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Combination Therapy for Severe Heart Failure
The 15th Annual Scientific Meeting
JHFS
S137
Symposium 11 S11-1 Early and Long-term Results of Left Ventriculoplasty for Ischemic Cardiomyopathy-Japanese Multicenter StudyYOSHIRO MATSUI1, HIROKUNI ARAI2, TADASHI ISOMURA3, KIYOKAZU KOKAJI4, JUNJIRO KOBAYASHI5, TATSUIHIKO KOMIYA6, YOSHIKI SAWA7, SHUICHIRO TAKANASHI8, HITOSHI YAKU9, ATSUSHI YAMAGUCHI10 1 Department of Cardiovascular Surgery, Hokkaido University Graduate School of Medicine, 2The Department of Cardiovascular Surgery, Tokyo, Japan, 3Hayama Heart Center, Hayama, Japan, 4Keio University, Tokyo, Japan, 5National Cardiovascular Center, Osaka, Japan, 6Kurashiki Central Hospital, Kurashiki, Japan, 7Osaka University, Osaka, Japan, 8Sakakibara Memorial Hospital, Chohu, Japan, 9Kyoto Prefectural University of Medicine, Kyoto, Japan, 10Saitama Medical Center, Jichi Medical University, Omiya, Japan The purpose of this retrospective study is to present the early and late results of left ventriculoplasty (LVP) for the patients with ischemic cardiomyopathy (ICM) in Japanese cohort. Methods: The study subjects were 323 patient with complete preoperative volume analysis, LV shape classification, and LVEF!35%. The median (interquartile) age was 64(57-70) years. The median LVEF was 24(18-30) %, LVDd was 63(59-70) mm, LVESVI was 113(88-142) ml/m2, and MR gradeO3 was 88 cases (27%). CABG was done in 247 cases (76%). The methods of LVP were Dor in 121, SAVE in 101, overlapping in 43, and other operations in 35. The annuloplasty was performed in 164 (51%). Results: Hospital mortality was 15 (5%). The 1, 5 and 10 year survival was 89, 73, and 59% respectively. LVDd and LVESVI were significantly reduced to 59 (53-63) mm and to 68 (55-93) ml/m2. LVEF significantly improved to 31 (24-39)% (p!0.001). Preoperative NYHA class IV, MRO3 and LVESVI were the independent predictors of postoperative death. LV shape classification or LVP methods did not influence on early and late results. Conclusions: LVP in Japanese cohort demonstrated satisfactory results. Preoperative NYHA class IV, severe MR, and large LV were significant predictors of postoperative death. LVP combined with artificial heart would be discussed as a bridge to recover.
S11-2 Treatment of Profound Heart Failure with Left Ventricular Assist Systems and Heart Transplantation TAKESHI NAKATANI, KOUICHI TODA, MASANOBU YANASE, TOMOYUKIO FUJITA, OSAMU SEGUCHI, YOSHIHIRO MURATA National Cerebral and Cardiovascular Center In cases of profound heart failure, left ventricular assist systems (LVAS) or heart transplantation (HTx) should be considered as the therapeutic option. We applied several types of LVAS including extracorporeal type, implantable-pulsatile type, and implantable-rotary type to 131 patients of acute deterioration of chronic heart failure. Of those, 31 patients were transplanted at our center and mean support duration was 889 days and the longest one was 1730 days by Niporo LVAS. New registry system for implantable LVAS, Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) was established and expected to promote their suitable application. Thirty-six heart transplantations were performed at our Center including cases of marginal donors and critical condition of candidates. Only one died 4.2 years after heart transplantation due to infection, and the others are doing well up to 12.2 years after heart transplantation. Implantable LVAS and heart transplantation are now therapeutic option for profound heart failure patients.
