Rotational atherectomy combined with cutting balloon to optimise stent expansion in calcified lesions: the ROTA-CUT randomised trial.

BACKGROUND: Percutaneous coronary intervention (PCI) of calcified lesions remains challenging for interventionalists. AIMS: We aimed to investigate whether combining rotational atherectomy (RA) with cutting balloon angioplasty (RA+CBA) results in more optimal stent expansion compared with RA followed by non-compliant balloon angioplasty (RA+NCBA). METHODS: ROTA-CUT is a prospective, multicentre, randomised trial of 60 patients with coronary artery disease undergoing PCI of moderately or severely calcified lesions with drug-eluting stent implantation. Patients were randomised 1:1 to either RA+CBA or RA+NCBA. The primary endpoint was the minimum stent area on intravascular ultrasound (IVUS). Secondary endpoints included minimum lumen area and stent expansion assessed by IVUS and acute lumen gain, final residual diameter stenosis and minimum lumen diameter assessed by angiography. Clinical endpoints were obtained at 30 days. RESULTS: The mean age was 71.1±9.4 years, and 22% were women. The procedural details of RA were similar between groups, as were procedure duration and contrast use. Minimum stent area was similar with RA+CBA versus RA+NCBA (6.7±1.7 mm2 vs 6.9±1.8 mm2; p=0.685). Furthermore, there were no significant differences regarding the other IVUS and angiographic endpoints. Procedural complications were rare, and 30-day clinical events included 2 myocardial infarctions and 1 target vessel revascularisation in the RA+CBA group and 1 myocardial infarction in the RA+NCBA group. CONCLUSIONS: Combining RA with CBA resulted in a similar minimum stent area compared with RA followed by NCBA in patients undergoing PCI of moderately or severely calcified lesions. RA followed by CBA was safe with rare procedural complications and few clinical adverse events at 30 days.

Efficacy and Safety of an Upfront RotaTripsy Strategy in the Treatment of De Novo and In-Stent Restenosis Cases.

BACKGROUND: Use of both rotational atherectomy (RA) and intravascular lithotripsy (IVL)-the "RotaTripsy" technique-offers a potentially synergistic calcium-modification strategy that can treat both luminal and abluminal calcification. An upfront RotaTripsy strategy using an undersized burr in large-caliber coronaries also offers the advantage of facilitating IVL catheter passage while being able to undertake the procedure with a 6-Fr system. METHODS: Consecutive patients with heavily calcified lesions on angiographic or intravascular imaging and large target-vessel caliber (≥3 mm) who underwent an upfront RA followed by IVL between July 2021 and January 2022 were included in this study. Study aims were to evaluate periprocedural efficacy and safety. RESULTS: Of the 21 patients included, RotaTripsy was used for treatment of de novo lesions in 12 patients (57%) and for in-stent-restenosis in 9 patients (43%). Seven cases of in-stent restenosis (ISR) involved 2 layers of stents. Mean reference vessel diameter was 3.67 ± 0.46 mm and baseline diameter stenosis was 77.4 ± 11.3%. Average RA burr-to-artery ratio was 0.43 ± 0.05 and IVL balloon-to-artery ratio was 0.93 ± 0.06, with IVL balloon crossing the lesion in all cases following RA. Procedural success was attained in 20 of 21 cases; 1 periprocedural complication (a death related to coronary perforation following stent postdilation) was recorded. CONCLUSIONS: An upfront RotaTripsy strategy is associated with a high degree of procedural success in de novo lesions and ISR cases by facilitating the use of a smaller burr-to-artery ratio and smaller-bore vascular access. Larger studies are required to further evaluate the potential benefits of an upfront RotaTripsy strategy from a safety and cost-benefit perspective.

Coronary In-Stent Restenosis: JACC State-of-the-Art Review.

