The first percutaneous coronary intervention (PCI) was performed in September 1977, and after 1980 this minimally invasive treatment was established in Japan. To deliver this treatment to a larger ...population, a number of cardiovascular clinics emerged across the country in the 2000s, and the number of PCI cases performed has been steadily increasing, to >250,000 cases per year. In the early 2000s, a single catheterization unit was profitable, if it performed a certain number of treatments and was adequately staffed without excessive capital investment. In the late 1990s, the price of a balloon catheter medical device used for PCI was approximately JPY300,000, although the price was reduced to JPY32,000, almost one-tenth in price, in the April 2022 revision of the National Health Insurance. The reimbursement of the mainstream drug-eluting stent has also decreased from JPY421,000, when it was first introduced, to JPY136,000 currently. In addition, the consumption tax and reforms in working hours will have a major impact on clinic management. We present a history of cardiovascular clinics in Japan and their present and future positions under the variable external environment.
Background: Angiographic fractional flow reserve (angioFFR) is a novel artificial intelligence (AI)-based angiography-derived fractional flow reserve (FFR) application. We investigated the diagnostic ...accuracy of angioFFR to detect hemodynamically relevant coronary artery disease.Methods and Results: Consecutive patients with 30–90% angiographic stenoses and invasive FFR measurements were included in this prospective, single-center study conducted between November 2018 and February 2020. Diagnostic accuracy was assessed using invasive FFR as the reference standard. In patients undergoing percutaneous coronary intervention, gradients of invasive FFR and angioFFR in the pre-senting segments were compared. We assessed 253 vessels (200 patients). The accuracy of angioFFR was 87.7% (95% confidence interval CI 83.1–91.5%), with a sensitivity of 76.8% (95% CI 67.1–84.9%), specificity of 94.3% (95% CI 89.5–97.4%), and area under the curve of 0.90 (95% CI 0.86–0.93%). AngioFFR was well correlated with invasive FFR (r=0.76; 95% CI 0.71–0.81; P<0.001). The agreement was 0.003 (limits of agreement: −0.13, 0.14). The FFR gradients of angioFFR and invasive FFR were comparable (n=51; mean ±SD 0.22±0.10 vs. 0.22±0.11, respectively; P=0.87).Conclusions: AI-based angioFFR showed good diagnostic accuracy for detecting hemodynamically relevant stenosis using invasive FFR as the reference standard. The gradients of invasive FFR and angioFFR in the pre-stenting segments were comparable.
Background:Myocardial perfusion imaging (MPI) and fractional flow reserve (FFR) are established approaches to the assessment of myocardial ischemia. Recently, various FFR cutoff values were proposed, ...but the diagnostic accuracy of MPI in identifying positive FFR using various cutoff values is not well established.Methods and Results:We retrospectively studied 273 patients who underwent stress MPI and FFR within a 3-month period. Results for FFR were obtained from 218 left anterior descending artery (LAD) lesions and 207 non-LAD lesions. Stress MPI and FFR demonstrated a good correlation in the detection of myocardial ischemia. However, the positive predictive value (PPV) of FFR for detecting MPI-positive lesions at the optimal FFR thresholds was insufficient (44% for LAD and 65% for non-LAD lesions). This was caused by a sharp drop in PPV at an FFR threshold of 0.7 or more. Notably, 41% of the lesions with normal MPI demonstrated FFRs <0.80. However, MPI-negative lesions had an extremely low lesion rate with FFR <0.65 (6%). Conversely, 78% and 41% of MPI-positive lesions had FFR <0.80 and <0.65, respectively.Conclusions:The data confirmed that decisions based on MPI are reasonable because MPI-negative patients have an extremely low rate of lesions with a FFR below the cutoff point for a hard event, and MPI-positive lesions include many lesions with FFR <0.65.
Objectives This study sought to compare the initial success rate of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) in a native coronary artery (NCA) in patients with and ...without previous coronary artery bypass grafting (CABG) and to assess predictive factors. Background Landmark novel wiring techniques for CTO-PCI have contributed to improvement in the initial success of CTO-PCI. However, challenges persist in CTO-PCI in NCA in pCABG patients. Methods Patients who underwent CTO-PCI in an NCA were selected and classified into 2 groups: pCABG (206 PCIs in 153 patients) and nCABG (1,431 PCIs in 1,139 patients). Results CTO was located more often in the left anterior descending artery (p = 0.0003), and severe calcified lesions were observed more frequently in the pCABG group (p < 0.0001). Although the retrograde attempt was tried more frequently in the pCABG group, the CTO-PCI success rate was significantly lower in the pCABG patients than in the nCABG patients (71% vs. 83%). Longer procedural time and greater radiation exposure were needed in the pCABG patients. Logistic regression analysis among the pCABG patients revealed that intravascular ultrasound use and parallel wiring were positive factors, and lesion tortuosity was a negative factor. Conclusions The initial success rate of CTO-PCI of an NCA in the pCABG group was significantly decreased compared with that in the nCABG group. Anatomic complexity and unstable hemodynamic state were unfavorable conditions. This study reveals that the issues to be overcome are lying with CTO revascularization in an NCA in pCABG patients.
