed dental prostheses (15%) and lack of stability (31%) and retention (29%) in removable dental prostheses. Having a removable prosthesis (versus natural dentition) in the opposing occlusion significantly decreased the odds of success (OR=0.26, 95% CI: 0.11-0.64). Definitively cemented fixed prostheses were more successful than those cemented with an interim cement (OR=4.56, 95% CI: 1.37-15.22). The overall success rate of the implant-retained prostheses placed in the program was low compared with previously published studies. This study revealed the need for an efficient, comprehensive recall system for patients receiving implant-retained prostheses, either fixed or removable. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Integrating bio-prosthetic valves in the Fontan operation - Novel treatment to control retrograde flow in caval veins

NASA Astrophysics Data System (ADS)

Vukicevic, Marija; Conover, Timothy; Zhou, Jian; Hsia, Tain-Yen; Figliola, Richard

2012-11-01

For a child born with only one functional heart ventricle, the sequence of palliative surgeries typically culminates in the Fontan operation. This procedure is usually successful initially, but leads to later complications, for reasons not fully understood. Examples are respiratory-dependent retrograde flows in the caval and hepatic veins, and increased pulmonary vascular resistance (PVR), hypothesized to be responsible for elevated pressure in the liver and disease of the liver and intestines. Here we study the parameters responsible for retrograde flows in the inferior vena cava (IVC) and hepatic vein (HV), and investigate two novel interventions to control retrograde flow: implanting either a Medtronic Contegra valved conduit or an Edwards lifescience pericardial aortic valve in the IVC or HV. We performed the experiments in a multi-scale, patient specific mock circuit, with normal and elevated PVR, towards the optimization of the Fontan circulation. The results show that both valves can significantly reduce retrograde flows in the veins, suggesting potential advantages in the treatment of the patients with congenital heart diseases. Fondation Leducq

[Photoelastic stress analysis of human femurs before and after implantation of different models of femur neck prostheses].

PubMed

Wieners, G; Pech, M; Streitparth, F; Jansson, V; Plitz, W

2007-01-01

The aim of this study was the detection of areas at risk at the proximal femur after implantation of different femur neck prostheses using the photoelastic stress analysis. Twelve pairs of human femurs were used as examination material. The analysis of the stress pattern was done with a stepwise increasing load up to the quadruple of body weight before and after implantation of three models of femur neck prostheses which were implanted cementless. The "CUT" and "Cigar" models are coated with a tripod structure. The "Cigar" model has a lateral thrust plate. The lateral end of the "CUT" model is curved and this end is attached to the lateral corticalis. The third model, the "rip prosthesis" has two layers for rotational stability. Subsequently, the micromotions of the implanted prosthesis in the femural neck were examined with alternating weight loads (1000 +/- 700 N). The Cigar prosthesis showed the most changes of stress distribution because of the lateral thrust plate with concentration of isochromatic lines to the lateral boring. In the region of the oseotomy an increase of strain up 1440 microm/m could be detected for the Cigar and up to 1000 microm/m for the rib prosthesis. The stress pattern after implantation of the CUT prosthesis remained very similar apart from a slight increase of stress values (720 microm/m). Only for the Cigar prostheses were the measured micromotions below the critical value for a possible osteointegration with a mean value of 134 microm/m. The stress pattern after implantation of the CUT prosthesis remained most similar to the preinterventional stress distribution. Because of this, it is to be expected that the osseous modification would stay at a low level. The question of osteointegration can only be answered in long-term in-vivo studies.

Simulation of personalised haemodynamics by various mounting positions of a prosthetic valve using computational fluid dynamics.

PubMed

Bongert, Markus; Geller, Marius; Pennekamp, Werner; Nicolas, Volkmar

2018-03-03

Diseases of the cardiovascular system account for nearly 42% of all deaths in the European Union. In Germany, approximately 12,000 patients receive surgical replacement of the aortic valve due to heart valve disease alone each year. A three-dimensional (3D) numerical model based on patient-specific anatomy derived from four-dimensional (4D) magnetic resonance imaging (MRI) data was developed to investigate preoperatively the flow-induced impact of mounting positions of aortic prosthetic valves to select the best orientation for individual patients. Systematic steady-state analysis of blood flow for different rotational mounting positions of the valve is only possible using a virtual patient model. A maximum velocity of 1 m/s was used as an inlet boundary condition, because the opening angle of the valve is at its largest at this velocity. For a comparative serial examination, it is important to define the standardised general requirements to avoid impacts other than the rotated implantation of the prosthetic aortic valve. In this study, a uniform velocity profile at the inlet for the inflow of the aortic valve and the real aortic anatomy were chosen for all simulations. An iterative process, with the weighted parameters flow resistance (1), shear stress (2) and velocity (3), was necessary to determine the best rotated orientation. Blood flow was optimal at a 45° rotation from the standard implantation orientation, which will offer a supply to the coronary arteries.

[Minor strut fracture of the Björk-Shiley mitral valve].

PubMed

Sugita, T; Yasuda, R; Watarida, S; Onoe, M; Tabata, R; Mori, A

1990-06-01

In May, 1982, a 49-year-old man underwent mitral valve replacement (MVR) in our hospital with a 31 mm Björk-Shiley prosthesis for mitral regurgitation. He had been doing well until his episode of palpitation and dyspnea of sudden onset, and was transferred to our ICU with severe cardiogenic shock in Aug, 1986. Chest X-ray film revealed pulmonary edema and breakage of the valve with migration of the disc and the minor strut of the prosthesis. He was operated upon 5 hours after the onset of his complaints. The minor strut was removed from the left upper pulmonary vein and mitral valve re-replacement was done with a 29 mm Björk-Shiley Monostrut valve. The disc which had dislocated into the abdominal aorta was also recovered on the twenty-third post operative day. His postoperative course was uneventful. Immediate diagnosis and subsequent re-operation is absolute indication for rescue from acute cardiac failure due to mechanical failure of any prosthetic valve.

Towards a Completely Implantable, Light-Sensitive Intraocular Retinal Prosthesis

DTIC Science & Technology

2001-10-25

electronic retinal prosthesis is under development to treat retinitis pigmentosa and age-related macular degeneration, two presently incurable...34Preservation of the inner retina in retinitis pigmentosa . A morphometric analysis," Arch Ophthalmol, vol. 115, no. 4, pp. 511-515, Apr.1997...Towards a completely implantable, light-sensitive intraocular retinal prosthesis. M.S. Humayun, J.D. Weiland, B. Justus1, C. Merrit1, J. Whalen, D

Experimental study on the effect of an artificial cardiac valve on the left ventricular flow

NASA Astrophysics Data System (ADS)

Wang, JiangSheng; Gao, Qi; Wei, RunJie; Wang, JinJun

2017-09-01

The use of artificial valves to replace diseased human heart valves is currently the main solution to address the malfunctioning of these valves. However, the effect of artificial valves on the ventricular flow still needs to be understood in flow physics. The left ventricular flow downstream of a St. Jude Medical (SJM) bileaflet mechanical heart valve (BMHV), which is a widely implanted mechanical bileaflet valve, is investigated with time-resolved particle image velocimetry in the current work. A tilting-disk valve is installed on the aortic orifice to guarantee unidirectional flow. Several post-processing tools are applied to provide combined analyses of the physics involved in the ventricular flow. The triple jet pattern that is closely related to the characteristics of the bileaflet valve is discussed in detail from both Eulerian and Lagrangian views. The effects of large-scale vortices on the transportation of blood are revealed by the combined analysis of the tracking of Lagrangian coherent structures, the Eulerian monitoring of the shear stresses, and virtual dye visualization. It is found that the utilization of the SJM BMHV complicates the ventricular flow and could reduce the efficiency of blood transportation. In addition, the kinematics of the bileaflets is presented to explore the effects of flow structures on their motion. These combined analyses could elucidate the properties of SJM BMHV. Furthermore, they could provide new insights into the understanding of other complex blood flows.

