Background After a median sternotomy, mediastinitis may develop, necessitating reopening of the c... more Background After a median sternotomy, mediastinitis may develop, necessitating reopening of the chest. Rarely, reoperation due to hematoma after cardiovascular surgery is experienced. In the present case, we experienced a patient who initially had mediastinitis, but later developed a chronic hematoma and underwent multiple surgeries. Case presentation The patient was a 40-year-old man who underwent aortic valve replacement for a bicuspid aortic valve and a graft for a dilated ascending aorta. Postoperatively, he developed hematoma in the anterior mediastinum on multiple occasions with repeated episodes of infection that required multiple median sternotomies. Conclusions We reported our experience with a rare case of multiple median sternotomies. In the early stage, mediastinitis due to infection was observed, and in the late stage, mediastinal dilatation due to hemorrhage was observed.
Journal of Heart and Lung Transplantation, Apr 1, 2020
PURPOSE Aortic valve incompetence (AI) is a serious complication that develops in 20% of LVAD pat... more PURPOSE Aortic valve incompetence (AI) is a serious complication that develops in 20% of LVAD patients within 12 months of implantation. Many LVAD patients with AI also develop mitral regurgitation (MR). Our goal in this study was to measure systemic flow (Qsys) and LVAD flow (QLVAD) during AI, MR and AI+MR. METHODS A mock circulatory loop with a dilated silicone LV and bioprosthetic valves was attached to a HeartMate II LVAD (Abbott Labs), and pressure and flow measured in the LV, LVAD and aorta. A Pre-LVAD ejection fraction of 20% without any valve dysfunction was established, followed LVAD support at speeds of 8, 9.4 and 11krpm. AI and MR were created with small stents that were non-obstructive to forward flow but prevented the leaflets from fully closing. Four conditions were tested: Normal, AI, MR and AI and MR combined. Average flow was obtained from ten cycles of data, and Q calculated as QLVAD/Qsys. RESULTS Pre-LVAD AI, MR and AI+MR produced a 28%, 12% and 45% reduction in Qsys, respectively. LVAD support at 9.4krpm increased Normal Qsys to 3.6 L/min with 95% of flow through the LVAD. MR reduced Qsys by 16% and QLVADby 21%; AI reduced by Qsys by 24% but QLVADby only 5%; and AI+MR reduced Qsys by 25% and QLVADby 7%, which was comparable to AI alone. In all conditions except AI+MR, Q increases with LVAD speed indicating that QLVAD increases faster than Qsys. This trend reverses when MR is present, reducing the impact of AI as LVAD speed is increased. CONCLUSION The major finding of these studies is that MR does not worsen Qsys when it coincides with AI and LVAD support. AI and MR occur during different phases of the cardiac cycle and sum in the absence of LVAD support. When an LVAD is added without valve dysfunction, QLVADis evenly distributed across systole and diastole. AI and MR reduces systolic and increases diastolic QLVAD, but AI+MR restores the original distribution. AI+MR produces the same overall Qsys but QLVADoccurs more evenly throughout the cardiac cycle resulting in a greater sensitivity to LVAD speed changes.
Purpose: To report the initial outcomes of physician-modified inner branched endovascular repair ... more Purpose: To report the initial outcomes of physician-modified inner branched endovascular repair (PMiBEVAR) for pararenal aneurysms (PRAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic arch aneurysms in high-surgical-risk patients. Materials and Methods: A total of 10 patients (6 men; median age, 83.0 years) treated using PMiBEVAR were enrolled in this retrospective, single-center study. All patients were at high surgical risk because of severe comorbidities (American Society of Anesthesiologists physical status score≥3 or emergency repair). End points were defined as technical success per patient and per vessel (successful deployment), clinical success (no endoleaks postoperatively), in-hospital death, and major adverse events. Results: There were 3 PRAs, 4 TAAAs, and 3 aortic arch aneurysms with 12 renal-mesenteric arteries and 3 left subclavian arteries incorporated by inner branches. The technical success rate was 90.0% (9/10) per patient and 93.3% (14/15) per vessel. The clinical success rate was 90% (9/10). There were 2 in-hospital deaths, unrelated to aneurysms. Paraplegia and shower emboli occurred separately in 2 patients. Three patients experienced prolonged ventilation for 3 days after surgery. Aneurysm sac shrinkage occurred in 4 patients, and aneurysm size stabilized in 1 patient during follow-up, more than 6 months later. None of the patients required intervention. Conclusion: PMiBEVAR is a feasible approach for treating complex aneurysms in high-surgical-risk patients. This technology may complement the existing technology in terms of improved anatomical adaptability, no time delay and practicability in many countries. However, long-term durability remains undetermined. Further large-scale and long-term studies are needed. Clinical impact This is the first clinical study to investigate outcomes of physician-modified inner branched endovascular repair (PMiBEVAR). PMiBEVAR for treating pararenal aneurysm, thoracoabdominal aortic aneurysm, or aortic arch aneurysm is a feasible procedure. This technology is likely to complement existing technology in terms of improved anatomical adaptability (compared to off-the-shelf devices), no time delay (compared to custom-made devices), and the potential to be performed in many countries. On the other hand, surgery time varied greatly depending on the case, suggesting a learning curve and the need for technological innovation to perform more consistent surgeries.
Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvi... more Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. Materials and Methods: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. Results: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan–Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). Conclusions: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. Clinical Impact This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.
Hematocrit (Hct) values after the initiation of cardiopulmonary bypass (CPB) must be maintained a... more Hematocrit (Hct) values after the initiation of cardiopulmonary bypass (CPB) must be maintained appropriately to avoid perioperative complications. Therefore, an accurate prediction is required. However, the standard prediction equation often results in actual values that are lower than the predicted values. This study aimed to clarify the limits of agreement (LOA) and bias of the prediction equations and investigate better the prediction equations. A retrospective study was performed on adult patients between April 2015 and December 2020. Study 1 included 158 patients, and Study 2 included 55 patients. The primary outcomes were the LOA and bias between the predicted and measured Hct values after the initiation of CPB, and two studies were conducted. In Study 1, total blood volume (TBV) was estimated, and the new blood volume index (BVI) was calculated. BVI was also evaluated for the overall value and gender differences. Therefore, the patient’s background was compared by gender differences. In, Study 2 the conventional predicted equation (Eq. 1), the predicted equation using the new BVI (Eq. 2), and the predicted equation using the new BVI including physiological factors in the TBV equation (Eq. 3) were compared. In Study 1, BVI was 53 (44–67) mL/kg. In Study 2, bias ± LOA was − 2.5 ± 6.8% for Eq. 1, 0.1 ± 6.6% for Eq. 2, and 0.4 ± 6.2% for Eq. 3. The new equation is expected to predict the Hct value after the initiation of CPB with better LOA and bias than the conventional equation.
Background After a median sternotomy, mediastinitis may develop, necessitating reopening of the c... more Background After a median sternotomy, mediastinitis may develop, necessitating reopening of the chest. Rarely, reoperation due to hematoma after cardiovascular surgery is experienced. In the present case, we experienced a patient who initially had mediastinitis, but later developed a chronic hematoma and underwent multiple surgeries. Case presentation The patient was a 40-year-old man who underwent aortic valve replacement for a bicuspid aortic valve and a graft for a dilated ascending aorta. Postoperatively, he developed hematoma in the anterior mediastinum on multiple occasions with repeated episodes of infection that required multiple median sternotomies. Conclusions We reported our experience with a rare case of multiple median sternotomies. In the early stage, mediastinitis due to infection was observed, and in the late stage, mediastinal dilatation due to hemorrhage was observed.
Journal of Heart and Lung Transplantation, Apr 1, 2020
PURPOSE Aortic valve incompetence (AI) is a serious complication that develops in 20% of LVAD pat... more PURPOSE Aortic valve incompetence (AI) is a serious complication that develops in 20% of LVAD patients within 12 months of implantation. Many LVAD patients with AI also develop mitral regurgitation (MR). Our goal in this study was to measure systemic flow (Qsys) and LVAD flow (QLVAD) during AI, MR and AI+MR. METHODS A mock circulatory loop with a dilated silicone LV and bioprosthetic valves was attached to a HeartMate II LVAD (Abbott Labs), and pressure and flow measured in the LV, LVAD and aorta. A Pre-LVAD ejection fraction of 20% without any valve dysfunction was established, followed LVAD support at speeds of 8, 9.4 and 11krpm. AI and MR were created with small stents that were non-obstructive to forward flow but prevented the leaflets from fully closing. Four conditions were tested: Normal, AI, MR and AI and MR combined. Average flow was obtained from ten cycles of data, and Q calculated as QLVAD/Qsys. RESULTS Pre-LVAD AI, MR and AI+MR produced a 28%, 12% and 45% reduction in Qsys, respectively. LVAD support at 9.4krpm increased Normal Qsys to 3.6 L/min with 95% of flow through the LVAD. MR reduced Qsys by 16% and QLVADby 21%; AI reduced by Qsys by 24% but QLVADby only 5%; and AI+MR reduced Qsys by 25% and QLVADby 7%, which was comparable to AI alone. In all conditions except AI+MR, Q increases with LVAD speed indicating that QLVAD increases faster than Qsys. This trend reverses when MR is present, reducing the impact of AI as LVAD speed is increased. CONCLUSION The major finding of these studies is that MR does not worsen Qsys when it coincides with AI and LVAD support. AI and MR occur during different phases of the cardiac cycle and sum in the absence of LVAD support. When an LVAD is added without valve dysfunction, QLVADis evenly distributed across systole and diastole. AI and MR reduces systolic and increases diastolic QLVAD, but AI+MR restores the original distribution. AI+MR produces the same overall Qsys but QLVADoccurs more evenly throughout the cardiac cycle resulting in a greater sensitivity to LVAD speed changes.
