14 results on '"Wendler, Olaf"'
Search Results
2. Fractional Flow Reserve-Guided PCI or Coronary Bypass Surgery for 3-Vessel Coronary Artery Disease: 3-Year Follow-Up of the FAME 3 Trial.
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Zimmermann, Frederik M., Ding, Victoria Y., Pijls, Nico H. J., Piroth, Zsolt, van Straten, Albert H. M., Szekely, Laszlo, Davidavicius, Giedrius, Kalinauskas, Gintaras, Mansour, Samer, Kharbanda, Rajesh, Östlund-Papadogeorgos, Nikolaos, Aminian, Adel, Oldroyd, Keith G., Al-Attar, Nawwar, Jagic, Nikola, Dambrink, Jan-Henk E., Kala, Petr, Angeras, Oskar, MacCarthy, Philip, and Wendler, Olaf
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- 2023
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3. Quality of Life After Fractional Flow Reserve-Guided PCI Compared With Coronary Bypass Surgery.
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Fearon, William F., Zimmermann, Frederik M., Ding, Victoria Y., Zelis, Jo M., Piroth, Zsolt, Davidavicius, Giedrius, Mansour, Samer, Kharbanda, Rajesh, Östlund-Papadogeorgos, Nikolaos, Oldroyd, Keith G., Wendler, Olaf, Reardon, Michael J., Woo, Y. Joseph, Yeung, Alan C., Pijls, Nico H.J., De Bruyne, Bernard, Desai, Manisha, Hlatky, Mark A., and FAME 3 Investigators
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- 2022
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4. SOURCE 3 Registry Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve
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University of Helsinki, III kirurgian klinikka (-2009), Wendler, Olaf, Schymik, Gerhard, Treede, Hendrik, Baumgartner, Helmut, Dumonteil, Nicolas, Ihlberg, Leo, Neumann, Franz-Josef, Tarantini, Giuseppe, Luis Zamarano, Jose, Vahanian, Alec, University of Helsinki, III kirurgian klinikka (-2009), Wendler, Olaf, Schymik, Gerhard, Treede, Hendrik, Baumgartner, Helmut, Dumonteil, Nicolas, Ihlberg, Leo, Neumann, Franz-Josef, Tarantini, Giuseppe, Luis Zamarano, Jose, and Vahanian, Alec
- Abstract
BACKGROUND: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. METHODS: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. RESULTS: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6 +/- 6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3 +/- 13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. CONCLUSIONS: Results from the S
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- 2017
5. Contemporary Presentation and Management of Valvular Heart Disease: The EURObservational Research Programme Valvular Heart Disease II Survey.
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Iung, Bernard, Delgado, Victoria, Rosenhek, Raphael, Price, Susanna, Prendergast, Bernard, Wendler, Olaf, De Bonis, Michele, Tribouilloy, Christophe, Evangelista, Arturo, Bogachev-Prokophiev, Alexander, Apor, Astrid, Ince, Hüseyin, Laroche, Cécile, Popescu, Bogdan A., Piérard, Luc, Haude, Michael, Hindricks, Gerhard, Ruschitzka, Frank, Windecker, Stefan, and Bax, Jeroen J.
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- 2019
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6. SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve.
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Wendler, Olaf, Schymik, Gerhard, Treede, Hendrik, Baumgartner, Helmut, Dumonteil, Nicolas, Ihlberg, Leo, Neumann, Franz-Josef, Tarantini, Giuseppe, Zamarano, José Luis, and Vahanian, Alec
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HEART valve transplantation , *MEDICAL quality control , *BIOPROSTHESIS , *MEDICAL technology - Abstract
Supplemental Digital Content is available in the text. Background: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. Methods: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. Results: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. Conclusions: Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used. [ABSTRACT FROM AUTHOR]
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- 2018
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7. SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve.
- Author
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Wendler, Olaf, Schymik, Gerhard, Treede, Hendrik, Baumgartner, Helmut, Dumonteil, Nicolas, Ihlberg, Leo, Neumann, Franz-Josef, Tarantini, Giuseppe, Zamarano, José Luis, and Vahanian, Alec
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CHEMOEMBOLIZATION , *HEART valves , *PERCUTANEOUS balloon valvuloplasty , *MITRAL valve insufficiency , *DIABETES , *KIDNEY failure , *PLATELET aggregation inhibitors , *STROKE-related mortality , *COMPARATIVE studies , *CORONARY disease , *CAUSES of death , *PROSTHETIC heart valves , *HEART valve diseases , *HEMODYNAMICS , *RESEARCH methodology , *MEDICAL cooperation , *RESEARCH , *STROKE , *TIME , *COMORBIDITY , *EVALUATION research , *TREATMENT effectiveness , *ACQUISITION of data , *DISEASE complications , *THERAPEUTICS - Abstract
Background: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given.Methods: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee.Results: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients.Conclusions: Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used. [ABSTRACT FROM AUTHOR]- Published
- 2017
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- View/download PDF
8. Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012.