The introduction and subsequent iterations of drug-eluting stent technologies have substantially improved the efficacy and safety of percutaneous coronary interventions. However, the incidence of in-stent restenosis (ISR) and the resultant need for repeated revascularization still occur at a rate of 1%-2% per year. Given that millions of drug-eluting stents are implanted each year around the globe, ISR can be considered as a pathologic entity of public health significance. The mechanisms of ISR are multifactorial. Since the first description of the angiographic patterns of ISR, the advent of intracoronary imaging has further elucidated the mechanisms and patterns of ISR. The armamentarium and treatment strategies of ISR have also evolved over time. Currently, an individualized approach using intracoronary imaging to characterize the underlying substrate of ISR is recommended. In this paper, we comprehensively reviewed the incidence, mechanisms, and imaging characterization of ISR and propose a contemporary treatment algorithm.

Relationship between hemoglobin A1C and characteristics of plaque vulnerability in stable coronary disease: an optical coherence tomography study.

Patients with diabetes mellitus are at increased risk of cardiovascular events. We aimed to analyze the impact of serum HbA1c levels on coronary plaque characteristics in stable coronary disease. Two hundred sixty-one patients who underwent optical coherence tomography (OCT) examination before elective percutaneous coronary intervention for a de novo obstructive lesions were included in this single-center retrospective analysis. Patients were divided into tertiles according to HbA1c level (tertile 1: HbA1c < 6.3%, tertile 2: 6.3 ≤ HbA1c < 7.8%, tertile 3: HbA1c ≥ 7.8%) and OCT findings were compared. Fibrous cap thickness (FCT) was significantly thinner in tertile 3 compared to tertile 1 and tertile 2 (103.9 ± 48.2 µm [tertile 1] vs. 107.5 ± 60.6 µm [tertile 2] vs. 86.2 ± 35.8 µm [tertile 3], p = 0.03). Higher prevalence of thin-cap fibroatheroma (TCFA) was observed in tertile 3 vs tertile 1 and tertile 2 (19.5% [tertile 1] vs. 19.5% [tertile 2] vs. 33.3% [tertile 3], p = 0.04). HbA1c inversely correlated with FCT (beta coefficient - 4.89, 95% confidence interval - 8.40 to - 1.39, p < 0.01). The logistic regression model revealed that the probability of having TCFA was positively associated with HbA1c with a small change in the range of low and medium HbA1c and a big change in the range of high HbA1c. Furthermore, minimal lumen area and reference lumen area were smaller in tertile 3. In patients with stable coronary disease, high serum HbA1c levels are associated with higher plaque burden and thinner FCT on OCT, while low and medium HbA1c levels result in similar plaque vulnerability.

Rationale and design of a randomized trial evaluating an external support device for saphenous vein coronary grafts.

BACKGROUND: Coronary artery bypass grafting (CABG) is the most common revascularization approach for the treatment of multi-vessel coronary artery disease. While the internal mammary artery is nearly universally used to bypass the left anterior descending coronary artery, autologous saphenous vein grafts (SVGs) are still the most frequently used conduits to grafts the remaining coronary artery targets. Long-term failure of these grafts, however, continues to limit the benefits of surgery. METHODS: The Cardiothoracic Surgical Trials Network trial of the safety and effectiveness of a Venous External Support (VEST) device is a randomized, multicenter, within-patient trial comparing VEST-supported versus unsupported saphenous vein grafts in patients undergoing CABG. Key inclusion criteria are the need for CABG with a planned internal mammary artery to the left anterior descending and two or more saphenous vein grafts to other coronary arteries. The primary efficacy endpoint of the trial is SVG intimal hyperplasia (plaque + media) area assessed by intravascular ultrasound at 12 months post randomization. Occluded grafts are accounted for in the analysis of the primary endpoint. Secondary confirmatory endpoints are lumen diameter uniformity and graft failure (>50% stenosis) assessed by coronary angiography at 12 months. The safety endpoints are the occurrence of major adverse cardiac and cerebrovascular events and hospitalization within 5 years from randomization. CONCLUSIONS: The results of the VEST trial will determine whether the VEST device can safely limit SVG intimal hyperplasia in patients undergoing CABG as treatment for coronary atherosclerotic disease.

