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2. Rotura de válvula tricúspide con insuficiencia masiva secundaria a traumatismo torácico cerrado: Caso clínico

Author

Ricardo Zalaquett S, Gastón Chamorro S, Guillermo Lema F, and Roberto González L.

Subjects
medicine.medical_specialty, Tricuspid valve, business.industry, Hemodynamics, Heart failure, General Medicine, Shock, traumatic, Tricuspid insufficiency, medicine.disease, Asymptomatic, Pericardial effusion, Surgery, medicine.anatomical_structure, Blunt, Internal medicine, cardiovascular system, medicine, Cardiology, Thoracic injuries, Tricuspid valve insufficiency, Decompensation, cardiovascular diseases, medicine.symptom, business, Papillary muscle
Abstract

Cardiac valve lesions after a blunt chest trauma are rare and lessthan 1% of cardiac lesions because of chest trauma affect the tricuspid valve. We report a 70year-old female that suffered a severe chest trauma in a car accident. During the repair of themultiple skeletal lesions, the patient had a severe hemodynamic decompensation. A myocardialtrauma with pericardial effusion and massive tricuspid insufficiency, due to anterior leafletprolapse, was diagnosed on echocardiography. After discharge the patient remained infunctional class II, with hepatomegaly, jugular ingurgitation and lower limb edema. A controlechocardiogram, perfomed six months after the accident, showed dilatation of right heartchambers and massive tricuspid insufficiency. The patient was operated, and a tricuspid valverepair was performed suturing the ruptured papillary muscle to the ventricular wall andperforming a triscuspid annuloplasty with a prosthetic ring. After 15 months of follow up, thepatient remains asymptomatic (Rev Med Chile 2008; 136: 1034-8).(

Published
2008

3. Combatiendo la epidemia de enfermedad coronaria en Chile: Potencialidades y problemas en el control de los factores de riesgo

Author

Gastón Chamorro S

Subjects
medicine.medical_specialty, business.industry, Public health, Cardiovascular risk factors, General Medicine, Disease, medicine.disease, Coronary artery disease, Surgery, Myocardial infarction, Diabetes mellitus, Attributable risk, Medicine, business, Intensive care medicine, Dyslipidemia, Dyslipidemias
Abstract

In this issue of the journal Lanas et al report an estimation ofpopulation attributable risk (PAR) for myocardial infarction (MI) derived from different riskfactors in Chile. Cigarette smoking, dyslipidemia and hypertension accounted for 71% of totalPAR. Mortality from MI has decreased in Chile, but epidemiologic surveys carried out indifferent hospitals across the country, strongly support that most of this effect comes from bettertreatment of MI. Recent changes in public health policies, favoring the treatment of hypertensionand diabetes may help control cardiovascular morbidity and mortality. However, a reallysignificant impact will be obtained when the development of the disease may be halted. Toevaluate this possibility, newer methods to diagnose atherosclerosis non invasively may come toour rescue. On the other hand, pharmacologic treatment of dyslipidemia and hypertensioncontinue to offer the most powerful way to decrease levels of cardiovascular risk factors.According to current knowledge, wise balance of non pharmacologic and pharmacologicmeans of primary prevention, with due respect for ethic aspects, is the most effective way tocurve the epidemic of coronary artery disease in Chile (Rev Med Chile 2008; 136: 551-4).(

Published
2008

4. Resultados alejados de la reparación versus reemplazo en insuficiencia mitral degenerativa

Author

Cristóbal Camplá C, Samuel Córdova A, Manuel J Irarrázaval Ll, Ricardo Zalaquett S, Iván Godoy J, Claudio Arretz V, Gastón Chamorro S, Pedro Becker R, Maximiliano Scheu G, Sergio Morán V, and Sandra Braun J

Subjects
medicine.medical_specialty, Mitral regurgitation, Mitral valve repair, business.industry, medicine.medical_treatment, Mitral valve replacement, Surgical mortality, General Medicine, Long term results, medicine.disease, Prosthesis, Surgery, Thoracic surgery, Internal medicine, Mitral valve, cardiovascular system, medicine, Cardiology, cardiovascular diseases, Mitral valve regurgitation, business, Survival rate, Mitral valve insufficiency
Abstract

Mitral valve repair is considered better than mitral valve replacement for degenerative mitral regurgitation. Aim: To evaluate late clinical results of mitral valve repair as compared to mitral valve replacement in patients with degenerative mitral regurgitation. Patients and methods: All patients subjected to open heart surgery for degenerative mitral regurgitation between 1990 and 2002 were assessed for surgical mortality, late cardiac and overall mortality, reoperation, readmission to hospital, functional capacity and anticoagulant therapy. Eighty eight patients (48 males) had mitral valve repair and 28 (19 males) had mitral valve replacement (23 with a mechanical prosthesis). Mean age was 59.9 ± 14.8 (SD) and 61.3 ± 14.6 years, respectively. Sixty three percent of patients with repair and 50% of those with valve replacement were in functional class III or IV before surgery. Results: Operative mortality was 2.3% for mitral valve repair and 3.6% for mitral valve replacement (NS). Also, there was no statistical difference in the need of reoperation during the follow-up period between both procedures (2.3% and 0%, respectively). Ninety four percent of the replacement patients but only 26% of the repair patients were in anticoagulant therapy at the end of the follow-up period (p

