Mid-term results of stent-less coronary intervention using rotational atherectomy and drug-coated balloon for de-novo lesions in hemodialysis patients.

BACKGROUND: Although drug-coated balloon (DCB)-based stent-less percutaneous coronary intervention (PCI) for de-novo lesions has attracted more attention, outcomes of the DCB procedure for hemodialysis (HD) patients are reported to be inferior to those for non-HD patients, similarly to drug-eluting stent (DES). Recent several reports have shown that rotational atherectomy (RA) followed by DCB treatment (RA/DCB) could be an option of revascularization strategy particularly for calcified de-novo lesions even in the new-generation DES era; however, efficacy of the RA/DCB procedure for HD patients remains unclear. METHODS: A total of 47 consecutive cases (53 lesions) undergoing RA/DCB for de-novo lesions were enrolled. According to the presence/absence of HD at baseline, the 47 cases were divided into the HD cases (N.=16) and the non-HD cases (N.=31), and the 53 lesions were divided into the HD lesions (N.=20) and the non-HD lesions (N.=33). RESULTS: The HD cases had a significantly lower prevalence of dyslipidemia and smoking than the non-HD cases. Final RA burr size, DCB diameter used, and angiographic success rate of PCI did not significantly differ between the 2 groups. Preprocedural, post-procedural, and follow-up QCA parameters were also similar between the 2 groups. Twelve-month clinical outcomes were comparable between the 2 groups. CONCLUSIONS: Mid-term outcomes of stent-less PCI using RA/DCB for de-novo lesions in HD patients might be comparable to those in non-HD patients, suggesting efficacy of pretreatment of RA prior to DCB treatment in HD patients.

Mortality risk after use of a paclitaxel-coated stent in femoropopliteal peripheral artery disease.

Although paclitaxel-based devices which demonstrated improved outcomes in the treatment of lower-extremity peripheral artery disease (PAD) have been used worldwide, Katsanos et al. reported a systematic review and summary-level meta-analysis of RCTs in which application of paclitaxel-based devices in the femoropopliteal artery was associated with an increased mortality risk. The purpose of this study was to describe the safety of endovascular therapy (EVT) using paclitaxel-coated stents for femoropopliteal disease by evaluating the mortality risk compared with patients treated with paclitaxel-free devices. A retrospective, multicenter, non-randomized study examined 481 de-novo symptomatic PAD patients treated in 13 Japanese medical centers from January 2011 to December 2015. The risk of all-cause mortality was analyzed between the 65 patients treated with a paclitaxel-coated stent (PTX-coated group) and 416 patients treated with an uncoated balloon or bare nitinol stent (PTX-free group). Overall survival of the PTX-coated group and the PTX-free group were compared after propensity score matching. The 2-year overall survival estimates were 87.7% in the PTX-coated group vs 88.7% in the PTX-free group. There were no significant differences in the mortality risk between the groups through a full follow-up of 2 years (p = 0.80). The multivariate cox proportional hazards model identified three significant predictors of mortality; age (HR, 1.08; 95% CI, 1.03-1.13; p = 0.002), hemodialysis (HR, 3.16; 95% CI, 1.34-7.42; p = 0.008), and albumin (g/dl) (HR, 0.46; 95% CI, 0.25-0.85; p = 0.01).

Temporal reverse flow by proximal femoral artery occlusion during drug-coated balloon dilatation: a technique to minimize downstream particle embolization and systemic adverse effects.

Downstream paclitaxel particle embolization for nonhealing ischemic ulcers and systemic adverse effects caused by a paclitaxel drug-coated balloon are of concern, and safety measures to prevent these adverse risks are needed. To reduce distal particle embolization and movement of the paclitaxel particles to systemic blood flow during drug-coated balloon inflation, proximal balloon occlusion using a sheathless temporary occlusion balloon-guiding catheter and extraction by manual aspiration of the paclitaxel-containing blood through the catheter are good treatment options to overcome these risks. Here, we introduce this method with tips and tricks, and demonstrate initial experience of this technique.

