80 results on '"Mulè, M"'
Search Results
2. Riociguat treatment in patients with chronic thromboembolic pulmonary hypertension: Final safety data from the EXPERT registry
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Ghofrani, H.-A. Gomez Sanchez, M.-A. Humbert, M. Pittrow, D. Simonneau, G. Gall, H. Grünig, E. Klose, H. Halank, M. Langleben, D. Snijder, R.J. Escribano Subias, P. Mielniczuk, L.M. Lange, T.J. Vachiéry, J.-L. Wirtz, H. Helmersen, D.S. Tsangaris, I. Barberá, J.A. Pepke-Zaba, J. Boonstra, A. Rosenkranz, S. Ulrich, S. Steringer-Mascherbauer, R. Delcroix, M. Jansa, P. Šimková, I. Giannakoulas, G. Klotsche, J. Williams, E. Meier, C. Hoeper, M.M. Caneva, J. Tuhay, G. Diez, M. Talavera, M.L. Acosta, A. Vulcano, N. Bosio, M. Maldonado, L. Deleo, S. Melatini, L. Keogh, A. Kotlyar, E. Feenstra, J. Dwyer, N. Adams, H. Stevens, W. Steele, P. Proudman, S. Minson, R. Reeves, G. Lavender, M. Ng, B. Mackenzie, M. Barry, L. Gruenberger, M. Huber, C. Lang, I. Tilea, I. Sadushi-Kolici, R. Löffler-Ragg, J. Feistmantl, L.-T. Evrard, P. Louis, R. Guiot, J. Naldi, M. De Pauw, M. Mehta, S. Camacho, R.C. Tovar, P.P. Londoño, A. Campo, F. Garcia, P. Lema, C. Orozco-Levi, M. Martinez, W. Gomez, J.E. Nielsen-Kudsk, J.E. Mellemkjaer, S. Anton, L. Altraja, A. Vihinen, T. Vasankari, T. Sitbon, O. Cottin, V. Têtu, L. Noël-Savina, E. Shearman, N. Tayler, S. Olzik, I. Kulka, C. Grimminger, J. Simon, M. Nolde, A. Oqueka, T. Harbaum, L. Egenlauf, B. Ewert, R. Schulz, C. Regotta, S. Kramer, T. Knoop-Busch, S. Gerhardt, F. Konstantinides, S. Pitsiou, G. Stanopoulos, I. Sourla, E. Mouratoglou, S. Karvounis, H. Pappas, A. Georgopoulos, D. Fanaridis, M. Mitrouska, I. Michalis, L. Pappas, K. Kotsia, A. Gaine, S. Vizza, C.D. Manzi, G. Poscia, R. Badagliacca, R. Agostoni, P. Bruno, N. Farina, S. D'Alto, M. Argiento, P. Correra, A. Di Marco, G.M. Cresci, C. Vannucchi, V. Torricelli, E. Garcea, A. Pesci, A. Sardella, L. Paciocco, G. Pane, F. D'Armini, A.M. Pin, M. Grazioli, V. Massola, G. Sciortino, A. Prediletto, R. Bauleo, C. Airò, E. Ndreu, R. Pavlickova, I. Lunardi, C. Mulè, M. Farruggio, S. Costa, S. Galgano, G. Petruzzi, M. De Luca, A. Lombardi, F. Roncon, L. Conte, L. Picariello, C. Wirtz, G. Alexandre, M. Vonk-Noordegraaf, A. Boogaard, H. Mager, J. Reesink, H. van den Toorn, L.M. Boomars, K. Andreassen, A.K. Castro, G. Tania, G. Baptista, R. Marinho, A. Shiang, T. Oliveira, A. Coutinho, D. Sousa, J. Loureiro, M.J. Repolho, D. Martins Jesus, S.M. Capinha, M. Agostinho, J. Cardoso, T. Rocha, A. Espinha, M. Ivanov, K.I. Alexeeva, D.E. Batalina, M.V. Hegya, D.V. Zvereva, T.N. Avdeev, S.N. Tsareva, N.A. Galyavich, A.S. Nikolaevich, B.A. Filippov, E.V. Yakovleva, O.E. Pavlova, O.B. Skripkina, E.S. Martynyuk, T.V. Bukatova, I.F. Tregubova, A.V. Platonov, D.Y. Kolomeytseva, T.M. Al Dalaan, A. Abdelsayed, A.A. Weheba, I. Saleemi, S. Sakkijha, H. Bohacekova, M. Valkovicova, T. Farkasova, I. Quezada, C.A. Piccari, L. Blanco, I. Sebastian, L. Roman, A. Lopez, M. Otero, R. Elias, T. Jara, L. Asencio, I. Arjona, J.J. Almagro, R.M. Cárdenas, S.L. García, S.A. Rodríguez, P.V. Lopez, R. Garcia, A. Avilés, F.F. De La Pava, S. Yotti, R. Peñate, G.P. Marrero, F.L. Cifrián Martínez, J.M. Martinez-Meñaca, A. Alonso, L.P. Rozas, S.F. Fernandez, D.I. Cuesta, V.M. Söderberg, S. Bartfay, S.-E. Rundqvist, B. Alfetlawi, M. Wodlin, P. Schwarz, E.I. Speich, R. Lador, F. Rochat, T. Gasche-Soccal, P. Hsu, C.-H. Lin, T.-H. Su, H.-M. Lai, W.-T. Chu, C.Y. Hsu, P.-C. Voon, W.-C. Yen, H.-W. Yih-Jer Wu, J. Wu, S.-H. Huang, W.-P. Fong, M.-C. Huang, C.-L. Kuo, P.-H. Lin, Y.-H. Lin, J.-L. Hung, C.-S. Wu, C.-K. Sung, S.-H. Huang, W.-C. Cheng, C.-C. Kuo, S.-H. Wang, W.-H. Ho, W.-J. Hsu, T.-S. Mutlu, B. Atas, H. Ongen, G. Un, Z. Okumus, G. Hanta, I. Corris, P. Peacock, A. Church, C. Toshner, M. Newnham, M. NEW COLLABORATORS LIST
- Abstract
Objective: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. Methods: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping riociguat treatment. Primary safety outcomes were adverse events (AEs) and serious adverse events (SAEs) coded using Medical Dictionary for Regulatory Activities preferred terms and System Organ Classes version 21.0, collected during routine clinic visits and collated via case report forms. Results: In total, 956 patients with CTEPH were included in the analysis. The most common AEs in these patients were peripheral edema/edema (11.7%), dizziness (7.5%), right ventricular (RV)/cardiac failure (7.7%), and pneumonia (5.0%). The most common SAEs were RV/cardiac failure (7.4%), pneumonia (4.1%), dyspnea (3.6%), and syncope (2.5%). Exposure-adjusted rates of hemoptysis/pulmonary hemorrhage and hypotension were low and comparable to those in the long-term extension study of riociguat (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase–Stimulator Trial [CHEST-2]). Conclusion: Data from EXPERT show that in patients with CTEPH, the safety of riociguat in routine practice was consistent with the known safety profile of the drug, and no new safety concerns were identified. © 2020 The Authors
- Published
- 2021
3. IMPROVING THE KNOWLEDGE, RISK STRATIFICATION AND OUTCOMES IN ADVANCED HEART FAILURE. THE ISMETT HEART FAILURE REGISTRY
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Nuzzi, V, Manca, P, Mulè, M, and Cipriani, M
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- 2024
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4. ROLE OF RIGHT VENTRICULAR MYOCARDIAL WORK IN THE STRATIFICATION OF PATIENTS AFFECTED BY ADVANCED HEART FAILURE
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Manca, P, Rugiano, G, Nuzzi, V, Mulè, M, Carvelli, A, Cannata, S, Fontana, A, and Cipriani, M
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- 2024
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5. Event review: European Patent System versus European Patent System
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Mulè, M., Rivas, V., and Berg Kaasin, J.
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- 2014
6. SAT0243 Reduction of Pulmonary Artery Pressure in Scleroderma Patients: The Role of Long-Term, Intensive IV Iloprost Treatment
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Foti, R., primary, Visalli, E., additional, Amato, G., additional, Benenati, A., additional, Converso, G., additional, Bellofiore, S., additional, Mulè, M., additional, and Di Gangi, M., additional
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- 2016
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7. Ruolo della Dialisi Peritoneale nel trattamento dei Pazienti con Scompenso Cardiaco Congestizio
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Rapisarda, Francesco, Sessa, C, Reina, A, Torrisi, I, Di Landro, A, Pruiti, P, Mulè, M, Tamburino, Corrado, and Fatuzzo, Pasquale Mario
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- 2012
8. Selection of patient for cardiac resynchronization therapy: role of QT corrected dispersion
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Timineri, S, Mulè, M, Puzzangara, E, Santangelo, G, Dugo, D, Schillaci, V, Di Grazia, A, Liotta, C, Scandura, S, Tempio, D, Tamburino, Corrado, and Calvi, Valeria Ilia
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congestive heart failure ,CRT - Published
- 2012
9. Percutaneous treatment of left side cardiac valves. Second Edition
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Tamburino, Corrado, Ussia, Gp, Capodanno, DAVIDE FRANCESCO MARIA, and Mulè, M.