Inflatable penile prosthesis implant length with baseline characteristic correlations: preliminary analysis of the PROPPER study

PubMed Central

Henry, Gerard; Karpman, Edward; Brant, William; Jones, LeRoy; Khera, Mohit; Kohler, Tobias; Christine, Brian; Rhee, Eugene; Kansas, Bryan; Bella, Anthony J.

2017-01-01

Background “Prospective Registry of Outcomes with Penile Prosthesis for Erectile Restoration” (PROPPER) is a large, multi-institutional, prospective clinical study to collect, analyze, and report real-world outcomes for men implanted with penile prosthetic devices. We prospectively correlated co-morbid conditions and demographic data with implanted penile prosthesis size to enable clinicians to better predict implanted penis size following penile implantation. We present many new data points for the first time in the literature and postulate that radical prostatectomy (RP) is negatively correlated with penile corporal length. Methods Patient demographics, medical history, baseline characteristics and surgical details were compiled prospectively. Pearson correlation coefficient was generated for the correlation between demographic, etiology of ED, duration of ED, co-morbid conditions, pre-operative penile length (flaccid and stretched) and length of implanted penile prosthesis. Multivariate analysis was performed to define predictors of implanted prosthesis length. Results From June 2011 to June 2017, 1,135 men underwent primary implantation of penile prosthesis at a total of 11 study sites. Malleable (Spectra), 2-piece Ambicor, and 3-piece AMS 700 CX/LGX were included in the analysis. The most common patient comorbidities were CV disease (26.1%), DM (11.1%), and PD (12.4%). Primary etiology of ED: RP (27.4%), DM (20.3%), CVD (18.0%), PD (10.3%), and Priapism (1.4%), others (22.6%). Mean duration of ED is 6.2¡À4.1 years. Implant length was weakly negatively correlated with White/Caucasian (r=−0.18; P<0.01), history of RP (r=−0.13; P<0.01), PD as comorbidity (r=−0.16; P<0.01), venous leak (r=−0.08; P<0.01), and presence of stress incontinence (r=−0.13; P<0.01). Analyses showed weak positive correlations with Black/AA (r=0.32; P<0.01), CV disease as primary ED etiology (r=0.08; P<0.01) and pre-operative stretched penile length (r=0.18; P<0.01). There is a moderate correlation with pre-operative flaccid penile length (r=0.30; P<0.01). Conclusions Implanted penile prosthesis length is negatively correlated with some ethnic groups, prostatectomy, and incontinence. Positive correlates include CV disease, preoperative stretched penile length, and flaccid penile length. PMID:29354506

[Heart failure provoked by a pacemaker lead-induced tricuspid stenosis].

PubMed

Chaudesaygues, E; Ferrini, M; Ritz, B

2017-04-01

Tricuspid stenosis (TS) is an uncommon complication of ventricular pacemaker implantation. Mechanisms described by the literature are ventricular inflow obstruction by tricuspid vegetations (endocarditis) or multiple pacemaker leads and fibrosis secondary to mechanical trauma, accounting for perforation or laceration of the TV leaflets, or adherence between redundant loops and valve tissue. We present the case of iatrogenic tricuspid stenosis, observed in a 77-year-old man. Extrinsic tricuspid valve stenosis was detected by transthoracic echocardiography. Further investigations confirmed the intramyocardial lead position. Tricuspid valve stenosis due to transvenous leads are reported to be treated by surgical replacement, surgical valvuloplasty, or percutaneous balloon valvuloplasty. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

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.

Early Feasibility Testing and Engineering Development of the Transapical Approach for the HeartWare MVAD Ventricular Assist System

PubMed Central

Tamez, Daniel; LaRose, Jeffrey A.; Shambaugh, Charles; Chorpenning, Katherine; Soucy, Kevin G; Sobieski, Michael A; Sherwood, Leslie; Giridharan, Guruprasad A; Monreal, Gretel; Koenig, Steven C; Slaughter, Mark S

2014-01-01

Implantation of ventricular assist devices (VADs) for treatment of end-stage heart failure (HF) falls decidedly short of clinical demand, which exceeds 100,000 HF patients per year. VAD implantation often requires major surgical intervention with associated risk of adverse events and long recovery periods. To address these limitations, HeartWare, Inc. (Miami Lakes, FL) has developed a platform of miniature ventricular devices with progressively reduced surgical invasiveness and innovative patient peripherals. One surgical implant concept is a transapical version of the miniaturized left ventricular assist device (MVAD). The HeartWare MVAD Pump® is a small, continuous flow, full-support device that has a displacement volume of 22mL. A new cannula configuration has been developed for transapical implantation, where the outflow cannula is positioned across the aortic valve. The two primary objectives for this feasibility study were to evaluate anatomic fit and surgical approach and efficacy of the transapical MVAD configuration. Anatomic fit and surgical approach were demonstrated using human cadavers (n=4). Efficacy was demonstrated in acute (n =2) and chronic (n = 1) bovine model experiments and assessed by improvements in hemodynamics, biocompatibility, flow dynamics, and histopathology. Potential advantages of the MVAD Pump include flow support in the same direction as the native ventricle, elimination of cardiopulmonary bypass, and minimally-invasive implantation. PMID:24399057

Application of digital diagnostic impression, virtual planning, and computer-guided implant surgery for a CAD/CAM-fabricated, implant-supported fixed dental prosthesis: a clinical report.

PubMed

Stapleton, Brandon M; Lin, Wei-Shao; Ntounis, Athanasios; Harris, Bryan T; Morton, Dean

2014-09-01

This clinical report demonstrated the use of an implant-supported fixed dental prosthesis fabricated with a contemporary digital approach. The digital diagnostic data acquisition was completed with a digital diagnostic impression with an intraoral scanner and cone-beam computed tomography with a prefabricated universal radiographic template to design a virtual prosthetically driven implant surgical plan. A surgical template fabricated with computer-aided design and computer-aided manufacturing (CAD/CAM) was used to perform computer-guided implant surgery. The definitive digital data were then used to design the definitive CAD/CAM-fabricated fixed dental prosthesis. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

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.

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.

Design and Characterization of a Quasi-Passive Pneumatic Foot-Ankle Prosthesis.