Published
2005

5. Ciruguía reparadora de la válvula aórtica bicúspide insuficiente

Author

Cristian Baeza P, Claudio Arretz V, Pedro Becker R, Maximiliano Scheu G, Iván Godoy J, Manuel J Irarrázaval Ll, Gastón Chamorro S, Cristóbal Camplá C, Sandra Braun J, Fernando Yáñez D, Samuel Córdova A, Ricardo Zalaquett S, and Sergio Moran

Subjects
Surgical repair, Aortic valve, medicine.medical_specialty, business.industry, medicine.medical_treatment, Perforation (oil well), Heart valve prosthesis implantation, General Medicine, Regurgitation (circulation), medicine.disease, Prosthesis, Surgery, medicine.anatomical_structure, Bicuspid aortic valve, Ventricle, Internal medicine, medicine, Cardiology, cardiovascular system, Endocarditis, Cardiovascular surgical procedures, business
Abstract

Background: Surgical valve repair is a good alternative for correction of incompetent bicuspid aortic valve. Aim: To report the early and late surgical, clinical and ecochardiographic results of surgical repair of incompetent bicuspid aortic valves. Patients and methods: Retrospective review of medical records of 18 patients aged 19 to 61 years, with incompetent bicuspid aortic valve in whom a valve repair was performed. Four patients had infectious endocarditis and 17 were in functional class I or II. Follow up ranged from 3 to 113 months after surgery. Results: A triangular resection of the prolapsing larger cusp, which included the middle raphe, was performed in 17 cases; in 13 of these, a complementary subcommisural annuloplasty was performed. In the remaining case, with a perforation of the non-coronary cusp, a pericardial patch was implanted; this procedure was also performed in 2 other cases. In 3 cases large vegetations were removed. Postoperative transesophageal echocardiography showed no regurgitation in 11 patients (62%) and mild regurgitation in 7 (38%). There was no operative morbidity or mortality. There were no deaths during the follow-up period. In 3 patients (17%) the aortic valve was replaced with a mechanical prosthesis, 8 to 108 months after the first operation. Reoperation was not needed in 93%±6,4% at 1 year and 85%±9,5% at 5 years, these patients were all in functional class I at the end of the follow-up period. 60% had no aortic regurgitation, 20% had mild and 20% moderate aortic regurgitation on echocardiographic examination. A significant reduction of the diastolic diameter of the left ventricle was observed, but there were no significant changes in systolic diameter or shortening fraction. Conclusions: Surgical repair of incompetent bicuspid aortic valves has low operative morbidity and mortality and has a low risk of reoperation (Rev Med Chile 2005; 133: 279-86)

Published
2005

6. Cirugía valvular reparadora en endocarditis infecciosa

Author

Carlos Pérez C, Samuel Córdova A, Sandra Braun J, Luis Garrido O, Pedro Becker R, Manuel J Irarrázaval Ll, Francisca Casas R, Iván Godoy J, Fernando Yáñez D, Sergio Morán V, Ricardo Zalaquett S, Jaime Labarca L, and Gastón Chamorro S

Subjects
Mechanical ventilation, Mitral valve repair, medicine.medical_specialty, business.industry, medicine.medical_treatment, Hemodynamics, Surgical procedures, operative), General Medicine, Regurgitation (circulation), medicine.disease, Surgery, medicine.anatomical_structure, Valve replacement, Mitral valve, Internal medicine, cardiovascular system, medicine, Cardiology, Cardiovascular surgical procedures, Endocarditis, bacterial, Endocarditis, Cardiovascular Surgical Procedure, cardiovascular diseases, business
Abstract

Background: Valve replacement has been the treatment of choice for patients with valvular complications of infectious endocarditis (IE). However, excellent results with valve repair allowed it to become a new therapeutic alternative for these patients. Aim: To evaluate the results of valve repair in patients with valvular complications of IE. Patients and Methods: From January 1991 to December 2000, 14 patients with valvular complications of IE underwent valve repair. Mean age was 37.9 ± 14.9. Results: New York Heart Association (NYHA) class was 2.8 ± 0.9. IE was located in the aortic in 6 (42%), in the mitral valve in 4 (29%) and in both valves in 4 cases (29%). Surgical indication was hemodynamic in 50% of the cases, echocardiographic in 29% and septic in 21%. Five aortic valves were bicuspid, 3 mitral valves were myxomatous and the rest were normal. The most common septic lesions were vegetations and leaflet perforations. A total of 23 aortic and 21 mitral valve repair procedures were performed. There were no deaths. Only 1 patient had a surgical complication (renal failure and prolonged mechanical ventilation). Follow-up was 100% complete. There was not late mortality. One patient with bone marrow aplasia required reoperation for a new episode of IE 19 months later. At the end of the follow-up NYHA class was 1.3 ± 0.6 and echocardiography showed a mild or absence of valve regurgitation in most patients. Conclusions: Valve repair surgery in IE has good results, with advantages over valve replacement (Rev Med Chile 2004; 132: 307-15). (Key Words: Cardiovascular surgical procedures; Endocarditis, bacterial; Surgical procedures, operative)

Published
2004

7. Resultados alejados de la cirugía reparadora de la insuficiencia mitral degenerativa

Author

Cristóbal Camplá C, Iván Godoy J, Ricardo Zalaquett S, Manuel J Irarrázaval Ll, Samuel Córdova A, Pedro Becker R, Gastón Chamorro S, Fernando Yáñez D, Sergio Morán V, and Sandra Braun J

