Retrospective comparison of clinical and angiographic outcomes after sirolimus-eluting and bare-metal stent implantation in 312 consecutive, nonrandomized severely calcified lesions using a rotablator.

In order to compare the long-term clinical and angiographic outcomes after sirolimus-eluting stent (SES) and bare-metal stent (BMS) placement in severely calcified lesions using a rotablator under the widespread indication of SES, a nonrandomized examination of 312 consecutive lesions after successful implantation of a BMS (99 lesions in 84 patients; from January 2003) or SES (213 in 167; from September 2004) using a rotablator was conducted. The lesion-based primary endpoints (cardiac death and nonfatal recurrent myocardial infarction) and the secondary endpoint [binary restenosis (BR) (diameter stenosis > 50%) at follow-up angiography] were retrospectively determined in August 2010. The incidence of primary endpoint in the SES group (2.3%; mean follow-up period of 1289 ± 526 days) was significantly lower than that in the BMS group (7.1%; P = 0.043; 1803 ± 887 days), although the several variables related to the endpoints were present in the SES group. Cox proportional hazard model analysis revealed that SES was not significantly related to a primary endpoint [hazard ratio of 0.42 (95% CI, 0.073-2.42; P = 0.33)]. The incidence of BR in the SES group (21.3%) was not significantly different from that in the BMS group (27.1%) (P = 0.33). Multivariate logistic regression analysis revealed that SES was not a significant predictor of BR [Odds ratio of 0.78 (95% CI, 0.41-1.51; P = 0.47)]. Thus, although the results of the present retrospective nonrandomized study demonstrate the long-term safety of SES for calcified lesions using a rotablator in daily practice, SES did not show a benefit for the angiographic outcomes compared to BMS.

Retrospective comparison of clinical and angiographic outcomes after primary stenting using sirolimus-eluting and bare-metal stents in nonrandomized consecutive 568 patients with first ST-segment elevated myocardial infarctions.

BACKGROUND AND PURPOSE: The long-term safety and efficacy of primary stenting using drug-eluting stents (DES) in patients with ST-segment elevation myocardial infarction (STEMI) are not fully understood in Japan. Therefore, we retrospectively examined the midterm clinical and angiographic outcomes in STEMI patients after primary stenting using sirolimus-eluting stents (SES) in a clinical setting through a historical comparison with those of bare-metal stents (BMS). METHODS AND RESULTS: The study design was a retrospective, nonrandomized, and single-center study. The clinical outcomes for 568 consecutive patients who presented within 12 h of their first STEMI and who were treated with BMS (n = 198; 184 STEMIs from June 2003 to August 2004 and 14 STEMIs from September 2004 to May 2007) or SES (n = 370; from August 2004 to May 2007) at our medical center in Japan were retrospectively investigated in February 2010. The incidence of post-discharge events (comprising cardiac death and nonfatal recurrent MI) after SES placement (3.9%) was not significantly different from that after BMS placement (6.7%). SES was not related to the risk of post-discharge events (mean follow-up for SES, 1327 ± 415 days; BMS, 1818 ± 681 days) (hazard ratio of 0.369 at 95% CI, 0.119-1.147, p = 0.085). The incidence of definite stent thromboses after SES placement (0.54%) was not significantly higher than that after BMS placement (0%). The incidence of binary in-stent restenosis (% diameter stenosis of more than 50% at secondary angiography) after SES placement (8.3%) was significantly lower than that after BMS placement (25.7%; p < 0.001). CONCLUSIONS: From the present historical comparison of SES and BMS, we conclude that primary stenting using SES in a clinical setting has favorable clinical and angiographic outcomes in Japanese STEMI patients.

Evaluation of (99m)Tc-myocardial Perfusion SPECT Attenuation Correction by Hybrid SPECT/CT-Examination by Quantitative Analysis-.