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- 2012
10. Quality of life in elderly patients 1 year after transcatheter aortic valve implantation for severe aortic stenosis
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Ussia, Gp, Barbanti, M, Cammalleri, V, Scarabelli, M, Mulè, M, Aruta, P, Sarkar, K, Capodanno, DAVIDE FRANCESCO MARIA, Immè, S, Gulino, S, Pistritto, Am, and Tamburino, Corrado
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- 2011
11. Reduction of mitral valve regurgitation with Mitraclip® percutaneous system
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Corrado TAMBURINO, Immè, S., Barbanti, M., Mulè, M., Pistritto, A. M., Aruta, P., Cammalleri, V., Scarabelli, M., Mangiafico, S., Scandura, S., and Ussia, G. P.
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Heart Valve Prosthesis Implantation ,Cardiac Surgical Procedures ,Humans ,Mitral Valve Insufficiency ,Surgical Instruments ,Settore MED/11 - Malattie dell'Apparato Cardiovascolare - Abstract
Mitral regurgitation (MR) is the second most common heart valve disease worldwide and the current gold-standard treatment is surgical repair or replacement. Nevertheless, many patients do not undergo surgical intervention due to several comorbidities. Percutaneous "edge-to-edge" mitral valve repair using the MitraClip System is an emerging and effective option to this subset of patients. This device has been used to treat both functional and degenerative mitral valve regurgitation and has been compared to surgery in the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) randomized trial. Although the field of percutaneous management of MR is at an early stage, it has been demonstrated that percutaneous approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.
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- 2010
12. Percutaneous treatment of associated aortic stenosis and mitral regurgitation: first human case report
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Barbanti, M, Ussia, Gp, Scandura, S, Mangiafico, M, Mulè, M, Cammalleri, V, Immè, S, Scarabelli, M, Aruta, A, Pistritto, Am, Capodanno, DAVIDE FRANCESCO MARIA, and Tamburino, Corrado
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- 2010
13. Outcomes of 'low risk' patients undergoing transcatheter aortic valve implantation: is it time to expand the indications?
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Barbanti, M, Ussia, Gp, Capodanno, DAVIDE FRANCESCO MARIA, Mulè, M, Scarabelli, M, Cammalleri, V, Immè, S, Aruta, P, Pistritto, Am, DI PASQUA MC, and Tamburino, Corrado
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- 2010
14. Two-year follow up of transcatheter aortic valve implantation: a single center experience
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Scarabelli, M, Ussia, Gp, Barbanti, M, Mulè, M, Cammalleri, V, Immè, S, Aruta, P, Pistritto, Am, Capodanno, DAVIDE FRANCESCO MARIA, Deste, W, Sanfilippo, A, and Tamburino, Corrado
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- 2010
15. Incidence and management of early device failure after transcatheter aortic valve implantation
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Ussia, Gp, Barbanti, M, Capodanno, DAVIDE FRANCESCO MARIA, Scarabelli, M, Cammalleri, V, Mulè, M, Immè, Aruta, P, Pistritto, Am, and Tamburino, Corrado
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- 2010
16. Management and outcomes of early implant failure during TAVI
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Barbanti, M, Ussia, Gp, Cammalleri, V, Mulè, M, Scarabelli, M, Immè, S, Aruta, P, Pistritto, Am, DI PASQUA MC, Capodanno, DAVIDE FRANCESCO MARIA, and Tamburino, Corrado
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- 2010
17. Quality of life and NYHA class after percutaneous aortic valve replacement for aortic stenosis
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Ussia, Gp, Mulè, M, Barbanti, M, Scarabelli, M, Cammalleri, V, Immè, S, Capodanno, DAVIDE FRANCESCO MARIA, and Tamburino, Corrado
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- 2009
18. Transcatheter aortic valve implantation with the third generation of Corevalve aortic valve prosthesis: institutional experience
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Ussia, Gp, Barbanti, M, Scarabelli, M, Cammalleri, V, Immè, S, Marchese, A, Tagliareni, F, Mulè, M, Aruta, P, Capodanno, DAVIDE FRANCESCO MARIA, and Tamburino, Corrado
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- 2009
19. Twelve-month improvement in quality of life and NYHA class after transcatheter aortic valve implantation for severe aortic stenosis
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Ussia, Gp, Barbanti, M, Capodanno, DAVIDE FRANCESCO MARIA, Mulè, M, Scarabelli, M, Cammalleri, V, Immè, S, Aruta, P, Pistritto, A, and Tamburino, Corrado
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- 2009
20. Single center experience in percutaneous aortic valve implantation using self-expandable prosthesis
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Ussia, Gp, Cammalleri, V, Barbanti, M, Scarabelli, M, Immè, S, Mulè, M, Pistritto, A, Tagliareni, F, Capodanno, DAVIDE FRANCESCO MARIA, and Tamburino, Corrado
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- 2009
21. Procedural Success And 30-Day Clinical Outcome After Percutaneous Aortic Valve Replacement Using Current Third Generation Self-Expanding CoreValve Prosthesis
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Tamburino, Corrado, Capodanno, DAVIDE FRANCESCO MARIA, Mulè, M, Scarabelli, M, Cammalleri, V, Barbanti, M, Calafiore, Am, and Ussia, Gp
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- 2009
22. Balloon aortic valvuloplasty as a bridge to transcatheter aortic valve implantation in hemodynamically unstable patients: institutional experience
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Ussia, Gp, Barbanti, M, Capodanno, DAVIDE FRANCESCO MARIA, Cammalleri, V, Scarabelli, M, Immè, S, Marchese, A, Mulè, M, Pristritto, Am, and Tamburino, Corrado
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- 2009
23. Percutaneous closure of patent foramen ovale with a bioabsorbable occluder device: single-center experience
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Ussia, Gp, Cammalleri, V, Mulè, M, Scarabelli, Barbanti, M, Scardaci, F, Mangiafico, S, Immè, S, Capodanno, C, and Tamburino, Corrado
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- 2009
24. Role of aortic baloon valvuloplasty as a bridge for transcatheter aortic valve implantation
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Ussia, Gp, Capodanno, DAVIDE FRANCESCO MARIA, Barbanti, M, Mulè, M, Cammalleri, V, Scarabelli, M, Immè, S, Pistritto, A, Aruta, P, and Tamburino, Corrado
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- 2009
25. Mode of Death in Patients with Pulmonary Arterial Hypertension
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Vizza, C.D., primary, Pezzuto, B., additional, Badagliacca, R., additional, Poscia, R., additional, Mezzapesa, M., additional, Nocioni, M., additional, D’Alto, M., additional, Ghio, S., additional, Vitulo, P., additional, Mulè, M., additional, Albera, C., additional, and Fedele, F., additional
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- 2013
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26. Nitric oxide test during cardiac catheterization decreases the serum concentrations of S100B protein in adult patients with idiopathic pulmonary hypertension
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Ussia, G. P., primary, Tina, L. G., additional, Scarabelli, M., additional, Nigro, F., additional, Li Volti, G., additional, Cavallaro, D., additional, Salvo, V., additional, Mulè, M., additional, Caruso, E., additional, Tamburino, C., additional, and Gazzolo, D., additional
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- 2007
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27. Exercise stress echocardiography of the pulmonary circulation: limits of normal and sex differences.
