Tatsuhiko Komiya

Coronary artery bypass surgery is superior to percutaneous coronary intervention with drug-eluting stents for patients with chronic renal failure on hemodialysis.

BACKGROUND Improvements in the results of percutaneous coronary intervention (PCI) with drug-eluting stents (DES) have been extending their use in patients with all forms of coronary artery disease. The purpose of this study was to compare the midterm clinical results of coronary artery bypass surgery (CABG) and PCI with DES in patients with chronic renal failure on hemodialysis. METHODS From January 2002 to December 2006, 29 patients underwent CABG, and 75 patients underwent PCI with DES. For CABG, 24 patients had off-pump surgery. The mean follow-up was 32.0 +/- 22.0 months for CABG and 23.5 +/- 14.8 months for PCI. Survival, cardiac death, major adverse cardiac events (cardiac death, myocardial infarction, revascularization), and target lesion revascularization were analyzed using the Kaplan-Meier method. RESULTS Preoperative characteristics and risk factors were compatible between the groups except for the European System for Cardiac Operative Risk Evaluation (7.3 +/- 2.7 for CABG and 5.0 +/- 2.4 for PCI, p < 0.0001) and the presence of a left main trunk lesion (53.3% for CABG and 18.7% for PCI). Thirty-day mortality was 3.3% for CABG and 4.0% for PCI. The 2-year survival rate was 84.0% for CABG and 67.6% for PCI (p = 0.0271). The cardiac death-free curve at 2 years was 100% for CABG and 84.1% for PCI (p = 0.0122). The major adverse cardiac events-free rate at 2 years was 75.8% for CABG and 31.5% for PCI (p < 0.0001). During the follow-up period, there were 6 late deaths in the CABG group and 27 late deaths (including 6 sudden deaths) in the PCI group. CONCLUSIONS Coronary artery bypass grafting was superior to PCI with DES in patients with chronic renal failure on hemodialysis in terms of long-term outcomes for cardiac death, major adverse cardiac events, and target lesion revascularization. The DES carried a higher risk for sudden death, which might be associated with stent thrombosis.

Surgical Treatment for Postinfarction Left Ventricular Free Wall Rupture

BACKGROUND Left ventricular (LV) free wall rupture is a catastrophic complication after acute myocardial infarction. The optimal therapeutic strategy is controversial and the midterm results are unknown. METHODS Between June 1993 and May 2006, 32 patients with an average age of 73 years (range, from 55 to 96 years) were surgically treated for LV free wall rupture. Sutureless technique (gluing autologous patch to the tear) was applied in all patients. RESULTS The interval between acute myocardial infarction and the rupture was 33 +/- 42 hours and the interval between the rupture and the operation was 3.6 +/- 2.6 hours. Preoperatively, cardiopulmonary resuscitation was performed in eight cases. Percutaneous cardiopulmonary support was placed in six cases and intraaortic balloon pumping in 20 cases preoperatively. The in-hospital mortality was 15.6%. Two patients died of rerupture within ten days. While there was no rerupture during the follow-up period, five patients developed dyskinetic LV aneurysm and one patient developed LV pseudoaneurysm. CONCLUSIONS The sutureless technique is a simple and effective option for the surgical treatment for LV free wall rupture. The preoperative moribund condition was highly associated with the operative mortality.