S11-3 New Era of Ventricular Assist Device Treatment for Adults and Children MINORU ONO1, TAKASHI NISHIMURA2, OSAMU KINOSHITA1, TARO SHIGA3, KOICHIRO KINUGAWA3, RYOZO NAGAI3, SHUNEI KYO2 1 Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan, 2 Department of Therapeutic Strategy for Heart Failure, The University of Tokyo, Tokyo, Japan, 3Department of Cardiology, The Uinversity of Tokyo, Tokyo, Japan Background: Major changes occurred recently in the treatment of advanced heart failure in Japan. Heart transplantation (HTx) is increasing thanks to the revised organ transplantation law. Two implantable ventricular assist devices (VAD) were approved for health insurance coverage in April 2011.Patients and methods: Seventy-four patients (mean age 39.0 years, 24 females) underwent VAD implantation in our hospital. Dilated cardiomyopathy was the leading cause (58%). Nipro paracorporeal VAD was used in 62 patients, whereas implantable VADs in 12. Outcomes in these patients were reviewed.Results: Mean assist duration was 556 days with significantly longer support in implantable VADs (811 days) than paracorporeal VAD (519 days). Twenty-five patients underwent HTx successfully, seven weaned from VAD and 17 on device. Actuarial survivals at 1, 3 and 5 years were 77.1%, 66.3% and 59.3% with favorable late survival in implantable VADs group. INTERMACS profile 1
patients had worse late survival than those in other profiles.Conclusions and discussion: Results of VAD implantation were improving. Emergence of implantable VADs may dramatically change the treatment flowchart of advanced heart failure patients in Japan. Earlier patients’ referral before profile 1 is important for favorable outcomes. Clinical trial of Berlin Heart pediatric Excor is about to be started. Expedite introduction of child VAD is strongly desired to equally offer VAD implantation to patients of all age group.
S11-4 Currenst Status of Heart Transplantation after Revision of the Japanese Organ Transplant Act NORIHIDE FUKUSHIMA, YOSHIKI SAWA Department of Cardiovascular Surgery, Osaka University, Suita, Japan Only 69 heart transplantations (HTx) were undergone and no children younger than 15 years of age could donate their organs after brain death until the Japanese Organ Transplantation Act was revised on 17th July in 2010, because only persons who had a written consent for organ donation after brain death could donate their organs. Therefore, small children could not undergo HTx in Japan and many Japanese children had been abroad to undergo HTx. By renewal of the law, organs can be donated after brain death by consent of their relatives, if he or she did not deny organ donation. From this reason, there is currently a possibility for small children to undergo HTx in Japan. After the revision of the Act, brain dead organ donation increased dramatically and 49 brain dead donations were preformed until the end of May, 2011. Out of 49 donors, 34 HTx were undergone. In April, a child with restrictive cardiomyopathy underwent HTx from a pediatric donor younger than 15 years of age. Currently, 2 surgeons from each heart transplant centers were selected as a medical consultant doctor to evaluate which organs could be transplanted and stabilized donor hemodynamics using anti-diuretic hormones before and during organ procurement operation. This system increased the number of organs transplanted from one donor to 5.8 in Japan (3.0 in USA).
S11-5 Combination Therapy for Severe Heart Failure YOSHIKI SAWA Department of Cardiovascular Surgery, Osaka University, Osaka, Japan Human cardiac regeneration therapy has been performed by using various sources of stem cell. Myoblasts and bone marrow cells have been injected for patients with ischemic cardiomyopathy in our clinical trial and improved cardiac performance. We had examined the efficacy of stem cell therapy using tissue engineered sheet technique compared to needle injection. This technique has advantages such as the ability for treatment to large area, and less invasive for host heart such as lethal arrhythmia. In vivo, implantation of autologous myoblast sheet had improved cardiac function of ischemic or dilated cardiomyopathy models using rat, hamster, canine and porcine models. We also showed that myoblast sheets provided various factors inducing angiogenesis, hematopoietic cell recruitment and anti-apoptosis, following anti-remodeling. Thus, after approved by IRB of our institution, we have started the clinical trial of myoblast sheet implantation for DCM patients, and assessed the feasibility and efficacy for the first patient. In this patient, any sequelae including arrhythmia have not occurred after implantation, and the cardiac function showed recovery. Furthermore, we have investigated several improvement of this technology for the layered implantation for ischemic heart, for right heart failure, and another cell source to construct the sheet. Thus, stem cell sheet implantation could be safe and eligible as cardiac regeneration therapy.