The characteristics of each scoring balloon seem to be different because material or configuration of scoring element in each device is unique. The aim of this study is to clarify the difference of ...scoring effect among 3 different scoring devices. We prepared 3 different scoring devices Wolverine™ Cutting Balloon™ (CB), ScoreFlex™ NC (SF), NSE Alpha™ (NSE),
n
= 5 respectively. Balloon diameter is 3 mm and 2 types of silicone tubes with different elasticity 140 kPa (tube S) and 576 kPa (tube H), respectively. Inner diameter is 3 mm. We dilated each balloon in each silicone tube with nominal pressure (NP) and 20 atmosphere (HP) and took a picture using a micro CT. We measured penetration depth of all scoring elements into silicone tube wall and calculated their percentage using the following formula; penetration depth/original scoring element height × 100. We also observed the deformation of scoring element during balloon inflation in each device. Scoring element of CB cut deeper into both tubes significantly than SF and NSE at both pressure (40.5% vs 25.1% and 16.8% at NP and 86.1% vs 33.5% and 29.1% at HP in tube S,
p
< 0.01, respectively, 62.6% vs 33.5% and 17.0% at NP and 93.3% vs 45.1% and 36.5% at HP in tube H,
p
< 0.01, respectively). Although no deformation of scoring element was recognized in CB, some deformations were observed in 50% of NSE and 40% of SF (
p
= 0.0377). Scoring balloon with sharp and firmly fixed scoring elements like CB may show definite scoring effect.
Guidewire recrossing into the branch through the stent strut is difficult when that branch was injured or occluded after stenting in the true bifurcation lesion. A 72-year-old man with chronic total ...occlusion in both mid-left anterior descending coronary artery (LAD) and 2nd diagonal branch (D) was admitted to our hospital. We put a 2.25 × 38 mm drug-eluting stent from the LAD to the D with culotte stenting. However, the LAD occluded after stenting. Although we tried to recross, it was impossible because the guidewire migrated subintimal space which was caused by guidewire manipulation. So, we advanced a 2.25 mm balloon catheter on the 1st guidewire which had already been placed outside of the stent in the LAD, and inflated it at bifurcation to compress the subintimal space. Subsequently, we advanced another guidewire through the strut along the surface of the balloon catheter. Immediately after the deflation of the balloon, the guidewire slipped into the distal LAD without resistance. Large branch occlusion after stenting is a serious complication in true bifurcation treatment. Our new bailout technique is effective for recrossing a guidewire into the dissected branch to preserve it.
<Learning objective: In the treatment of bifurcation, the dissection at the branch ostium is a major cause of rewiring failure or periprocedural myocardial infarction. The Real JAB (Rewiring to the dissected branch along the jailed balloon) technique is a useful technique to re-cross the wire into the dissected branch. The principle of this technique is to occupy subintimal space with dilated jailed balloon that is used as navigator of guide wire into distal true lumen.>
•Limitations of single use of intravascular ultrasound (IVUS) or optical coherence tomography (OCT) for evaluation of coronary artery disease.•Usefulness and limitations of sequential use of IVUS or ...OCT.•Advances in hybrid IVUS-OCT imaging devices.•Clinical application and usefulness of hybrid IVUS-OCT imaging devices.
Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) play a crucial role in elucidating the pathophysiology of coronary artery disease (CAD) with the goal to improve patient outcomes of medical and/or interventional CAD management. However, no single intravascular imaging technique has been proven to provide complete and detailed evaluation of all CAD lesions due to some limitations. Although sequential use of multiple modalities may sometimes be performed, there may be issues related to risk, time, and cost. To overcome these problems, several hybrids involving dual-probe combined IVUS-OCT catheters have been developed.
The aim of this review article is to demonstrate some limitations of stand-alone imaging devices for evaluation of CAD, summarize the advances in hybrid IVUS-OCT imaging devices, discuss the technical challenges, and present the potential value in the clinical setting, especially in patients receiving medical or interventional CAD management.
