Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Background: Cardiac tamponade developing in the catheter ablation procedure is a very rare complication, but might result in the fatal outcome unless the prompt diagnosis and appropriate treatments are done. There are few published reports regarding the surgical intervention for this critical complication. Objective and Methods: From January 2012 to December 2021, 10 patients underwent emergency surgical repair of cardiac chamber injuries by atrial fibrillation catheter ablation. The trends of the injury and the strategy of the emergency surgery were assessed. Results: All the patients were successfully rescued by emergency surgical repair. Two of them underwent the surgery under cardiopulmonary bypass. There were 12 injury sites including 5 of left atrium and left atrial appendage. Intraoperative findings suggested that the cause of the cardiac tamponade was mainly due to mechanical chamber injury by ablation catheter manipulations in all cases. Four patients who were all octogenarians necessitated prolonged hospitalization due to disuse syndrome secondary to acute renal failure postoperatively. Conclusions: Cardiac chamber injury by catheter ablation for atrial fibrillation could be surgically repaired by the evaluation of pre-operative dynamic state and predictive diagnosis of injury sites. Pre-operative evaluation of drained pericardial blood gas analysis and hemodynamic state provide helpful information to organize surgical strategies. The left atrial roof seems to be easily injured because of anatomical reasons and the contact force of the ablation catheter. Pre-operative cardiogenic shock status was suspected as the principal cause of the post-operative complication. Owing to the pre-operative dynamic instability, aged patients in particular might suffer from serious complication such as acute renal injury followed by disuse syndrome. Mutual collaboration with cardiologists should lead to prompt and exact treatment.

Objective: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. Results: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. Conclusion Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.

No abstract available.
Aorta, Thoracic ; Transcatheter Aortic Valve Replacement

[Background] Surgical septal myectomy is the gold-standard therapy for hypertrophic obstructive cardiomyopathy (HOCM) in Europe and America. However, few cases underwent surgical septal myectomy in Japan. We have performed the surgical transaortic extended left ventricular myectomy (LV myectomy) as a first choice in HOCM patients unresponsive to pharmacologic therapy. We report the short and medium term clinical outcomes. Methods : From May 2012 to September 2014, 9 patients underwent extended LV myectomy without other accompanying procedures. All cases were symptomatic and peak left ventricular outflow tract pressure gradients (LVOTG) were 50 mmHg or more. We assessed clinical and echocardiographic outcomes at the short and medium term, intra-operative findings and cardiomyocyte pathological findings. Results : All patients (mean age 64.3 years, 56% female) underwent transaortic LV myectomy with no obvious complications. Postoperative LVOTG were controlled within 10 mmHg or less. SAM disappeared completely in all patients and MR decreased to mild or less. LVOTG sustained good control of 10 mmHg or less under low-dose dobutamine stress echocardiography at the medium term. Conclusion : Our transaortic extended LV myectomy procedure is effective in decreasing LVOTG, SAM and MR with low operative morbidity and mortality.

A 66-year-old woman suffered from an effort angina attack and visited our clinic. Coronary angiography revealed severe stenosis in the ostium of bilateral coronary arteries. Preoperative computed tomography (CT) demonstrated severe calcification of the aorta and aneurysmal change in the thoracic descending aorta. Off-pump CABG was performed without mechanical cardiac support using composite grafts of the right internal mammary artery and a saphenous vein graft. Graft patency was intraoperatively confirmed by SPY as well as by coronary multi detector-row computed tomography (MDCT) 3 months postoperatively.