PubMed

Lee, Jeffrey D; Mooney, Luke M; Rouse, Elliott J

2017-07-01

The majority of commercially available passive prosthetic feet are not capable of providing joint mechanics that match that of the intact human ankle. Due to their cantilever design, their stiffness characteristics contrast with what has been observed in the biological ankle, namely, an increase in stiffness during the stance phase of walking. In this paper, we introduce the design and control of a pneumatic foot-ankle prosthesis that attempts to provide biomimetic mechanics. The prosthesis is comprised of a pneumatic cylinder in series with a fiberglass leaf spring, and a solenoid valve to control the flow of air between the two sides of the cylinder. The solenoid valve acts as a mechanical clutch, enabling resetting of the ankle's equilibrium position. By adjusting the pressure inside the cylinder, the prosthesis can be customized to provide a range of ankle mechanics. A mechanical testing machine is used to compare the torque-angle curve of the pneumatic prosthesis with a low-profile passive prosthetic foot. Finally, data are presented of one transtibial amputee walking with the prosthesis at 1.2 m/s. The testing shows that the pneumatic prosthesis is capable of providing an appropriate range of motion as well a maximum torque of 94 Nm, while returning approximately 11.5 J of energy.

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.

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.

Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement

PubMed Central

Gunning, Paul S.; Saikrishnan, Neelakantan; Yoganathan, Ajit P.; McNamara, Laoise M.

2015-01-01

Transcatheter aortic valve replacements (TAVRs) are a percutaneous alternative to surgical aortic valve replacements and are used to treat patients with aortic valve stenosis. This minimally invasive procedure relies on expansion of the TAVR stent to radially displace calcified aortic valve leaflets against the aortic root wall. However, these calcium deposits can impede the expansion of the device causing distortion of the valve stent and pericardial tissue leaflets. The objective of this study was to elucidate the impact of eccentric TAVR stent distortion on the dynamic deformation of the tissue leaflets of the prosthesis in vitro. Dual-camera stereophotogrammetry was used to measure the regional variation in strain in a leaflet of a TAVR deployed in nominal circular and eccentric (eccentricity index = 28%) orifices, representative of deployed TAVRs in vivo. It was observed that (i) eccentric stent distortion caused incorrect coaptation of the leaflets at peak diastole resulting in a ‘peel-back’ leaflet geometry that was not present in the circular valve and (ii) adverse bending of the leaflet, arising in the eccentric valve at peak diastole, caused significantly higher commissure strains compared with the circular valve in both normotensive and hypertensive pressure conditions (normotension: eccentric = 13.76 ± 2.04% versus circular = 11.77 ± 1.61%, p = 0.0014, hypertension: eccentric = 15.07 ± 1.13% versus circular = 13.56 ± 0.87%, p = 0.0042). This study reveals that eccentric distortion of a TAVR stent can have a considerable impact on dynamic leaflet deformation, inducing deleterious bending of the leaflet and increasing commissures strains, which might expedite leaflet structural failure compared to leaflets in a circular deployed valve. PMID:26674192

Comparison of retention and stability of implant-retained overdentures based upon implant number and distribution.

PubMed

Scherer, Michael D; McGlumphy, Edwin A; Seghi, Robert R; Campagni, Wayne V

2013-01-01

The purpose of this investigation was to evaluate the effects of number and distribution of implants upon in vitro dislodging forces to a simulated implant-supported overdenture and to examine differences between several different attachment systems. An experiment was undertaken utilizing a model simulating a mandibular edentulous ridge with dental implants in positions on the model approximating tooth positions in the natural dentition. A cobalt-chromium-cast testing framework was used to measure the peak load required to disconnect an attachment. Four different types of commercially available attachments were used in various positions on the model in sequence to evaluate the effects of retention and stability of overdentures based on implant number and distribution: (1) ERA, (2) O-Ring, (3) Locator, and (4) Ball. For each group, 10 measurements were made of peak dislodging forces. Means were calculated and differences among the systems, directions, and groups were identified using a repeated measured analysis of variance (α = .05). The interactions between the attachment system, direction of force, and implant number and distribution were statistically significant. Vertical dislodging forces of the simulated overdenture prosthesis increased with additional widely spaced implants. Oblique dislodging forces of the simulated prosthesis increased with additional widely spaced implants except in the two-implant model with all attachments, and in the four-implant groups with Locator attachments. Anteroposterior dislodging forces of a simulated overdenture prosthesis increased with additional widely spaced implants except in the four-implant groups with Ball and Locator attachments. Ball attachments reported the highest levels of retention and stability followed by Locator, O-Ring, and ERA. Within the limitations of this study, retention and stability of an implant overdenture prosthesis are significantly affected by implant number, implant distribution, and abutment type.

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 reserved.

Impact of sexual activity on glycated hemoglobin levels in patients with type 2 diabetes mellitus after penile prosthesis implantation.

PubMed

Talib, Raidh A; Canguven, Onder; Al Ansari, Abdulla

2014-09-06

To examine the benefits of sexual activity on glycated hemoglobin (HbA1c)in penile prosthesis implanted patients with type 2 diabetes mellitus (DM). Sixty-seven male subjects who had HbA1c levels of ≥ 6.5% before and could perform regular sexual activity after the implantations were enrolled. The contribution of sexual activity on glycemic control assessed by HbA1c level as well as age, duration of DM and frequency of sexual activity were evaluated. Mean age and mean time from the surgery of the study patients was 59.9 years (range,30-82) and 22.6 months (range, 10-63), respectively. The average of penile prosthesis usage for sexual activity was 9.9 times per month (range, 2-28). Compared with the preimplantation, the absolute mean change in HbA1c after penile prosthesis implantation was found as - 0.2% (P > .05). This study also revealed that more sexual activity was associated with more reduction in HbA1c. The present study demonstrated that sexual activity is associated with HbA1c reduction, which is clinically important in patients with type 2 DM after penile prosthesis implantation.

In-vivo assessment of the morphology and hemodynamic functions of the BioValsalva™ composite valve-conduit graft using cardiac magnetic resonance imaging and computational modelling technology.

PubMed

Kidher, Emaddin; Cheng, Zhuo; Jarral, Omar A; O'Regan, Declan P; Xu, Xiao Yun; Athanasiou, Thanos

2014-12-09

The evaluation of any new cardiac valvular prosthesis should go beyond the classical morbidity and mortality rates and involve hemodynamic assessment. As a proof of concept, the objective of this study was to characterise for the first time the hemodynamics and the blood flow profiles at the aortic root in patients implanted with BioValsalva™ composite valve-conduit using comprehensive MRI and computer technologies. Four male patients implanted with BioValsalva™ and 2 age-matched normal controls (NC) underwent cardiac magnetic resonance imaging (MRI). Phase-contrast imaging with velocity-mapping in 3 orthogonal directions was performed at the level of the aortic root and descending thoracic aorta. Computational fluid dynamic (CFD) simulations were performed for all the subjects with patient-specific flow information derived from phase-contrast MR data. The maximum and mean flow rates throughout the cardiac cycle at the aortic root level were very comparable between NC and BioValsalva™ patients (541 ± 199 vs. 567 ± 75 ml/s) and (95 ± 46 vs. 96 ± 10 ml/s), respectively. The maximum velocity (cm/s) was higher in patients (314 ± 49 vs. 223 ± 20; P = 0.06) due to relatively smaller effective orifice area (EOA), 2.99 ± 0.47 vs. 4.40 ± 0.24 cm2 (P = 0.06), however, the BioValsalva™ EOA was comparable to other reported prosthesis. The cross-sectional area and maximum diameter at the root were comparable between the two groups. BioValsalva™ conduit was stiffer than the native aortic wall, compliance (mm2 • mmHg(-1) • 10(-3)) values were (12.6 ± 4.2 vs 25.3 ± 0.4.; P = 0.06). The maximum time-averaged wall shear stress (Pa), at the ascending aorta was equivalent between the two groups, 17.17 ± 2.7 (NC) vs. 17.33 ± 4.7 (BioValsalva™ ). Flow streamlines at the root and ascending aorta were also similar between the two groups apart from a degree of helical flow that occurs at the outer curvature at the angle developed near the suture line. BioValsalva™ composite valve-conduit prosthesis is potentially comparable to native aortic root in structural design and in many hemodynamic parameters, although it is stiffer. Surgeons should pay more attention to the surgical technique to maximise the reestablishment of normal smooth aortic curvature geometry to prevent unfavourable flow characteristics.