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Argiento P, Vanderpool RR, Mulè M, Russo MG, D'Alto M, Bossone E, Chesler NC, Naeije R, Argiento, Paola, Vanderpool, Rebecca R, Mulè, Massimiliano, Russo, Maria Giovanna, D'Alto, Michele, Bossone, Eduardo, Chesler, Naomi C, and Naeije, Robert
- Abstract
Background: Exercise stress echocardiography has not been recommended in the diagnostic workup of pulmonary hypertension because of insufficient certainty about feasibility and limits of normal.Methods: Doppler echocardiography pulmonary hemodynamic measurements were performed at a progressively increased workload in 56 healthy male and 57 healthy female volunteers aged 19 to 63 years. Mean pulmonary artery pressure (mPAP) was estimated from the maximal tricuspid regurgitation jet velocity. Cardiac index was calculated from the left ventricular outflow velocity-time integral. Pulmonary vascular distensibility a index, the percentage change of vessel diameter permm Hg of mPAP, was calculated from multipoint mPAP-cardiac output (CO) plots.Results: Peak exercise at 175 ±50 W was associated with an mPAP of 33±7 mm Hg and a CO of 18 ±5 L/min. The slope of mPAP-CO relationships was 1.5 ± 0.5 mm Hg/L/min, and the distensibility coefficient ( α ) was 1.3%± 1.0%/mm Hg. Maximal workload and cardiac index were higher in men than in women ( P , .05), but mPAP-cardiac index relationships were not different. However,women had a higher a (1.6%± 1.3%/mm Hg vs 1.1%± 0.6%/mm Hg, P < .05). The average mPAP-cardiac index slope was higher and a lower in subjects ≥50 years old. Upper limits of normal of mPAP at exercise were 34 mm Hg at a CO , 10 L/min, 45 mm Hg at a CO <20 L/min, and 52 mm Hg at a CO<30 L/min. These values are in keeping with previously reported invasive measurements.Conclusions: Exercise stress echocardiography of the pulmonary circulation is feasible and allows for fl ow-corrected definition of upper limits of normal. Women have a more distensible pulmonary circulation. [ABSTRACT FROM AUTHOR]- Published
- 2012
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28. Exercise pathophysiology in patients with chronic mountain sickness exercise in chronic mountain sickness.
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Groepenhoff H, Overbeek MJ, Mulè M, van der Plas M, Argiento P, Villafuerte FC, Beloka S, Faoro V, Macarlupu JL, Guenard H, de Bisschop C, Martinot JB, Vanderpool R, Penaloza D, Naeije R, Groepenhoff, Herman, Overbeek, Marieke J, Mulè, Massimiliano, van der Plas, Mart, and Argiento, Paola
- Abstract
Background: Chronic mountain sickness (CMS) is characterized by a combination of excessive erythrocytosis,severe hypoxemia, and pulmonary hypertension, all of which affect exercise capacity.Methods: Thirteen patients with CMS and 15 healthy highlander and 15 newcomer lowlander control subjects were investigated at an altitude of 4,350 m (Cerro de Pasco, Peru). All of them underwent measurements of diffusing capacity of lung for nitric oxide and carbon monoxide at rest, echocardiography for estimation of mean pulmonary arterial pressure and cardiac output at rest and at exercise, and an incremental cycle ergometer cardiopulmonary exercise test.Results: The patients with CMS, the healthy highlanders, and the newcomer lowlanders reached a similar maximal oxygen uptake at 32 1, 32 2, and 33 2 mL/min/kg, respectively, mean SE( P 5 .8), with ventilatory equivalents for C O 2 vs end-tidal P CO 2 , measured at the anaerobic threshold,of 0.9 0.1, 1.2 0.1, and 1.4 0.1 mm Hg, respectively ( P , .001); arterial oxygen content of 26 1, 21 2, and 16 1 mL/dL, respectively ( P , .001); diffusing capacity for carbon monoxide corrected for alveolar volume of 155% 4%, 150% 5%, and 120% 3% predicted, respectively( P , .001), with diffusing capacity for nitric oxide and carbon monoxide ratios of 4.7 0.1 at sea level decreased to 3.6 0.1, 3.7 0.1, and 3.9 0.1, respectively ( P , .05) and a maximal exercise mean pulmonary arterial pressure at 56 4, 42 3, and 31 2 mm Hg, respectively ( P , .001).Conclusions: The aerobic exercise capacity of patients with CMS is preserved in spite of severe pulmonary hypertension and relative hypoventilation, probably by a combination of increased oxygen carrying capacity of the blood and lung diffusion, the latter being predominantly due to an increased capillary blood volume. [ABSTRACT FROM AUTHOR]- Published
- 2012
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29. Short term prognostic role of NT-proBNP in patients after myocardial infarction
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Giuseppe Coppola, Corrado, E., Augugliaro, S., Mulè, M. C., Rotolo, A., Ciaramitaro, G., Farinella, M., Evola, G., Novo, G., Evola, S., Andolina, G., Caruso, M., Cospite, V., Vitale, F., Hoffmann, E., Assennato, P., Novo, S., coppola, g, corrado, e, augugliaro, mulè, mc, rotolo, a, ciaramitaro, g, farinella, m, evola, g, novo, g, evola, andolina, g, caruso, m, cospite, v, vitale, f, hoffmann, e, assennato, p, novo, s, Coppola, G, Corrado, E, Augugliaro, S, Mulè, MC, Rotolo, A, Ciaramitaro, G, Farinella, M, Evola, G, Novo, G, Evola, S, Andolina, G, Caruso, M, Cospite, V, Vitale, F, Hoffmann, E, Assennato, P, and Novo, S
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Male ,Time Factors ,Myocardial Infarction ,Middle Aged ,Prognosis ,Settore MED/11 - Malattie Dell'Apparato Cardiovascolare ,NT-proBNP, myocardial infarction ,Peptide Fragments ,Logistic Models ,Predictive Value of Tests ,Risk Factors ,NT-proBNP ,Natriuretic Peptide, Brain ,Humans ,Female ,Biomarkers ,Aged ,Follow-Up Studies ,Retrospective Studies - Abstract
Aim. The clinical and prognostic role of cardiac natriuretic peptides (CNP) in patients with heart failure is well known; recently, several studies have evaluated the possibility of using CNP to evaluate their potential prognostic role in patients with acute coronary syndromes (ACS). The aim of this study was to evaluate the short term prognostic value of NT-proBNP in 70 patients admitted for ACS. Methods. The authors studied 70 patients with ACS, evaluating, at admission, clinical-anamnestic, instrumental and laboratory characteristics including NT-proBNP plasma levels. Patients were monitored in a 6-month-follow-up to record adverse fatal events and their possible correlation with baseline characteristics. Results. The incidence of adverse events during the follow-up period was 28% (10 patients). In patients with adverse events, the authors observed lower left ventricle ejection fraction (P=0.01), higher prevalence of ST elevation myocardial infarction (P=0.03) and higher NT-proBNP levels (P=0.03), compared to those without adverse events. Moreover, the logistic regression analysis underlined how ST elevation myocardial infarction (P=0.05) and higher NT-proBNP levels (P=0.05) were the only predictive variables for adverse events during the follow up period. Conclusion. This study demonstrates the short term prognostic role of NT-pro BNP in patients admitted for ACS
30. Dual antiplatelet therapy versus aspirin alone in patients undergoing transcatheter aortic valve implantation.
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Ussia GP, Scarabelli M, Mulè M, Barbanti M, Sarkar K, Cammalleri V, Immè S, Aruta P, Pistritto AM, Gulino S, Deste W, Capodanno D, and Tamburino C
- Published
- 2011
31. Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis.
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Tamburino C, Barbanti M, Capodanno D, Mignosa C, Gentile M, Aruta P, Pistritto AM, Bonanno C, Bonura S, Cadoni A, Gulino S, Di Pasqua MC, Cammalleri V, Scarabelli M, Mulè M, Immè S, Del Campo G, and Ussia GP
- Published
- 2012
32. Marine organisms as source of bioactive molecules applied in restoration projects
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G. Barresi, Matteo Cammarata, Maria Rosa Trapani, Maria Giovanna Parisi, Maria Francesca Mule, Franco Palla, Enza Di Carlo, Chiara Chille, Palla, F, Di Carlo, E, Barresi,G, Trapani,MR, Parisi,MG, Chillè,C, Mulè,MF, Cammarata,M, Barresi, G., Di Carlo, E., Trapani, M., Parisi, M., Chillè, C., Mulè, M., Cammarata, M., and Palla, F.