Benefits of Off-Pump Coronary Artery Bypass Grafting in High-Risk Patients

Background— The benefits of off-pump coronary artery bypass graft (OPCAB) compared with conventional on-pump coronary artery bypass graft (CCAB) remain controversial. Thus, it is important to investigate which patient subgroups may benefit the most from OPCAB rather than CCAB. Methods and Results— Among the patients undergoing first coronary revascularization enrolled in the CREDO-Kyoto Registry (a registry of first-time percutaneous coronary intervention and coronary artery bypass graft patients in Japan), 2468 patients undergoing coronary artery bypass graft were entered into the study (mean age, 67±9 years). Predicted risk of operative mortality (PROM) of each patient was calculated by logistic EuroSCORE. Patients were divided into tertile based on their PROM. Mortality rates and the incidences of cardiovascular events were compared between CCAB and OPCAB within each PROM tertile using propensity score analysis. A total of 1377 patients received CCAB whereas 1091 received OPCAB. Adjusted 30-day mortality was not significantly different between CCAB and OPCAB patients regardless of their PROM range. However, the odds ratio of 30-day stroke in CCAB compared with OPCAB in the high-risk tertile was 8.30 (95% confidence interval, 2.25–30.7; P<0.01). Regarding long-term outcomes, hazard ratio of stroke in CCAB compared with OPCAB in the high-risk tertile was 1.80 (95% confidence interval, 1.07–3.02; P=0.03). Nevertheless, hazard ratio of overall mortality in the high-risk tertile was 1.44 (95% confidence interval, 0.98–2.11; P=0.06), indicating no statistically significant difference between the 2 procedures. Conclusions— OPCAB as opposed to CCAB is associated with short-term and long-term benefits in stroke prevention in patients at higher risk as estimated by EuroSCORE. No survival benefit of OPCAB was shown regardless of preoperative risk level.

Comparison of Long-Term Outcome After Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Unprotected Left Main Coronary Artery Disease (from the CREDO-Kyoto PCI/CABG Registry Cohort-2)

The long-term outcome of percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG) for unprotected left main coronary artery disease (ULMCAD) remains to be investigated. We identified 1,005 patients with ULMCAD of 15,939 patients with first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG Registry Cohort-2. Cumulative 3-year incidence of a composite of death/myocardial infarction (MI)/stroke was significantly higher in the PCI group than in the CABG group (22.7% vs 14.8%, p = 0.0006, log-rank test). However, the adjusted outcome was not different between the PCI and CABG groups (hazard ratio [HR] 1.30, 95% confidence interval [CI] 0.79 to 2.15, p = 0.30). Stratified analysis using the SYNTAX score demonstrated that risk for a composite of death/MI/stroke was not different between the 2 treatment groups in patients with low (<23) and intermediate (23 to 33) SYNTAX scores (adjusted HR 1.70, 95% CI 0.77 to 3.76, p = 0.19; adjusted HR 0.86, 95% CI 0.37 to 1.99, p = 0.72, respectively), whereas in patients with a high SYNTAX score (≥33), it was significantly higher after PCI than after CABG (adjusted HR 2.61, 95% CI 1.32 to 5.16, p = 0.006). In conclusion, risk of PCI for serious adverse events seemed to be comparable to that after CABG in patients with ULMCAD with a low or intermediate SYNTAX score, whereas PCI compared with CABG was associated with a higher risk for serious adverse events in patients with a high SYNTAX score.

Comparison of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Unprotected Left Main Coronary Artery Disease – 5-Year Outcome From CREDO-Kyoto PCI/CABG Registry Cohort-2 –

BACKGROUND Studies evaluating long-term (≥5 years) outcome of percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease (ULMCAD) are still limited, despite concerns for late adverse events after drug-eluting stents implantation. METHODS AND RESULTS We identified 1,004 patients with ULMCAD (PCI: n=364, CABG: n=640) among 15,939 patients with first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG registry cohort-2. The primary outcome measure in the current analysis was a composite of death, myocardial infarction, and stroke (death/MI/stroke). The cumulative 5-year incidence of and the adjusted risk for death/MI/stroke were significantly higher in the PCI group than in the CABG group (34.5% vs. 24.1%, log-rank P<0.001, adjusted hazard ratio (HR): 1.48 [95% confidence interval (CI): 1.07-2.05, P=0.02]). The adjusted risks for all-cause death was not significantly different between the 2 groups. Regarding the stratified analysis by the SYNTAX score, the adjusted risk for death/MI/stroke was not significantly different between the 2 groups in patients with low (<23) or intermediate (23-33) SYNTAX score, whereas it was significantly higher in the PCI group than in the CABG group in patients with high (≤33) SYNTAX score. CONCLUSIONS CABG as compared with PCI was associated with better long-term outcome in patients with ULMCAD, especially those with high anatomical complexity.

