Incidence, Predictors, and Clinical Impact of the Impeded-By-Stent Phenomenon After Placing Two-Linked Design New Generation Drug-Eluting Stents.

BACKGROUND: When a catheter device is delivered during percutaneous coronary intervention, its passage can be disrupted by a deployed in a coronary artery. However, the condition and details of this phenomenon, that is impeded-by-stent phenomenon (ISP), remain unclear. METHODS: We designed a prospective, open-label, single-center, observational study to clarify the incidence, predictors, and clinical impact of ISP in drug-eluting stents (DESs). Two independent operators observed and judged the occurrence of ISP, which was defined as all disturbances to a device delivery by deployed DESs. We consecutively used the Ultimaster™ (Terumo, Tokyo, Japan) DES for one month (109 patients, October 2018), followed by the Synergy™ (Boston Scientific Corporation, Marlborough, MA, USA) DES the next month (119 patients, November 2018). RESULTS: DESs (2.5-4.0 mm in diameter) were implanted in 230 de novo coronary vessels. ISPs were observed in 17 of 239 stented segments (7.1 %). Multivariate analysis showed that bifurcation lesions (adjusted odds ratio [OR], 4.2; 95 % confidence interval [CI], 1.5-12.6; p = 0.008), predilatation balloon diameter (mm) (OR, 0.2; 95 % CI, 0.1-0.9; p = 0.03), and Ultimaster™ use (OR, 6.0; 95 % CI, 1.9-27.2; p = 0.002) were independent predictors of ISPs. During the 1.5-year follow-up period, no repeat revascularization or stent thrombosis occurred in patients with ISP. CONCLUSIONS: ISP itself does not trigger notable clinical outcomes, including repeat revascularization and stent thrombosis. However, caution should be considered regarding the latent risk of procedural complications.

Factors Contributing to Efficient Recanalization Procedures for Chronic Total Occlusion of the Superficial Femoral Artery.

BACKGROUND: This study aimed to clarify the factors for efficient procedures (EP) in superficial femoral artery (SFA) chronic total occlusion (CTO). METHODS: We retrospectively analyzed 200 consecutive limbs that underwent treatment for SFA CTO. The patients were divided into three groups according to the main strategies: subintimal angioplasty (SIA) (n = 123), Crosser use (n = 50), and 0.014″ CTO guidewire (CTO-GW) (n = 27). To determine the factors for an EP (EP; contrast volume <130 mL and procedure time <20 min; derived from non-CTO [control] procedures), the variables (P < 0.2) underwent multivariate analysis. RESULTS: SIA included more Trans-Atlantic Inter-Society Consensus C/D lesions and contralateral femoral approaches, and additional GW use (P < 0.05). CTO-GW presented a shorter occlusion length and elapsed time, and used less retrograde approach than the other strategies (P < 0.05). Crossers had a higher incidence of perforation (P = 0.002). The prompt retrograde approach had a similar actual retrograde procedure time, but a shorter total procedure time, compared to that of the delayed adoption (P < 0.001). EP was achieved in 14 limbs (7.0%). Multivariate analysis revealed that occlusion length (adjusted odds ratio [OR], 0.89; 95% CI, 0.81-0.96; P = 0.004) and SIA (OR, 8.71; 95% CI, 1.32-175.27; P = 0.02) were associated with EP. CONCLUSIONS: SIA contributed to EP. The timing of the retrograde approach was crucial because its delay resulted in an excessive procedure time.

Coil Embolization for Coronary Artery Perforation: A Retrospective Analysis of 110 Patients.

