Although there have been several studies that compared the efficacy of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the impact of off-pump CABG (OPCAB) has not been well elucidated. Among the 9,877 patients undergoing first myocardial revascularization enrolled in the CREDO-Kyoto Registry (a registry of first-time PCI using bare-metal stents and CABG patients in Japan), 6,327 patients with multivessel and/or left main disease were enrolled in the present study (PCI 3,877/CABG 2,450). Median follow-up was 3.5 years. Propensity-score-adjusted all-cause mortality after PCI was higher than that of CABG (hazard ratio [95% confidence interval] : 1.37 [1.15-1.63], p< 0.01). The incidence of stroke was lower after PCI than that after CABG (0.75 [0.59-0.96], p=0.02). The predicted risk of operative mortality (PROM) of each patient of on-pump/off-pump CABG was calculated by the logistic EuroSCORE. Patients were divided into tertiles based on their PROM. The hazard ratio of the incidence of stroke in on-pump CABG compared with off-pump CABG in the high-risk tertile was 1.80 ([1.07-3.02], p=0.03). The adjusted overall mortality was not significantly different between the two procedures even in the high-risk tertile (1.44 [0.98-2.11], p=0.06). In patients with multivessel and/or left main disease, CABG was associated with better survival outcomes than PCI using bare-metal stents. Off-pump CABG as opposed to on-pump CABG is associated with short-and long-term benefits in stroke prevention in patients with higher risk as evaluated by the EuroSCORE. No survival benefit of OPCAB was shown, regardless of preoperative risk level.

A 22-year-old woman with pseudocoarctation of the aorta as a complication of disal arch aortic aneurysm and aberrant right subclavian artery was successfully treated. She was the elder of identical twins, with a past history of spontaneous closure of the ventricular septal defect. Preoperative angiograms suggested pseudocoarctation of the aorta complicated by distal arch aortic aneurysm with aberrant right subclavian artery. At operation, the distal arch was replaced with a 14mm woven dacron graft and the left subclavian artery was reconstructed by interposition of 6mm IMPRA graft between the vessel and ascending aorta. The postoperative angiograms indicated successful reconstructions. Contrast-enhanced CT scans of the younger identical twin showed no anomaly of the thoracic aorta.

Isolated tricuspid regurgitation is extremely rare, and in most of the previously reported cases, both tricuspid leaflets and subvalvar tissue have been absent, hypoplastic or fused. For this reason, tricuspid valvoplasty was difficult and valve replacement was adopted in many cases. In the present case, a 52-year-old man, however, the tricuspid valve showed no abnormalities other than a severely dilated tricuspid annulus. Ring annuloplasty was performed, and this resulted in a subsequent satisfactory course.

For treatment of Stanford type A aortic dissection, we have operated only on the ascending aorta out of consideration of operative invasions and complications. However, if only the ascending aorta is replaced, the residual distal false lumen and its dilatation become problematic. We examined the risks of postoperative dilatation of the distal false lumen in terms of the following three factors (1) patency of the distal false lumen, (2) Marfan's syndrome, (3) aortic medial degeneration. Between 1984 and 1993, 55 cases of acute and chronic type A aortic dissection were treated surgically at our hospital, and a total of 33 survivors were subsequently followed up. The mean follow-up period was 92 months. None of the survivors died of late aortic complications. Five patients (15%) had Marfan's syndrome. As a result, all 18 patients (55%) with a closed distal false lumen did not show late distal dilatation or late deaths. Marfan patients had a high incidence of distal dilatation of the aorta and required additional aortic operations. Aortic medial degeneration was a high risk factor for younger onset (>40 years old) of aortic dissection, patent false lumen, and late dilatation, not only for Marfan patients but for non-Marfan patients. Non-Marfan patients with onset of aortic dissection under 40 years of age, showed significantly high incidence of medial degeneration. In conclusion, patent false lumen and medial degeneration of non-Marfan patients is a high risk factor of late dilatation as well as those of Marfan patients. On the other hand, patent false lumen is not a risk factor of late dilatation for non-Marfan patients without medial degeneration. Therefore, in both Marfan and non-Marfan patients with onset under 40 years of age, concomitant aortic arch repair should be performed because the rate of reoperation is significantly high.