Subjects
medicine.medical_specialty, Mitral valve repair, Mitral regurgitation, RUPTURED CHORDAE TENDINEAE, business.industry, Mortality rate, medicine.medical_treatment, Operative mortality, Diastole, General Medicine, Surgery, medicine.anatomical_structure, Left atrial, Internal medicine, Mitral valve, medicine, Cardiology, cardiovascular system, cardiovascular diseases, business, Mitral valve insufficiency
Abstract

Background: Mitral valve repair is probably the procedure of choice for the surgical treatment of degenerative mitral insufficiency. Aim: To evaluate the late results of mitral valve repair in degenerative mitral insufficiency. Patients and method: The records of 88 patients who underwent mitral valve repair for degenerative mitral insufficiency from December 1991 through June 2002 were reviewed. Mean age was 59.9 years (range 22 to 82). At least moderate mitral insufficiency was present in every patient. Mean left atrial diameter was 55 mm and mean end diastolic and end systolic left ventricular diameters were 61 and 37 mm respectively. Results: The most common underlying lesion was ruptured chordae tendineae (66%) and posterior leaflet prolapse (68%). The surgical procedure most frecuently performed was quadrilateral resection of the posterior leaflet (68%). A Carpentier-Edwards ring was placed in 97% of patients. An associated procedure was performed in 34%. Operative mortality was 2.3%. A complete follow up was obtained in 93% of cases with a mean of 54±36 months. Overall survival rate was 98% at one year, 88% at 5 and 82% at 10 years. Free of cardiac death rates were 94% at 5 and 89% at 10 years. Only 2 patients were reoperated during follow up, resulting in a 98% reoperation free rate follow up. Functional class improved in all patients at the end of follow up. Late echocardiographic evaluation showed absent or minimal mitral regurgitation in 83% and mild mitral regurgitation in 17%. Conclusion: Good late results have been obtained with mitral valve repair, avoiding the inconveniencies of prosthetic replacement. Therefore, mitral valve repair should be the procedure of choice to treat degenerative mitral insufficiency (Rev Med Chile 2003; 131: 1355-64). (Key Words: Mitral valve insufficiency)

Published
2003

8. Experiencia de 36 años con marcapasos implantables: Un análisis histórico

Author

Eugenio Marchant D, Gustavo Maturana B, Pablo Casanegra P., Jorge Jalil M, Sandra Braun J, Ramón Corbalán H, Ricardo Zalaquett S, Juan Dubernet M., Jorge González M., Rolando González A, Gastón Chamorro S, Jose A. Rodriguez, Manuel J Irarrázaval Ll, Jorge Urzúa U, Alejandro Fajuri N, and Sergio Moran

Subjects
medicine.medical_specialty, business.industry, Cardiovascular abnormalities, Patient survival, General Medicine, Surgical procedures, Pacemaker implantation, Surgery, Cardiovascular diseases, Quality of life, Pacemaker replacement, Pacemaker, artificial, Medicine, In patient, Cardiac pacing, artificial, business, Clinical record, Median survival
Abstract

Background: The implantation of pacemakers improves cardiac function and quality of life, in particular with dual chamber DDD and DDDR modes. Aim: To evaluate our clinical experience and results on pacemaker implantation, from 1963 to 1998. Material and methods: Computerized data collected from 2,445 consecutive paced patients was reviewed. A total of 3,554 operative procedures were performed, including 412 procedures for complications and 697 pacemaker replacement. Patient survival was determined from clinical records, inquiry to pacemaker manufacturers and death certificates from Servicio de Registro Civil e Identificacion de Chile (Chilean Civil and Identification Registry). Results: Use of dual chamber (DDD and DDDR) pacemakers increased progressively up to 74% from 1988 to 1998. Complication rate was 42% in the 1963-1976 study period, it decreased to 10.6% in the 1977-1987 study period, and to 5.6% by 1988-1998. Only two patients died during surgery in the study period (0.08%). In the 1977-1987 period, pacemakers lasted 10.6 years. Survival rates were 52% at ten years, 33% at 15 years, and 21% at 20 years, with a median survival of 11.7 years, and 7.24 years in patients over 80 years old. Conclusions: Transvenous permanent pacing can be accomplished today with a low complication rate, mainly due to better technology and surgical procedures (Rev Med Chile 2002; 130: 132-42)

Published
2002

9. Surgery for ischemic mitral regurgitation

Author

Gastón Chamorro S, Sergio Moran, Luis Garrido O, Pedro Becker R, Gustavo Maturana B, Sandra Braun J, Manuel J Irarrázaval Ll, Samuel Córdova A, Iván Godoy J, and Ricardo Zalaquett S

Subjects
Mitral valve repair, Mitral regurgitation, medicine.medical_specialty, business.industry, medicine.medical_treatment, Mortality rate, Surgical mortality, Mitral valve replacement, Heart valve prosthesis implantation, General Medicine, Perioperative, Surgery, medicine.anatomical_structure, Concomitant, Internal medicine, Mitral valve, medicine, Cardiology, business, Cardiac surgical procedures, Mitral valve insufficiency
Abstract