OBJECTIVE: Coil embolization (CE) for coronary artery perforation (CAP) has not been thoroughly evaluated. This study aimed to evaluate the extent of myocardial damage and impact on cardiac function after CE for CAP. METHODS: A total of 110 consecutive patients treated with CE for CAP were retrospectively identified. The degree of myocardial damage and impact on cardiac function were evaluated. RESULTS: Forty-nine (44.5%) cases involved chronic total occlusions. A guidewire was the cause of perforation in 97 (88.2%) patients. The success rate of CE was 98.2%. Almost all patients were prescribed either antiplatelet drugs or anticoagulant medication or both. Patients with perforation types III and IV were found to be prone to creatinine kinase (CK) elevation and epicardial main vessel perforation, thereby causing myocardial damage. No changes were noted in the ejection fraction (EF) in patients with type V distal perforation and collateral channel perforation, while patients with perforation of the epicardial main vessel may show impaired cardiac function afterward. CONCLUSIONS: CE is safe and effective for treating CAP, especially when collateral channels and distal vessels are involved. Meanwhile, efforts should be taken to prevent CAP in epicardial main vessels since it may be difficult to treat with CS and cause myocardial damage when bailed out with CE leading to vessel sacrifice. We found that it was not necessary to change the anticoagulant regimen after CE owing to its ability to achieve robust hemostasis.

The composition of the human fecal microbiota might be significantly associated with fecal SCFA levels under hyperbaric conditions.

The fecal microbiota and short-chain fatty acids (SCFAs) play important roles in the human body. This study examined how hyperbaric conditions affect the fecal microbiota and fecal SCFAs. Fecal samples were obtained from 12 divers at three points during deep-diving training (before the diving training, at 2.1 MPa, and after decompression). At 2.1 MPa, the changes in the frequency of Clostridium cluster IV and fecal iso-valerate levels were positively correlated, and the changes in the frequencies of Bacteroides and Clostridium subcluster XIVa were inversely correlated. After decompression, positive correlations were detected between the changes in the frequency of Bifidobacterium and fecal n-valerate levels and between the changes in the fecal levels of iso-butyrate and iso-valerate. On the other hand, inverse correlations were detected between the changes in the frequency of Clostridium cluster IX and fecal iso-butyrate levels, between the changes in the frequency of Clostridium cluster IX and fecal iso-valerate levels, and between the changes in the frequencies of Bacteroides and Clostridium cluster IV plus subcluster XIVa. During the study period, the changes in fecal iso-butyrate and iso-valerate levels were positively correlated, and inverse correlations were seen between the changes in the frequency of Clostridium cluster IV and fecal propionate levels and between the changes in the frequencies of Prevotella and Clostridium subcluster XIVa. These findings suggest that hyperbaric conditions affect the fecal microbiota and fecal SCFA levels and that intestinal conditions reversibly deteriorate under hyperbaric conditions.

Predictors of clinical outcome after rotational atherectomy-facilitated percutaneous coronary intervention in hemodialysis patients.

BACKGROUND: Percutaneous coronary intervention (PCI) in hemodialysis patients with severely calcified and diffused lesions is associated with extremely high rates of major adverse cardiovascular events (MACE), even when facilitated by rotational atherectomy (ROTA). Potential risk factors for MACE with ROTA-facilitated PCI in hemodialysis patients should be identified. METHODS: We retrospectively analyzed a consecutive cohort of patients from the Sapporo Cardiovascular Clinic database, who were on maintenance hemodialysis with severe calcified lesions and treated with ROTA-facilitated PCI. Clinical and interventional procedure characteristics were collected and compared between patients with and without MACE, defined as all-cause death, hospitalization due to heart failure, definite stent thrombosis, or target lesion revascularization (TLR) at 1-year follow-up. The individual outcomes of MACE and TLR in the cohort were presented as Kaplan-Meier percentages. Cox regression analyses were performed to identify independent predictors of MACE. RESULTS: A total of 138 patients undergoing hemodialysis and followed up for 362.50 (243.75, 382.25) days. Sixty-one patients in the cohort had MACE, most of which were TLR (47.5%, 29/61). Cumulative all-cause death at 30-day and 1-year follow-up were 6.52% and 18.8%, respectively. Patients with right coronary artery (RCA) lesions, in-stent restenosis (ISR) lesions, and were more likely to have MACE, even with larger reference vessel diameter and greater acute gain after PCI. Cox regression analysis demonstrated that ISR lesion was positively associated with both MACE (HR 3.21, 95% CI: 1.59-6.48) and TLR (HR 5.08, 95% CI: 1.78-14.47), latter of which was also proved to be significantly related to greater acute gain (HR 1.95, 95% CI: 1.12-3.39). In subgroup analysis, RCA was found to be positively associated with MACE in de novo lesion (HR 2.83, 95% CI: 1.28-6.28). CONCLUSIONS: We found that the overall prognosis of ROTA-facilitated PCI in hemodialysis patients was poor. ISR was a significant risk factor for MACE, especially TLR.

