Comparative assessment of the antirestenotic efficacy of two paclitaxel drug-eluting balloons with different coatings in the treatment of in-stent restenosis.

BACKGROUND/OBJECTIVES: Preclinical investigations have suggested that coating technology is crucial for the efficacy of drug-eluting balloons (DEB). Aim of this study is to compare the antirestenotic efficacy of two paclitaxel DEB with different coatings in the treatment of in-stent restenosis (ISR) by means of a morphological and functional assessment. METHODS: In a single center, prospective, non-randomized study, the shellac-paclitaxel coated DIOR, and the urea-paclitaxel coated IN.PACT Falcon were compared in the setting of ISR. Quantitative angiography, fractional flow reserve (FFR), and optical coherence tomography (OCT) were performed at baseline, postprocedure and 6-month follow-up. Main endpoints were QCA, FFR and OCT-based parameters of restenosis. RESULTS: Forty-five patients were included, 20 (44 %) received treatment with the DIOR and 25 (56 %) with the IN.PACT Falcon. Angiographic and device success were 100 and 90 % for the DIOR, and 100 and 92 % for the IN.PACT Falcon, respectively. After 6-months, in-segment late lumen loss (-0.03 ± 0.43 vs. 0.36 ± 0.48 mm, p = 0.014) and diameter stenosis (30.7 ± 16.2 vs. 41.3 ± 22.6 %, p = 0.083) were lower for the IN.PACT Falcon. FFR distal of the stent was significantly higher in the IN.PACT Falcon group (0.92 ± 0.07 vs. 0.84 ± 0.13, p = 0.029) and in-stent FFR gradient was lower (0.05 ± 0.05 vs. 0.13 ± 0.12, p = 0.002). Between postprocedure and follow-up, a 16 % decrease in neointimal volume was observed for the IN.PACT Falcon, while a 30 % increase was observed for the DIOR (p = 0.006). CONCLUSIONS: The IN.PACT Falcon DEB showed higher antirestenotic efficacy than the DIOR in the treatment of ISR, demonstrating that DEB with an excipient-based coating is not equally effective.

[Innovative therapies for the treatment of refractory angina: the Reducer, a percutaneous device to narrow the coronary sinus]. / Terapie innovative per il trattamento dell'angina refrattaria: il Reducer, dispositivo percutaneo di restringimento del seno coronarico venoso.

Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease that is not improved by a combination of medical therapy and percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy, but rehospitalization rates remain high. This mandates the need for new therapies targeting an improvement of symptoms in this population, taking into account also the potential impact in terms of healthcare and costs. The increase in coronary sinus pressure seems to reduce myocardial ischemia leading to a redistribution of blood flow to the ischemic territories. The coronary sinus Reducer is a percutaneous implantable device, made of a stainless steel hourglass-shaped stent, designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. In various studies, the Reducer was safely implanted percutaneously via the right jugular vein in patients with refractory angina who were not amenable to revascularization and was associated with an improvement in anginal symptoms and ischemia. These results support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.

Serial morphological and functional assessment of drug-eluting balloon for in-stent restenotic lesions: mechanisms of action evaluated with angiography, optical coherence tomography, and fractional flow reserve.