- Subjects
Archeology ,Biocide ,Protease ,Marine invertebrate, Biocleaning, Protein layer, Protease, Antimicrobial peptides, Biodegradation control ,biology ,medicine.medical_treatment ,Micrococcus ,Bioactive molecules ,Conservation ,Bacterial growth ,Aspergillus sojae ,biology.organism_classification ,Antimicrobial ,Minimum inhibitory concentration ,Marine organism ,Penicillium ,Settore BIO/03 - Botanica Ambientale E Applicata ,medicine ,Food science - Abstract
In recent decades research in the conservation and restoration field has provided sustainable alternatives to traditional procedures for cleaning or controlling the microbial colonization of works of art. In the present study, for the first time novel bioactive molecules extracted from marine invertebrate organisms (Anthozoa) were tested instead of chemical compounds for removing protein layers or as a biocide for controlling fungal or bacterial colonization. In particular, Bioactive Molecules with Protease activity (BMP), acting in a temperature range of 4- 30°C, were tested for the hydrolysis of protein layers on laboratory specimens. The cleaning protocol provides a selective procedure to avoid damage to the original materials constituting the heritage object. Concurrently, enzymatic cleaning was also performed using commercial Protease from Aspergillus sojae (Type XIX), in order to compare their hydrolytic activities. Bioactive Molecules with Antimicrobial activity (BMA1, BMA2) were tested to control bacterial (Bacillus, Micrococcus) or fungal (Aspergillus, Penicillium) growth, previously isolated from colonized canvas samples and characterized by an integrated approach based on in vitro culture, microscopy and molecular investigations. These molecules were tested to define the Minimal Inhibitory Concentration (MIC) and Minimal Bactericidal/ Fungicidal Concentration (MBC/MFC). Specifically, BMAs were used to control fungal growth during the relining of the painting (laboratory specimens), carried out using a canvas support, and glue paste as binder. In our hypothesis, these molecules provide an important contribution to the development of innovative protocols for biocleaning or microbial growth control, based on fast and easy application, operator friendly and environmentally sustainable molecules.
- Published
- 2015
33. SGLT2 inhibitor therapy in patients with advanced heart failure and reduced ejection fraction.
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Nuzzi V, Manca P, Parisi F, Madaudo C, Sciacca S, Cannizzo N, Mulè M, and Cipriani MG
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- Humans, Female, Male, Middle Aged, Treatment Outcome, Aged, Biomarkers blood, Follow-Up Studies, Heart Failure drug therapy, Heart Failure physiopathology, Sodium-Glucose Transporter 2 Inhibitors therapeutic use, Stroke Volume physiology, Natriuretic Peptide, Brain blood, Peptide Fragments blood, Glomerular Filtration Rate
- Abstract
Aims: Sodium-glucose cotransporter inhibitors (SGLT2-i) improve outcomes in patients with heart failure (HF) and reduced ejection fraction (HFrEF). However, evidence in patients with advanced HF is lacking. We aimed to determine the effect of SGLT2-i in advanced HFrEF compared to their effect on a non-advanced population., Methods: Consecutive HFrEF outpatients who started SGLT2-i were observed for 6-months. Patients were categorized as having advanced or non-advanced HFrEF. The primary outcome was the trend of NTproBNP in the two groups. Secondary outcomes included changes in New York Heart Association (NYHA) class, glomerular filtration rate (GFR), and ejection fraction (LVEF). The association between advanced HF diagnosis and including N-terminal pro-brain natriuretic peptide (NTproBNP) reduction was tested using multivariate analysis., Results: Overall, 105 patients (45 advanced, 60 non-advanced) were included. Mean age was 56 ± 10 years, 22 % were female, and 35 % had ischemic heart disease. Median NTproBNP at baseline for advanced and non-advanced patients was 1672pg/ml (IQR 520-3320) vs. 481 pg/ml (IQR 173-917), respectively (p < 0.001). At follow-up, only non-advanced patients reduced their NTproBNP (-32 % (95 % CI -51 to -3), p < 0.001), while advanced patients had an increase in NTproBNP. LVEF and NYHA class improved only in non-advanced patients. GFR was stable in both subgroups. At multivariate analysis a diagnosis of advanced HF was independently associated with a reduced probability of NTproBNP reduction (OR 0.041 (95 % CI 0.002-0.752), p = 0.031). Only one patient discontinued the drug due to side effects., Conclusion: In advanced HFrEF, SGLT2-i do not impact on NTproBNP, LVEF or NYHA class but are well tolerated., Competing Interests: Declaration of competing interest The authors have not any conflict of interest to declare, (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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34. Right ventricular phenotyping in incident patients with idiopathic pulmonary arterial hypertension.
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Ghio S, Badagliacca R, D'Alto M, Scelsi L, Argiento P, Brunetti ND, Casu G, Cedrone N, Confalonieri M, Corda M, Correale M, D'Agostino C, De Tommasi E, Filomena D, Galgano G, Greco A, Grimaldi M, Lombardi C, Madonna R, Manzi G, Mercurio V, Mihai A, Mulè M, Paciocco G, Papa S, Recchioni T, Romaniello A, Romeo E, Stolfo D, Vitulo P, Benza RL, and Vizza CD
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- Humans, Male, Female, Middle Aged, Adult, Echocardiography, Retrospective Studies, Ventricular Function, Right physiology, Incidence, Ventricular Remodeling physiology, Cardiac Catheterization, Prognosis, Ventricular Dysfunction, Right physiopathology, Ventricular Dysfunction, Right diagnosis, Ventricular Dysfunction, Right diagnostic imaging, Risk Assessment methods, Follow-Up Studies, Phenotype, Heart Ventricles diagnostic imaging, Heart Ventricles physiopathology, Familial Primary Pulmonary Hypertension physiopathology, Familial Primary Pulmonary Hypertension diagnosis
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Background: Right ventricular (RV) imaging has not a definite role in risk stratification of pulmonary arterial hypertension (PAH) patients. We tested the hypothesis that echocardiography-derived phenotypes, depicting different degrees of RV remodeling and dysfunction, may provide additional prognostic information to current risk stratification tools., Methods: Consecutive incident PAH patients aged ≥18 years, diagnosed between January 2005 and December 2021, underwent clinical assessment, right heart catheterization, standard echocardiography. Simple echocardiographic variables were combined in order to define a priori four phenotypes representing different degrees of RV dilatation and RV-pulmonary arterial (PA) coupling: Phenotype 1 with mildy dilated right ventricle and preserved RV-PA coupling (n = 152 patients); phenotype 2 with mildly dilated right ventricle and poor RV-PA coupling (n = 143 patients); phenotype 3 with severely dilated right ventricle and preserved RV-PA coupling (n = 201 patients); phenotype 4 with severely dilated right ventricle and poor RV-PA coupling, with or without severe tricuspid regurgitation (n = 519 patients). Risk stratification was based on the European Society of Cardiology/European Respiratory Society (ESC/ERS) 3-strata model and Registry to Evaluate Early and Long-Term PAH disease Management (REVEAL) 2.0 score., Results: These phenotypes were present in all risk groups. Notably, regardless of the ESC/ERS risk stratum assigned to the patient, phenotype 4 was associated with a 2-fold increase of the odds of death (HR 2.1, 95% CI 1.6-2.8, p < 0.001), while phenotype 1 was associated with a 71% reduction in the odds of dying (HR 0.29, 95% CI 0.18-0.47, p < 0.001)., Conclusions: Echocardiography-derived phenotypes describing RV remodeling and dysfunction may provide prognostic information which is independent of and additional to the clinically defined risk in incident PAH patients., (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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35. Gaps in evidence in the management of patients with intermediate-risk pulmonary arterial hypertension: Considerations following the ESC/ERS 2022 guidelines.
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D'Alto M, Badagliacca R, Airò E, Ameri P, Argiento P, Garascia A, Lombardi CM, Mulè M, Raineri C, Scelsi L, Vizza CD, and Ghio S
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- Humans, Risk Factors, Risk Assessment, Female, Male, Predictive Value of Tests, Evidence-Based Medicine standards, Treatment Outcome, Middle Aged, Clinical Decision-Making, Pulmonary Artery physiopathology, Arterial Pressure drug effects, Decision Support Techniques, Practice Guidelines as Topic, Antihypertensive Agents therapeutic use, Pulmonary Arterial Hypertension diagnosis, Pulmonary Arterial Hypertension physiopathology, Pulmonary Arterial Hypertension therapy, Pulmonary Arterial Hypertension epidemiology
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A comprehensive evaluation of risk, using multiple indices, is necessary to provide reliable prognostic information and guide therapy in pulmonary arterial hypertension (PAH). The current ESC/ERS guidelines suggest using a three-strata model for incident (newly diagnosed) patients and a four-strata model for prevalent patients with PAH. The four-strata model serves as a fundamental risk-stratification tool and relies on a minimal dataset of indicators that must be considered during follow-up. Nevertheless, there are still areas of vagueness and ambiguity when classifying and managing patients in the intermediate-risk category. For these patients, considerations should include right heart imaging, hemodynamics, as well as individual factors such as age, sex, genetic profile, disease type, comorbidities, and kidney function. The aim of this report is to present case studies, with a specific focus on patients ultimately classified as intermediate risk. We aim to emphasize the challenges and complexities encountered in the realms of diagnosis, classification, and treatment for these particular patients., Competing Interests: Declaration of competing interest MD reports participation on a monitoring board or travel fee for Janssen, MSD, Dompè, AOP and Ferrer, outside the submitted work. SG reports personal fees from MSD and Ferrer, outside the submitted work. PA received speaker, advisory board and consultancy fees from Boehringer Ingelheim, Astra Zeneca, Bayer, Novartis, Janssen, MSD, and Gossamer Bio, and speaker and advisor fees and travel support from Daiichi Sankyo., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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36. Relevance of comorbidities on initial combination therapy in pulmonary arterial hypertension.