The "Fracking" technique: a novel approach to crack deep calcified plaque in the common femoral artery with hydraulic pressure.

BACKGROUND: The patency achieved by conventional peripheral interventions for atherosclerotic lesions in the common femoral artery (CFA), called the "no stenting zone", is not superior to that achieved by surgical endarterectomy due to calcified plaque occupying the area. Plaque modification strategies to obtain acute gain in CFA patency provide the better clinical outcomes than standard balloon angioplasty. Atherectomy devices, which focus on the modification of superficial calcifications, contribute to the improvement of clinical outcomes. However, deep calcifications resist vessel expansion such that luminal gain is not easily achieved. MAIN TEXT: We propose a novel calcified plaque modification technique, named the "fracking technique" (FT). The term fracking refers to how a rock is fractured by the high hydraulic pressure. In this technique, deep calcifications are cracked with hydraulic pressure via a balloon indeflator through an 18-gauge needle, which punctures calcifications to achieve greater acute luminal gain. Case 1 involved an 81-year-old male with eccentric calcified plaque in the right CFA. Conventional balloon angioplasty for the lesion yielded a suboptimal minimal lumen area (MLA), which increased from 6.2 to 10.7-mm2 on intravascular ultrasound (IVUS). The FT was implemented to obtain a larger MLA. After the FT was repeated at three locations at up to 8-atm, a greater MLA of 27.1-mm2 was achieved without complications. Case 2 involved a 72-year-old male undergoing hemodialysis due to diabetes mellitus who presented with ischemic pain in his right limbs at rest due to severe stenosis with eccentric calcification in the distal CFA. The MLA on IVUS before and after balloon angioplasty was 10.0-mm2 and 13.1-mm2, respectively, and this result was still suboptimal. The FT was attempted and successfully yielded a greater MLA of 28.9-mm2 without complications. Restenosis has not been detected for 2 years follow-up period. CONCLUSIONS: The FT is an effective option for treating calcified CFA lesions to achieve a larger lumen area. Long-term follow-up studies are necessary.

The "Needle bypass" technique: Percutaneous anatomical bypass with needle rendezvous for patients with peripheral arterial disease that have no other surgical options.

BACKGROUND: The ideal method for recanalization of complex peripheral lesions has not been determined, despite the use of the latest endovascular devices. We describe a novel method for a fully percutaneous anatomical bypass, named the "needle bypass" technique, for treatment of complex vascular lesions with failed previous surgical therapy. MAIN TEXT: A 68-year-old male patient with chronic limb-threatening ischemia presented to our department. He previously had received surgical treatment 10 years prior that included the removal of the right distal common femoral artery and two surgical bypasses, an axillary-femoral bypass and an iliofemoral bypass, because he had repeated infections. He was referred to our center in order to have peripheral interventions. Since the previous conventional bridging/revascularization of the removed common femoral bifurcation had failed, the "needle bypass" technique was then used. With this novel technique, the tips of two percutaneous and bidirectional inserted needles were aligned ("needle rendezvous") for the externalization of a guidewire in a through-and-through manner. Once this was achieved, an endovascular stent graft and an interwoven stent were deployed to cover and connect the lesion. This new technique is a minimally invasive anatomical bypass that directly connects artery to artery without any disturbance of the venous flow, and this technique, as the only option available, was performed successfully in our no-option patient. CONCLUSIONS: The "needle bypass" technique is an effective percutaneous treatment method in patients with no other surgical options.

Comparison of Drug-Eluting Stent and Plain Old Balloon Angioplasty After Rotational Atherectomy in Severe Calcified and Large Coronary.