Rotational Atherectomy for the Management of Undilatable In-Stent Restenosis with Single or Multiple Stent Layers.

BACKGROUND: There is no consensus on the best treatment of undilatable coronary in-stent restenosis (ISR) regardless of the number of stent layers. We aimed to evaluate the procedural and clinical outcomes of rotational atherectomy (RA) to treat undilatable coronary ISR with single or multiple stent layers. METHODS: We retrospectively evaluated consecutive patients treated with RA for undilatable ISR with single or multiple stent layers in the Mount Sinai catheterization laboratory between January 2016 and September 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE): a composite of death, myocardial infarction (MI), and target lesion revascularization (TLR). Clinical outcomes were assessed at one-year post-procedure. RESULTS: A total of 26 patients were included in the study, in which 18 (69.2%) patients were with multiple stent layers. After RA, 9 (34.6%) were received a new drug-eluting stent, and 6 (23.1%) were treated with intravascular brachytherapy. Angiographic success was achieved in 24 (92.3%) patients, and procedural success was achieved in 22 (84.6%) patients. In-hospital MACE occurred in 4 (15.4%) patients, all due to periprocedural non-Q wave MI. Within one year, MACE occurred in 9 (34.6%) patients with 5 (19.2%) TLR. CONCLUSIONS: RA for undilatable ISR with single or multiple stent layers was performed with favorable procedural outcomes and a relatively high MACE rate driven by TLR within one year.

Meta-Analysis Comparing Same-Sitting and Staged Percutaneous Coronary Intervention of Non-Culprit Artery for ST-Elevation Myocardial Infarction with Multivessel Coronary Disease.

Recent trials and meta-analysis have indicated that complete revascularization (CR) of multivessel coronary disease is beneficial in patients with ST-segment elevation myocardial infarction (STEMI) compared to culprit-only intervention. However, the optimal timing of CR remains unclear. We aimed to analyze the optimal timing of CR in patients with STEMI and multivessel disease by performing an updated network meta-analysis using the recent largest randomized controlled trial. PUBMED and EMBASE were searched through October 2020 to identify randomized controlled trials comparing CR and culprit-only revascularization. A random-effect network meta-analysis comparing three arms (same-sitting [during the index procedure] CR versus staged CR versus culprit-only) and 4 arms (same-sitting CR versus staged CR [in-hospital] versus staged CR [out-hospital] versus culprit-only) were performed. Eleven studies with a total of 7,015 patients were included in our analysis. There was no significant difference in major adverse cardiovascular event (MACE) (HR 0.82, 95% CI 0.64-1.05), cardiovascular death (HR 0.69, 95%CI 0.35-1.33), myocardial infarction (HR 0.66, 95%CI 0.37-1.16), and revascularization (HR 1.05, 95%CI 0.70-1.58) between same-sitting CR and staged CR. When staged CR was further divided into staged CR during the hospitalization and after discharge, there was no significant difference in these outcomes between staged CR (in-hospital) and staged CR (out-hospital). In conclusion, in patients with multivessel disease presenting with STEMI, complete revascularization at any timing, including same-sitting, staged in-hospital, and staged out-hospital, may have similar benefits.

Side branch fractional flow reserve after provisional stenting of calcified bifurcation lesions: The ORBID-FFR study.