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Ludman, Peter F, Moat, Neil, de Belder, Mark A, Blackman, Daniel J, Duncan, Alison, Banya, Winston, MacCarthy, Philip A, Cunningham, David, Wendler, Olaf, Marlee, Damian, Hildick-Smith, David, Young, Christopher P, Kovac, Jan, Uren, Neal G, Spyt, Tomasz, Trivedi, Uday, Howell, Jonathan, Gray, Huon, and UK TAVI Steering Committee and the National Institute for Cardiovascular Outcomes Research*
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- 2015
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9. The European Registry of Transcatheter Aortic Valve Implantation Using the Edwards SAPIEN Valve.
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Thomas, Martyn, Schymik, Gerhard, Walther, Thomas, Himbert, Dominique, Lefèvre, Thierry, Treede, Hendrik, Eggebrecht, Holger, Rubino, Paolo, Colombo, Antonio, Lange, Rüdiger, Schwarz, Rebecca R., and Wendler, Olaf
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- 2011
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10. Coronary Access and Percutaneous Coronary Intervention Up to 3 Years After Transcatheter Aortic Valve Implantation With a Balloon-Expandable Valve.
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Tarantini, Giuseppe, Nai Fovino, Luca, Le Prince, Pascal, Darremont, Olivier, Urena, Marina, Bartorelli, Antonio L., Vincent, Flavien, Hovorka, Tomas, Alcalá Navarro, Yasmina, Dumonteil, Nicolas, Ohlmann, Patrick, and Wendler, Olaf
- Abstract
Background: Coronary artery disease and aortic stenosis often coexist. Transcatheter aortic valve implantation (TAVI) has emerged as a valid therapeutic option for younger, lower-risk patients who may eventually require coronary artery disease treatment. Thus, post-TAVI coronary access (CA) and percutaneous coronary intervention are expected to increase. The purpose of this study was to retrospectively evaluate patients who were enrolled in the SOURCE 3 (SAPIEN 3 Aortic Bioprosthesis European Outcome) European registry for treatment with the balloon-expandable SAPIEN 3 transcatheter heart valve and underwent CA with or without percutaneous coronary intervention after TAVI. Methods: Baseline characteristics and clinical outcomes of patients with or without CA up to 3 years after TAVI were compared. A Kaplan-Meier estimate with a univariate model determined the impact of CA on cardiac mortality. Results: Of 1936 TAVI patients (mean age 81.6 years, 52% male), 68 (3.5%) had CA within 3 years (mean 441±332 days) after TAVI. At baseline, the logistic EuroSCORE was similar (20.2% versus 18.3%, P =0.2, CA and non-CA groups, respectively). Higher rates of coronary artery disease (76.5% versus 50.6%, P <0.001), myocardial infarction (20.6% versus 11.5%, P =0.03) and previous coronary artery bypass graft (22.1% versus 11.0%, P =0.01) were present in the CA group. In 100% of patients, CA was successfully achieved. The clinical success of percutaneous coronary intervention was 97.9%. Cardiovascular mortality was numerically higher in patients with CA than in those without CA. Conclusions: In the large SOURCE 3 European registry, CA was needed at 3-year follow-up after TAVI with a balloon-expandable valve in 3.5% of patients and was successful in all patients. The clinical success of percutaneous coronary intervention was 97.9%. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02698956. [ABSTRACT FROM AUTHOR]
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- 2020
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11. One-year outcomes of cohort 1 in the Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) registry: the European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
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Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Colombo A, Lange R, Schwarz RR, and Wendler O
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- Aged, Aged, 80 and over, Cardiac Catheterization, Carotid Stenosis mortality, Cause of Death, Female, Humans, Hyperlipidemias mortality, Hypertension mortality, Kidney Diseases mortality, Liver Diseases mortality, Male, Postoperative Complications mortality, Registries, Smoking mortality, Treatment Outcome, Aortic Valve Stenosis mortality, Aortic Valve Stenosis surgery, Cohort Studies, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation mortality
- Abstract