Drug-eluting stent (DES) is well known to be effective in severely calcified lesion after rotational atherectomy (ROTA). However, there are still some situations when stents should be avoided and plain old balloon angioplasty (POBA) should be the preferred option. The present study aims to explore whether POBA is comparably effective to DES in large and calcified coronary pretreated by ROTA in clinical outcomes.Consecutive patients treated for severely calcified lesions in the large (≥ 3 mm) coronary using ROTA + DES or ROTA + POBA were retrospectively analyzed. The major adverse cardiac events (MACE), including all-cause/cardiac death and target lesion revascularization (TLR) at 1 year and 2 years posttreatment, were compared between groups using the Cox regression analysis to identify independent predictors of TLR and MACE.The analysis included 285 cases in the ROTA + DES group and 47 cases in the ROTA + POBA group, without relevant differences in clinical baseline characteristics. Of note, lesion length was greater in the ROTA + DES group (37.2 versus 19.3 mm, P < 0.001); the ROTA + DES group had a higher rate of chronic total occlusion (CTO) lesions, with 8.4%, and the ROTA + POBA group had none. The inhospital/30-day mortality rate (5.3%, ROTA + DES; 6.4%, ROTA + POBA) and the 12- and 24-month all-cause/cardiac mortality rate (9.3%, ROTA + DES; 7.7%, ROTA + POBA) were not significantly different between the two groups. TLR rates were not significantly different between the two groups at 12 (4.6%, ROTA + DES; 4.3%, ROTA + POBA) and 24 (5.3%, ROTA + DES; 6.4%, ROTA + POBA) months.Outcomes were comparable for ROTA + DES and ROTA + POBA in severely calcified large coronary artery intervention with respect to midterm death or TLR rate, especially for short lesion of < 20 mm.

Reappraisal Value of a Modified Rotational Atherectomy Technique in Contemporary Coronary Angioplasty Era.

OBJECTIVES: To introduce a modified rotational atherectomy (RA) procedure and investigate the early and midterm outcomes of the RA-facilitating diversified percutaneous coronary intervention (PCI) in a large group of aged patients with higher cardiovascular risk. BACKGROUND: Previous studies about the outcomes of RA were limited with small sample size and low-risk population. METHODS: Between January 2013 and November 2015, 1169 consecutive patients treated with modified RA-facilitated PCI were retrospectively enrolled, including de novo calcified lesions and in-stent restenosis. Patients were regularly followed up for at least 1 year. Major adverse cardiac events (MACE) were analyzed for all participants by different strategies. Cox regression analysis was performed to identify risk factors for the events. RESULTS: The median age of patients was 75 years, with 11.7% of patients on maintenance hemodialysis. Most lesions (99.9%) were complex (American Heart Association type B2/C), and 68.3% were treated with RA + drug-eluting-stent (DES). Successful angiography was achieved in 97.8% cases, with 1.7% (20/1169) experiencing coronary perforation (including guidewire perforation). The incidence of MACE was 20.5% and 26.8% at 1-year and 2-year follow-up and were mainly driven by target lesion revascularization (TLR) (10.3% and 12.5%, respectively). The strategy of RA + DES had the lowest 2-year MACE, compared with the RA + drug-coated balloon and RA + plain old balloon angioplasty (14.5%, 30.5%, and 26.0%, respectively). CONCLUSIONS: The modified RA technique is a safe and effective tool in the contemporary PCI era, even in high-risk patients. The TLR rate was relatively high but acceptable in such complex lesions.

Utility of Hyperbaric Oxygen Therapy for Acute Acoustic Trauma: 20 years' Experience at the Japan Maritime Self-Defense Force Undersea Medical Center

Introduction: Acute acoustic trauma, which is a kind of sensorineural hearing loss, is caused by acoustic overstimulation. Hyperbaric oxygen therapy (HBOT) is reported to be effective against acute acoustic trauma. Objective: We aimed to evaluate the efficacy of HBOT against acoustic hearing loss based on our 20 years of experience with such cases. Methods: Patients who were treated with HBOT for acute acoustic trauma between April 1997 and August 2017 were evaluated in this study. Thirty-five patients with a mean age of 25.7 ± 9.2 (range: 16­48) years were included. Thirty-nine out of 70 ears (35 patients) were damaged. We investigated the initial level of hearing loss; the extent to which hearing recovered; subjective symptoms, such as tinnitus and aural fullness; and the treatment administered. Results: The planned HBOT was completed in 37 of 39 ears. Twenty-six of the 37 ears (70.2%) displayed improved hearing, and 31 of the 37 ears (83.9%) exhibited symptom improvement. Twenty-three (76.7%) and 26 (86.7%) of the 30 ears treated with steroids demonstrated improvements in hearing and subjective symptoms, respectively. Conclusion: A combination of HBOT and steroids should be considered as a treatment for acute acoustic trauma in cases involving symptoms such as tinnitus and aural fullness (AU)

Utility of Hyperbaric Oxygen Therapy for Acute Acoustic Trauma: 20 years' Experience at the Japan Maritime Self-Defense Force Undersea Medical Center.