A non-uniform attenuation correction is necessary for the myocardial perfusion image (MPI) SPECT that is one of the images of the trunk. Simultaneous non-uniform attenuation correction during the process of SPECT reconstruction was enabled by developing hybrid SPECT/CT. Image acquisition of (99m)Tc MPI with hybrid SPECT/CT was performed in a phantom study and clinical cases. We evaluated the effect of non-uniform attenuation correction by Filtered Back Projection (FBP) or Ordered Subsets-Expectation Maximization (OS-EM) using visual analysis and quantitative analysis with a 17-segment model. The phantom study and the clinical cases differed somewhat as follows. In the phantom study, the count increased significantly with non-uniform attenuation correction in visual analysis and quantitative analysis. In the clinical cases, non-uniform attenuation correction increased the quantitative count in the basal and middle layer of the heart, and visual uniformity of the whole heart improved. However, the visual and quantitative count in the apex decreased with non-uniform attenuation correction. As a result, diagnostic performance for coronary heart disease is expected to be improved by this new technique using hybrid SPECT/CT.

A case of myasthenia gravis with cardiac fibrosis and easily provoked sustained ventricular tachycardia.

A 65-year-old male, who had been diagnosed to have myasthenia gravis (MG) 25 years previously, was admitted to our hospital with faintness. Cardiac ultrasonography showed decreased left ventricular function. Magnetic resonance imaging depicted delayed contrast enhancement in localized regions. No significant coronary artery stenosis was found, and due to the reproducible susceptibility for sustained ventricular tachycardia, he underwent cardioverter-defibrillator implantation. Although relatively uncommon, cardiac manifestations should not be overlooked in MG patients, as they may be associated with ventricular arrhythmias and cardiac dysfunction.

Significantly lower incidence of early definite stent thrombosis of drug-eluting stents after unrestricted use in Japan using ticlopidine compared to western countries using clopidogrel: a retrospective comparison with western mega-studies.

BACKGROUND AND OBJECTIVES: The incidence of definite stent thrombosis (ST) after use of drug-eluting stents (DES), as defined by the Academic Research Consortium, is known to be lower in Japan than in western countries. However, a statistical difference in the incidence of early definite ST (EDST) associated with the unrestricted use of DES has not yet been documented. Therefore, the incidence of EDST in our Japanese institute after unrestricted use of DES was retrospectively compared with those reported in western mega-studies. METHODS AND RESULTS: During the 40 months from August 2004 to November 2007 (before approval of clopidogrel in Japan), DES were implanted in 3605 lesions in 1885 patients in our institute; lesion- and patient-associated percentages of DES use were 95.2% and 94.7%, respectively. Mean stent length per lesion was 33.2 mm, emergent procedures and ST-elevation myocardial infarctions made up 33.7% and 16.4% of the procedures, respectively, intravascular ultrasonography was used 96.0% of the time, a distal protection device for acute coronary syndrome was used 68.7% of the time, and the mean maximum inflation pressure was 19.5 atm. EDST was observed in five lesions (0.139%) in four patients (0.212%). The incidence of patient-associated EDST at our center was significantly lower than in four western mega-studies (0.736%, 66 of 8970 patients; 0.634%, 149 of 23,500; 0.595%, 52 of 8402; 0.997%, 20 of 2006) (p<0.05, <0.01, <0.05, <0.01, respectively, using a chi(2)-test). CONCLUSION: Due to differences in procedural approaches in Japan, the incidence of EDST after unrestricted use of DES was significantly lower than in western countries.

Angiographic and clinical outcomes after sirolimus-eluting stent implantation to de novo ostial lesion of the right coronary artery: a retrospective study.

BACKGROUND: Although ostial lesion (defined as being within 3 mm of the ostia) of the right coronary artery (RCAos) has been a limitation of percutaneous coronary intervention after using previous various devices, the angiographic and clinical outcomes after the deployment of a sirolimus-eluting stent (SES) to RCAos have not been fully estimated. Therefore, the incidences of binary restenosis (BR; % diameter stenosis at chronic phase

Predictors of target lesion revascularization and documented stent thrombosis beyond 30 days after sirolimus-eluting stent implantation: retrospective analysis in consecutive 1,070 angiographic follow-up lesions.