Purpose: To report the initial outcomes of physician-modified inner branched endovascular repair ... more Purpose: To report the initial outcomes of physician-modified inner branched endovascular repair (PMiBEVAR) for pararenal aneurysms (PRAs), thoracoabdominal aortic aneurysms (TAAAs), and aortic arch aneurysms in high-surgical-risk patients. Materials and Methods: A total of 10 patients (6 men; median age, 83.0 years) treated using PMiBEVAR were enrolled in this retrospective, single-center study. All patients were at high surgical risk because of severe comorbidities (American Society of Anesthesiologists physical status score≥3 or emergency repair). End points were defined as technical success per patient and per vessel (successful deployment), clinical success (no endoleaks postoperatively), in-hospital death, and major adverse events. Results: There were 3 PRAs, 4 TAAAs, and 3 aortic arch aneurysms with 12 renal-mesenteric arteries and 3 left subclavian arteries incorporated by inner branches. The technical success rate was 90.0% (9/10) per patient and 93.3% (14/15) per vessel. The clinical success rate was 90% (9/10). There were 2 in-hospital deaths, unrelated to aneurysms. Paraplegia and shower emboli occurred separately in 2 patients. Three patients experienced prolonged ventilation for 3 days after surgery. Aneurysm sac shrinkage occurred in 4 patients, and aneurysm size stabilized in 1 patient during follow-up, more than 6 months later. None of the patients required intervention. Conclusion: PMiBEVAR is a feasible approach for treating complex aneurysms in high-surgical-risk patients. This technology may complement the existing technology in terms of improved anatomical adaptability, no time delay and practicability in many countries. However, long-term durability remains undetermined. Further large-scale and long-term studies are needed. Clinical impact This is the first clinical study to investigate outcomes of physician-modified inner branched endovascular repair (PMiBEVAR). PMiBEVAR for treating pararenal aneurysm, thoracoabdominal aortic aneurysm, or aortic arch aneurysm is a feasible procedure. This technology is likely to complement existing technology in terms of improved anatomical adaptability (compared to off-the-shelf devices), no time delay (compared to custom-made devices), and the potential to be performed in many countries. On the other hand, surgery time varied greatly depending on the case, suggesting a learning curve and the need for technological innovation to perform more consistent surgeries.
Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvi... more Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. Materials and Methods: Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. Results: The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan–Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). Conclusions: The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. Clinical Impact This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.
Hematocrit (Hct) values after the initiation of cardiopulmonary bypass (CPB) must be maintained a... more Hematocrit (Hct) values after the initiation of cardiopulmonary bypass (CPB) must be maintained appropriately to avoid perioperative complications. Therefore, an accurate prediction is required. However, the standard prediction equation often results in actual values that are lower than the predicted values. This study aimed to clarify the limits of agreement (LOA) and bias of the prediction equations and investigate better the prediction equations. A retrospective study was performed on adult patients between April 2015 and December 2020. Study 1 included 158 patients, and Study 2 included 55 patients. The primary outcomes were the LOA and bias between the predicted and measured Hct values after the initiation of CPB, and two studies were conducted. In Study 1, total blood volume (TBV) was estimated, and the new blood volume index (BVI) was calculated. BVI was also evaluated for the overall value and gender differences. Therefore, the patient’s background was compared by gender differences. In, Study 2 the conventional predicted equation (Eq. 1), the predicted equation using the new BVI (Eq. 2), and the predicted equation using the new BVI including physiological factors in the TBV equation (Eq. 3) were compared. In Study 1, BVI was 53 (44–67) mL/kg. In Study 2, bias ± LOA was − 2.5 ± 6.8% for Eq. 1, 0.1 ± 6.6% for Eq. 2, and 0.4 ± 6.2% for Eq. 3. The new equation is expected to predict the Hct value after the initiation of CPB with better LOA and bias than the conventional equation.
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Papers by Tomohiro Nakajima