OBJECTIVES: We examined the incidence of side branch (SB) compromise after provisional stenting of calcified bifurcation lesions treated with rotational atherectomy (RA) or cutting balloon angioplasty (CBA) and the utility of optical coherence tomography (OCT) to detect functionally significant SB stenoses. BACKGROUND: The comparative impact of RA versus CBA on SB compromise and functional significance remains poorly characterized. METHODS: Seventy-one consecutive patients with 71 calcified bifurcation lesions with angiographically intermediate SB stenoses were randomized to RA (n = 35) or CBA (n = 36). The primary endpoint was SB compromise defined as SB diameter stenosis ≥70%, SB dissection or thrombolysis in myocardial infarction flow grade < 3 after provisional stenting. Secondary endpoints included SB FFR in noncompromised SBs and its correlation with SB ostium area (SBOA) assessed by three-dimensional OCT. RESULTS: SB compromise after provisional stenting was observed in 7 (20.0%) lesions that underwent RA and in 9 (25.0%) lesions treated with CBA (p = .62). Mean SB FFR was 0.83 ± 0.08 and was similar between the study arms. Functionally significant SB stenosis (FFR ≤ 0.80) was detected in 17(30.9%) angiographically noncompromised SBs. SBOA after stenting was an independent predictor of FFR ≤ 0.80 (OR 0.002, 95% CI: 0.00-0.15, p = .002). The optimal cutoff value for SBOA to predict functionally significant SB stenosis was 0.76 mm2 (sensitivity 82%, specificity 89% and area under the curve 0.92, 95% CI: 0.84-0.99). CONCLUSIONS: The rates of SB compromise and functionally significant stenosis after provisional stenting of calcified bifurcation lesions were similar between two lesion preparation strategies. OCT SBOA can detect SB branches with FFR ≤ 0.80 with high sensitivity and specificity.

Comparison of coronary angioscopic findings 8 months after stent implantation between two kinds of biodegradable polymer-coated and one durable polymer-coated drug-eluting stent.

BACKGROUND: The difference of chronic neointimal conditions of biodegradable polymer-coated and durable polymer-coated drug-eluting stent have not been well investigated. OBJECTIVE: We aimed to compare the angioscopic findings among SYNERGY biodegradable polymer-coated everolimus-eluting stent (BP-EES), ULTIMASTER biodegradable polymer-coated sirolimus-eluting stent (BP-SES), and XIENCE Alpine durable polymer-coated everolimus-eluting stent (DP-EES) 8 months after stent implantation. METHODS: Patients who underwent implantation of BP-EES (n = 30), BP-SES (n = 26), or DP-EES (n = 21) in Osaka Rosai Hospital from December 2015 to April 2017 were retrospectively enrolled. Coronary angioscopic evaluation including dominant grade of neointimal coverage (NIC) over the stent, maximum yellow plaque grade, and existence of red thrombi were performed 8 months after stent implantation. The incidence of major adverse cardiac events (MACE) including cardiac death, nonfatal myocardial infarction, and target vessel revascularization were assessed 1 year after coronary angioscopic evaluation among the three groups. RESULTS: The patient and lesion characteristics were similar among the three groups. Dominant grade of NIC and maximum yellow plaque grade were not significantly different among BP-EES, BP-SES, and DP-EES groups [mean ± SD, 1.50 ± 0.73, 1.58 ± 0.64, and 1.33 ± 0.48 (P = 0.38) and 0.83 ± 0.59, 0.81 ± 0.75, and 0.95 ± 0.38 (P = 0.68), respectively]. The existence of red thrombi was similar among the three groups [20, 12, and 19% (P = 0.67)]. There was no significant difference in the MACE 1 year after coronary angioscopic evaluation among the three groups [0, 8, and 0% (P = 0.13)]. CONCLUSIONS: Coronary angioscopic findings revealed that BP-EES, BP-SES, and DP-EES produced similar favorable NIC 8 months after stent implantation.

Procedural and 1-year clinical outcomes of orbital atherectomy for treatment of coronary in-stent restenosis: A single-center, retrospective study.