Functional evaluation of a CAD/CAM prosthesis for immediate defect repair after total maxillectomy: a case series of 18 patients with maxillary sinus cancer.

PubMed

Jiang, Fei-Fei; Hou, Yan; Lu, Li; Ding, Xiao-Xu; Li, Wei; Yan, Ai-Hui

2015-01-01

To evaluate the facial profiles and functional recovery of 18 patients treated by a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis) after total maxillectomy for malignant maxillary sinus tumor. A retrospective observational study was performed to evaluate the facial profiles and functional recovery of 18 patients with T3-4a N0 M0 maxillary sinus cancer, who were treated by total maxillectomy and simultaneous implantation of a computer-aided designed/manufactured hollow obturator prosthesis (CAD/CAM prosthesis). Follow-ups were performed 1, 3, 6, and 12 months after surgery. Facial measurements, speech intelligibility, and chewing and swallowing functions were examined. Thirteen patients converted to a permanent prosthesis 6 months after surgery. Comparisons were made between patients with and without the CAD/CAM or permanent prosthesis at various times using SPSS13.0 statistical software (SPSS Inc., Chicago, IL, USA). Speech intelligibility, facial depression, and eyeball prolapse results showed improvements with prosthesis use at 1, 3, and 6 months after surgery (p < 0.05). Swallowing function improved from level V to level II-IV with prosthesis use at 1, 3, and 6 months, and reached level I or II with permanent prosthesis use at 12 months after surgery. Simultaneous CAD/CAM prosthesis implantation recovered the facial profile, enhanced the speaking, swallowing, and chewing functions, and improved the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. Therefore, this operation is recommended for simultaneous excision repair and functional reconstruction after total maxillectomy. This surgical treatment of maxillary sinus cancer is applied rarely in China, but it has a good effect based on our observation. Simultaneous CAD/CAM prosthesis implantation after total maxillectomy can recover the facial profile, enhance the speaking, swallowing, and chewing functions, and improve the quality of life of patients. Tumor recurrence can be detected by direct observation of the postoperative maxillary cavity. This technique avoids the need for dental implants because the bottom part of the prosthesis contains a palatal plate with dentures. © 2014 Wiley Periodicals, Inc.

Usefulness of Mitral Valve Prosthetic or Bioprosthetic Time Velocity Index Ratio to Detect Prosthetic or Bioprosthetic Mitral Valve Dysfunction.

PubMed

Luis, Sushil Allen; Blauwet, Lori A; Samardhi, Himabindu; West, Cathy; Mehta, Ramila A; Luis, Chris R; Scalia, Gregory M; Miller, Fletcher A; Burstow, Darryl J

2017-10-15

This study aimed to investigate the utility of transthoracic echocardiographic (TTE) Doppler-derived parameters in detection of mitral prosthetic dysfunction and to define optimal cut-off values for identification of such dysfunction by valve type. In total, 971 TTE studies (647 mechanical prostheses; 324 bioprostheses) were compared with transesophageal echocardiography for evaluation of mitral prosthesis function. Among all prostheses, mitral valve prosthesis (MVP) ratio (ratio of time velocity integral of MVP to that of left ventricular outflow tract; odds ratio [OR] 10.34, 95% confidence interval [95% CI] 6.43 to 16.61, p<0.001), E velocity (OR 3.23, 95% CI 1.61 to 6.47, p<0.001), and mean gradient (OR 1.13, 95% CI 1.02 to 1.25, p=0.02) provided good discrimination of clinically normal and clinically abnormal prostheses. Optimal cut-off values by receiver operating characteristic analysis for differentiating clinically normal and abnormal prostheses varied by prosthesis type. Combining MVP ratio and E velocity improved specificity (92%) and positive predictive value (65%) compared with either parameter alone, with minimal decline in negative predictive value (92%). Pressure halftime (OR 0.99, 95% CI 0.98 to 1.00, p=0.04) did not differentiate between clinically normal and clinically abnormal prostheses but was useful in discriminating obstructed from normal and regurgitant prostheses. In conclusion, cut-off values for TTE-derived Doppler parameters of MVP function were specific to prosthesis type and carried high sensitivity and specificity for identifying prosthetic valve dysfunction. MVP ratio was the best predictor of prosthetic dysfunction and, combined with E velocity, provided a useful parameter for determining likelihood of dysfunction and need for further assessment. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Evaluation of a new composite prosthesis for the repair of abdominal wall defects.

PubMed

Losi, Paola; Munaò, Antonella; Spiller, Dario; Briganti, Enrica; Martinelli, Ilaria; Scoccianti, Marco; Soldani, Giorgio

2007-10-01

The degree of integration of biomaterials used in the repair of abdominal wall defects seems to depend upon the structure of the prosthesis. The present investigation evaluates the behaviour in terms of adhesion formation and integration of a new composite prosthesis that could be employed in this clinical application. Full-thickness abdominal wall defects (7 x 5 cm) were created in 16 anaesthetized New Zealand white rabbits and the prosthesis were placed in direct contact with the visceral peritoneum during the experiment. The defects were repaired with a composite prosthesis or pure polypropylene mesh to establish two study groups (n = 8 each). The composite device was constituted by a polypropylene mesh physically attached to a poly(ether)urethane-polydimethylsiloxane laminar sheet. Animals were sacrificed 7, 14, 21 and 30 days after implant and prosthesis/surrounding tissue specimens subjected to light and electron microscopy. Firm adhesions were detected in the polypropylene implants, while they were not present in the composite implants. The excellent behaviour of the composite prosthesis shown in this study warrants further investigation on its use for the repair of abdominal wall defects when a prosthetic device needs to be placed in contact with the intestinal loops.

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.

Emerging Transcatheter Options for Tricuspid Regurgitation

PubMed Central

Kalra, Ankur; Uberoi, Angad S.; Latib, Azeem; Khera, Sahil; Little, Stephen H.; Bhatt, Deepak L.; Reardon, Michael J.; Kleiman, Neal S.; Barker, Colin M.

2017-01-01

Tricuspid regurgitation (TR) presents as either primary valve pathology or secondary to pulmonary or left-sided heart disease. Severe TR portends a worse prognosis independent of age, right ventricular size and function, severe left ventricular dysfunction, and increased pulmonary arterial pressures. Surgical treatment for TR has mostly been limited to patients undergoing mitral valve repair since those at high surgical risk are not candidates for traditional TR surgery. For these patients, minimally invasive techniques could be of great benefit, yet these techniques have been slow to develop because of the various anatomic and physiological aspects of the tricuspid valve apparatus. Several promising new techniques are currently undergoing clinical investigation, including caval valve implantation, percutaneous tricuspid annuloplasty techniques (Trialign, TriCinch, Cardioband), edge-to-edge repair with the MitraClip system, the FORMA device, and the GATE tricuspid Atrioventricular Valved Stent. Further evaluation of their safety and long-term efficacy is warranted prior to commercial approval and widespread adoption. PMID:29743996

Biomechanical evaluation of two types of short-stemmed hip prostheses compared to the trust plate prosthesis by three-dimensional measurement of micromotions.