S11-6 The New Era of Transcatheter Aortic Valve Implantation for the Treatment of Aortic Valve Stenosis TORU KURATANI1, KEI TORIKAI1, ISAMU MIZOTE2, KAZUO SHIMAMURA1, YASUSHI SAKATA2, YASUHARU TAKEDA2, SATHOSHI NAKATANI2, SHINSUKE NANTO2, YOSHIKI SAWA1 1 Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2Department of Cardiovascular Medicine, Osaka University of Graduate School of Medicine Transcatheter aortic valve implantation was first carried out in 2002, and has been performed in over 20,000 cases across the globe. In 2009, we performed the first case of TAVI in Japan, and have since carried out a total of 23 cases at our institution. Given the prohibition of disclosing data from clinical trials to the public in Japan, we
JHFS
S137
Symposium 11 S11-1 Early and Long-term Results of Left Ventriculoplasty for Ischemic Cardiomyopathy-Japanese Multicenter StudyYOSHIRO MATSUI1, HIROKUNI ARAI2, TADASHI ISOMURA3, KIYOKAZU KOKAJI4, JUNJIRO KOBAYASHI5, TATSUIHIKO KOMIYA6, YOSHIKI SAWA7, SHUICHIRO TAKANASHI8, HITOSHI YAKU9, ATSUSHI YAMAGUCHI10 1 Department of Cardiovascular Surgery, Hokkaido University Graduate School of Medicine, 2The Department of Cardiovascular Surgery, Tokyo, Japan, 3Hayama Heart Center, Hayama, Japan, 4Keio University, Tokyo, Japan, 5National Cardiovascular Center, Osaka, Japan, 6Kurashiki Central Hospital, Kurashiki, Japan, 7Osaka University, Osaka, Japan, 8Sakakibara Memorial Hospital, Chohu, Japan, 9Kyoto Prefectural University of Medicine, Kyoto, Japan, 10Saitama Medical Center, Jichi Medical University, Omiya, Japan The purpose of this retrospective study is to present the early and late results of left ventriculoplasty (LVP) for the patients with ischemic cardiomyopathy (ICM) in Japanese cohort. Methods: The study subjects were 323 patient with complete preoperative volume analysis, LV shape classification, and LVEF!35%. The median (interquartile) age was 64(57-70) years. The median LVEF was 24(18-30) %, LVDd was 63(59-70) mm, LVESVI was 113(88-142) ml/m2, and MR gradeO3 was 88 cases (27%). CABG was done in 247 cases (76%). The methods of LVP were Dor in 121, SAVE in 101, overlapping in 43, and other operations in 35. The annuloplasty was performed in 164 (51%). Results: Hospital mortality was 15 (5%). The 1, 5 and 10 year survival was 89, 73, and 59% respectively. LVDd and LVESVI were significantly reduced to 59 (53-63) mm and to 68 (55-93) ml/m2. LVEF significantly improved to 31 (24-39)% (p!0.001). Preoperative NYHA class IV, MRO3 and LVESVI were the independent predictors of postoperative death. LV shape classification or LVP methods did not influence on early and late results. Conclusions: LVP in Japanese cohort demonstrated satisfactory results. Preoperative NYHA class IV, severe MR, and large LV were significant predictors of postoperative death. LVP combined with artificial heart would be discussed as a bridge to recover.
S11-2 Treatment of Profound Heart Failure with Left Ventricular Assist Systems and Heart Transplantation TAKESHI NAKATANI, KOUICHI TODA, MASANOBU YANASE, TOMOYUKIO FUJITA, OSAMU SEGUCHI, YOSHIHIRO MURATA National Cerebral and Cardiovascular Center In cases of profound heart failure, left ventricular assist systems (LVAS) or heart transplantation (HTx) should be considered as the therapeutic option. We applied several types of LVAS including extracorporeal type, implantable-pulsatile type, and implantable-rotary type to 131 patients of acute deterioration of chronic heart failure. Of those, 31 patients were transplanted at our center and mean support duration was 889 days and the longest one was 1730 days by Niporo LVAS. New registry system for implantable LVAS, Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) was established and expected to promote their suitable application. Thirty-six heart transplantations were performed at our Center including cases of marginal donors and critical condition of candidates. Only one died 4.2 years after heart transplantation due to infection, and the others are doing well up to 12.2 years after heart transplantation. Implantable LVAS and heart transplantation are now therapeutic option for profound heart failure patients.