Three-year outcome after percutaneous coronary intervention and coronary artery bypass grafting in patients with triple-vessel coronary artery disease: observations from the CREDO-Kyoto PCI/CABG registry cohort-2.

AIMS We sought to investigate medium-term outcome of percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG) in patients with triple-vessel coronary artery disease (TVD). METHODS AND RESULTS We identified 2,981 patients with TVD (PCI: N=1,825, CABG: N=1,156) among 15,939 patients with first coronary revascularisation enrolled in the CREDO-Kyoto PCI/CABG registry cohort-2. Excess adjusted three-year risk of the PCI group relative to the CABG group for death/myocardial infarction (MI)/stroke was significant (HR 1.47 [95% CI: 1.13-1.92, p=0.004]). Adjusted risk for all-cause death was also significantly higher with PCI as compared with CABG (HR 1.62 [95% CI: 1.16-2.27, p=0.005]), while risk for cardiac death was neutral between the two groups (HR 1.3 [95% CI: 0.81-2.07, p=0.28]). PCI was also associated with a markedly higher risk for any coronary revascularisation. Regarding the analysis stratified by the SYNTAX score, the adjusted HR of PCI relative to CABG for death/MI/stroke was 1.66 (95% CI: 1.04-2.65, p=0.03) in the low-score (<23: N=874, and N=257), 1.24 (95% CI: 0.83-1.85, p=0.29) in the intermediate-score (23-32: N=638, and N=388), and 1.59 (95% CI: 0.998-2.54, p=0.051) in the high-score (≥ 33: N=280, and N=375) tertiles, respectively. CONCLUSIONS PCI as compared with CABG was associated with significantly higher risk for serious adverse events in TVD patients.

Preoperative evaluation of patients with liver cirrhosis undergoing open heart surgery

ObjectiveClinical outcomes after open heart surgery in patients with liver cirrhosis are not satisfactory. For evaluating hepatic function, the Child-Pugh classification has been widely used. It has been reported that open heart surgery can be performed safely in patients with mild liver cirrhosis. In this study, we examined the clinical outcomes after open heart surgery in patients with liver cirrhosis and evaluated the usefulness of the Child-Pugh classification.MethodsThere were 12 liver cirrhosis patients who underwent open heart surgery between January 2002 and December 2006 at our institution. The severity of cirrhosis was graded according to the Child-Pugh classification. We reviewed clinical outcomes, such as postoperative mortality and morbidity, and tried to determine the risk factors. Finally, we assessed the usefulness of the Child-Pugh classification.ResultsSix patients were classified as having Child class A, and the other six patients were classified as B. The overall mortality of group A was 50%, and that of group B was 17%. Postoperative major morbidities occurred in half of the patients of Child class A and in all of the patients of Child class B. Patients who experienced major morbidities had markedly lower levels of serum cholinesterase (106 ± 46 vs. 199 ± 72 IU/l; P = 0.02) and lower platelet level (7.5 ± 2.9 vs. 11.9 ± 3.6 × 104/μl; P = 0.04).ConclusionThe mortality and morbidity rates were high even in the Child class A patients. The Child classification may be an insufficient method for evaluating hepatic function. We have to assess other factors, such as the serum cholinesterase level or the platelet count.

First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: The Massy study group vs. the PREVAIL JAPAN trial

BACKGROUND The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. METHODS AND RESULTS Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m(2) vs. 1.72±0.18m(2); p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91). CONCLUSIONS Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort.

Comparison of five-year outcomes of coronary artery bypass grafting versus percutaneous coronary intervention in patients with left ventricular ejection fractions≤50% versus >50% (from the CREDO-Kyoto PCI/CABG Registry Cohort-2).