BACKGROUND: Outcomes after sirolimus-eluting stent (SES: Cypher) implantation remained to be elucidated in Japan. METHODS AND RESULTS: Among 1,070 consecutive angiographic follow-up lesions, 99 lesions underwent target lesion revascularization (TLR) with in-stent restenosis (ISR). Retrospective estimation by multivariate analysis including 50 variables showed that the ostiums of right coronary and left circumflex arteries, hemodialysis, calcification, non-direct stenting, ISR of SES, and non-eccentric lesion were the predictors of TLR. There was no documented late stent thrombosis (LST) among 2,166 lesions and very LST (VLST) among 1,423 lesions. CONCLUSION: Further revises are needed to implant SES to these predictive lesions. LST and VLST were very rare.

Feasibility and safety of granulocyte colony-stimulating factor treatment in patients with acute myocardial infarction.

BACKGROUND: This study examined feasibility and safety of granulocyte colony-stimulating factor (G-CSF) treatment for patients with acute myocardial infarction (AMI). METHODS: Forty patients with AMI related with the left anterior descending coronary artery, who underwent successful percutaneous coronary intervention (PCI), were randomized into G-CSF group (n=18) or Control group (n=22). G-CSF treatment was started within 24 h after PCI. 99mTc-tetrofosmin single-photon emission computed tomography (SPECT) was performed at 4 days and 6 months after AMI. SPECT data was analyzed for LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), LV ejection fraction (LVEF) and myocardial perfusion. RESULTS: LVEF at 6 months was significantly better than that at 4 days in G-CSF group (p=0.013), but not changed in Control group (p=0.245). Although no significant difference was observed for LVEDV between the two groups, LVESV tended to be decreased only in G-CSF group. In G-CSF group, defect score (DS) was significantly decreased from 4 days to 6 months after AMI. Restenosis rate at 6 months after AMI was not significantly different between the two groups. CONCLUSIONS: G-CSF treatment for patients with AMI was effective and did not have any clinical and angiographic adverse effects.

Effectiveness of a sirolimus-eluting stent (Cypher) for diffuse in-stent restenosis inside a bare metal stent.

We estimated the benefit of a sirolimus-eluting stent (SES, Cypher) for diffuse (> 10 mm) in-stent restenosis (ISR) inside bare metal stents (BMS) because the feasibility of the SES was not confirmed after its recent approval in Japan. Clinical and angiographic outcomes after SES implantation to 93 diffuse ISR were compared with those of 3 groups treated by plain old balloon angioplasty (POBA, (n = 54)), cutting balloon angioplasty (CB, (n = 24)), and BMS (n = 41) in a series of 153 patients whose follow-up quantitative coronary angiography (QCA) evaluated 3-9 months after the treatments was obtained from January 2003 through December 2005. For 33 lesions in the SES group, 12-month follow-up QCA results were obtained and compared with those at 6 months. Ticlopidine (200 mg/day) was prescribed for at least 12 weeks after SES implantation and for 2 weeks after BMS in addition to aspirin (81-100 mg/day). Patient characteristics and the characteristics of previous implanted BMS in the SES group were not significantly different from those in the other groups. Death from cardiac causes and nonfatal myocardial infarction did not occur in any group. Stent thrombosis was not observed in the BMS and SES groups. The incidence of repeat target lesion revascularization (re-TLR) in the SES group (3.23%) was significantly lower compared with that of the POBA (37.0%), CB (25.0%), and BMS (29.3%) groups (P < 0.001, respectively). Late loss in the SES group (0.44 +/- 0.41 mm) was significantly smaller than that in the BMS group (1.34 +/- 0.74 mm) (P < 0.05). The rate of recurrent ISR (re-ISR) in SES (5.38%) was significantly lower than that in POBA (46.3%), CB (41.7%), and BMS (46.3%) (P < 0.001, respectively). The QCA variables at 6 months in the SES group were not significantly different from those at 12 months. Thus, SES implantation for diffuse ISR was far superior since it markedly reduced the incidence of re-TLR with re-ISR at up to 6-months follow-up. In addition, this angiographic patency after SES implantation continued until 12 months.