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Badagliacca R, D'Alto M, Ghio S, Argiento P, Brunetti ND, Casu G, Cedrone N, Confalonieri M, Corda M, Correale M, D'Agostino C, De Michele L, Di Marino S, Filomena D, Galgano G, Greco A, Lombardi C, Manzi G, Mercurio V, Mulè M, Paciocco G, Papa S, Romeo E, Scelsi L, Stolfo D, Vitulo P, and Vizza CD
- Abstract
Rationale: Demographic characteristics of pulmonary arterial hypertension (PAH) patients have changed over time, but the effects of cardiovascular risk factors on risk status and pulmonary vascular resistance (PVR) reduction with initial oral combination therapy are not known. Therefore, we tested the relevance of cardiovascular comorbidities in this setting., Methods: The study enrolled 181 treatment-naive PAH patients with a 6-month (IQR 144-363 days) right heart catheterisation and risk assessment after initial oral combination therapy., Results: Group A included 96 (53.0%) patients without cardiac comorbidities; Group B included 54 (29.8%) patients with one cardiac comorbidity; Group C included 31 (17.1%) patients with two cardiac comorbidities or more. Group C patients were older with a balanced sex distribution. There was a significant difference in PVR reduction moving from the absence to one or at least two cardiac comorbidities, respectively: median -45.0%, -30.3%, -24.3%. A European Respiratory Society/European Society of Cardiology low-risk status was present at first follow-up in 50 (52.0%) patients in Group A, 19 (35.1%) in Group B and 9 (29.0%) in Group C; a REVEAL 2.0 low-risk status was present at first follow-up in 41 (42.0%) patients in Group A, 15 (27.7%) in Group B and 7 (22.6%) in Group C. Group A patients were 2.3 times more likely to achieve/maintain a low-risk status compared with Group B and C (OR 2.27, 95% CI 1.15-4.54, p=0.02). No significant difference was observed between patients with non-cardiac comorbidities and those without comorbidities., Conclusion: Initial oral combination therapy seems associated with a less effective response for patients with cardiovascular comorbidities compared with the others, related to the magnitude of treatment-induced decrease in PVR., Competing Interests: Conflict of interest: R. Badagliacca reports personal fees from UT, Dompè, Ferrer, Bayer, MSD and AOP Orphan Pharmaceuticals, outside the submitted work. M. D'Alto reports personal fees from Bayer, Dompè, GSK, MSD and Ferrer, outside the submitted work. C.D. Vizza reports personal fees from GSK, UT, Dompè, Bayer and MSD, outside the submitted work. The other authors have nothing to disclose., (Copyright ©The authors 2022.)
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- 2022
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37. The paradox of pulmonary arterial hypertension in Italy in the COVID-19 era: is risk of disease progression around the corner?
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Badagliacca R, Papa S, D'Alto M, Ghio S, Agostoni P, Ameri P, Argiento P, Brunetti ND, Casamassima V, Casu G, Cedrone N, Confalonieri M, Corda M, Correale M, D'Agostino C, De Michele L, Famoso G, Galgano G, Greco A, Lombardi CM, Manzi G, Madonna R, Mercurio V, Mulè M, Paciocco G, Romaniello A, Romeo E, Scelsi L, Serra W, Stolfo D, Toma M, Vatrano M, Vitulo P, and Vizza CD
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- Disease Progression, Familial Primary Pulmonary Hypertension, Humans, Natriuretic Peptide, Brain, SARS-CoV-2, COVID-19, Pulmonary Arterial Hypertension epidemiology
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Objective: The coronavirus disease 2019 (COVID-19) outbreak has led to significant restrictions on routine medical care. We conducted a multicentre nationwide survey of patients with pulmonary arterial hypertension (PAH) to determine the consequences of governance measures on PAH management and risk of poor outcome in patients with COVID-19., Materials and Methods: The present study, which included 25 Italian centres, considered demographic data, the number of in-person visits, 6-min walk and echocardiographic test results, brain natriuretic peptide/N-terminal pro-brain natriuretic peptide test results, World Health Organization functional class assessment, presence of elective and non-elective hospitalisation, need for treatment escalation/initiation, newly diagnosed PAH, incidence of COVID-19 and mortality rates. Data were collected, double-checked and tracked by institutional records between March 1 and May 1, 2020, to coincide with the first peak of COVID-19 and compared with the same time period in 2019., Results: Among 1922 PAH patients, the incidences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and COVID-19 were 1.0% and 0.46%, respectively, with the latter comparable to that in the overall Italian population (0.34%) but associated with 100% mortality. Less systematic activities were converted into more effective remote interfacing between clinicians and PAH patients, resulting in lower rates of hospitalisation (1.2% versus 1.9%) and related death (0.3% versus 0.5%) compared with 2019 (p<0.001). A high level of attention is needed to avoid the potential risk of disease progression related to less aggressive escalation of treatment and the reduction in new PAH diagnoses compared with 2019., Conclusion: A cohesive partnership between healthcare providers and regional public health officials is needed to prioritise PAH patients for remote monitoring by dedicated tools., Competing Interests: Conflict of Interest: All authors have nothing to disclose., (Copyright ©The authors 2022.)
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- 2022
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38. Risk Reduction and Hemodynamics with Initial Combination Therapy in Pulmonary Arterial Hypertension.
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Badagliacca R, D'Alto M, Ghio S, Argiento P, Bellomo V, Brunetti ND, Casu G, Confalonieri M, Corda M, Correale M, D'Agostino C, De Michele L, Galgano G, Greco A, Lombardi C, Manzi G, Mercurio V, Mulè M, Paciocco G, Papa S, Romeo E, Scelsi L, Stolfo D, Vitulo P, Naeije R, and Vizza CD
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- Administration, Oral, Aged, Aged, 80 and over, Drug Combinations, Endothelin Receptor Antagonists administration & dosage, Female, Humans, Male, Middle Aged, Phosphodiesterase 5 Inhibitors administration & dosage, Risk Reduction Behavior, Treatment Outcome, Antihypertensive Agents therapeutic use, Endothelin Receptor Antagonists therapeutic use, Hemodynamics drug effects, Phosphodiesterase 5 Inhibitors therapeutic use, Pulmonary Arterial Hypertension diagnosis, Pulmonary Arterial Hypertension drug therapy, Vascular Resistance drug effects
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Rationale: An initial oral combination of drugs is being recommended in pulmonary arterial hypertension (PAH), but the effects of this approach on risk reduction and pulmonary vascular resistance (PVR) are not known. Objectives: To test the hypothesis that a low-risk status would be determined by the reduction of PVR in patients with PAH treated upfront with a combination of oral drugs. Methods: The study enrolled 181 treatment-naive patients with PAH (81% idiopathic) with a follow-up right heart catheterization at 6 months (interquartile range, 144-363 d) after the initial combination of endothelin receptor antagonist + phosphodiesterase-5 inhibitor drugs and clinical evaluation and risk assessments by European guidelines and Registry to Evaluate Early and Long-Term PAH Disease Management scores. Measurements and Main Results: Initial combination therapy improved functional class and 6-minute-walk distance and decreased PVR by an average of 35% (median, 40%). One-third of the patients had a decrease in PVR <25%. This poor hemodynamic response was independently predicted by age, male sex, pulmonary artery pressure and cardiac index, and at echocardiography, a right/left ventricular surface area ratio of greater than 1 associated with low tricuspid annular plane systolic excursion of less than 18 mm. A low-risk status at 6 months was achieved or maintained in only 34.8% (Registry to Evaluate Early and Long-Term PAH Disease Management score) to 43.1% (European score) of the patients. Adding criteria of poor hemodynamic response improved prediction of a low-risk status. Conclusions: A majority of patients with PAH still insufficiently improved after 6 months of initial combinations of oral drugs is identifiable at initial evaluation by hemodynamic response criteria added to risk scores.
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- 2021
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39. Influence of various therapeutic strategies on right ventricular morphology, function and hemodynamics in pulmonary arterial hypertension.