PubMed

Fottner, Andreas; Schmid, Markus; Birkenmaier, Christof; Mazoochian, Farhad; Plitz, Wolfgang; Volkmar, Jansson

2009-06-01

Stemless and short-stemmed hip prostheses have been developed to preserve femoral bone stock. While all these prostheses claim a more or less physiological load transfer, clinical long-term results are only available for the stemless thrust plate prosthesis. In this study, the in vitro primary stability of the thrust plate prosthesis was compared to two types of short-stemmed prostheses. In addition to the well-established Mayo prosthesis, the modular Metha prosthesis was tested using cone adapters with 130 degrees and 140 degrees neck-shaft-angles. The prostheses were implanted in composite femurs and loaded dynamically (300-1700 N). Three-dimensional micromotions at the bone-prosthesis interface were measured. In addition, the three-dimensional deformations at the surface of the composite femur were measured to gain data on the strain distribution. For all tested prostheses, the micromotions did not exceed 150 microm, the critical value for osteointegration. The thrust plate prosthesis revealed similar motions as the short-stemmed prostheses. The short-stemmed prosthesis with the 130 degrees cone tended to have the highest micromotions of all tested short-stemmed prostheses. The thrust plate prosthesis revealed the lowest alteration of bone surface deformation after implantation. The comparably low micromotions of the thrust plate prosthesis and the short-stemmed prostheses should be conducive to osseous integration. The higher alteration of load transmission after implantation reveals a higher risk of stress shielding for the short-stemmed prostheses.

Accidental aspiration in a patient with Parkinson's disease during implant-supported prosthesis construction: a case report.

PubMed

Deliberador, Tatiana Miranda; Marengo, Gláucia; Scaratti, Rodrigo; Giovanini, Allan Fernando; Zielak, João César; Baratto Filho, Flares

2011-01-01

This article reports on a case history of an elderly patient with Parkinson's disease (PD) who sought treatment at a private dental office. His chief complaint was "difficulty in eating due to an illfitting prosthesis." Laboratory tests and oral radiographs were made. The surgical placement of an implant was done and, subsequently, an implant-supported prosthesis was fitted for the patient. During the impression for the construction of the implant-supported prosthesis, the patient accidentally aspirated the implant screwdriver. The object was found in the lower right lobe of the bronchus, and its removal was necessary in a hospital using bronchoscopy under general anesthesia. Patients with PD are considered at risk of aspirating and/or ingesting dental instruments. Short treatment periods are recommended, preferably during the morning, when the medication prescribed for PD is most effective. When treating patients who have a risk for aspirating and ingesting small objects, it is important to treat them in a more vertical position, and small-sized objects should be secured with dental floss to aid retrieval. © 2011 Special Care Dentistry Association and Wiley Periodicals, Inc.

Transition from a failing dentition to a removable implant-supported prosthesis: a staged approach.

PubMed

Cordaro, Luca; Torsello, Ferruccio; Ribeiro, Carlos Accorsi

2010-05-01

Patients with hopeless dentition often present difficulties in the management of the transitional phase to the final restoration. This article describes a staged approach to achieve a full-arch, implant-supported, removable prosthesis in patients with a hopeless dentition. The approach described allows the clinician to proceed in a staged manner and facilitate prosthetic steps by keeping fixed references for vertical dimension. This technique includes initial conservative periodontal care and, afterward, extraction of some strategic teeth, while others are temporarily maintained. At this point, the implants are positioned, and during the healing period, the remaining natural abutments are used for occlusal reference and to stabilize the removable provisional prosthesis. After osseointegration of the implants, the residual teeth are extracted and the final prosthesis is delivered. The main advantages of the technique include maintenance of function during treatment, stabilization of the removable provisional (especially in the mandibular arch), prosthetic-guided insertion of implants, and easier retrieval of prosthetic references. The main drawbacks are longer treatment time and the need for two surgical steps.

Stability of the Giliberty bipolar hip: report of three cases.

PubMed

Langan, P; Weiss, C A

1978-01-01

The Giliberty Bipolar Hip Prosthesis consists of an unbonded acetabular cup which snap-fits over the head of the femoral prosthesis. Because of the free movement permitted at the cup-pelvic junction as well as at the snap-fit interface, there has been a great deal of concern over the potential for dislocation. Three patients in whom this unit was implanted sustained significant skeletal trauma subsequent to surgery. None of them dislocated. In each case the prosthetic head was known to be in a relatively vertical orientation with respect to the transverse axis of the pelvis prior to the injury. In 2 of the 3 cases radiographically identifiable movement of the cup was present before and after the injury. These observations suggest that the persistently mobile, vertically positioned unbonded cup remain stable despite the stress of significant trauma. It is probable that the potential for cup movement, even where on the X-ray it appears to have stopped, acts as a safety valve in absorbing force that might otherwise dislocate the hip or cause fractures of the femur or the pelvis.

Usefulness of Tricuspid Annular Diameter to Predict Late Right Sided Heart Failure in Patients With Left Ventricular Assist Device.

PubMed

Nakanishi, Koki; Homma, Shunichi; Han, Jiho; Takayama, Hiroo; Colombo, Paolo C; Yuzefpolskaya, Melana; Garan, Arthur R; Farr, Maryjane A; Kurlansky, Paul; Di Tullio, Marco R; Naka, Yoshifumi; Takeda, Koji

2018-07-01

Although late-onset right-sided heart failure is recognized as a clinical problem in the treatment of patients with left ventricular assist devices (LVADs), the mechanism and predictors are unknown. Tricuspid valve (TV) deformation leads to the restriction of the leaflet motion and decreased coaptation, resulting in a functional tricuspid regurgitation that may act as a surrogate marker of late right-sided heart failure. This study aimed to investigate the association of preoperative TV deformation (annulus dilatation and leaflet tethering) with late right-sided heart failure development after continuous-flow LVAD implantation. The study cohort consisted of 274 patients who underwent 2-dimensional echocardiography before LVAD implantation. TV annulus diameter and tethering distance were measured in an apical 4-chamber view. Late right-sided heart failure was defined as right-sided heart failure requiring readmission and medical and/or surgical treatment after initial LVAD implantation. During a mean follow-up of 25.1 ± 19.0 months after LVAD implantation, late right-sided heart failure occurred in 33 patients (12.0%). Multivariate Cox proportional hazard analysis demonstrated that TV annulus diameter (hazard ratio 1.221 per 1 mm, p <0.001) was significantly associated with late right-sided heart failure development, whereas leaflet tethering distance was not. The best cut-off value of the TV annular diameter was 41 mm (area under the curve 0.787). Kaplan-Meier analysis showed that patients with dilated TV annulus (TV annular diameter ≥41 mm) exhibited a significantly higher late right-sided heart failure occurrence than those without TV annular enlargement (log-rank p <0.001). In conclusion, preoperative TV annulus diameter, but not leaflet tethering distance, predicted the occurrence of late right-sided heart failure after LVAD implantation. Copyright © 2018 Elsevier Inc. All rights reserved.