Documented subacute stent thrombosis within thirty days after stenting with sirolimus-eluting stent (Cypher) for acute myocardial infarction: a Japanese single center retrospective non-randomized study.

BACKGROUND: The incidence of subacute stent thrombosis (SAT) within 30 days after stenting with a sirolimus-eluting stent (Cypher) for acute myocardial infarction (AMI) was retrospectively compared to that with bare-metal stents (BMS). METHODS AND RESULTS: Among 559 lesions in 558 consecutive AMI from April 2003 to February 2006, the incidence of documented SAT after Cypher implantation (2/276 lesions, 0.72%) was almost the same as for BMS (2 cases, 0.71%). Aspirin (81-100 mg/day) plus ticlopidine (200 mg/day) were administered continuously after admission in all 4 cases. CONCLUSION: Documented SAT did not increase after stenting with Cypher for AMI under aspirin plus ticlopidine.

Facilitation of rotablator-stenting by measuring angiographic lesion length with the navicath (type-MUTO), a new measuring microcatheter.

In the present study, the usefulness and feasibility of a new measuring microcatheter, the Navicath (Type-MUTO) microcatheter, for facilitating the stenting procedure subsequent to ablation using a rotablator (rota-stenting) is described. A method for measuring the length of the targeted lesion (lesion length) angiographically with the Navicath when exchanging the guide wires is presented using 2 representative cases of rota-stenting. In addition, the validity of the selected stent according to the measurement of lesion length with the Navicath was evaluated by comparing the length of the selected stent with lesion length before PCI measured by quantitative coronary angiography. Based on the results obtained, we believe the Navicath is useful for facilitating rota-stenting, and may even be applicable to PCI in general.

[Initial and mid-term effects of > or = 30 mm long sirolimus-eluting stents in patients with diffuse long coronary lesions: comparison with bare metal stents].

OBJECTIVES AND METHODS: Sirolimus-eluting stents (SES) can reduce restenosis and reintervention compared with bare metal stents (BMS). However, the safety and efficacy of SES for diffuse long lesions remain unknown. This study compared the efficacy of SES and BMS using the initial and mid-term outcomes of 124 patients with 130 long coronary lesions (SES lengths > or = 30 mm) compared to 141 patients with 146 lesions treated with BMS. RESULTS: Quantitative coronary arteriography parameters and initial success rate were not significantly different between the two groups. Occurrence of stent thrombosis was not different between the groups (1 case, 0.7% in group SES vs 0 case, 0% in group BMS). Restenosis and major adverse cardiac event rates at 6 months were lower in the SES group than in the BMS group (3.1% vs 34.2%, p < 0.0001, 3.8% vs 31.5%, p < 0.0001). CONCLUSIONS: Initial effects of sirolimus-eluting stents for diffuse long lesions are as useful and as safe as BMS. The mid-term outcomes for SES are superior due to the lower rates of both restenosis and major adverse cardiac event.

Deteriorative effect of smoking on target lesion revascularization after implantation of coronary stents with diameter of 3.0 mm or less.