S11-3 New Era of Ventricular Assist Device Treatment for Adults and Children MINORU ONO1, TAKASHI NISHIMURA2, OSAMU KINOSHITA1, TARO SHIGA3, KOICHIRO KINUGAWA3, RYOZO NAGAI3, SHUNEI KYO2 1 Department of Cardiac Surgery, The University of Tokyo, Tokyo, Japan, 2 Department of Therapeutic Strategy for Heart Failure, The University of Tokyo, Tokyo, Japan, 3Department of Cardiology, The Uinversity of Tokyo, Tokyo, Japan Background: Major changes occurred recently in the treatment of advanced heart failure in Japan. Heart transplantation (HTx) is increasing thanks to the revised organ transplantation law. Two implantable ventricular assist devices (VAD) were approved for health insurance coverage in April 2011.Patients and methods: Seventy-four patients (mean age 39.0 years, 24 females) underwent VAD implantation in our hospital. Dilated cardiomyopathy was the leading cause (58%). Nipro paracorporeal VAD was used in 62 patients, whereas implantable VADs in 12. Outcomes in these patients were reviewed.Results: Mean assist duration was 556 days with significantly longer support in implantable VADs (811 days) than paracorporeal VAD (519 days). Twenty-five patients underwent HTx successfully, seven weaned from VAD and 17 on device. Actuarial survivals at 1, 3 and 5 years were 77.1%, 66.3% and 59.3% with favorable late survival in implantable VADs group. INTERMACS profile 1
patients had worse late survival than those in other profiles.Conclusions and discussion: Results of VAD implantation were improving. Emergence of implantable VADs may dramatically change the treatment flowchart of advanced heart failure patients in Japan. Earlier patients’ referral before profile 1 is important for favorable outcomes. Clinical trial of Berlin Heart pediatric Excor is about to be started. Expedite introduction of child VAD is strongly desired to equally offer VAD implantation to patients of all age group.
S11-4 Currenst Status of Heart Transplantation after Revision of the Japanese Organ Transplant Act NORIHIDE FUKUSHIMA, YOSHIKI SAWA Department of Cardiovascular Surgery, Osaka University, Suita, Japan Only 69 heart transplantations (HTx) were undergone and no children younger than 15 years of age could donate their organs after brain death until the Japanese Organ Transplantation Act was revised on 17th July in 2010, because only persons who had a written consent for organ donation after brain death could donate their organs. Therefore, small children could not undergo HTx in Japan and many Japanese children had been abroad to undergo HTx. By renewal of the law, organs can be donated after brain death by consent of their relatives, if he or she did not deny organ donation. From this reason, there is currently a possibility for small children to undergo HTx in Japan. After the revision of the Act, brain dead organ donation increased dramatically and 49 brain dead donations were preformed until the end of May, 2011. Out of 49 donors, 34 HTx were undergone. In April, a child with restrictive cardiomyopathy underwent HTx from a pediatric donor younger than 15 years of age. Currently, 2 surgeons from each heart transplant centers were selected as a medical consultant doctor to evaluate which organs could be transplanted and stabilized donor hemodynamics using anti-diuretic hormones before and during organ procurement operation. This system increased the number of organs transplanted from one donor to 5.8 in Japan (3.0 in USA).
S11-5 Combination Therapy for Severe Heart Failure YOSHIKI SAWA Department of Cardiovascular Surgery, Osaka University, Osaka, Japan Human cardiac regeneration therapy has been performed by using various sources of stem cell. Myoblasts and bone marrow cells have been injected for patients with ischemic cardiomyopathy in our clinical trial and improved cardiac performance. We had examined the efficacy of stem cell therapy using tissue engineered sheet technique compared to needle injection. This technique has advantages such as the ability for treatment to large area, and less invasive for host heart such as lethal arrhythmia. In vivo, implantation of autologous myoblast sheet had improved cardiac function of ischemic or dilated cardiomyopathy models using rat, hamster, canine and porcine models. We also showed that myoblast sheets provided various factors inducing angiogenesis, hematopoietic cell recruitment and anti-apoptosis, following anti-remodeling. Thus, after approved by IRB of our institution, we have started the clinical trial of myoblast sheet implantation for DCM patients, and assessed the feasibility and efficacy for the first patient. In this patient, any sequelae including arrhythmia have not occurred after implantation, and the cardiac function showed recovery. Furthermore, we have investigated several improvement of this technology for the layered implantation for ischemic heart, for right heart failure, and another cell source to construct the sheet. Thus, stem cell sheet implantation could be safe and eligible as cardiac regeneration therapy.
S11-6 The New Era of Transcatheter Aortic Valve Implantation for the Treatment of Aortic Valve Stenosis TORU KURATANI1, KEI TORIKAI1, ISAMU MIZOTE2, KAZUO SHIMAMURA1, YASUSHI SAKATA2, YASUHARU TAKEDA2, SATHOSHI NAKATANI2, SHINSUKE NANTO2, YOSHIKI SAWA1 1 Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, 2Department of Cardiovascular Medicine, Osaka University of Graduate School of Medicine Transcatheter aortic valve implantation was first carried out in 2002, and has been performed in over 20,000 cases across the globe. In 2009, we performed the first case of TAVI in Japan, and have since carried out a total of 23 cases at our institution. Given the prohibition of disclosing data from clinical trials to the public in Japan, we