New Soft Tissue Implants Using Organic Elastomers

NASA Astrophysics Data System (ADS)

Ku, David N.

Typical biomaterials are stiff, difficult to manufacture, and not initially developed for medical implants. A new biomaterial is proposed that is similar to human soft tissue. The biomaterial provides mechanical properties similar to soft tissue in its mechanical and physical properties. Characterization is performed for modulus of elasticity, ultimate strength and wear resistance. The material further exhibits excellent biocompatibility with little toxicity and low inflammation. The material can be molded into a variety of anatomic shapes for use as a cartilage replacement, heart valve, and reconstructive implant for trauma victims. The biomaterial may be suitable for several biodevices of the future aimed at soft-tissue replacements.

Clinical evaluation of satisfaction in patients rehabilitated with an immediately loaded implant-supported prosthesis: a controlled prospective study.

PubMed

Scala, Rudy; Cucchi, Alessandro; Ghensi, Paolo; Vartolo, Francesco

2012-01-01

The purpose of this controlled prospective study was to compare the satisfaction of patients rehabilitated with an immediately loaded implant-supported prosthesis and patients rehabilitated with a conventional denture in the mandible. Selected mandibular partially or totally edentulous patients were included in this prospective study. Patients' mandibles were completely rehabilitated with immediately loaded implants supporting a screw-retained full-arch prosthesis (test group) or with a conventional denture (control group). The Satisfaction Profile (SAT-P), which investigates a number of psychologic aspects related to the function and esthetics of the stomatognathic apparatus, was administered to each patient 1 month before and 3 months after provisional prosthetic rehabilitation. The questionnaire comprised four different SAT-P items: quality of eating, eating behavior, mood, and self-confidence. A visual analog scale was used to elicit patient responses. SAT-P item scores were analyzed statistically by means of the Student t test and the chi-square test (or the Mann-Whitney nonparametric test), with P < .05 considered significant. Forty-one patients were consecutively treated with 205 immediately loaded implants supporting a screw-retained full-arch prosthesis (test group); 38 patients were consecutively treated with a conventional denture (control group). Statistically significant differences were observed between the test and control groups for all four SAT-P items. The test group reported greater satisfaction for all items versus the control group. In both groups, the differences between pre- and postrehabilitation values were statistically significant. Each patient was satisfied with their treatment outcomes, but patients who received an implant-supported prosthesis were more satisfied than the patients who received a conventional denture. The results suggest that a screw-retained full-arch prosthesis on immediately loaded implants is a predictable means of enhancing patient satisfaction.

Immediate Versus Delayed Loading of Implant for Replacement of Missing Mandibular First Molar: A Randomized Prospective Six Years Clinical Study.

PubMed

Chidagam, Prudhvi Raj Lakshmi Venkata; Gande, Vijaya Chandra; Yadlapalli, Sravanthi; Venkata, Ramani Yarlagadda; Kondaka, Sudheer; Chedalawada, Sravya

2017-04-01

Emergence of dental implants made the replacement of missing tooth easy. During the early days of introduction, implants were loaded three to six months after implant insertion, but understanding of healing cascade and improved production technology has changed the phase of restoration from delayed to immediate loading. To evaluate and compare the clinical outcome of immediate and delayed loaded implant supported prosthesis for missing mandibular first molar. The objectives were bleeding on probing, probing depth, implant mobility, marginal bone level and peri-implant radiolucency were evaluated during follow up period. Twenty patients were included in this study who were in the need of fixed implant supported prosthesis for missing mandibular first molar. Single tooth implant with immediate loading done within two days of implant insertion in one group and another group were loaded after three months of implant insertion. These groups were evaluated clinically and radiographically over a period of 72 months after loading using Wilcoxon matched pairs test and Mann-Whitney U test. The study consists of 14 male and six female patients with the age range of 19 to 31 years. There was no bleeding on probing and probing depth remained well within the normal range even after 72 months of loading among both the groups. Minimal marginal bone loss observed with no mobility and peri-implant radiolucency. Implant supported prosthesis for missing mandibular first molar with immediate loading can be used as a successful treatment modality. It reduces treatment time, provides early function and prevents undue migration of adjacent tooth. Immediate loading showed similar clinical and radiographic results as that of delayed loading, indicating it as an equally efficient technique for implant supported prosthesis.

Simulated bone remodeling around two types of osseointegrated implants for direct fixation of upper-leg prostheses.

PubMed

Tomaszewski, P K; Verdonschot, N; Bulstra, S K; Rietman, J S; Verkerke, G J

2012-11-01

Direct attachment of an upper leg prosthesis to the skeletal system by a percutaneous implant is an alternative solution to the traditional socket fixation. In this study, we investigated long-term periprosthetic bone changes around two types of fixation implants using two different initial conditions, namely immediate post-amputation implantation and the conventional implantation after considerable time of socket prosthesis use. We questioned the difference in bone modeling response the implants provoked and if it could lead to premature bone fracture. Generic CT-based finite element models of an intact femoral bone and amputated bone implanted with models of two existing direct-fixation implants, the OPRA system (Integrum AB) and the ISP Endo/Exo prosthesis (ESKA Implants AG) were created for this study. Adaptive bone-remodeling simulations used the heel-strike and toe-off loads from a normal walking cycle. The bone loss caused by prolonged use of socket prosthesis had more severe effects on the ultimate bone quality than adaptation induced by the direct-fixation implants. Both implants showed considerable bone remodeling; the titanium screw implant (OPRA system) provoked more bone loss than the porous coated CoCrMo stem (ISP implant). The chance of the peri-prosthetic bone fracture remained higher for the post-socket case as compared to the direct amputation cases. In conclusion, both direct-fixation implants lead to considerable bone loss and bone loss is more severe after a prolonged period of post-socket use. Hence, from a biomechanical perspective it is better to limit the post-socket time and to re-design direct fixation devices to reduce bone loss and the probability of peri-prosthetic bone fractures. Copyright © 2012 Elsevier Ltd. All rights reserved.

Feasibility of the runt cow for in vivo testing of a spinal interbody prosthesis with preliminary results.

PubMed

Buttermann, Glenn R; Mendenhall, H Vincent

2012-04-01

The optimal lumbar spinal disc prosthesis has yet to be developed. Failures of clinical device studies may be minimized by appropriate large animal preclinical studies. The lumbar spine of the mature "runt" cow, Corrientes breed, has been shown to have a number of desirable characteristics to the human. This study assessed the feasibility of the "runt" cow for in vivo testing of human-sized lumbar interbody implants and the ability to perform common analyses of explants. Eight cows (four experimental and four controls) were compared. The experimental animals had transosseous implantation of the disc prosthesis at L4-L5, and their spines were harvested at four or six months. They were evaluated for the ease of surgical access and healing, motion segment mobility, ability to remove the implant nondestructively, and microradiography and histomorphology. All animals had successful implantation. All explantations were performed without alteration to the devices. All animals had surgical healing and intended device motion, and histology found device stability by demonstrating bone ingrowth into the device's porous plates. There was a significant 46% increase in the amount of trabecular bone adjacent to the implants. The mature runt cow allows for implantation of human-sized interbody and intrabody spinal prostheses. This animal model allowed for macro- and histological analysis of the implant and surrounding tissues. In vivo stability was demonstrated for the disc prosthesis while also allowing for evaluation of intended mobility. Additionally, this is the first study to suggest increased bone density supporting an interbody prosthesis.