Stentless Interventional Procedure Using Rotational Atherectomy and Drug-Coated Balloon for Noncalcified De Novo Lesions.

BACKGROUND: Several recent reports have shown that a stentless interventional procedure using rotational atherectomy followed by drug-coated balloon (DCB) treatment (RA/DCB) is a potent revascularization therapy for calcified de novo lesions even in the new-generation drug-eluting stent era; however, the role of the RA/DCB procedure for noncalcified de novo lesions remains unclear. METHODS: A total of 47 consecutive patients (53 lesions) who underwent RA/DCB for coronary de novo lesions were enrolled. According to the presence or absence of severe calcification at target lesions on fluoroscopy, the 47 patients were divided into the noncalcified cases (n = 12) and the calcified cases (n = 35), and the 53 lesions were divided into the noncalcified lesions (n = 14) and the calcified lesions (n = 39). RESULTS: The noncalcified cases tended to have a higher frequency of bleeding risk and had a significantly lower prevalence of dual antiplatelet therapy compared with the calcified cases. The main lesion-specific factors for the RA/DCB procedure among the noncalcified lesions were presence of left circumflex coronary artery ostial lesion. The final burr size, DCB diameter used, and angiographic success rate did not significantly differ between the 2 groups. The noncalcified lesions had a larger reference diameter and a shorter lesion length than the calcified lesions, whereas acute gain and late lumen loss did not differ between the 2 groups. Nine-month clinical outcomes were comparable between the 2 groups. CONCLUSIONS: Under drug-eluting stent-unsuitable clinical or lesion conditions, acute and midterm outcomes of RA/DCB for noncalcified de novo lesions might be comparable with those for calcified de novo lesions.

CONTEXTE: Plusieurs rapports récents ont montré qu'une revascularisation sans endoprothèse effectuée par athérectomie rotationnelle (AR) suivie d'un traitement par ballonnet médicamenté (BM) constitue une méthode efficace pour traiter les nouvelles lésions calcifiées, même à l'ère des endoprothèses médicamentées de nouvelle génération; on ne connaît toutefois pas bien l'utilité de l'intervention par AR et BM en cas de nouvelles lésions non calcifiées. MÉTHODOLOGIE: Au total, 47 patients consécutifs (53 lésions) ayant subi une intervention par AR et BM pour traiter de nouvelles lésions coronariennes ont été admis dans l'étude. Ces 47 patients ont été répartis en deux groupes, en fonction de l'absence (n = 12) ou de la présence (n = 35) de lésions . cibles sévèrement calcifiées observées à la fluoroscopie. Les 53 lésions ont aussi été réparties en deux groupes : lésions non calcifiées (n = 14) et lésions calcifiées (n = 39). RÉSULTATS: Les patients n'ayant pas de lésion calcifiée étaient généralement plus susceptibles de présenter des saignements et significativement moins nombreux à être sous bithérapie antiplaquettaire, comparativement aux patients ayant des lésions calcifiées. Dans le cas des lésions non calcifiées, la principale caractéristique justifiant une AR et un traitement par BM était la présence d'une lésion ostiale du rameau circonflexe de l'artère coronaire gauche. La taille de la dernière fraise utilisée, le diamètre du BM utilisé et le taux de réussite objectivée par angiographie étaient comparables dans les deux groupes. Les lésions non calcifiées avaient un diamètre de référence plus grand et étaient plus courtes que les lésions calcifiées, tandis que le gain aigu et la perte luminale tardive étaient similaires dans les deux groupes. Les résultats cliniques à neuf mois étaient aussi similaires dans les deux groupes. CONCLUSIONS: Lorsque les conditions cliniques ou les lésions ne se prêtent pas à l'utilisation d'une endoprothèse médicamentée, le traitement des nouvelles lésions non calcifiées par AR et BM pourrait donner des résultats immédiats et à moyen terme comparables à ceux du traitement des nouvelles lésions calcifiées.

[Acute headache resulting from intracranial venous reflux due to occlusion of the brachiocephalic vein ipsilateral to a dialysis shunt].