OBJECTIVES: We evaluated the procedural and 1-year clinical outcomes of orbital atherectomy (OA) for treatment of coronary in-stent restenosis (ISR). BACKGROUND: The optimal treatment for ISR remains uncertain. While rotational and laser atherectomy have been used as neointimal debulking techniques for ISR, there have been few reports on OA for ISR. METHODS: This is a retrospective observational study of consecutive patients who underwent percutaneous coronary intervention (PCI) for ISR with OA in Mount Sinai catheterization laboratory between November 2013 and January 2018. Procedural success was defined as angiographic success without in-hospital major adverse cardiac events (MACE; the composite of all-cause death, myocardial infarction [MI], or target vessel revascularization). Clinical outcomes were assessed at 1 month and 12 months postprocedure. RESULTS: A total of 87 patients were included in the study. All 87 patients were treated with OA, after which 49 (56.3%) patients also received new drug-eluting stents. Angiographic success was achieved in 87 (100%) patients and procedural success was achieved in 79 (90.8%) patients. In-hospital MACE occurred in 8 (9.2%) patients, all due to periprocedural non-Q-wave MI. Acute lumen gain was 1.19 ± 0.57 mm after OA plus balloon angioplasty and 1.75 ± 0.50 mm after stent placement. MACE within 1 year occurred in 17 (19.5%) patients. CONCLUSIONS: OA for ISR was performed with favorable procedural and 1-year clinical outcomes. Randomized trials are warranted to determine whether OA improves the poor prognosis of patients with ISR treated without debulking.

Relationship between high shear stress and OCT-verified thin-cap fibroatheroma in patients with coronary artery disease.

High-risk coronary plaques have been considered predictive of adverse cardiac events. Both wall shear stress (WSS) in patients with hemodynamically significant lesions and optical coherence tomography (OCT) -verified thin-cap fibroatheroma (TCFA) are associated with plaque rupture, the most common underlying mechanism of acute coronary syndrome. The aim of the study was to test the hypothesis that invasive coronary angiography-based high WSS is associated with the presence of TCFA detected by OCT in obstructive lesions. From a prospective study of patients who underwent OCT examination for angiographically obstructive lesions (Yellow II), we selected patients who had two angiographic projections to create a 3-dimensional reconstruction model to allow assessment of WSS. The patients were divided into 2 groups according to the presence and absence of TCFA. Mean WSS was assessed in the whole lesion and in the proximal, middle and distal segments. Of 70 patients, TCFA was observed in 13 (19%) patients. WSS in the proximal segment (WSSproximal) (10.20 [5.01, 16.93Pa]) and the whole lesion (WSSlesion) (12.37 [6.36, 14.55Pa]) were significantly higher in lesions with TCFA compared to WSSproximal (5.84 [3.74, 8.29Pa], p = 0.02) and WSSlesion (6.95 [4.41, 11.60], p = 0.04) in lesions without TCFA. After multivariate analysis, WSSproximal was independently associated with the presence of TCFA (Odds ratio 1.105; 95%CI 1.007-1.213, p = 0.04). The optimal cutoff value of WSSproximal to predict TCFA was 6.79 Pa (AUC: 0.71; sensitivity: 0.77; specificity: 0.63 p = 0.02). Our results demonstrate that high WSS in the proximal segments of obstructive lesions is an independent predictor of OCT-verified TCFA.

Which factors are associated with length of stay in older patients with acute decompensated heart failure with preserved ejection fraction?: AURORA study.