Introduction Acute acoustic trauma, which is a kind of sensorineural hearing loss, is caused by acoustic overstimulation. Hyperbaric oxygen therapy (HBOT) is reported to be effective against acute acoustic trauma. Objective We aimed to evaluate the efficacy of HBOT against acoustic hearing loss based on our 20 years of experience with such cases. Methods Patients who were treated with HBOT for acute acoustic trauma between April 1997 and August 2017 were evaluated in this study. Thirty-five patients with a mean age of 25.7 ± 9.2 (range: 16-48) years were included. Thirty-nine out of 70 ears (35 patients) were damaged. We investigated the initial level of hearing loss; the extent to which hearing recovered; subjective symptoms, such as tinnitus and aural fullness; and the treatment administered. Results The planned HBOT was completed in 37 of 39 ears. Twenty-six of the 37 ears (70.2%) displayed improved hearing, and 31 of the 37 ears (83.9%) exhibited symptom improvement. Twenty-three (76.7%) and 26 (86.7%) of the 30 ears treated with steroids demonstrated improvements in hearing and subjective symptoms, respectively. Conclusion A combination of HBOT and steroids should be considered as a treatment for acute acoustic trauma in cases involving symptoms such as tinnitus and aural fullness.

Effects of hyperbaric conditions on fecal microbiota.

We aimed to determine whether the composition of the fecal microbiota changes under hyperbaric conditions. In this study, we collected fecal samples from 6 healthy divers at three points during deep diving training (before, 2.1 MPa, end). The frequency of Clostridium cluster XVIII tended to be increased after compression. The frequencies of Clostridium cluster IV and subcluster XIVa were inversely correlated with that of Bacteroides. The compositional changes in the fecal microbiota exhibited interindividual variability. These findings suggest that hyperbaric conditions affect the fecal microbiota.

Predictors of clinical outcomes after coronary implantation of bioresorbable polymer sirolimus-eluting Ultimaster stents in all-comers: A report of 1,727 cases.

BACKGROUND: Although bioresorbable polymer sirolimus-eluting Ultimaster stents (BP-SESs) are likely useful for percutaneous coronary interventions (PCIs), the clinical data from real-world cases are insufficient. Furthermore, the predictors of adverse clinical outcomes after BP-SES implantation have not been fully investigated. OBJECTIVES: This study evaluated the 1-year clinical outcomes after BP-SES implantation in real-world PCI cases and identified the predictors of adverse outcomes. METHODS: In this single-center, all-comers study, we consecutively implanted BP-SESs in all patients who required coronary stents between October 2015 and August 2016. We conducted a clinical follow-up assessment of these patients. RESULTS: The sample comprised 1,727 patients; 67% were men, the mean age was 72 years, and 37% had diabetes. Of the 2,085 lesions detected, 88% were type B2/C lesions, 4% were chronic total occlusions (CTOs), and 23% were bifurcations. The cumulative incidences of target lesion revascularization (TLR) and target lesion failure (TLF) at 1-year were 2.4% and 5.2%, respectively. A multivariate analysis revealed that hemodialysis (HD) (hazard ratio [HR] 8.40) and CTO (HR 4.21) were independent predictors of TLR. Stent sizes ≤2.5 mm were not associated with either TLR or TLF. CONCLUSIONS: The current study indicates that patients on HD and those with CTO were more likely to experience adverse clinical outcomes after BP-SES implantation. In contrast, small vessel diameter was not significantly related to adverse outcomes. The 1-year clinical outcomes after BP-SES implantation were found to be favorable among all-comer PCI cases, including patients receiving HD and those with in-stent restenosis.

Treatment for in-stent restenosis requiring rotational atherectomy.