A 72-year-old man on hemodialysis for 7 years with end-stage renal disease was admitted to our institution due to an acute headache. Physical examination revealed normal signs except for noise on the back of his neck. His head CT and brain MRI showed no abnormal findings, while his MRA demonstrated abnormal signals in the left transverse to sigmoid sinus (T-S) suggesting a left dural arteriovenous fistula. After admission, his headache persisted and left orbital numbness also occurred. His digital subtraction angiography performed on the 5th day after admission showed no vascular malformation of either the T-S or cavernous sinus (CS). However, it showed occlusion of the left brachiocephalic vein (BCV) and the origin of the left internal jugular vein (IJV) resulting in intracranial venous reflux. These findings indicated the possibility that his acute headache was caused by intracranial venous reflux and increase of intracranial pressure resulting from the occlusion of the BCV ipsilateral to a dialysis shunt. Percutaneous transluminal angioplasty (PTA) for occlusion of the left BCV was performed on the 9th day and successful dilation of the lesion with a residual stenotic ratio less than 30 percent was obtained. After the angioplasty, venous reflux to the intracranial vein was markedly reduced and his headache and orbital numbness disappeared. One day after the procedure, MRA demonstrated the disappearance of the abnormal signals of the left T-S. Twelve months after discharge, he felt discomfort in the left of his face and the re-occlusion of the left VCV was demonstrated by angiography, therefore he received re-PTA. We recommend that physicians consider occlusion of the BCV ipsilateral to a dialysis shunt and intracranial venous reflux as a cause of acute headache in patients on hemodialysis.

Angiographic and Clinical Outcomes After Stent-less Coronary Intervention Using Rotational Atherectomy and Drug-Coated Balloon in Patients with De Novo Lesions.

OBJECTIVES: We investigated angiographic and clinical outcomes in patients with de novo lesions undergoing rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation (RA/DCB). BACKGROUND: Implantation of drug-eluting stent (DES) has been a mainstay of the interventional treatment of coronary artery disease (CAD); however, there still remain several DES-unsuitable clinical/lesion conditions. Nowadays DCB for de novo lesions has attracted more attention, and RA, which tends not to cause major dissection but to debulk intima, might be one of suitable pre-treatments before DCB. METHODS AND RESULTS: Thirty patients (34 lesions) undergoing RA/DCB for de novo lesions were enrolled. Clinical/lesion background included severe calcification, calcified nodule, inlet/outlet of aneurysm, ostial lesion, severe thrombocytopenia, bleeding tendency, and/or sequelae of Kawasaki disease. The largest burr size used was 1.83 ±â€¯0.23 mm, and the mean DCB diameter was 2.71 ±â€¯0.47 mm. Angiographic success was obtained in 94% of the lesions. No acute closure but 1 no reflow occurred. Repeat angiography (mean, 6.6 months after procedure) was performed for 19 lesions. Frequency of binary restenosis was 21.1%, and late lumen loss was 0.34 ±â€¯0.30 mm. During a mean follow-up period of 13.1 months, 6 deaths (2 sudden deaths, 1 cardiac death, 3 non-cardiac deaths), 2 strokes, and 2 target lesion revascularizations were observed. CONCLUSIONS: Stent-less PCI using RA/DCB might be an alternative revascularization therapy for CAD patients complicated with DES-unsuitable conditions.

Effects of Baseline Thrombocytopenia on In-hospital Outcomes in Patients Undergoing Elective Percutaneous Coronary Intervention.