Background. Ischemic mitral regurgitation (IMR) is a severe condition which may be best treated by surgery, nowithstanding a relatively high mortality rate. Objectives. To evaluate the results of mitral valve replacement or repair in patients with IMR. Patients and methods. Retrospective review of the clinical records in 29 patients with IMR who were surgically treated from 1990 to 1999. They represent 8% of surgical procedures on the mitral valve. Results. Mean age was 67 ± 9 years. Surgery was performed urgently in 19 patients (66,5%). NYHA functional class was 3.4 ± 0.8. The mechanism of IMR was annular dilatation and spreading of papillary muscles in 18 patients, papillary muscle rupture in 9 and fibrosis in 2. Mitral valve replacement was performed in 14 patients and mitral valve repair in 15. Twenty four patients (83%) had concomitant myocardial revascularization. Overall surgical mortality was 24%; 26% for mitral replacement and 13% for mitral valve repair (p=0.215). On follow up of 26±33 months, one year survival was 76±0.8% and 5 years survival was 59±12%. Excluding in hospital mortality, survival was 100% at one year and 78±14% at 5 years. Functional class improved in all survivors, to 1.4±0.5. Late echocardiographic evaluation of patients with mitral valve repair showed absence of mitral regurgitation in 58%, 1+ MR in 17% and 2+ MR in 25%. Conclusion. In spite of a high perioperative mortality, surgery for IMR is a valuable procedure for patients with an otherwise highly lethal disease (Rev Med Chile 2002; 130: 9-16)

Published
2002

10. Long term results of reconstructive surgery for mitral insufficiency

Author

Michael Howard G, Sergio Morán V, Manuel Irarrázaval Li, Gastón Chamorro S, Pedro Becker R, Sandra Braun J, Gustavo Maturana B, Samuel Córdova A, Luis Garrido O, Ricardo Zalaquett S, Claudio Arretz V, and Carla Sacco C

Subjects
Surgical repair, Reconstructive surgery, medicine.medical_specialty, Mitral valve repair, Additional Surgical Procedure, business.industry, medicine.medical_treatment, Mitral valve replacement, General Medicine, Surgery, medicine.anatomical_structure, Echocardiography, Internal medicine, Mitral valve, medicine, Etiology, Cardiology, Surgery, operative, transesophageal, business, Pathological, Mitral valve insufficiency
Abstract

Background: Surgical repair is the procedure of choice for mitral insufficiency since it preserves better left ventricular structure and function. Aim: To assess the long term clinical and echocardiographic results of mitral valve reconstructive surgery. Material and methods: A review of clinical and echocardiographic data of 68 patients (34 male, age range 17 to 82 years), subjected to surgical mitral valve repair between December 1991 and March 1998. Preoperative functional capacity of these patients was 2.96 ± 0.7. Surgical repair was assessed using transesophagic echocardiography in all subjects. Results: The etiology of mitral insufficiency was degenerative in 43 patients, rheumatic in 10, infectious in 6, ischemic in 5 and miscellaneous in 4. The most frequent pathological findings were dilatation of the mitral ring in 42% of patients, chordae tendinae rupture in 32% and enlargement in 24%. A mitral anuloplasty was done in 90% of patients, a cuadrilateral resection of posterior leaflet in 52% and chordae tendinae transference in 12%. An additional surgical procedure was done in 34% of subjects. Three patients died during hospitalization (4.4%). During the follow up of 36.5 ± 22.3 months, five patients died and one required a mitral valve replacement. The actuarial survival probability was 95.3 ± 2.6% at one year and 83.5 ± 6.5% at five years. The reoperation free survival was 100% at one year and 97.4 ± 2.5% at five years. At the end of follow up the functional capacity improved to 1.25 ± 0.4. Echocardiography showed absence of mitral insufficiency in 48.4% of patients, minimal, mild and moderate insufficiency in 35.5, 14.5 and 1.6% of patients respectively. Conclusions: Surgical valve reconstruction in mitral insufficiency has satisfactory long term results and should be the procedure of choice for eligible patients.

Published
1999

11. Prueba de inclinación en la evaluación del sincope o presíncope de etiología no precisada en niños y adolescentes

Author

Jorge Jalil M, Francisco J. Radrigán V, Susy Cohen C, Eduardo Dumas R, Susana Becerra G, Felipe Heusser R, Gastón Chamorro S, and Filar Arnaiz G

Subjects
Bradycardia, medicine.medical_specialty, Presyncope, biology, business.industry, síncope, isoproterenol, Syncope (genus), biology.organism_classification, medicine.disease, tilt test, Internal medicine, syncope, Pediatrics, Perinatology and Child Health, Heart rate, Systolic arterial pressure, medicine, Cardiology, Tilt test, prueba de inclinación, medicine.symptom, business
Abstract

Unexplained syncope or presyncope are rather common problems in children, whose evaluation is not simple. In adults, the t i l t test a'lows to reproduce symptoms and some associated hernodynamic mechanisms in 30 to 75% of the patients with this condition. The purpose of this wox has been to analyze hernodynamic responses during 70 tilt test in 26 consecutive patients younger than 19 years, refered to our center with the diagnosis of unexplained syncope in a period of 2 years. Fifty percent of the tilt test were positive, most of them using isoproterenol (mean dose ± 0.4 micrograms/minute), increasing heart rate by 41%. Systolic arterial pressure decreased significantly in all patients with a positive t i l t test to less than 70 mmHg. Reduction or heart rate was also observed, rarely to marked bradycardia by the end of tne test. Original symptoms were always reproduced during the test. It is concluded that tit test may constitute an imoortant test in the clinical workup of unexpkcined syncope in children and adolescents. This method reproduces clinical symptoms associated 'o syncope or presyncope and precises their hernodynamic mechanisms in aporoxima'e'y 50% of hese patients.