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Badagliacca R, Raina A, Ghio S, D'Alto M, Confalonieri M, Correale M, Corda M, Paciocco G, Lombardi C, Mulè M, Poscia R, Scelsi L, Argiento P, Sciomer S, Benza RL, and Vizza CD
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- Drug Therapy, Combination, Familial Primary Pulmonary Hypertension physiopathology, Female, Heart Ventricles pathology, Hemodynamics, Humans, Male, Middle Aged, Retrospective Studies, Echocardiography, Familial Primary Pulmonary Hypertension drug therapy, Heart Ventricles diagnostic imaging, Heart Ventricles physiopathology
- Abstract
Background: In idiopathic pulmonary arterial hypertension (IPAH) treatment goals include improving right ventricular (RV) function, hemodynamics and symptoms to move patients to a low-risk category for adverse clinical outcomes. No data are available on the effect of upfront combination therapy on RV improvement as compared with monotherapy. The aim of this study was to evaluate echocardiographic RV morphology and function in patients affected by IPAH and treated with different strategies., Methods: Sixty-nine consecutive, treatment-naive IPAH patients treated with first-line upfront combination therapy at 10 centers were retrospectively evaluated and compared with 2 matched cohorts treated with monotherapy after short-term follow-up. Evaluation included clinical, hemodynamic and echocardiographic parameters., Results: At 155 ± 65 days after baseline evaluation, patients in the oral+prostanoid group (Group 1) had the most clinical and hemodynamic improvement compared with the double oral group (Group 2), the oral monotherapy group (Group 3) and the prostanoid monotherapy group (Group 4). The more extensive reduction of pulmonary vascular resistance in Groups 1, 2 and 4 was associated with significant improvement in all RV echocardiographic parameters compared with Group 3. Considering the number of patients who reached the target goals suggested by established guidelines, 8 of 27 (29.6%) and 7 of 42 (16.7%) patients in Groups 1 and 2, respectively, achieved low-risk status, as compared with 2 of 69 (2.8%) and 6 of 27 (22.2%) in Groups 3 and 4, respectively., Conclusions: In advanced treatment-naive IPAH patients, an upfront combination therapy strategy seems to significantly improve hemodynamics and RV morphology and function compared with oral monotherapy. The most significant results seem to be achieved with prostanoids plus oral drug, whereas the use of the double oral combination and prostanoids as monotherapy seem to produce similar results., (Copyright © 2018 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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40. Prognostic relevance of pulmonary arterial compliance after therapy initiation or escalation in patients with pulmonary arterial hypertension.
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Ghio S, D'Alto M, Badagliacca R, Vitulo P, Argiento P, Mulè M, Tuzzolino F, Scelsi L, Romeo E, Raineri C, Martino L, Tamburino C, Poscia R, and Vizza CD
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- Aged, Cardiac Catheterization, Cohort Studies, Female, Humans, Hypertension, Pulmonary diagnosis, Male, Middle Aged, Prognosis, ROC Curve, Vascular Resistance physiology, Hypertension, Pulmonary physiopathology, Hypertension, Pulmonary therapy, Pulmonary Artery physiopathology
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Background: Conventional hemodynamic parameters are considered to be the gold standard indices of outcome in pulmonary arterial hypertension (PAH); on the contrary, few data support the hypothesis that the pulsatile component of right ventricular afterload provides important prognostic information. The aim of the study was to investigate the prognostic significance of pulmonary arterial compliance (PCa) after therapy initiation or escalation in PAH patients., Methods: A cohort of 419 consecutive PAH patients (308 naive and 111 prevalent) underwent right heart catheterisation (RHC) prior to initiating or escalating PAH-targeted therapy. RHC was repeated in 255 patients (61%) after 4 to 12months of therapy as 62 patients (15%) died and 102 (24%) did not undergo a follow-up RHC within the first year., Results: After the follow-up RHC, 63 patients died over a median follow-up period of 39months. At multivariate analysis, age>50years old, male gender, etiology associated with systemic sclerosis, persistence of WHO class III/IV, and reduced PCa at follow-up RHC were the independent parameters significantly associated with poor prognosis. At ROC analysis, the optimal cut-off point of PCa to predict survival was 1.4mL/mmHg (AUC 0.73, sensitivity 81.8%, specificity 58.8%)., Conclusions: In PAH patients hospitalized to initiate or to escalate PAH-specific therapy, failure to improve PCa after therapy is a strong hemodynamic predictor of poor prognosis., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)
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- 2017
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41. Long-term clinical stabilization of scleroderma patients treated with a chronic and intensive IV iloprost regimen.
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Foti R, Visalli E, Amato G, Benenati A, Converso G, Farina A, Bellofiore S, Mulè M, and Di Gangi M
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- Adult, Aged, Disease Progression, Female, Humans, Iloprost administration & dosage, Infusions, Intravenous, Middle Aged, Raynaud Disease etiology, Scleroderma, Systemic complications, Skin Ulcer etiology, Treatment Outcome, Vasodilator Agents administration & dosage, Iloprost therapeutic use, Raynaud Disease drug therapy, Scleroderma, Systemic drug therapy, Skin Ulcer drug therapy, Vasodilator Agents therapeutic use
- Abstract
Intravenous iloprost is a first-line option for the treatment of scleroderma-related digital vasculopathy, and some studies have suggested its favourable role on disease progression. The aim of our study is to evaluate the disease progression, specifically in terms of cardiopulmonary function, in a group of consecutive patients chronically treated with intravenous iloprost. Our retrospective study enrolled 68 scleroderma patients (68 F, 54.4 ± 12.3 years) treated with iloprost for 7.1 ± 2.9 years, with a schedule of 5-6 consecutive daily infusions per month (6 h/day, 0.5-2.0 ng/kg/min). In all patients, modified Rodnan skin score (4.7 ± 5.3 vs. 3.7 ± 5.3, p < 0.0001), systolic pulmonary arterial pressure (sPAP) (30.9 ± 6.4 vs. 24.0 ± 3.2 mmHg, p < 0.0001), tricuspid annular plane systolic excursion (22.1 ± 2.4 vs. 23.8 ± 3.5 mm, p = 0.0001), pro-brain natriuretic peptide (97.2 ± 69.3 vs. 65.8 ± 31.7 pg/ml, p = 0.0005) showed statistically significant improvement from baseline. In the subgroup of patients with baseline sPAP ≥36 mmHg (n = 17), a significant sPAP reduction was observed (from 39.5 ± 3.8 to 25.1 ± 4.5 mmHg, p < 0.0001) after 7.6 ± 2.5 years of follow-up. The number of patients with digital ulcers (DUs) at follow-up was reduced from baseline (42.6 vs. 11.8%, p < 0.001), and none of the free-DU patients at baseline presented DUs at follow-up. An intensive and chronic regimen of IV iloprost administration seems to stabilize and potentially improve the long-term development of disease in SSc patients, as suggested by stabilization or significant improvement of cardiopulmonary parameters and vasculopathy., Competing Interests: Alberto Farina is an employee of Italfarmaco S.p.A., and the other authors report no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent Informed consent was obtained from all individual participants included in the study.
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- 2017
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42. New perspectives on management of idiopathic pulmonary fibrosis.
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Puglisi S, Torrisi SE, Vindigni V, Giuliano R, Palmucci S, Mulè M, and Vancheri C
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Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive parenchymal lung disease characterized by a median survival of 3-5 years following diagnosis. The diagnosis is based on clinical, radiological and histopathological evaluation. Therefore, a multidisciplinary team is needed to reach the correct diagnosis. For a long time, supportive care and lung transplantation in selected cases, have been considered the only possible treatments for IPF. In the last decade many studies have investigated IPF pathogenesis, leading to an improved knowledge of the mechanisms underlying the disease and to the approval of two new drugs for IPF treatment (pirfenidone and nintedanib). The therapeutic approach of IPF cannot be limited to the administration of antifibrotic drugs, but it is necessary for improving the quality of life of patients and for facilitating, as far as possible, the performance of normal daily activities and relationships. IPF patients are also afflicted by disease-related complications such as gastroesophageal reflux, pulmonary hypertension, acute exacerbations and an increased risk of developing lung cancer. The clinician who treats IPF patients, should also treat these possible complications to slow disease progression, thus maintaining the possibility of a pulmonary transplantation.
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- 2016
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43. Circulating biomarkers in pulmonary arterial hypertension: update and future direction.