Coronary heart disease is a major risk factor for left ventricular (LV) systolic dysfunction. However, limited data are available regarding long-term benefits of percutaneous coronary intervention (PCI) in the era of drug-eluting stent or coronary artery bypass grafting (CABG) in patients with LV systolic dysfunction with severe coronary artery disease. We identified 3,584 patients with 3-vessel and/or left main disease of 15,939 patients undergoing first myocardial revascularization enrolled in the CREDO-Kyoto PCI/CABG Registry Cohort-2. Of them, 2,676 patients had preserved LV systolic function, defined as an LV ejection fraction (LVEF) of >50% and 908 had impaired LV systolic function (LVEF≤50%). In patients with preserved LV function, 5-year outcomes were not different between PCI and CABG regarding propensity score-adjusted risk of all-cause and cardiac deaths. In contrast, in patients with impaired LV systolic function, the risks of all-cause and cardiac deaths after PCI were significantly greater than those after CABG (hazard ratio 1.49, 95% confidence interval 1.04 to 2.14, p=0.03 and hazard ratio 2.39, 95% confidence interval 1.43 to 3.98, p<0.01). In both patients with moderate (35%<LVEF≤50%) and severe (LVEF≤35%) LV systolic dysfunction, the risk of cardiac death after PCI was significantly greater than that after CABG (hazard ratio 2.25, 95% confidence interval 1.15 to 4.40, p=0.02 and hazard ratio 4.42, 95% confidence interval 1.48 to 13.24, p=0.01). Similarly, the risk of all-cause death tended to be greater after PCI than after CABG in both patients with moderate and severe LV systolic dysfunction without significant interaction (hazard ratio 1.57, 95% confidence interval 0.96 to 2.56, p=0.07 and hazard ratio 1.42, 95% confidence interval 0.71 to 2.82, p=0.32; interaction p=0.91). CABG was associated with better 5-year survival outcomes than PCI in patients with impaired LV systolic function (LVEF≤50%) with complex coronary disease in the era of drug-eluting stents. In both patients with moderate (35%<LVEF≤50%) and severe (LVEF≤35%) LV systolic dysfunction, CABG tended to have better survival outcomes than PCI.

Comparison of Frequency of Postoperative Stroke in Off-Pump Coronary Artery Bypass Grafting Versus On-Pump Coronary Artery Bypass Grafting Versus Percutaneous Coronary Intervention

The stroke rate after coronary artery bypass grafting (CABG) compared to percutaneous coronary intervention (PCI) is generally considered high because cardiopulmonary bypass and aortic manipulations are often associated with cerebrovascular complications. However, an increasing number of CABGs performed without cardiopulmonary bypass (OPCAB) may improve those outcomes. Of 6,323 patients with multivessel and/or left main coronary artery disease, 3,877 patients underwent PCI, 1,381 conventional on-pump CABG, and 1,065 OPCAB. Median follow-up was 3.4 years. Stroke types were classified as early (onset of stroke within 24 hours after revascularization), delayed (within 30 days), and late (after 30 days). Propensity score analysis showed that the incidences of early, delayed, and late stroke did not differ between PCI and OPCAB (0.65, 95% confidence interval 0.08 to 5.45, p = 1.00; 0.36, 0.10 to 1.29, p = 0.23; 0.81, 0.52 to 1.27, p = 0.72, respectively). In contrast, incidence of early stroke after on-pump CABG was higher than after OPCAB (7.22, 1.67 to 31.3, p = 0.01), but incidences of delayed and late stroke were not different (1.66, 0.70 to 3.91, p = 0.50; 1.18, 0.83 to 1.69, p = 0.73). In conclusion, occurrence of stroke was not found to differ in patients after PCI versus OPCAB regardless of onset of stroke. Occurrence of early stroke after OPCAB was lower than that after on-pump CABG, yet occurrences of delayed and late strokes were similar for the 3 revascularization strategies.