Published
1995

12. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

François-Xavier Lescure, Hitoshi Honda, Robert A Fowler, Jennifer Sloane Lazar, Genming Shi, Peter Wung, Naimish Patel, Owen Hagino, Ignacio J. Bazzalo, Marcelo M. Casas, Sebastián A. Nuñez, Yael Pere, Carlos M. Ibarrola, Marco A. Solis Aramayo, Maria C. Cuesta, Andrea E. Duarte, Pablo M. Gutierrez Fernandez, Maria A. Iannantuono, Erica A. Miyazaki, Javier P. Silvio, Dario G. Scublinsky, Alessandra Bales, Daniela Catarino, Elie Fiss, Sara Mohrbacher, Victor Sato, Antonio Baylao, Adilson Cavalcante, Francini Correa, Celso A. de Andrade, Juvencio Furtado, Nelson Ribeiro Filho, Valéria Telles, Leopoldo T. Trevelin, Ricardo Vipich, Rodrigo Boldo, Paula Borges, Suzana Lobo, Graziela Luckemeyer, Luana Machado, Maysa B. Alves, Ana C. Iglessias, Marianna M. Lago, Daniel W. Santos, Hugo Chapdelaine, Emilia L. Falcone, Rahima Jamal, Me-Linh Luong, Madeleine Durand, Stephane Doucet, François-Martin Carrier, Bryan A. Coburn, Lorenzo Del Sorbo, Sharon L. Walmsley, Sara Belga, Luke Y. Chen, Allison D. Mah, Theodore Steiner, Alissa J. Wright, J. Hajek, Neill Adhikari, Robert A. Fowler, Nick Daneman, Kosar A. Khwaja, Jason Shahin, Carolina Gonzalez, Rafael Silva, Marcelo Lindh, Gabriel Maluenda, Patricia Fernandez, Maite Oyonarte, Martin Lasso, Alexandre Boyer, Didier Bronnimann, Hoang-Nam Bui, Charles Cazanave, Helene Chaussade, Arnaud Desclaux, Mailys Ducours, Alexandre Duvignaud, Denis Malvy, Lisa Martin, Didier Neau, Duc Nguyen, Thierry Pistone, Gaetane Soubrane-Wirth, Julie Leitao, Clotilde Allavena, Charlotte Biron, Sabelline Bouchez, Benjamin Gaborit, Antoine Gregoire, Paul Le Turnier, Anne-Sophie Lecompte, Raphael Lecomte, Maeva Lefebvre, Francois Raffi, David Boutoille, Pascale H. Morineau, Romain Guéry, Emmanuel Chatelus, Nathalie Dumoussaud, Renaud Felten, Florina Luca, Bernard Goichot, Francis Schneider, Marie-Caroline Taquet, Matthieu Groh, Mathilde Roumier, Mathilde Neuville, Antoine Bachelard, Valentina Isernia, F-Xavier Lescure, Bao-Chau Phung, Anne Rachline, Aurelie Sautereau, Dorothee Vallois, Yves Bleher, Delphine Boucher, Clémentine Coudon, Jean Esnault, Thomas Guimard, Sophie Leautez-Nainville, Dominique Merrien, Marine Morrier, Pauline Motte-Vincent, Romain Gabeff, Hélène Leclerc, Céline Cozic, Romain Decours, Ronan Février, Gwenhael Colin, Sophie Abgrall, Dorothee Vignes, Raluca Sterpu, Mira Kuellmar, Melanie Meersch-Dini, Raphael Weiss, Alexander Zarbock, Christiane Antony, Marc Berger, Thorsten Brenner, Christian Taube, Frank Herbstreit, Sebastian Dolff, Margarethe Konik, Karsten Schmidt, Markus Zettler, Oliver Witzke, Boris Boell, Jorge Garcia Borrega, Philipp Koehler, Thomas Zander, Fabian Dusse, Othman Al-Sawaf, Philipp Köhler, Dennis Eichenauer, Matthias Kochanek, Alexander Shimabukuro-Vornhagen, Sibylle Mellinghoff, Annika Claßen, Jan-Michel Heger, Charlotte Meyer-Schwickerath, Paul Liedgens, Katrin Heindel, Ana Belkin, Asaf Biber, Mayan Gilboa, Itzchak Levy, Vladislav Litachevsky, Galia Rahav, Anat Finesod Wiedner, Tal Zilberman-Daniels, Yonatan Oster, Jacob Strahilevitz, Sigal Sviri, Elena M. Baldissera, Corrado Campochiaro, Giulio Cavalli, Lorenzo Dagna, Giacomo De Luca, Emanuel Della Torre, Alessandro Tomelleri, Davide Bernasconi De Luca, Amedeo F. Capetti, Massimo Coen, Maria V. Cossu, Massimo Galli, Andrea Giacomelli, Guido A. Gubertini, Stefano Rusconi, Giulia J. Burastero, Margherita Digaetano, Giovanni Guaraldi, Marianna Meschiari, Cristina Mussini, Cinzia Puzzolante, Sara Volpi, Marina Aiello, Alarico Ariani, Alfredo A. Chetta, Annalisa Frizzelli, Andrea Ticinesi, Domenico Tuttolomondo, Stefano Aliberti, Francesco B. Blasi, Marta F. Di Pasquale, Sofia Misuraca, Tommaso Pilocane, Edoardo Simonetta, Alessio M. Aghelmo, Claudio Angelini, Enrico Brunetta, Giorgio W. Canonica, Michele Ciccarelli, Sara Dal Farra, Maria De Santis, Sebastian Ferri, Marco Folci, Giacomo M. Guidelli, Enrico M. Heffler, Ferdinando Loiacono, Giacomo Malipiero, Giovanni Paoletti, Rosa Pedale, Francesca A. Puggioni, Francesca Racca, Aurora Zumbo, Morihiko Satou, Tatyana Lisun, Denis Protsenko, Nikolay Rubtsov, Irina Beloglazova, Daria Fomina, Mariana Lysenko, Sofia Serdotetskova, Vitali Firstov, Ivan Gordeev, Ilia Kokorin, Ksenia