Background Multislice computed tomography (MSCT) is a promising noninvasive method of detecting coronary artery disease (CAD). However, most data have been obtained in selected series of patients. ...The purpose of the present study was to investigate the accuracy of 64-slice MSCT (64 MSCT) in daily practice, without any patient selection. Methods and Results Using 64-slice MSCT coronary angiography (CTA), 69 consecutive patients, 39 (57%) of whom had previously undergone stent implantation, were evaluated. The mean heart rate during scan was 72 beats/min, scan time 13.6 s and the amount of contrast media 72 mL. The mean time span between invasive coronary angiography (ICAG) and CTA was 6 days. Significant stenosis was defined as a diameter reduction of >50%. Of 966 segments, 884 (92%) were assessable. Compared with ICAG, the sensitivity of CTA to diagnose significant stenosis was 90%, specificity 94%, positive predictive value (PPV) 89% and negative predictive value (NPV) 95%. With regard to 58 stented lesions, the sensitivity, specificity, PPV and NPV were 93%, 96%, 87% and 98%, respectively. On the patient-based analysis, the sensitivity, specificity, PPV and NPV of CTA to detect CAD were 98%, 86%, 98% and 86%, respectively. Eighty-two (8%) segments were not assessable because of irregular rhythm, calcification or tachycardia. Conclusion Sixty-four-MSCT has a high accuracy for the detection of significant CAD in an unselected patient population and therefore can be considered as a valuable noninvasive technique. (Circ J 2006; 70: 564 - 571)
Optical coherence tomography (OCT) is a fiber-optic technology that enables high-resolution intracoronary imaging. The aim of this study was to evaluate the safety and feasibility of intracoronary ...imaging with OCT in the clinical setting; 76 patients with coronary artery disease from 8 centers were enrolled. The OCT imaging system (ImageWire, Light Imaging Inc., Westford, Massachusetts) consists of a 0.006 inch fiber-optic core that rotates within a 0.016 inch transparent sheath. OCT imaging was performed during occlusion of the artery with a compliant balloon and continuous flushing. Intravascular ultrasound (IVUS) imaging was performed in the same segments. We assessed the safety and feasibility of the OCT imaging, compared with IVUS. Vessel occlusion time was 48.3 ± 13.5 seconds and occlusion-balloon pressure was 0.4 ± 0.1 atmospheres. Flushing with lactated Ringer’s solution was performed at a rate of 0.6 ± 0.4 ml/s. No significant adverse events, including vessel dissection or fatal arrhythmia, were observed. Procedural success rates were 97.3% by OCT and 94.5% by IVUS. The OCT image wire was able to cross 5 of 6 tight lesions that the IVUS catheter was unable to cross. Of the 98 lesions in which both OCT and IVUS were successfully performed, OCT imaging had an advantage over IVUS for visualization of the lumen border. Minimum lumen diameter and area measurements were significantly correlated between OCT and IVUS imaging (r = 0.91, p <0.0001 and r = 0.95, p <0.0001, respectively). In conclusion, this multicenter study demonstrates the safety and feasibility of OCT imaging in the clinical setting.
Despite its recommendation by the current guidelines, the role of long-term oral beta-blocker therapy has never been evaluated by randomized trials in uncomplicated ST-segment elevation myocardial ...infarction (STEMI) patients without heart failure, left ventricular dysfunction or ventricular arrhythmia who underwent primary percutaneous coronary intervention (PCI).
In a multi-center, open-label, randomized controlled trial, STEMI patients with successful primary PCI within 24 hours from the onset and with left ventricular ejection fraction (LVEF) ≥40% were randomly assigned in a 1-to-1 fashion either to the carvedilol group or to the no beta-blocker group within 7 days after primary PCI. The primary endpoint is a composite of all-cause death, myocardial infarction, hospitalization for heart failure, and hospitalization for acute coronary syndrome. Between August 2010 and May 2014, 801 patients were randomly assigned to the carvedilol group (N = 399) or the no beta-blocker group (N = 402) at 67 centers in Japan. The carvedilol dose was up-titrated from 3.4±2.1 mg at baseline to 6.3±4.3 mg at 1-year. During median follow-up of 3.9 years with 96.4% follow-up, the cumulative 3-year incidences of both the primary endpoint and any coronary revascularization were not significantly different between the carvedilol and no beta-blocker groups (6.8% and 7.9%, P = 0.20, and 20.3% and 17.7%, P = 0.65, respectively). There also was no significant difference in LVEF at 1-year between the 2 groups (60.9±8.4% and 59.6±8.8%, P = 0.06).
Long-term carvedilol therapy added on the contemporary evidence-based medications did not seem beneficial in selected STEMI patients treated with primary PCI.
CAPITAL-RCT (Carvedilol Post-Intervention Long-Term Administration in Large-scale Randomized Controlled Trial) ClinicalTrials.gov.number, NCT 01155635.
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