Background: Transcatheter aortic valve implantation was developed to provide a therapeutic option for patients considered to be ineligible for, and to mitigate mortality and morbidity associated with, high-risk surgical aortic valve replacement., Methods and Results: The Edwards SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess initial post commercial clinical transcatheter aortic valve implantation results of the Edwards SAPIEN valve in consecutive patients in Europe. Cohort 1 consists of 1038 patients enrolled at 32 centers. One-year outcomes are presented. Patients with the transapical approach (n=575) suffered more comorbidities than transfemoral patients (n=463) with a significantly higher logistic EuroSCORE (29% versus 25.8%; P=0.007). These groups are different; therefore, outcomes cannot be directly compared. Total Kaplan Meier 1-year survival was 76.1% overall, 72.1% for transapical and 81.1% for transfemoral patients, and 73.5% of surviving patients were in New York Heart Association (NYHA) class I or II at 1 year. Combined transapical and transfemoral causes of death were cardiac in 25.1%, noncardiac in 49.2%, and unknown in 25.7%. Pulmonary complications (23.9%), renal failure (12.5%), cancer (11.4%), and stroke (10.2%) were the most frequent noncardiac causes of death. Multivariable analysis identified logistic EuroSCORE, renal disease, liver disease, and smoking as variables with the highest hazard ratios for 1-year mortality whereas carotid artery stenosis, hyperlipidemia, and hypertension were associated with lower mortality., Conclusion: The SOURCE Registry is the largest consecutively enrolled registry for transcatheter aortic valve implantation procedures. It demonstrates that with new transcatheter aortic techniques excellent 1-year survival in high-risk and inoperable patients is achievable and provides a benchmark against which future transcatheter aortic valve implantation cohorts and devices can be measured.
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- 2011
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12. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
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Thomas M, Schymik G, Walther T, Himbert D, Lefèvre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, and Wendler O
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- Analysis of Variance, Aortic Valve diagnostic imaging, Coronary Restenosis epidemiology, Coronary Restenosis surgery, Europe, Follow-Up Studies, Heart Valve Diseases diagnostic imaging, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Humans, Japan, Multivariate Analysis, Myocardial Revascularization methods, Myocardial Revascularization statistics & numerical data, Patient Selection, Radiography, Recurrence, Registries, Reoperation statistics & numerical data, Risk Factors, Time Factors, Aortic Valve surgery, Heart Valve Diseases surgery, Heart Valve Prosthesis Implantation methods
- Abstract
Background: Transcatheter aortic valve implantation was developed to mitigate the mortality and morbidity associated with high-risk traditional aortic valve replacement. The Edwards SAPIEN valve was approved for transcatheter aortic valve implantation transfemoral delivery in the European Union in November 2007 and for transapical delivery in January 2008., Methods and Results: The SAPIEN Aortic Bioprosthesis European Outcome (SOURCE) Registry was designed to assess the initial clinical results of the Edwards SAPIEN valve in consecutive patients in Europe after commercialization. Cohort 1 consists of 1038 patients enrolled at 32 centers. Patients who were treated with the transapical approach (n=575) suffered more comorbidities than the transfemoral patients (n=463), resulting in a significantly higher logistic EuroSCORE (29.1% versus 25.7%; P<0.001). Therefore, these groups are considered different, and outcomes cannot be compared. Overall short-term procedural success was observed in 93.8%. The incidence of valve embolization was 0.3% (n=3), and coronary obstruction was reported for 0.6% (n=6 cases). Incidence of stroke was 2.5% and similar for both procedural approaches. Thirty-day mortality was 6.3% in transfemoral patients and 10.3% in transapical patients. The occurrence of vascular complications was not a predictor of <30-day mortality in the transfemoral population., Conclusions: Technical proficiency can be learned and adapted readily as demonstrated by the short-term procedural success rate and low 30-day mortality rates reported in the SOURCE Registry. Specific complication management and refinement of patient selection are needed to further improve outcomes.
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- 2010
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13. Aortic valve repair using a differentiated surgical strategy.