BACKGROUND: Although smoking cessation is widely encouraged because of the associated risk of cardiovascular events, the impact of smoking on target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) is controversial. Therefore, the present study retrospectively investigated the effect of smoking on TLR after plain-old balloon angioplasty (POBA; n=376) and stenting (STENT; n=434) in patients undergoing secondary coronary angiography at a single center. METHODS AND RESULTS: A smoker was defined as current smoking or quitting within 2 years of the first PCI. In the POBA group, the predictors for TLR, as calculated by multiple logistic regression analysis, were a complex type of lesion (p<0.0001) and the left anterior descending artery (LAD) as affected vessel (p<0.05). In the STENT group, the predictors were the final % diameter of stenosis after stenting, measured by quantitative coronary arteriography (p<0.0005), LAD (p<0.01), and smoking (p=0.049). When the STENT group was divided into 2 groups according to the diameter of the implanted stent, smoking was a predictive factors for TLR in the group that received relatively small stents (diameter < or =3.0 mm) (p<0.02), but not in the group that received larger stents (diameter > or =3.5 mm). CONCLUSION: Smoking has a deteriorative effect on TLR after implantation of relatively small coronary stents with a diameter of 3.0 mm or less.

[Survivor of cardiogenic shock following acute myocardial infarction with Churg-Strauss syndrome: first angiographic documention of coronary recanalization of infarct-related arteries: a case report].

A 42-year-old man was treated under a diagnosis of Churg-Strauss syndrome with predonisolone pulse therapy. Three days later, he developed cardiogenic shock following acute myocardial infarction. Coronary angiography showed total occlusions in three peripheral coronary vessels. Intraaortic balloon pumping was used to maintain hemodynamics and predonisolone pulse therapy was repeated. However, he developed cardiogenic shock again after the second pulse therapy and needed percutaneous cardiopulmonary support and intraaortic balloon pumping. Accordingly, combination therapy of predonisolone and cyclophosphamide was given. He then recovered. Follow-up angiography showed recanalization of the infarct-related arteries.

Usefulness of a 6 fr right judkins catheter for mechanically extracting a massive intracoronary thrombus from an ectasic right coronary artery: a report on two different cases of thrombectomy.

In order to bail out the slow-flow phenomenon (slow flow) created by a massive thrombus in an ectasic right coronary artery, a thrombus was mechanically extracted with a 6 Fr right Judkins (JR) catheter, which proved to be more useful than a usual thrombectomy using a Rescue PT system catheter (Rescue). In case 1, the Rescue was used in combination with thrombolysis but failed to alleviate the slow flow that was implicated in a large infarction. On the other hand, in case 2, aggressive thrombectomy with a 6 Fr JR catheter with an 8 Fr Amplatz guiding catheter successfully extracted the massive intracoronary thrombus, restoring good coronary flow. Therefore, mechanical extraction with a 6 Fr JR catheter is safe and useful in cases of massive thrombus when diffuse coronary artery ectasia complicates an acute myocardial infarction. In addition, this method should be applicable to cases of acute coronary syndrome with massive thrombus.

Do indices of coronary conductance after reperfusion reflect the extent of salvaged myocardium?

Existing indices of coronary conductance (hyperemic flow-versus-pressure slope index, FPSI, and zero flow pressure, Pzf) have been developed as measures of microcoronary resistance. These indices, however, refer to cases of normal hearts, and there are no reports studying these indices following acute myocardial infarction. In this study, we investigated whether FPSI and Pzf truly measure the extent of myocardial salvage after successful reperfusion therapy. We also developed a new index of zero pressure flow, Fzp. Nineteen patients who underwent successful reperfusion therapy to the proximal portion of the left anterior descending artery (LAD) were studied. After successful reperfusion therapy, a Doppler wire was placed into the LAD. Aortic pressure was recorded in real time. Results from the aortic pressure and flow meter were combined to produce FPSI, Pzf, and Fzp. All cases underwent a resting thallium (Tl) and BMIPP scintigram within five days of successful reperfusion therapy. Infarcted myocardium was estimated using a severity score calculated from the Tl scintigraphy (TlSS), and the BMIPP (BMIPPSS) was estimated using a severity score. Patients with a TlSS/BMIPPSS ratio of less than 0.4 were assigned to the successful salvage group (group S), while the others were assigned to the failed salvage group (group F). FPSI of group F was 1.91 +/- 0.26 m/sec and of group S was 0.92 +/- 0.43 m/sec (P < 0.01). Pzf of group F was 51 +/- 3 mmHg and of group S was 51 +/- 5 mmHg (NS). Fzp of group F was -98 +/- 16 cm/sec and of group S was -46 +/- 4 cm/sec (P < 0.05). FPSI and the new index of Fzp were useful in estimating the extent of myocardial salvage. Our results suggest that the Pzf index could not differentiate between the two groups.