OBJECTIVES: This study aimed to evaluate the outcomes of patients with in-stent restenosis (ISR) who underwent rotablation (RA) followed by balloon angioplasty (BA), drug-eluting stent (DES) implantation, or drug-coated balloon (DCB) angioplasty. BACKGROUND: Interventional treatment of ISR is occasionally challenging. Despite the availability of various percutaneous treatments, the optimal solution remains unclear. METHODS AND RESULTS: A total of 200 patients with ISR who underwent RA were retrospectively identified from our institutional database. Clinical outcomes at 12 months and independent predictors of target lesion revascularization (TLR) were assessed. Of patients, 90, 55, and 55 underwent BA, DES implantation, and DCB angioplasty, respectively. The incidence of all-cause death, cardiac death, and hospitalization due to heart failure was low in all groups. Moreover, no definite stent thrombosis was observed in the three groups. The TLR rate of BA, DES implantation, and DCB angioplasty following RA for ISR were 40.7%, 35.0%, and 27.3%, respectively. The adjusted outcomes for TLR using the inverse probability of treatment weighting method based on propensity scores indicated that DCB angioplasty following RA was superior to BA after RA. Intraprocedural complications, which could be successfully managed with interventional treatment, were identified in only three cases. CONCLUSIONS: TLR at 12 months is dismal. RA is not effective for ISR requiring RA. In unfavorable settings, DCB angioplasty following RA is the most effective treatment option in patients with ISR requiring debulking strategy.

Rotational atherectomy and new-generation drug-eluting stent implantation.

OBJECTIVES: The aim of this study was to evaluate the clinical outcomes of rotational atherectomy (RA) followed by new-generation drug-eluting stent (DES) implantation in patients with an extensive amount of calcified and fibrotic plaque. BACKGROUND: RA followed by new-generation DES implantation for complex lesions has not been thoroughly evaluated. METHODS: A total of 744 consecutive patients (770 lesions) treated with new-generation DES implantation following RA for de novo lesions between January 2013 and November 2015 were retrospectively identified using our institutional database. Clinical outcomes at 12 months were evaluated and the independent predictors of all-cause death and target vessel failure (TVF) were assessed using Cox regression models. RESULTS: Target lesion revascularization occurred in 22 lesions (2.9%) and TVF occurred in 51 lesions (6.6%). In a multivariate analysis, hemodialysis, non-ST-segment elevation acute coronary syndrome, low ejection fraction, and HbA1c ≧ 7% were associated with 12-month mortality. Hemodialysis and right coronary artery were identified as independent predictors of TVF (hazard ratio (HR) 4.107, 95% confidence interval (CI) 2.194-7.685, P < .001; HR 2.491, 95% CI 1.023-6.062, P = .044, respectively). CONCLUSIONS: A good debulking with RA followed by new-generation DES implantation is recommended for patients with an excessive amount of calcified and fibrotic plaque, as this will likely improve the clinical outcomes.

Up-Regulation of Antioxidant Proteins in the Plasma Proteome during Saturation Diving: Unique Coincidence under Hypobaric Hypoxia.

Saturation diving (SD) is one of the safest techniques for tolerating hyperbaric conditions for long durations. However, the changes in the human plasma protein profile that occur during SD are unknown. To identify differential protein expression during or after SD, 65 blood samples from 15 healthy Japanese men trained in SD were analyzed by two-dimensional fluorescence difference gel electrophoresis. The expression of two proteins, one 32.4 kDa with an isoelectric point (pI) of 5.8 and the other 44.8 kDa with pI 4.0, were elevated during SD to 60, 100, and 200 meters sea water (msw). The expression of these proteins returned to pre-diving level when the SD training was completed. The two proteins were identified using in-gel digestion and mass spectrometric analysis; the 32.4 kDa protein was transthyretin and the 44.8 kDa protein was alpha-1-acid glycoprotein 1. Oxidation was detected at methionine 13 of transthyretin and at methionine 129 of alpha-1-acid glycoprotein 1 by tandem mass spectrometry. Moreover, haptoglobin was up-regulated during the decompression phase of 200 msw. These plasma proteins up-regulated during SD have a common function as anti-oxidants. This suggests that by coordinating their biological effects, these proteins activate a defense mechanism to counteract the effects of hyperbaric-hyperoxic conditions during SD.