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Langer F, Aicher D, Kissinger A, Wendler O, Lausberg H, Fries R, and Schäfers HJ
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- Actuarial Analysis, Adult, Aged, Aortic Valve pathology, Coronary Artery Bypass statistics & numerical data, Disease-Free Survival, Feasibility Studies, Female, Follow-Up Studies, Hospital Mortality, Humans, Male, Middle Aged, Mitral Valve surgery, Postoperative Complications epidemiology, Reoperation statistics & numerical data, Treatment Outcome, Aortic Valve surgery, Aortic Valve Insufficiency surgery
- Abstract
Background: Reconstruction of the aortic valve for aortic regurgitation (AR) remains challenging, in part because of not only cusp or root pathology but also a combination of both can be responsible for this valve dysfunction. We have systematically tailored the repair to the individual pathology of cusps and root., Methods: Between October 1995 and August 2003, aortic valve repair was performed in 282 of 493 patients undergoing surgery for AR and concomitant disease. Root dilatation was corrected by subcommissural plication (n=59), supracommissural aortic replacement (n=27), root remodeling (n=175), or valve reimplantation within a graft (n=24). Cusp prolapse was corrected by plication of the free margin (n=157) or triangular resection (n =36), cusp defects were closed with a pericardial patch (n=16). Additional procedures were arch replacement (n=114), coronary artery bypass graft (n=60) or mitral repair (n=24). All patients were followed-up (follow-up 99.6% complete), and cumulative follow-up was 8425 patient-months (mean, 33+/-27 months).Results- Eleven patients died in hospital (3.9%). Nine patients underwent reoperation for recurrent AR (3.3%). Actuarial freedom from AR grade > or =II at 5 years was 81% for isolated valve repair, 84% for isolated root replacement, and 94% for combination of both; actuarial freedom from reoperation at 5 years was 93%, 95%, and 98%, respectively. No thromboembolic events occurred, and there was 1 episode of endocarditis 4.5 years postoperatively., Conclusions: Aortic valve repair is feasible even for complex mechanisms of AR with a systematic and individually tailored approach. Operative mortality is low and mid-term durability is encouraging. The incidence of valve-related morbidity is low compared with valve replacement.
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- 2004
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14. Effects of sildenafil (viagra) on human myocardial contractility, in vitro arrhythmias, and tension of internal mammaria arteries and saphenous veins.
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Cremers B, Scheler M, Maack C, Wendler O, Schäfers HJ, Südkamp M, and Böhm M
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- 3',5'-Cyclic-GMP Phosphodiesterases, Cyclic Nucleotide Phosphodiesterases, Type 5, Electric Stimulation, Heart Atria drug effects, Heart Ventricles drug effects, Humans, In Vitro Techniques, Isometric Contraction drug effects, Isometric Contraction physiology, Isoproterenol, Mammary Arteries physiology, Milrinone pharmacology, Muscle, Smooth, Vascular drug effects, Muscle, Smooth, Vascular physiology, Myocardial Contraction physiology, Nitric Oxide Donors pharmacology, Phosphodiesterase Inhibitors adverse effects, Phosphoric Diester Hydrolases metabolism, Piperazines adverse effects, Purines, S-Nitroso-N-Acetylpenicillamine pharmacology, Saphenous Vein physiology, Sildenafil Citrate, Sulfones, Vasodilation drug effects, Vasodilation physiology, Vasodilator Agents pharmacology, Arrhythmias, Cardiac chemically induced, Mammary Arteries drug effects, Myocardial Contraction drug effects, Phosphodiesterase Inhibitors pharmacology, Piperazines pharmacology, Saphenous Vein drug effects
- Abstract
Sildenafil (Viagra) has been proved effective in the therapy for erectile dysfunction. Cardiovascular adverse effects are a matter of continuous debate. The aim of the study was to investigate effects of sildenafil on isolated human cardiovascular tissue directly. Isometric force of contraction was determined in isolated, electrically stimulated (1 Hz, 37 degrees C) human right atrial and left ventricular muscle strips. Vascular tension was determined in rings of human internal mammaria arteries and saphenous veins. Sildenafil (0.0001-10 microM) neither in human atrium (n = 12) nor in failing (n = 8) or nonfailing (n = 5) ventricle exerted a significant inotropic response. Furthermore, no effect on isoprenaline-elicited arrhythmias was observed. Neither addition of isoprenaline (0.1 microM) nor addition of the nitric oxide donor S-nitroso-N-acetylpenicillamine (SNAP) (100 microM) affected myocardial contractility in the presence of sildenafil (10 microM). In precontracted arteries and veins, addition of sildenafil (0.1-10 microM) led to pronounced vasorelaxation (maximal 35.5 +/- 2.2% and 45.6 +/- 6.3%, respectively, in the presence of 10 microM sildenafil). In the presence of SNAP (0.03 microM), this effect was markedly increased in arteries (72.4 +/- 10.1%, n = 4, P < 0.02) as well as in veins (73.5 +/- 6.3%, n = 6, P < 0.02). Sildenafil exerts potent vasodilatory actions but has no direct influence on human myocardial contractility or proarrhythmic effects in vitro.
- Published
- 2003
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