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Pezzuto B, Badagliacca R, Poscia R, Ghio S, D'Alto M, Vitulo P, Mulè M, Albera C, Volterrani M, Fedele F, and Vizza CD
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- Humans, Hypertension, Pulmonary physiopathology, Prognosis, Pulmonary Artery physiopathology, Vascular Resistance physiology, Biomarkers blood, Hypertension, Pulmonary blood, Oxidative Stress
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Pulmonary arterial hypertension (PAH) is a complex disease with a poor prognosis. In recent years, great advances have occurred in our understanding of the pathophysiologic mechanisms underlying the characteristic vascular proliferative lesions, thus allowing the development of several specific drugs. Nevertheless, PAH still presents a high mortality; therefore, early diagnosis and prognostic stratification seem to be of paramount importance in order to choose the best therapeutic strategies. Circulating biomarkers have been proposed as potentially noninvasive and objective parameters for diagnosis, prognosis, and response to therapy. The molecules evaluated to date, including markers of dysfunction and neurohormonal activation, myocardial injury, inflammation and oxidative stress, vascular damage and remodelling, end-organ failure, and gene expression, reflect the complex pathophysiology of PAH. However, not one of these shows all the characteristics of the ideal biomarker; thus, a multiparameter approach is probably desirable. Moreover, future direction could be research of structural proteins specifically expressed in the pathologic tissue that act as disease-specific markers. This report presents an extensive review of circulating biomarkers in PAH and some consideration about potential future direction in this area., (Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
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- 2015
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44. 'Real-life' information on pulmonary arterial hypertension: the iPHnet Project.
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Poscia R, Ghio S, D'Alto M, Vitulo P, Mulè M, Albera C, Parisi F, Badagliacca R, Fedele F, and Vizza CD
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- Humans, Hypertension, Pulmonary diagnosis, Hypertension, Pulmonary therapy, Italy epidemiology, Databases, Factual, Hypertension, Pulmonary epidemiology, Medical Records Systems, Computerized, Registries
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Background: Over the last two decades the development and analysis of a number of registries have enhanced the knowledge of the epidemiology, presentation, natural history, and pathophysiology of pulmonary arterial hypertension (PAH). The understanding of the effectiveness of available treatments has also been greatly improved. However, most of the registries present some methodological issues, such as differences in the classification of patients and presence of confounding factors or missing values, that can impact on the generalizability of the results., Objective: The aim of this study is to present the Italian Pulmonary Hypertension Network (iPHnet) Project, a database used to collect health records on patients with PAH that can also be used for research purposes to retrieve ad hoc information., Results: iPHnet presents various characteristics such as facilitated access, data sharing and interoperability, update, patient's anonymity and data integrity. The system also enables the creation of patients' electronic health records (EHRs), the exportation and personalization of data and the possibility to design clinical report forms (CRFs) and collect information usable in clinical trials. In addition, it is possible to analyze the information present in the registry, creating graphs or other immediately available charts to evaluate the trends of a specific data and perform therapeutic or clinic adjustments. Treatment of data in the iPHnet database complies with FDA requirements, backup and disaster recovery policies and patients' privacy., Conclusions: iPHnet is a flexible tool that integrates the capabilities of an EHR for PAH patients with those of a PAH registry. The ability to retrieve relevant information - although with all the limitations of any registry-based analysis - and to create appropriate CRFs will facilitate the development of prospective and retrospective trials aimed at providing new 'real-life' evidence on PAH.
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- 2014
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45. Lung membrane conductance and capillary volume derived from the NO and CO transfer in high-altitude newcomers.
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Martinot JB, Mulè M, de Bisschop C, Overbeek MJ, Le-Dong NN, Naeije R, and Guénard H
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- Adult, Altitude, Arterial Pressure physiology, Blood Pressure physiology, Capillaries metabolism, Double-Blind Method, Humans, Lung metabolism, Pulmonary Alveoli blood supply, Pulmonary Alveoli metabolism, Pulmonary Alveoli physiology, Pulmonary Circulation physiology, Pulmonary Diffusing Capacity physiology, Rest physiology, Blood Volume physiology, Capillaries physiology, Carbon Monoxide metabolism, Lung blood supply, Lung physiology, Nitric Oxide metabolism
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Acute exposure to high altitude may induce changes in carbon monoxide (CO) membrane conductance (DmCO) and capillary lung volume (Vc). Measurements were performed in 25 lowlanders at Brussels (D0), at 4,300 m after a 2- or 3-day exposure (D2,3) without preceding climbing, and 5 days later (D7,8), before and after an exercise test, under a trial with two arterial pulmonary vasodilators or a placebo. The nitric oxide (NO)/CO transfer method was used, assuming both infinite and finite values to the NO blood conductance (θNO). Doppler echocardiography provided hemodynamic data. Compared with sea level, lung diffusing capacity for CO increased by 24% at D2,3 and is returned to control at D7,8. The acute increase in lung diffusing capacity for CO resulted from increases in DmCO and Vc with finite and infinite θNO assumptions. The alveolar volume increased by 16% at D2,3 and normalized at D7,8. The mean increase in systolic arterial pulmonary pressure at rest at D2,3 was minimal. In conclusion, the acute increase in Vc may be related to the increase in alveolar volume and to the increase in capillary pressure. Compared with the infinite θNO value, the use of a finite θNO value led to about a twofold increase in DmCO value and to a persistent increase in DmCO at D7,8 compared with D0. After exercise, DmCO decreased slightly less in subjects treated by the vasodilators, suggesting a beneficial effect on interstitial edema.
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- 2013
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46. Selection of patient for cardiac resynchronization therapy: role of QT corrected dispersion.
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Timineri S, Mulè M, Puzzangara E, Santangelo G, Dugo D, Schillaci V, Di Grazia A, Liotta C, Scandura S, Tempio D, Tamburino C, and Calvi V
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- Female, Heart Failure complications, Humans, Male, Middle Aged, Reproducibility of Results, Sensitivity and Specificity, Ventricular Dysfunction, Left complications, Cardiac Resynchronization Therapy, Electrocardiography methods, Heart Failure diagnosis, Heart Failure prevention & control, Patient Selection, Ventricular Dysfunction, Left diagnosis, Ventricular Dysfunction, Left prevention & control
- Abstract
Aims: About 30 to 50% of patients undergoing cardiac resynchronization therapy (CRT) may not show clinical or echocardiographic improvement, despite fulfilling guidelines recommendations for CRT. For this reason, we need a more accurate method to assess CRT eligibility. The aims of this study were to verify, on a 12-month follow-up, the usefulness of QT corrected dispersion (QTcD) in a patient's selection for CRT., Methods: We stratified 53 patients who underwent CRT, into two groups based on the estimation of QTcD, that is, QTcD > 60 ms and QTcD ≤ 60 ms. In all patients were performed New York Heart Association (NYHA) class determination, six-minute walking test, QtcD, and QRS measurements, and complete echocardiographic assessment at 1, 3, 6, and 12 months after implantation., Results: At baseline, there were no significant differences in clinical, echocardiographic, and electrocardiographic parameters duration between two groups. At 12-month follow-up between the two groups, there were significant differences in NYHA (1.2 ± 0.4 vs 2 ± 0.6; P < 0.01), six-minute walking distance (422 ± 68 vs 364 ± 68; P < 0.01), left ventricular (LV) ejection fraction (34 ± 7% vs 28 ± 6%; P < 0.01), LV end-diastolic diameter (57 ± 7 vs 63 ± 8; P < 0.01), and LV intraventricular dyssynchrony (24 ± 14 vs 39 ± 23; P < 0.01)., Conclusion: This study suggests that QTc dispersion in addition to QRS duration could improve the sensitivity of electrocardiogram in a patient's selection for CRT., (©2012, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)
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- 2012
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47. Accuracy of intracardiac echocardiography for aortic root assessment in patients undergoing transcatheter aortic valve implantation.