Komissarova, Nina Lapochkina, Elena Luchinkina, Valentin Malimon, Sevinch Mamedguseyinova, Ksenia Polubatonova, Natalia Suvorova, Jose Arribas, Alberto M. Borobia Perez, Fernando de la Calle Prieto, Juan Carlos Figueira, Rocio Motejano Sanchez, Marta Mora-Rillo, Concepcion Prados Sanchez, Javier Queiruga Parada, Francisco Fernandez Arnalich, Maria Guerro Barrientos, Alejandro Bendala Estrada, Aranzazu Caballero Marcos, Maria E. Garcia Leoni, Rita García-Martínez, Ana María Collado, Patricia Munoz Garcia, Ana Torres do Rego, María V. Villalba García, Almudena Burrillo, Maricela Valerio Minero, Paloma Gijon Vidaurreta, Sonsoles Infante Herrero, Elena Velilla, Marina Machado, Maria Olmedo, Blanca Pinilla, Benito Almirante Gragera, Maria de la Esperanza Cañas Ruano, Sofia Contreras Medina, Alejandro Cortés Herrera, Vicenç Falcó Ferrer, Ricard Ferrer Roca, Xavier Nuvials Casals, Esteve Ribera Pascuet, Paula Suanzes Diez, Pedro Rebollo Castro, Felipe Garcia Alcaide, Alejandro Soriano, Aina Oliver Caldes, Ana González Cordón, Celia Cardozo, Lorena De la Mora Cañizo, Romina Pena López, Sandra Chamorro, Clara Crespillo-Andujar, Rosa Escudero Sanchez, Jesús Fortún-Abete, Begoña Monge-Maillo, Ana Moreno Zamora, Francesca Norman, Matilde Sanchez Conde, Sergio Serrano Villar, Pilar Vizcarra, Lescure, F. -X., Honda, H., Fowler, R. A., Lazar, J. S., Shi, G., Wung, P., Patel, N., Hagino, O., Bazzalo, I. J., Casas, M. M., Nunez, S. A., Pere, Y., Ibarrola, C. M., Solis Aramayo, M. A., Cuesta, M. C., Duarte, A. E., Gutierrez Fernandez, P. M., Iannantuono, M. A., Miyazaki, E. A., Silvio, J. P., Scublinsky, D. G., Bales, A., Catarino, D., Fiss, E., Mohrbacher, S., Sato, V., Baylao, A., Cavalcante, A., Correa, F., de Andrade, C. A., Furtado, J., Ribeiro Filho, N., Telles, V., Trevelin, L. T., Vipich, R., Boldo, R., Borges, P., Lobo, S., Luckemeyer, G., Machado, L., Alves, M. B., Iglessias, A. C., Lago, M. M., Santos, D. W., Chapdelaine, H., Falcone, E. L., Jamal, R., Luong, M. -L., Durand, M., Doucet, S., Carrier, F. -M., Coburn, B. A., Del Sorbo, L., Walmsley, S. L., Belga, S., Chen, L. Y., Mah, A. D., Steiner, T., Wright, A. J., Hajek, J., Adhikari, N., Daneman, N., Khwaja, K. A., Shahin, J., Gonzalez, C., Silva, R., Lindh, M., Maluenda, G., Fernandez, P., Oyonarte, M., Lasso, M., Boyer, A., Bronnimann, D., Bui, H. -N., Cazanave, C., Chaussade, H., Desclaux, A., Ducours, M., Duvignaud, A., Malvy, D., Martin, L., Neau, D., Nguyen, D., Pistone, T., Soubrane-Wirth, G., Leitao, J., Allavena, C., Biron, C., Bouchez, S., Gaborit, B., Gregoire, A., Le Turnier, P., Lecompte, A. -S., Lecomte, R., Lefebvre, M., Raffi, F., Boutoille, D., Morineau, P. H., Guery, R., Chatelus, E., Dumoussaud, N., Felten, R., Luca, F., Goichot, B., Schneider, F., Taquet, M. -C., Groh, M., Roumier, M., Neuville, M., Bachelard, A., Isernia, V., Phung, B. -C., Rachline, A., Sautereau, A., Vallois, D., Bleher, Y., Boucher, D., Coudon, C., Esnault, J., Guimard, T., Leautez-Nainville, S., Merrien, D., Morrier, M., Motte-Vincent, P., Gabeff, R., Leclerc, H., Cozic, C., Decours, R., Fevrier, R., Colin, G., Abgrall, S., Vignes, D., Sterpu, R., Kuellmar, M., Meersch-Dini, M., Weiss, R., Zarbock, A., Antony, C., Berger, M., Brenner, T., Taube, C., Herbstreit, F., Dolff, S., Konik, M., Schmidt, K., Zettler, M., Witzke, O., Boell, B., Garcia Borrega, J., Koehler, P., Zander, T., Dusse, F., Al-Sawaf, O., Kohler, P., Eichenauer, D., Kochanek, M., Shimabukuro-Vornhagen, A., Mellinghoff, S., Classen, A., Heger, J. -M., Meyer-Schwickerath, C., Liedgens, P., Heindel, K., Belkin, A., Biber, A., Gilboa, M., Levy, I., Litachevsky, V., Rahav, G., Finesod Wiedner, A., Zilberman-Daniels, T., Oster, Y., Strahilevitz, J., Sviri, S., Baldissera, E. 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E., Contreras Medina, S., Cortes Herrera, A., Falco Ferrer, V., Ferrer Roca, R., Nuvials Casals, X., Ribera Pascuet, E., Suanzes Diez, P., Rebollo Castro, P., Garcia Alcaide, F., Soriano, A., Oliver Caldes, A., Gonzalez Cordon, A., Cardozo, C., De la Mora Canizo, L., Pena Lopez, R., Chamorro, S., Crespillo-Andujar, C., Escudero Sanchez, R., Fortun-Abete, J., Monge-Maillo, B., Moreno Zamora, A., Norman, F., Sanchez Conde, M., Serrano Villar, S., and Vizcarra, P.

