Original article
Women with nonischemic cardiomyopathy have a favorable prognosis and a better left ventricular remodeling than men after cardiac resynchronization therapy Manlio Cipriania, Maurizio Landolinab, Fabrizio Olivaa, Stefano Ghiob, Sara Vargiua, Roberto Rordorfb, Claudia Rainerib, Enrico Ammiratia, Barbara Petraccib, Claudia Campoc, Silvia Bisettid and Maurizio Lunatia Aims Cardiac resynchronization therapy (CRT) is a well established therapy in heart failure patients who are on optimal medical therapy and have reduced left ventricular ejection fraction (LVEF) and wide QRS complexes. Although women and patients with nonischemic cardiomyopathy are under-represented in CRT trials and registries, there is evidence that these two groups of patients can benefit more from CRT. The aim of our analysis was to investigate the impact of female sex on mortality in a population that included a high percentage of patients (61%) with nonischemic cardiomyopathy. Methods We analyzed data on 507 consecutive patients (20% women) who received CRT at two Italian Heart Transplant centers and were followed up for a maximum of 48 months. Results After multivariate adjustment, women showed a trend toward better survival with regard to all-cause mortality [hazard ratio (HR) 0.32, confidence interval (CI) 0.10–1.04; P U 0.059]. However, this benefit was limited to nonischemic patients with regard to all-cause mortality
Introduction Cardiac resynchronization therapy (CRT) has been shown to reduce the risk of death or hospitalization because of worsening heart failure and to improve functional status and left ventricular function in patients with advanced heart failure, left ventricular dysfunction and wide QRS.1–4 More recently, CRT indications have been also extended to mildly symptomatic patients.5–7 It is acknowledged that there are sex differences in heart failure epidemiology, clinical presentation, response to therapy and prognosis.8–13 Indeed, heart failure is slightly less common in women than in men. Moreover, better prognoses among women have been observed in epidemiological surveys, which have been clouded by female under-representation and limited power.14 Women have also been under-represented in large randomized CRT clinical trials, and the results concerning the relative benefit for women in CRT experiences have been conflicting.15–17 Patients with nonischemic causes of heart failure have also been under-represented (generally below 40%) in 1558-2027 ß 2016 Italian Federation of Cardiology. All rights reserved.
(HR 0.20, CI 0.05–0.87, P U 0.032) and cardiovascular mortality (HR 0.14, CI 0.02–1.05, P U 0.056). Conclusion Female CRT recipients, at mid-term, have a favorable prognosis than male patients and this benefit appears to be more evident in nonischemic patients. Thus, we strongly believe that the apparent under-utilization of CRT in females is an anomaly that should be corrected. J Cardiovasc Med 2016, 17:291–298 Keywords: cardiac resynchronization therapy, heart failure, outcome, sex a ‘A De Gasperis’ Cardiac Department, Niguarda Ca’ Granda, Granda Hospital, Milan, bCardiac Department, Policlinico San Matteo, Pavia, cMedtronic Clinical Research Institute and dMedtronic Italia S.p.A., Milano, Italy
Correspondence to Manlio Cipriani, Dipartimento CardioToracoVascolare ‘A. De Gasperis’ Ospedale Niguarda Ca’ Granda, Piazza Ospedale Maggiore 3, 20162 Milano, Italy Tel: +39 02 6444 7791; fax: +39 02 6444 2566; e-mail: [email protected] Received 11 February 2014 Revised 27 June 2014 Accepted 30 June 2014
most trials and registries that have evaluated the impact of female sex on response to CRT. Moreover, little is known about the impact of ischemic vs. nonischemic cause on CRT outcomes in females as opposed to males. Finally, data on the impact of sex have mainly been provided by North American and Northern Europe studies, whereas no large datasets are available for Southern Europe. We analyzed the impact of sex on 1-year postimplantation clinical and echocardiographic responses and on midterm outcome in a large cohort of CRT patients, many of whom (61%) had heart failure of nonischemic cause, who had undergone implantation and had been followed up by two Italian Heart Transplant centers.