Objective The purpose of the present study was to examine the relationship between thrombocytopenia at baseline and in-hospital outcomes in unselected patients undergoing elective percutaneous coronary intervention (PCI) in Japan. Methods Among a total of 1,247 consecutive elective PCI-treated patients, patients with a baseline platelet count 150,000-449,000/µL and 50,000-149,000/µL were assigned to the normal platelet (n=1,009) and thrombocytopenia (n=226) groups, respectively. The thrombocytopenia group was further divided into the mild thrombocytopenia (100,000-149,000/µL, n=187) and moderate thrombocytopenia (50,000-99,000/µL, n=39) groups. Results The angiographic success rate of PCI and in-hospital mortality rate did not differ to a statistically significant extent between the normal platelet and thrombocytopenia groups or between the mild thrombocytopenia and moderate thrombocytopenia groups, whereas the moderate thrombocytopenia group had a significantly higher rate of access site-related bleeding complications than the normal platelet group. According to a multivariate analysis, moderate thrombocytopenia was an independent predictor of access site-related bleeding complications. Conclusion Among patients with mild to moderate thrombocytopenia, elective PCI might be feasible and effective in the short term; however, more attention should be paid to access site-related bleeding complications, particularly in patients with moderate thrombocytopenia.

Potent Stent-Less Procedure Using Rotational Atherectomy and Drug-Coated Balloon to Right Coronary Ostial Lesion.

BACKGROUND: Even in the drug-eluting stent era, ostial lesion of the right coronary artery (RCA) still remains therapeutic challenge for interventional cardiologists. Case Series Case 1 (76 y.o. male) with angina on effort underwent transradial stent-less percutaneous coronary intervention (PCI) using rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation alone (RA/DCB) against a calcified de novo RCA ostial lesion. Case 2 (86 y.o. female) with recurrent unstable angina and hemodialysis underwent transfemoral RA/DCB against a severe repeat in-stent restenosis probably due to calcified nodule in the RCA ostium. In the both patients, PCI was successfully completed under intravascular ultrasound imaging (IVUS) guidance without complications. Follow-up CAG performed 4-5 months after the procedure revealed no significant lumen narrowing in the both RCA ostial lesions. CONCLUSIONS: The both cases suggest that stent-less PCI using RA/DCB under IVUS might be an alternative revascularization therapy of choice for calcified RCA ostial lesions.

Bifurcation Intervention in Single Coronary Artery.

A 77-year-old man was referred to our hospital for angina on effort. Coronary angiography and computed tomography demonstrated a single coronary artery arising from the right sinus of Valsalva. The left circumflex coronary artery (LCx) anomalously deriving near from the ostium of right coronary artery exhibited severe stenosis in the bifurcation of the obtuse marginal branch. Although the bifurcation lesion still remains a therapeutic challenge for guide extension catheter (GEC)-based percutaneous coronary intervention, under the guidance of intravascular ultrasound imaging, we successfully implanted an everolimus-eluting stent at the bifurcated LCx lesion and performed kissing balloon inflation using 0.014- and 0.010-inch systems through GECs.

Stent-less percutaneous coronary intervention using rotational atherectomy and drug-coated balloon: A case series and a mini review.

BACKGROUND: Experiences of rotational atherectomy (RA) followed by drug-coated balloon (DCB) dilation alone (RA/DCB) for de novo coronary artery lesion have been limited. CASE SERIES: Case 1 (65 year-old male) with silent myocardial ischemia and hemodialysis had old anterior myocardial infarction and intact LM/LCx, and underwent RA/DCB against a diffuse calcified lesion in the proximal LAD and a tandem lesion in the proximal RCA. Case 2 (88 year-old female) with post-infarction unstable angina had severe thrombocytopenia and anemia due to myelodysplastic syndrome (platelet 6000/µL, hemoglobin 8.3 g/dL), and underwent RA/DCB against a severe stenosis in the mid LCx after transfusions. Case 3 (47 year-old male) with silent myocardial ischemia due to possible sequelae of Kawasaki disease underwent RA/DCB against a restenotic lesion at the in-let of the calcified aneurysm in the proximal LAD. In all of the patients, PCI was successfully completed under optical frequency domain imaging (OFDI) without complications. Follow-up CAG performed 6-7 months after the procedure revealed no restenosis in case 1 and case 3, and all of the 3 cases have been free of cardiovascular/hemorrhagic events for 11-37 months since the last stent-less procedures. CONCLUSIONS: These cases suggest that RA/DCB under OFDI might be an alternative stent-less revascularization therapy of choice for patients who may be unsuitable for drug-eluting stent implantation.