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Critical Care, International Cooperation, Population, Antibodies, Monoclonal, Humanized, Placebo, Severity of Illness Index, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Intensive care, Severity of illness, medicine, Clinical endpoint, Humans, Immunologic Factors, 030212 general & internal medicine, Mortality, education, Respiratory Distress Syndrome, education.field_of_study, Dose-Response Relationship, Drug, SARS-CoV-2, business.industry, Hazard ratio, COVID-19, Articles, Middle Aged, Receptors, Interleukin-6, Sarilumab, Treatment Outcome, 030228 respiratory system, Female, Drug Monitoring, Cytokine Release Syndrome, business
Abstract

Summary Background Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. Methods We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. Findings Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference −1·7 [−9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [−6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI −7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. Interpretation This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. Funding Sanofi and Regeneron Pharmaceuticals.

Published
2021

13. Global surveillance of trends in cancer survival 2000-14 (concord-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries

Author

Claudia Allemani, Tomohiro Matsuda, Veronica Di Carlo, Rhea Harewood, Melissa Matz, Maja Nikšić, Audrey Bonaventure, Mikhail Valkov, Christopher J Johnson, Jacques Estève, Olufemi J Ogunbiyi, Gulnar Azevedo e Silva, Wan-Qing Chen, Sultan Eser, Gerda Engholm, Charles A Stiller, Alain Monnereau, Ryan R Woods, Otto Visser, Gek Hsiang Lim, Joanne Aitken, Hannah K Weir, Michel P Coleman, S Bouzbid, M Hamdi-Chérif, Z Zaidi, K Meguenni, D Regagba, S Bayo, T Cheick Bougadari, S S Manraj, A Fabowale, O J Ogunbiyi, D Bradshaw, N I M Somdyala, I Kumcher, F Moreno, G H Calabrano, S B Espinola, B Carballo Quintero, R Fita, M C Diumenjo, W D Laspada, S G Ibañez, C A Lima, P C F De Souza, K Del Pino, C Laporte, M P Curado, J C de Oliveira, C L A Veneziano, D B Veneziano, M R D O Latorre, L F Tanaka, M S Rebelo, M O Santos, G Azevedo e Silva, J C Galaz, M Aparicio Aravena, J Sanhueza Monsalve, D A Herrmann, S Vargas, V M Herrera, C J Uribe, L E Bravo, L S Garcia, N E Arias-Ortiz, D Morantes, D M Jurado, M C Yépez Chamorro, S Delgado, M Ramirez, Y H Galán Alvarez, P Torres, F Martínez-Reyes, L Jaramillo, R Quinto, J, M Mendoza, P Cueva, J G Yépez, B Bhakkan, J Deloumeaux, C Joachim, J Macni, R Carrillo, J Shalkow Klincovstein, R Rivera Gomez, E Poquioma, G Tortolero-Luna, D Zavala, R Alonso, E Barrios, A Eckstrand, C Nikiforuk, R R Woods, G Noonan, D Turner, E Kumar, B Zhang, F R McCrate, S Ryan, M MacIntyre, N Saint-Jacques, D E Nishri, C A McClure, K A Vriends, S Kozie, H Stuart-Panko, T Freeman, J T George, J T Brockhouse, D K O'Brien, A Holt, L Almon, S Kwong, C Morris, R Rycroft, L Mueller, C E Phillips, H Brown, B Cromartie, A G Schwartz, F Vigneau, G M Levin, B Wohler, R Bayakly, K C Ward, S L Gomez, M McKinley, R Cress, M D Green, K Miyagi, C J Johnson, L P Ruppert, C F Lynch, B Huang, T C Tucker, D Deapen, L Liu, M C Hsieh, X C Wu, M Schwenn, S T Gershman, R C Knowlton, G Alverson, G E Copeland, S Bushhouse, D B Rogers, J Jackson-Thompson, D Lemons, H J Zimmerman, M Hood, J Roberts-Johnson, J R Rees, B Riddle, K S Pawlish, A Stroup, C Key, C Wiggins, A R Kahn, M J Schymura, S Radhakrishnan, C Rao, L K Giljahn, R M Slocumb, R E Espinoza, F Khan, K G Aird, T Beran, J J Rubertone, S J Slack, L Garcia, D L Rousseau, T A Janes, S M Schwartz, S W Bolick, D M Hurley, M A Whiteside, P Miller-Gianturco, M A Williams, K Herget, C Sweeney, A T Johnson, M B Keitheri Cheteri, P Migliore Santiago, S E Blankenship, S Farley, R Borchers, R Malicki, J R Espinoza, J Grandpre, H K Weir, R Wilson, B K Edwards, A Mariotto. 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(UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Claudia Allemani, Tomohiro Matsuda, Veronica Di Carlo, Rhea Harewood, Melissa Matz, Maja Nikšić, Audrey Bonaventure, Mikhail Valkov, Christopher J Johnson, Jacques Estève, Olufemi J Ogunbiyi, Gulnar Azevedo e Silva, Wan-Qing Chen, Sultan Eser, Gerda Engholm, Charles A Stiller, Alain Monnereau, Ryan R Woods, Otto Visser, Gek Hsiang Lim, Joanne Aitken, Hannah K Weir, Michel P Coleman, S Bouzbid, M Hamdi-Chérif, Z Zaidi, K Meguenni, D Regagba, S Bayo, T Cheick Bougadari, S S Manraj, A Fabowale, O J Ogunbiyi, D Bradshaw, N I M Somdyala, I Kumcher, F Moreno, G H Calabrano, S B Espinola, B Carballo Quintero, R Fita, M C Diumenjo, W D Laspada, S G Ibañez, C A Lima, P C F De Souza, K Del Pino, C Laporte, M P Curado, J C de Oliveira, C L A Veneziano, D B Veneziano, M R D O Latorre, L F Tanaka, M S Rebelo, M O Santos, G Azevedo e Silva, J C Galaz, M 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Subjects
0301 basic medicine, Universal Health Coverage, population-based registries, Relative Survival, Settore MED/42 - Igiene Generale E Applicata, Cancer -- Treatment, Humans, Neoplasms, Population Surveillance, Registries, Survival Rate, Medicine (all), 0302 clinical medicine, cancer survival, education.field_of_study, Relative survival, EPICENE, General Medicine, 3. Good health, trend, 030220 oncology & carcinogenesis, Public-Health, cancer surveillance, Liver cancer, survival, cancer registry, CONCORD-3, Cure, Childhood-Cancer, medicine.medical_specialty, population-based cancer registries, Womens Cancers, Population, Medicine (all),cancer survival, population-based cancer registries, Socio-culturale, United-States, Article, 03 medical and health sciences, Breast cancer, Cancer epidemiology, medicine, Nordic-Countries, Cancer -- Mortality, education, Survival rate, Cancer prevention, Alternative Approach, business.industry, Public health, Cancer, Cancer -- Patients -- Long-term care, medicine.disease, 030104 developmental biology, High-Income Countries, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Demography
Abstract