Feasibility of pig and human-derived aortic valve interstitial cells seeding on fixative-free decellularized animal pericardium.

PubMed

Santoro, Rosaria; Consolo, Filippo; Spiccia, Marco; Piola, Marco; Kassem, Samer; Prandi, Francesca; Vinci, Maria Cristina; Forti, Elisa; Polvani, Gianluca; Fiore, Gianfranco Beniamino; Soncini, Monica; Pesce, Maurizio

2016-02-01

Glutaraldehyde-fixed pericardium of animal origin is the elective material for the fabrication of bio-prosthetic valves for surgical replacement of insufficient/stenotic cardiac valves. However, the pericardial tissue employed to this aim undergoes severe calcification due to chronic inflammation resulting from a non-complete immunological compatibility of the animal-derived pericardial tissue resulting from failure to remove animal-derived xeno-antigens. In the mid/long-term, this leads to structural deterioration, mechanical failure, and prosthesis leaflets rupture, with consequent need for re-intervention. In the search for novel procedures to maximize biological compatibility of the pericardial tissue into immunocompetent background, we have recently devised a procedure to decellularize the human pericardium as an alternative to fixation with aldehydes. In the present contribution, we used this procedure to derive sheets of decellularized pig pericardium. The decellularized tissue was first tested for the presence of 1,3 α-galactose (αGal), one of the main xenoantigens involved in prosthetic valve rejection, as well as for mechanical tensile behavior and distensibility, and finally seeded with pig- and human-derived aortic valve interstitial cells. We demonstrate that the decellularization procedure removed the αGAL antigen, maintained the mechanical characteristics of the native pig pericardium, and ensured an efficient surface colonization of the tissue by animal- and human-derived aortic valve interstitial cells. This establishes, for the first time, the feasibility of fixative-free pericardial tissue seeding with valve competent cells for derivation of tissue engineered heart valve leaflets. © 2015 Wiley Periodicals, Inc.

Complications and Clinical Considerations of the Implant-Retained Zirconia Complete-Arch Prosthesis with Various Opposing Dentitions.

PubMed

Gonzalez, Jorge; Triplett, Robert G

To evaluate the performance of the implant-retained zirconia complete-arch prosthesis with various opposing dentitions. The 40 patients included in this retrospective case series study were treated with one or two implant-retained zirconia complete-arch prostheses (ZIRCAP) using the Zirkonzahn protocol. Prettau zirconia frames were created with strategic cutbacks in the structure to extend zirconia incisal coverage of the esthetic anterior sextants and complete monolithic zirconia in the molar areas; subsequent layers of porcelain were applied to nonfunctional and esthetic areas. Patients had three possible occlusal scenarios: (1) maxillary ZIRCAP and mandibular ZIRCAP, (2) maxillary ZIRCAP and mandibular natural dentition, and (3) maxillary ZIRCAP and mandibular conventional hybrid prosthesis. Complications were recorded during follow-up appointments 3, 6, and 12 months after definitive prosthesis delivery. The mean treatment observation period was 33 months. Eight prosthetic complications were noted for the 40 implant-retained zirconia complete-arch prostheses (18.18%), including six cases of minor porcelain chipping and two cases of debonding of the metal insert from the zirconia framework. Maxillary ZIRCAP opposing mandibular ZIRCAP and maxillary ZIRCAP opposing mandibular natural dentition occlusal scenarios presented the same complication ratio of 4. No complications were seen in the maxillary ZIRCAP opposing mandibular conventional hybrid prosthesis group, yet 16 complications were found as denture tooth fractures in 12 mandibular conventional hybrid prostheses (ratio of 0.75). The results indicate that the implant-retained zirconia complete-arch prosthesis offers acceptable performance for use as an alternative to the conventional titanium framework acrylic veneer prosthesis for complete edentulism with a lower incidence of prosthetic complications and fewer maintenance appointments. Chipping of veneering porcelain was the most common complication, but a low incidence was observed in this study. Acrylic denture teeth may represent the weakest link when restoring complete edentulism with a maxillary ZIRCAP and mandibular conventional hybrid prosthesis.

Recently patented transcatheter aortic valves in clinical trials.

PubMed

Neragi-Miandoab, Siyamek; Skripochnik, Edvard; Salemi, Arash; Girardi, Leonard

2013-12-01

The most widely used heart valve worldwide is the Edwards Sapien, which currently has 60% of the worldwide transcatheter aortic valve implantation (TAVI) market. The CoreValve is next in line in popularity, encompassing 35% of the worldwide TAVI market. Although these two valves dominate the TAVI market, a number of newer transcatheter valves have been introduced and others are in early clinical evaluation. The new valves are designed to reduce catheter delivery diameter, improve ease of positioning and sealing, and facilitate repositioning or removal. The most recent transcatheter valves for transapical use include Acurate TA (Symetis), Engager (Medtronic), and JenaValve the Portico (St Jude), Sadra Lotus Medical (Boston Scientific), and the Direct Flow Medical. These new inventions may introduce more effective treatment options for high-risk patients with severe aortic stenosis. Improvements in transcatheter valves and the developing variability among them may allow for more tailored approaches with respect to patient's anatomy, while giving operators the opportunity to choose devices they feel more comfortable with. Moreover, introducing new devices to the market will create a competitive environment among producers that will reduce high prices and expand availability. The present review article includes a discussion of recent patents related to Transcatheter Aortic Valves.

Prosthetic Consideration in Implant-supported Prosthesis: A Review of Literature

PubMed Central

Gowd, Manga Snigdha; Shankar, Thatapudi; Ranjan, Rajeev; Singh, Arpita

2017-01-01

Modern dentistry has changed tremendously with implant therapy. For the successful implant therapy, making a proper treatment plan considering both surgical and prosthetic part in mind is the key of success. Often practitioners tend to create a treatment plan overlooking the basic principles of prosthetic part. This present review has discussed various prosthetic consideration of implant-supported prosthesis. A step-by-step detailed prosthetic option with their indications has been discussed to help all dental implant practitioners in making of an optimal treatment plan for each case. PMID:28713760

Retrospective study of 68 implants placed in the pterygomaxillary region using drills and osteotomes.

PubMed

Peñarrocha, Miguel; Carrillo, Celia; Boronat, Araceli; Peñarrocha, Maria

2009-01-01

The aim of this study was to evaluate the success rate of implants placed in the pterygomaxillary region using drills and osteotomes with a minimum of 12 months' follow-up. Bone loss after 1 year of loading and patient satisfaction with the prosthesis were evaluated. A retrospective case study was made. The sample was composed of patients rehabilitated with pterygoid implants between January 2000 and January 2006. The inclusion criteria were patients in good general health with severe atrophy of the posterior maxilla who had been rehabilitated with one or two pterygoid implants inserted using drills and osteotomes and had been followed for 12 months after implant loading. Implant success was defined according to the criteria of Albrektsson et al. Bone loss was measured on panoramic radiographs on the mesial and distal of each implant, and the largest value (whether mesial or distal) was selected as the bone loss for the implant in question. Subjects indicated satisfaction with the new prosthesis on a visual analogue scale. Forty-five patients were treated with 268 implants (200 anterior and 68 pterygoid). The success rate of pterygoid implants was 97.05%. The mean bone loss around implants in the pterygomaxillary region after 1 year of loading was 0.71 mm (range, 0 to 3.20). All prostheses were stable at the end of the observation period. Patients were satisfied with comfort and stability, ability to speak, ease of cleaning, and esthetics and functionality of the prosthesis. Placement of implants in the posterior pterygomaxillary region using drills and osteotomes is a viable alternative treatment modality for rehabilitation of atrophic posterior maxilla. Patients were satisfied with a prosthesis supported by pterygoid implants.