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Ussia GP, Barbanti M, Sarkar K, Cumbo M, Aruta P, Scarabelli M, Cammalleri V, Immè S, Pistritto AM, Gulino S, Deste W, Zingali G, Garretto V, Mulè M, Scandura S, and Tamburino C
- Subjects
- Adult, Echocardiography methods, Female, Heart Valve Prosthesis Implantation, Humans, Male, Multidetector Computed Tomography, Prospective Studies, Reproducibility of Results, Aortic Valve diagnostic imaging, Aortic Valve Stenosis surgery, Sinus of Valsalva diagnostic imaging, Ultrasonography, Interventional
- Abstract
Background: Multislice computed tomography (MSCT) has generally been accepted as the most accurate modality fulfilling this purpose with good reproducibility. A major drawback of MSCT consists in the use of contrast dye, which may be unsafe in transcatheter aortic valve implantation (TAVI) patients who frequently are affected by renal failure. We sought to appraise the accuracy of intracardiac echocardiography (ICE) in measurements of structures in the aortic root in patients undergoing TAVI., Methods: Aortic annulus and sinus of Valsalva diameters were measured using ICE, performed during standard invasive preprocedural assessment in 30 consecutive patients with severe aortic stenosis referred for TAVI. Multislice computed tomography was performed in all patients afterward, and aortic root measurements were made by an independent radiologist., Results: Effective ICE measurements were obtained in all patients, easily and without any complication. Mean aortic annulus diameters were 21.9 ± 1.8 mm using ICE, 22.0 ± 1.9 mm using MSCT (3-chamber [3-C] view) and 22.8 ± 1.8 mm using the mean of long-axis and short-axis (L-ax/S-ax) view MSCT (P = .192, ICE vs 3-C MSCT; P < .001, ICE vs L-ax/S-ax MSCT, respectively). Correlation between ICE and both MSCT measurements was good (r(2) = 0.83, P < .001; r(2) = 0.80, P < .001, respectively). Mean sinus of Valsalva diameters were 32.3 ± 3.3 mm using ICE and 32.5 ± 3.1 mm using 3-C MSCT view (P = .141). Even in this case, correlation between ICE and both MSCT measurements was excellent (r(2) = 0.96, P < .001)., Conclusions: In patients referred for TAVI, measurements of the aortic annulus and the sinus of Valsalva using ICE compare favorably with those made at MSCT. This approach might be a useful and reproducible strategy in patients with severe renal impairment to avoid the administration of contrast dye during MSCT., (Copyright © 2012 Mosby, Inc. All rights reserved.)
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- 2012
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48. Quality of life following percutaneous mitral valve repair with the MitraClip System.
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Ussia GP, Cammalleri V, Sarkar K, Scandura S, Immè S, Pistritto AM, Caggegi A, Chiarandà M, Mangiafico S, Barbanti M, Scarabelli M, Mulè M, Aruta P, and Tamburino C
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- Aged, Aged, 80 and over, Disability Evaluation, Female, Follow-Up Studies, Humans, Male, Mental Health, Middle Aged, Mitral Valve Insufficiency physiopathology, Motor Activity, Surveys and Questionnaires, Health Surveys, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Mitral Valve Insufficiency psychology, Mitral Valve Insufficiency surgery, Quality of Life
- Abstract
Background: Percutaneous valve repair with MitraClip System is an emerging alternative for high surgical risk patients with severe mitral regurgitation (MR). QoL is a critical measure of effectiveness of this procedure. We sought to evaluate quality of life (QoL) and NYHA class following this novel procedure., Methods: The study included 39 consecutive patients who underwent mitral valve repair with the MitraClip System, both for functional (64%) and degenerative (36%) MR. All patients received the SF-12v2 questionnaire pre-procedure and at 6 months follow-up to assess the physical and mental health., Results: Acute procedural success was obtained in 100%. Three patients experienced minor procedural complications. At follow-up 86% of patients had MR ≤ 1+ and 14% experienced a moderate MR. Mean pre-procedural SF-12v2 scores of our patients showed a severe impairment of perceived QoL, both for physical and mental scores; after six months a striking improvement in physical (PCS 35.44 vs 44.67, p<0.0001) and mental (MCS 38.07 vs 46.94, p<0.0001) aspect of QoL was observed. Furthermore, physical and mental status upgrading was higher in patients with functional MR. NYHA functional class improved in all patients., Conclusion: Our results show an early marked improvement in functional status and physical and mental health in patients underwent percutaneous mitral valve repair with the MitraClip System., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)
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- 2012
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49. Transcatheter aortic bioprosthesis dislocation: technical aspects and midterm follow-up.
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Ussia GP, Barbanti M, Sarkar K, Aruta P, Scarabelli M, Cammalleri V, Immè S, Pistritto AM, Gulino S, Mulè M, Deste W, Cannata S, and Tamburino C
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- Aged, 80 and over, Aorta pathology, Aortic Valve Stenosis diagnostic imaging, Bioprosthesis adverse effects, Embolism diagnostic imaging, Embolism etiology, Embolism pathology, Female, Follow-Up Studies, Humans, Male, Postoperative Complications surgery, Radiography, Stents, Aortic Valve Stenosis surgery, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation methods, Prosthesis Failure, Reoperation methods
- Abstract
Aims: Prosthesis dislocation during transcatheter aortic valve implantation (TAVI) is a rare but important complication. There is scarce data on the performance of prosthesis in the aorta that have become dislocated from their intended anatomical position in the aortic annulus. We investigated the causes of dislocation during TAVI of the self-expanding CoreValve ReValving™ System (CRS) (Medtronic Inc., Minneapolis, MN, USA). This included midterm follow-up of patients experiencing this acute complication., Methods and Results: Among 176 consecutive patients undergoing TAVI with the CRS prosthesis, seven (3.9%) experienced acute valve dislocation. A comprehensive analysis of the mechanism of dislocation and clinical outcomes of patients experiencing this complication was performed. Based on the underlying mechanism, all cases of prosthesis displacement were classified into the following three groups: 1) accidental dislocation immediately after valve implantation (n=1; 14.3%); 2) dislocation during the snaring manoeuvre to reposition a low deployment of the CRS prosthesis (lower edge >10 mm) below the aortic annulus accompanied with haemodynamically significant regurgitation (n=4; 57.1%); 3) intentional dislocation performed with the snaring manoeuvre as a bailout in cases of coronary ostia impairment or severe prosthetic leak due to higher deployment for a suboptimal sealing of the device with valve calcifications (n=2; 28.6%). The majority of cases occurred during early experiences with the new Accutrak™ (Medtronic Inc., Minneapolis, MN, USA) delivery system. In six patients a second CRS was implanted in the appropriate position. The dislodged CRS functioned normally, without any evidence of structural deterioration, thrombosis or further distal migration and showed complete apposition against the aortic wall. No thromboembolic events were reported in any patient., Conclusions: Dislocation of a CRS device can be managed effectively with the implantation of a second device in a standard fashion leaving the dislocated device safely in the aorta. Intentional repositioning of a CRS device in the aorta can be accomplished by experienced operators without any serious neurologic or vascular events in the post-procedure period or at midterm follow-up.
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- 2012
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50. Early- and mid-term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: a comparative analysis between different risk strata.
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Tamburino C, Barbanti M, Capodanno D, Sarkar K, Cammalleri V, Scarabelli M, Mulè M, Immè S, Aruta P, and Ussia GP
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- Aged, Aged, 80 and over, Aortic Valve Stenosis diagnosis, Aortic Valve Stenosis mortality, Cerebrovascular Disorders etiology, Chi-Square Distribution, Female, Heart Diseases etiology, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Heart Valve Prosthesis Implantation mortality, Humans, Italy, Kaplan-Meier Estimate, Logistic Models, Male, Odds Ratio, Patient Selection, Proportional Hazards Models, Prosthesis Design, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Aortic Valve Stenosis therapy, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Cardiac Catheterization mortality, Heart Valve Prosthesis Implantation methods
- Abstract
Background: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. The European consensus document recommended TAVI for prohibitive-risk patients not eligible for conventional surgery (prohibitive risk defined as expected mortality ≥ 20% calculated with the Logistic EuroScore (LES) in association with clinical judgment). To date, there is lack of clarity on data about outcomes of TAVI in lower risk patients. We sought to evaluate the outcomes of patients undergoing TAVI with LES ≥ 20% in comparison with patients with LES < 20%., Method: Of 165 patients who underwent TAVI using the 18-French Medtronic CoreValve (N = 153) and the Sapien Edwards™ (N = 12) at our Institution between June 2007 and September 2010, we identified those with LES < 20%, with prosthesis implantation (n = 84), and reported on their clinical outcome compared with patients with LES ≥ 20% (n = 78). The primary endpoint was the incidence of overall death and major adverse cerebrovascular and cardiac events (MACCE) at 30-day and midterm follow-up stratifying patients by clinical characteristics., Results: At 30-day, a significant higher incidence of MACCE (20.8% vs. 6.0%, odds ratio [OR] 4.08 95% confidence interval [CI] 1.42-11.74, P = 0.009) and death (15.6% vs. 2.4%, OR 7.45 95% CI 1.61-34.48, P = 0.010) was reported in the LES ≥ 20% group as compared with the LES < 20% group, respectively. The 12-month MACCE rates was (27.1% vs. 11.4%, hazard ratio [HR] 2.47 95% CI 0.93-6.63, P = 0. 071) for LES ≥ 20% and LES < 20% patients, respectively (mortality rates was 25.7% vs. 6.8% HR 4.21 95% CI 1.24-14.30, P = 0.021)., Conclusion: This study tends to suggest that current mortality reported after TAVI could be significantly affected by the very-high risk profile of the population which currently undergoes this procedure, making comparison with surgical series rather unreliable., (Copyright © 2011 Wiley Periodicals, Inc.)
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- 2012
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