OBJECTIVES: This study sought to elucidate the underlying mechanism through which drug-eluting balloons (DEB) restore coronary blood flow, by assessing the coronary vessel before, immediately after, and at 6-month follow-up with angiography, optical coherence tomography (OCT), and fractional flow reserve (FFR). BACKGROUND: In-stent restenosis (ISR) treatment remains challenging. Drug-eluting balloons have been shown to be a valid treatment option in several studies. These studies focused on efficiency of the device, whereas the mechanisms of action of DEB in ISR treatment have not been investigated. METHODS: In this prospective, single-center observational study, patients with ISR were treated with a second-generation DEB. Serial angiographic, OCT, and FFR measurements were performed before and after the procedure, as well as at 6-month follow-up. RESULTS: Twenty-five patients were assigned to DEB treatment, with an angiographic and device success of 100% and 92%, respectively. Late luminal loss was 0.01 ± 0.43 mm. Median percent changes [interquartile range] between pre-and post-procedure, and post-procedure and follow-up were, respectively: lumen volume 75.1% increase [43.7 to 115.0], and 8% increase [-14.0 to 25.8]; stent volume 23.7% increase [15.5 to 40.0], and -1.2% decrease [-6.9 to 5.9]; and neointimal volume -14.4% decrease [-29.2 to -9.5], and -15.8% decrease [-38.1 to 28.3]. The FFR gradient along the treated stent (difference in FFR between the distal and the proximal stent edge) was 0.37 ± 0.18 pre-procedure, 0.06 ± 0.04 post-procedure, and 0.05 ± 0.05 at follow-up. In all post-procedural OCT images, intrastent dissections were seen, which were sealed at follow-up OCT. CONCLUSIONS: DEB restore coronary blood flow by means of a short-term mechanical effect, causing an increase in lumen and stent volumes and compression of neointimal hyperplasia (with intra-stent dissections). Due to the local drug effect, patency persists and may even improve at follow-up, with further increase in lumen volume, decrease in neointimal volume, and complete sealing of neointimal dissections.

Assessment of a transcatheter heart valve prosthesis with multidetector computed tomography: in vitro and in vivo imaging characteristics.

Multidetector-row computed tomography (MDCT) image quality (IQ) of the commonly implanted Sapien prosthesis was assessed both in vitro and in vivo. The prosthesis was imaged in an in vitro model with a 256-slice CT system under pulsatile conditions using three protocols (1) retrospectively ECG-gating at 120 kV/600 mAs and (2) 140 kV/406 mAs, and (3) prospective triggering at 120 kV/210 mAs (10 acquisitions per protocol). After reconstruction in three perpendicular planes, IQ of the supra-,peri-,sub-,and intraprosthetic as well as leaflet regions was scored on a four-point scale (1 = non-diagnostic, 2 = moderate, 3 = good and 4 = excellent) by two observers. IQ was also assessed for twenty-one post-operative scans. The in vitro scans of the two retrospective protocols and twenty-one in vivo scans were analyzed during systole and diastole. The prospectively triggered scans were analyzed during diastole. Except for the valve leaflets in 5 systolic reconstructions, the in vitro scores were moderate to excellent. In vivo, 7 systolic and 3 diastolic reconstructions of the valve leaflets were non-diagnostic as well as 3 peri-prosthetic regions in diastole. All other scores were moderate to excellent. The Sapien prosthesis surrounded by a radiopaque stainless steel stent can be visualized with MDCT with moderate to good IQ, except for the valve leaflet region that has generally non-diagnostic or moderate IQ.

Optical coherence tomography assessment of a coronary bare cobalt chromium stent deformed by the removal of an entrapped "jailed" guidewire.

A 64-year-old male with an ongoing acute coronary syndrome was treated percutaneously for a subtotal occlusion of a first diagonal branch. After predilatation of the diagonal, an important secondary branch was evident at the level of the subocclusion. A jailed wire was placed in this vessel, and stenting of the main diagonal branch was performed with a last-generation thin-strut bare cobalt-chromium stent. Conventional retrieval of the jailed wire was impossible, as the distal tip of the wire remained entrapped at the level of the stent. The strong pulling of the wire led only to a deep intubation of the guiding catheter with possible risk of dissection. Retrieval of the wire was finally possible with the support of an over-the-wire microcatheter. However, the stent, though still patent, appeared deformed. At a scheduled control angiogram 4 months later (while the patient was still asymptomatic), an optical coherence tomography (OCT) investigation of the stented segment confirmed the deformation of the stent. OCT showed a complete lack of stent struts on the side of origin of the secondary branch and an "overlap" or "accumulation" of several layers of stent struts on the other side. There were no signs of uncovered struts overall nor malapposition, and even the sites where multiple stent layers were visible were completely covered by neointimal hyperplasia. Despite the multiple layers of metal, the neointimal reaction was moderate and did not lead to a flow-limiting stenosis, thus the patient was further treated medically without the need for a new intervention.