Relationship between the oxygen uptake during cardiopulmonary exercise testing and left ventricular function in patients with acute myocardial infarction.

The relationship between exercise capacity and left ventricular function has been evaluated in 35 patients with acute myocardial infarction (34 males and 1 female; mean age 55.5 ± 7.1 years). Single photon emission computed tomography (SPECT) was used to measure left ventricular function in the acute phase (4.9 ± 2.2 days after onset) and the chronic phase (188.5 ± 22.9 days after onset). More than 10% left ventricular dilatation from the acute phase to the chronic phase was defined as remodeling (RM) and the subjects were divided into 2 groups: RM and non-RM. Cardiopulmonary exercise testing was performed at 1 month (1M), 3 months (3M) and 6 months (6M) after onset. In the RM group, anaerobic threshold (AT) and peak oxygen uptake (Peak ) did not change significantly. In the non-RM group, AT was 15 ± 1 (ml/min/Kg) at 1M, 16 ± 2 at 3M and 18 ± 4 at 6M. Peak was 26 ± 3 (ml/min/Kg) at 1M, 30 ± 2 at 3M and 32 ± 3 at 6M. Both parameters in the chronic phase increased significantly compared with those at 1M (p<0.002 and p<0.0001). Thus, change in exercise capacity would correlate with change in left ventricular function.

Effect of continuous ATP injection on human hemodynamics.

Continuous ATP injection is used clinically for Tl imaging or coronary flow measurement and because the effect on human hemodynamics is unknown, the present study investigated it in 14 patients undergoing heart catheter examination. Continuous ATP injection induced chest symptoms in 13 of the patients and second-degree atrioventricular block in one, but these complications disappeared immediately after the end of ATP infusion. Continuous ATP injection decreased aortic pressure, but increased pulmonary artery pressure, right atrial pressure and pulmonary capillary wedge pressure. ATP increased heart rate, stroke volume and cardiac output, the latter the result of an increase in preload, a decrease in afterload, and the increase in heart rate.

[A newly developed maneuver, field change conversion (FCC), improved evaluation of the left ventricular volume more accurately on quantitative gated SPECT (QGS) analysis].

PURPOSE: To investigate whether a newly developed maneuver that reduces the reconstruction area by a half more accurately evaluates left ventricular (LV) volume on quantitative gated SPECT (QGS) analysis. METHODS: The subjects were 38 patients who underwent left ventricular angiography (LVG) followed by G-SPECT within 2 weeks. Acquisition was performed with a general purpose collimator and a 64 x 64 matrix. On QGS analysis, the field magnification was 34 cm in original image (Original: ORI), and furthermore it was changed from 34 cm to 17 cm to enlarge the re-constructed image (Field Change Conversion: FCC). End-diastolic volume (EDV) and end-systolic volume (ESV) of the left ventricle were also obtained using LVG. RESULTS: EDV was 71 +/- 19 ml, 83 +/- 20 ml and 98 +/- 23 ml for ORI, FCC and LVG, respectively (p < 0.001: ORI versus LVG, p < 0.001: ORI versus FCC, p < 0.001: FCC versus LVG). ESV was 28 +/- 12 ml, 34 +/- 13 ml and 41 +/- 14 ml for ORI, FCC and LVG, respectively (p < 0.001: ORI versus LVG, p < 0.001: ORI versus FCC, p < 0.001: FCC versus LVG). CONCLUSION: FCC was better than ORI for calculating LV volume in clinical cases. Furthermore, FCC is a useful method for accurately measuring the LV volume on QGS analysis.