Ultrasound based mitral valve annulus tracking for off-pump beating heart mitral valve repair

NASA Astrophysics Data System (ADS)

Li, Feng P.; Rajchl, Martin; Moore, John; Peters, Terry M.

2014-03-01

Mitral regurgitation (MR) occurs when the mitral valve cannot close properly during systole. The NeoChordtool aims to repair MR by implanting artificial chordae tendineae on flail leaflets inside the beating heart, without a cardiopulmonary bypass. Image guidance is crucial for such a procedure due to the lack of direct vision of the targets or instruments. While this procedure is currently guided solely by transesophageal echocardiography (TEE), our previous work has demonstrated that guidance safety and efficiency can be significantly improved by employing augmented virtuality to provide virtual presentation of mitral valve annulus (MVA) and tools integrated with real time ultrasound image data. However, real-time mitral annulus tracking remains a challenge. In this paper, we describe an image-based approach to rapidly track MVA points on 2D/biplane TEE images. This approach is composed of two components: an image-based phasing component identifying images at optimal cardiac phases for tracking, and a registration component updating the coordinates of MVA points. Preliminary validation has been performed on porcine data with an average difference between manually and automatically identified MVA points of 2.5mm. Using a parallelized implementation, this approach is able to track the mitral valve at up to 10 images per second.

Implant-supported and magnet-retained oral-nasal combination prosthesis in a patient with a total rhinectomy and partial maxillectomy due to cancer: A clinical report.

PubMed

Won, Alexander M; Montgomery, Patti; Aponte-Wesson, Ruth; Chambers, Mark

2017-02-01

This clinical report describes the fabrication of an implant-supported and magnet-retained combination oral-nasal prosthesis for a patient with a midline midfacial defect. The patient had undergone a total rhinectomy and partial maxillectomy as part of his cancer treatment. The nasal prosthesis was retained on the face by a magnet attached to the implant-supported maxillary denture, resulting in improved appearance and the recovery of speech, mastication, and swallowing functions. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Wide-awake Anesthesia No Tourniquet Trapeziometacarpal Joint Prosthesis Implantation.

PubMed

Müller, Camillo Theo; Christen, Thierry; Heidekruger, Paul I; Lamouille, Jessie; Raffoul, Wassim; McKee, Daniel; Lalonde, Donald H; Durand, Sébastien

2018-04-01

Wide awake local anesthesia no tourniquet (WALANT) hand surgery is a rapidly growing in popularity. WALANT has been used by hand surgeons when operating on bones, tendons, ligaments, nerve entrapments. We offer a case report of the first case in the literature describing WALANT technique when performing trapeziometacarpal joint arthroplasty with prosthesis implantation. We offer technical points on how to perform this procedure and the advantages that are associated with using WALANT for prosthesis arthroplasty.

[Application of a tape-like bandage for the ascending aorta in its poststenotic dilation and correction of the aortal valve stenosis].

PubMed

Popov, V V; Bol'shak, A A

2014-06-01

The aortal valve prosthesis in combination with a tape-like bandage of ascending aorta application was performed in 106 patients, suffering a failure with predominance of the aortal valve stenosis in conjunction with the ascending aorta poststenotic dilation, in a 2005 - 2014 yrs period in the clinic. The hospital lethality have constituted 0.9%. In accordance to echocardiography, the ascending aorta diameter preoperatively have constituted (48.7 +/- 1.4) mm at average, before discharge from the hospital--(40.1 +/- 1.2) mm, in late follow-up period--(41.3 +/- 1.2) mm. It is expedient to recommend the original method of a tape-like bandage of ascending aorta from the base of noncoronary sinus in the aortal sinuses dilation (45 mm and more) in combination with the aortal valve prosthesis in poststenotic dilation of ascending aorta.

21 CFR 872.3970 - Interarticular disc prosthesis (interpositional implant).

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Interarticular disc prosthesis (interpositional implant). 872.3970 Section 872.3970 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3970 Interarticular...

Clinical Experience With the Subcutaneous Implantable Cardioverter-Defibrillator in Adults With Congenital Heart Disease.

PubMed

Moore, Jeremy P; Mondésert, Blandine; Lloyd, Michael S; Cook, Stephen C; Zaidi, Ali N; Pass, Robert H; John, Anitha S; Fish, Frank A; Shannon, Kevin M; Aboulhosn, Jamil A; Khairy, Paul

2016-09-01

Sudden cardiac death is a major contributor to mortality for adults with congenital heart disease. The subcutaneous implantable cardioverter-defibrillator (ICD) has emerged as a novel tool for prevention of sudden cardiac death, but clinical performance data for adults with congenital heart disease are limited. A retrospective study involving 7 centers over a 5-year period beginning in 2011 was performed. Twenty-one patients (median 33.9 years) were identified. The most common diagnosis was single ventricle physiology (52%), 9 palliated by Fontan operation and 2 by aortopulmonary shunts: d-transposition of the great arteries after Mustard/Senning (n=2), tetralogy of Fallot (n=2), aortic valve disease (n=2), and other biventricular surgery (n=4). A prior cardiac device had been implanted in 7 (33%). The ICD indication was primary prevention in 67% and secondary in 33% patients. The most common reason for subcutaneous ICD placement was limited transvenous access for ventricular lead placement (n=10) followed by intracardiac right-to-left shunt (n=5). Ventricular arrhythmia was induced in 17 (81%) and was converted with ≤80 Joules in all. There was one implant complication related to infection, not requiring device removal. Over a median follow-up of 14 months, 4 patients (21%) received inappropriate and 1 (5%) patient received appropriate shocks. There was one arrhythmic death related to asystole in a single ventricle patient. Subcutaneous ICD implantation is feasible for adults with congenital heart disease patients. Most candidates have single ventricle heart disease and limited transvenous options for ICD placement. Despite variable anatomy, this study demonstrates successful conversion of induced ventricular arrhythmia and reasonable rhythm discrimination during follow-up. © 2016 American Heart Association, Inc.

Osseocutaneous integration of an intraosseous transcutaneous amputation prosthesis implant used for reconstruction of a transhumeral amputee: case report.

PubMed

Kang, Norbert V; Pendegrass, Catherine; Marks, Linda; Blunn, Gordon

2010-07-01

Exoprosthetic replacement with an artificial limb is the main option for reconstruction after traumatic amputation of an upper limb. Direct skeletal attachment using an osseointegrated implant improves the ease of fixation of the exoprosthesis to the amputation stump. We now report the use of an intraosseous transcutaneous amputation prosthesis that is designed to achieve osseocutaneous integration. Osseocutaneous integration differs from osseointegration because the aim is to create a stable interface among the implant, the bone, and the soft tissues. This reduces the risk of soft tissue infection and troublesome discharge, which are problems encountered with current osseointegrated implants that focus largely on the bone-implant interface. We describe our experience with an intraosseous transcutaneous amputation prosthesis in a case of transhumeral amputation with 2 years of follow-up. Copyright 2010 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.