Aortobronchopulmonary fistula (ABPF) caused by thoracic aortic aneurysm is uniformly fatal if not treated surgically. Here we report 12 cases, and discuss the cause, surgical treatment, and results. Between 1993 and 1998, we encountered 12 cases of ABPF. ABPFs were complicated by (A) true aneurysms without infection (n=4), (B) aortic dissection (n=1), and (C) infective pseudoaneurysms occurring after thoracic aortic surgery (n=4). Three patients refused surgery. The ABPFs were located in the ascending aorta to the trachea (n=1), the distal arch to the upper lobe of the left lung (n=6), and the descending aorta to the lower lobe (n=5). They were repaired by graft replacement or patch closure. All four patients in group A have shown an uneventful course 10 patient-years after surgery. One patient in group B died of mediastinitis. The other three patients in group B were discharged from hospital, but died of sudden recurrent hemoptysis at their homes. A patient with aortic dissection underwent patch closure of an ABPF located at the distal arch, however he died of recurrent hemoptysis due to bleeding from another ABPF at the descending aorta. All of the three patients who refused surgery died of hemoptysis at various times after diagnosis. The surgical results in the non-infection group (A) were satisfactory. The group with infection (C) showed poor results after surgery and died due to recurrence of hemoptysis caused by new ABPFs arising from infected pseudoaneurysms. ABPF caused by aortic dissection (B) is difficult to repair because of severe adhesions to the lung and the unclear location of the fistula. ABPF infection is difficult to control after thoracic surgery and it is the reason for the fatal outcomes, due mainly to sudden hemoptysis. Early diagnosis and prompt surgical intervention are important for patients with ABPF.

Over 40 years, Post-maketing surveillance (PMS) studies have been conducted as a legal obligation in Japan. Though the contribution of these studies to the better use of the drug has been acknowledged, there are criticisms that these PMS studies have been stereotyped and need to be improved. The ICH-E2E guideline entitled as "Pharmcovigilance Planning", agreed in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has been implemented in the concerned countries. The legislation of the guideline in Japan in 2005 seems to have urged drug companies and regulatory agency to review the current PMS practices in contrast with the today's highest scientific standard. We investigated the theoretical and practical aspects of pharmacoepidemiology required when the drug company evaluates safety specification prior to developing the pharmacovigilance plan and designs a PMS study along the lines stipulated in the ICH-E2E guideline. To meet this end, we evaluated the profiles of the drug, summarized "Important identified risks", "Important potential risks" and "Important missing information" to be identified and examined the pharmacovigilance plan suggested by the regulatory agency and that proposed and implemented by the drug company. We examined those aspects for 6 new products selected from 168 drugs newly approved during the period between January 2004 and October 2006. In 5 of 6 cases, we judged that the use of a comparator group would have been appropriate to asses the association between the drug and adverse events of interest. In addition, in one half (3) of 6 cases, it would have been preferable to use the database for the patient registration and/or other types of databases. The issues of relevant legislation and the infrastructure and funding for the investigations needed to develop a desirable study design and conduct a good pharmacoepidemiology study are however beyond a single company's capacity and should be set as a national strategy. The issues of post-marketing safety in the nation is becoming more and more important as the data in the countries outside Japan are being used more often for the processes of marketing authorization application of a new drug and its approval. It is urgent to secure the practice of pharmacoepidemiology to achieve the effective post-approval pharmacovigilance studies.

A 60-year-old man was admitted to our institution with abnormal ECG findings. Coronary CT and angiography showed coronary aneurysms from the left main trunk to the bifurcation of the left anterior descending artery, and the left circumflex artery, with severe stenosis and complete obstruction of the proximal right coronary artery. Morphological evaluation findings strongly suggested that the coronary aneurysms were highly related to childhood Kawasaki disease. We successfully performed triple vessel coronary artery bypass grafting. Here, we report a very rare case of coronary aneurysms presumed to be due to childhood Kawasaki disease in an elderly man.

Extensive calcification of the mitral annulus presents a formidable technical challenge to surgeons and increases the risk of serious complications such as intractable hemorrhage, atrioventricular disruption, and ventricular rupture during mitral valve surgery. We present a case of aortic and mitral valve replacements for a patient with extensive calcification of an intervalvular fibrous body. A 76-year-old woman was admitted with dyspnea on effort, leg edema and syncope. Transthoracic echocardiography showed severe aortic stenosis, and mitral stenosis with regurgitation, and extensive mitral annular calcification. Decalcification was performed with CUSA and we selected a trans-aortic-valve approach for decalcification of the intervalvular fibrous body. The calcification was left to a certain extent in order to preserve annular strength. Postoperative echocardiography showed no perivalvular leakage from either prostheses. The patient was transferred to a local hospital for further rehabilitation.