AIM: In heart failure with preserved ejection fraction (HFpEF), it is unclear which factors on admission are correlated with long stays. In contrast, acute decompensated heart failure (ADHF) in older patients is associated with a high risk of a long stay. To manage older ADHF patients with HFpEF, it is important to reveal the risk factors for a long stay on admission. METHODS: We enrolled consecutive older patients (aged >75 years) with HFpEF (ejection fraction ≥50%) who were admitted to control ADHF from May 2014 to April 2016 using the acute heart failure registry in Osaka Rosai Hospital. We compared various factors, including age; sex; body mass index; heart rate; systolic blood pressure (SBP); atrial fibrillation; atherosclerotic risk factors, including dyslipidemia, diabetes mellitus, hypertension, smoking and chronic kidney disease; laboratory data, including brain natriuretic peptide and albumin; and medications, including loop diuretics, on pre-admission between short-stay (<14 days) and long-stay groups. RESULTS: The long-stay group consisted of 122 patients (59.5%). Multivariate analysis showed that male sex, SBP and albumin were independent predictors for long stays. According to the classification and regression tree and receiving operating characteristic curve analysis, all three factors on admission, including male sex, relatively low SBP (<155 mmHg) and hypoalbuminemia (<3.4 g/dL) could well predict the patients that would require long stays (area under curve 0.738). CONCLUSIONS: Among older ADHF patients with HFpEF, male patients with relatively low SBP and hypoalbuminemia on admission should initially undergo more intensive management to reduce the length of stay. Geriatr Gerontol Int 2019; 19: 1084-1087.

Successful ablation for premature ventricular contraction originating from moderator band of morphologic right ventricle in congenitally corrected transposition of great arteries.

A 54-year-old man with congenitally corrected transposition of great arteries (CCTGA) was referred to our hospital for palpitation. 24-hour Holter ECG showed frequent premature ventricular contraction (PVC) and we performed catheter ablation for this PVC. Pace-mapping was performed in morphologic right ventricle (RV) by transaortic approach. Perfect pace-map was achieved in morphologic RV midpart lateral and ablation at this site could eliminate the clinical PVC. After the ablation, by integrating ablation site and 3D mapping, we diagnosed that the clinical PVC was originated from the moderator band (MB) of morphologic RV.

Predictors of cardiac function in acute heart failure patients with mid-range ejection fraction: AURORA study.

AIM: The factors correlated with prognosis in heart failure with mid-range ejection fraction (HFmrEF) is unclear, especially for acute heart failure (AHF) with HFmrEF. Thus, we investigated the factors correlated with the improvement in the ejection fraction (EF) over 1 year in AHF patients with HFmrEF. METHODS AND RESULTS: In Acute Heart Failure Registry in the Osaka Rosai Hospital, we examined 159 consecutive HFmrEF patients out of 1051 HF patients who were admitted to our hospital for AHF from January 2015 to December 2017. We divided them into improved EF (IM) group whose EF improved (≧10%) and non-IM group who had no improvement. We compared the baseline characteristics, echocardiographic data, medications, examinations for ischaemia, invasive treatments, and clinical outcomes between IM group and non-IM group. IM group consisted of 21 patients (20%). IM group had a significantly more de novo heart failure, higher serum albumin (Alb), lower EF, smaller left ventricular dimension during diastole, more frequent coronary angiogram during hospitalization, and coronary intervention. Multivariate analysis revealed that Alb, left ventricular dimension during diastole, and coronary angiogram performed during hospitalization were independently associated with the improvement in the EF. In addition, IM group had less rehospitalizations over 1 year and a greater reduction in the B-type natriuretic peptide level during the follow-up than non-IM group. CONCLUSIONS: In AHF patients with HFmrEF, we should evaluate for any ischaemic heart disease during hospitalization, especially in patients with non-enlarged left ventricular and non-reduced serum Alb. AHF patients with HFmrEF who showed improvement in the EF tended to have better prognosis than those without improvement.

Postmortem late phase histopathology after pulmonary vein isolation using a cryoballoon: A case report.

We report the autopsy case of 68-year-old woman who received cryoballoon (CB) ablation for paroxysmal atrial fibrillation 7 months before death. Both macroscopic and microscopic findings revealed no thrombus formation around pulmonary veins. Previous experimental studies have shown the lower risk of thrombus formation in CB ablation as compared to radiofrequency ablation. Our findings in the human autopsy case may support this merit of CB ablation. To confirm this benefit of CB ablation, further studies regarding histopathology of CB ablation should be performed.