Methods Patient cohort
We evaluated 507 patients (Table 1) who had received CRT alone (CRT-P) or in combination with an implantable cardioverter defibrillator (ICD) (CRT-D) between 1999 and 2010 at 2 Italian Heart Transplantation Centers. DOI:10.2459/JCM.0000000000000187
© 2016 Italian Federation of Cardiology. All rights reserved
All variables associated to a P value
Women with nonischemic cardiomyopathy have a favorable prognosis and a better left ventricular remodeling than men after cardiac resynchronization therapy Manlio Cipriania, Maurizio Landolinab, Fabrizio Olivaa, Stefano Ghiob, Sara Vargiua, Roberto Rordorfb, Claudia Rainerib, Enrico Ammiratia, Barbara Petraccib, Claudia Campoc, Silvia Bisettid and Maurizio Lunatia Aims Cardiac resynchronization therapy (CRT) is a well established therapy in heart failure patients who are on optimal medical therapy and have reduced left ventricular ejection fraction (LVEF) and wide QRS complexes. Although women and patients with nonischemic cardiomyopathy are under-represented in CRT trials and registries, there is evidence that these two groups of patients can benefit more from CRT. The aim of our analysis was to investigate the impact of female sex on mortality in a population that included a high percentage of patients (61%) with nonischemic cardiomyopathy. Methods We analyzed data on 507 consecutive patients (20% women) who received CRT at two Italian Heart Transplant centers and were followed up for a maximum of 48 months. Results After multivariate adjustment, women showed a trend toward better survival with regard to all-cause mortality [hazard ratio (HR) 0.32, confidence interval (CI) 0.10–1.04; P U 0.059]. However, this benefit was limited to nonischemic patients with regard to all-cause mortality
Introduction Cardiac resynchronization therapy (CRT) has been shown to reduce the risk of death or hospitalization because of worsening heart failure and to improve functional status and left ventricular function in patients with advanced heart failure, left ventricular dysfunction and wide QRS.1–4 More recently, CRT indications have been also extended to mildly symptomatic patients.5–7 It is acknowledged that there are sex differences in heart failure epidemiology, clinical presentation, response to therapy and prognosis.8–13 Indeed, heart failure is slightly less common in women than in men. Moreover, better prognoses among women have been observed in epidemiological surveys, which have been clouded by female under-representation and limited power.14 Women have also been under-represented in large randomized CRT clinical trials, and the results concerning the relative benefit for women in CRT experiences have been conflicting.15–17 Patients with nonischemic causes of heart failure have also been under-represented (generally below 40%) in 1558-2027 ß 2016 Italian Federation of Cardiology. All rights reserved.
(HR 0.20, CI 0.05–0.87, P U 0.032) and cardiovascular mortality (HR 0.14, CI 0.02–1.05, P U 0.056). Conclusion Female CRT recipients, at mid-term, have a favorable prognosis than male patients and this benefit appears to be more evident in nonischemic patients. Thus, we strongly believe that the apparent under-utilization of CRT in females is an anomaly that should be corrected. J Cardiovasc Med 2016, 17:291–298 Keywords: cardiac resynchronization therapy, heart failure, outcome, sex a ‘A De Gasperis’ Cardiac Department, Niguarda Ca’ Granda, Granda Hospital, Milan, bCardiac Department, Policlinico San Matteo, Pavia, cMedtronic Clinical Research Institute and dMedtronic Italia S.p.A., Milano, Italy
Correspondence to Manlio Cipriani, Dipartimento CardioToracoVascolare ‘A. De Gasperis’ Ospedale Niguarda Ca’ Granda, Piazza Ospedale Maggiore 3, 20162 Milano, Italy Tel: +39 02 6444 7791; fax: +39 02 6444 2566; e-mail: [email protected] Received 11 February 2014 Revised 27 June 2014 Accepted 30 June 2014
most trials and registries that have evaluated the impact of female sex on response to CRT. Moreover, little is known about the impact of ischemic vs. nonischemic cause on CRT outcomes in females as opposed to males. Finally, data on the impact of sex have mainly been provided by North American and Northern Europe studies, whereas no large datasets are available for Southern Europe. We analyzed the impact of sex on 1-year postimplantation clinical and echocardiographic responses and on midterm outcome in a large cohort of CRT patients, many of whom (61%) had heart failure of nonischemic cause, who had undergone implantation and had been followed up by two Italian Heart Transplant centers.
Methods Patient cohort
We evaluated 507 patients (Table 1) who had received CRT alone (CRT-P) or in combination with an implantable cardioverter defibrillator (ICD) (CRT-D) between 1999 and 2010 at 2 Italian Heart Transplantation Centers. DOI:10.2459/JCM.0000000000000187
© 2016 Italian Federation of Cardiology. All rights reserved
All variables associated to a P value