Eser, Sultan (Balikesir Author), Background In 2015, the second cycle of the CONCORD programme established global surveillance of cancer survival as a metric of the effectiveness of health systems and to inform global policy on cancer control. CONCORD-3 updates the worldwide surveillance of cancer survival to 2014. Methods CONCORD-3 includes individual records for 37.5 million patients diagnosed with cancer during the 15-year period 2000-14. Data were provided by 322 population-based cancer registries in 71 countries and territories, 47 of which provided data with 100% population coverage. The study includes 18 cancers or groups of cancers: oesophagus, stomach, colon, rectum, liver, pancreas, lung, breast (women), cervix, ovary, prostate, and melanoma of the skin in adults, and brain tumours, leukaemias, and lymphomas in both adults and children. Standardised quality control procedures were applied; errors were rectified by the registry concerned. We estimated 5-year net survival. Estimates were age-standardised with the International Cancer Survival Standard weights.Findings For most cancers, 5-year net survival remains among the highest in the world in the USA and Canada, in Australia and New Zealand, and in Finland, Iceland, Norway, and Sweden. For many cancers, Denmark is closing the survival gap with the other Nordic countries. Survival trends are generally increasing, even for some of the more lethal cancers: in some countries, survival has increased by up to 5% for cancers of the liver, pancreas, and lung. For women diagnosed during 2010-14, 5-year survival for breast cancer is now 89.5% in Australia and 90.2% in the USA, but international differences remain very wide, with levels as low as 66.1% in India. For gastrointestinal cancers, the highest levels of 5-year survival are seen in southeast Asia: in South Korea for cancers of the stomach (68.9%), colon (71.8%), and rectum (71.1%); in Japan for oesophageal cancer (36.0%); and in Taiwan for liver cancer (27.9%). By contrast, in the same world region, survival is generally lower than elsewhere for melanoma of the skin (59.9% in South Korea, 52.1% in Taiwan, and 49.6% in China), and for both lymphoid malignancies (52.5%, 50.5%, and 38.3%) and myeloid malignancies (45.9%, 33.4%, and 24.8%). For children diagnosed during 2010-14, 5-year survival for acute lymphoblastic leukaemia ranged from 49.8% in Ecuador to 95.2% in Finland. 5-year survival from brain tumours in children is higher than for adults but the global range is very wide (from 28.9% in Brazil to nearly 80% in Sweden and Denmark). Interpretation The CONCORD programme enables timely comparisons of the overall effectiveness of health systems in providing care for 18 cancers that collectively represent 75% of all cancers diagnosed worldwide every year. It contributes to the evidence base for global policy on cancer control. Since 2017, the Organisation for Economic Co-operation and Development has used findings from the CONCORD programme as the official benchmark of cancer survival, among their indicators of the quality of health care in 48 countries worldwide. Governments must recognise population-based cancer registries as key policy tools that can be used to evaluate both the impact of cancer prevention strategies and the effectiveness of health systems for all patients diagnosed with cancer., American Cancer Society Centers for Disease Control and Prevention Swiss Re Swiss Cancer Research foundation Swiss Cancer League Institut National du Cancer La Ligue Contre le Cancer Rossy Family Foundation US National Cancer Institute Susan G Komen Foundation

Published
2018

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