Comparative analysis of lumen enlargement mechanisms achieved with the bifurcation dedicated BiOSS) stent versus classical coronary stent implantations by means of provisional side branch stenting strategy: an intravascular ultrasound study.

The aim of this study was to analyze the mechanisms of lumen enlargement in bifurcation lesions, as assessed by intravascular ultrasound (IVUS), after percutaneous treatment with classic provisional "T" stenting with conventional drug-eluting stents (DES) versus bifurcation dedicated BiOSS (Balton, Warsaw, Poland) stent. In this prospective study between Jan and Dec/11, 32 patients with single de novo coronary bifurcation lesions suitable for treatment with BiOSS stents were randomized (1:1). IVUS method included pre- and post-procedure analysis in the parent vessel. Vessel, lumen and plaque cross-sectional areas were determined at the target lesion [minimum lumen area (MLA) site], proximal limb, distal limb, and "window"-defined as the segment between the carina (flow divider) and the vessel wall at the level of the side branch inflow. All lesions were treated with provisional approach and only 1 case in BiOSS group had a stent implanted in the side branch. Angiographic and IVUS results including MLA at the target site and proximal/distal references were similar. However, mean window length-largest diameter within the window, was similar at baseline, but BiOSS measured significantly longer at postprocedure (2.21 ± 0.37 vs. 1.76 ± 0.52 mm, p = 0.01). In addition, the magnitude of changes in vessel (27 ± 24% vs. 9 ± 10%, p = 0.01) and plaque (2 ± 26% vs. -2 ± 26%, p = 0.02) areas at the window were significantly different for DES versus BiOSS groups, respectively. The contribution of vessel extension for lumen enlargement represented 54 versus 43%, 130 versus 46%, 98 versus 80% and 51 versus 19% of the result achieved at the proximal limb, window, distal limb and MLA sites for DES versus BiOSS, respectively; as for plaque re-distribution, results were 36 versus 57%, -30 versus 54%, 2 versus 20%, and 49 versus 81%, at the proximal limb, window, distal limb and MLA sites, respectively. These results suggest different mechanisms of lumen enlargement comparing conventional DES versus BiOSS dedicated bifurcation stent, which can impact side branch compromise during procedure.

[Heart failure in female patient in peripartum period - how to determine the aetiology?]. / Niewydolnosc serca u chorej w okresie okoloporodowym ­ jak okreslac etiologie?

Peripartum cardiomyopathy (PPM) is an acquired disease of increasing incidence. Its diagnosis and treatment is often problematic. We report a case of 31-year-old woman who was diagnosed with PPM three weeks after delivery and died nine months later despite proper therapy.

Dedicated paclitaxel-eluting bifurcation stent BiOSS® (bifurcation optimisation stent system): 12-month results from a prospective registry of consecutive all-comers population.

AIMS: Dedicated bifurcation stents seem to be the most promising solution for treating bifurcations. The aim of our study was to present the 12 months results of a new dedicated stent for coronary bifurcation lesions -the paclitaxel-eluting stent- BiOSS® Expert (Bifurcation Optimisation Stent System, Balton, Warsaw, Poland). METHODS AND RESULTS: Sixty-three patients with 65 lesions were enrolled in the registry. Forty-six % of the patients were classified as NSTEMI or unstable angina, 27% were diabetics, 30% had previous myocardial infarction and 48% had a history of previous revascularisation. In addition, hypertension and dyslipidaemia were the most common risk factors (58% and 40%). Sixty-five stents were successfully implanted (100% device success rate). The analysis of 30 days follow-up for 63 patients revealed good clinical results showing lack of death, target lesion revascularisation procedures (TLR) and target vessel revascularisation procedures (TVR). There were six (9,5%) cases of in-hospital raised troponin, however, only one showed an additional increase in CK-MB levels and was qualified as non-Q myocardial infarction (MI). There was a need for percutaneous coronary intervention (PCI) in a non-index vessel in one patient due to exertional angina. The analysis of 12-month follow-up for 63 patients revealed good clinical results. There were two (3.2%) cases of death (three and 10 months after index procedure). The first patient, in good physical shape, drowned, while the second was found dead by his family. There were no incidents of MI or stroke in the rest of the population. At 12 months there were seven (10.8% per lesion; 11.1% per patient) cases of TLR and nine (13.8% per lesion; 14.3% per patient) TVR. There were also 15 (23.8%) cases of PCI on vessels not related to BiOSS® Expert stent implantation. CONCLUSIONS: Our registry showed that bifurcation treatment with a single dedicated paclitaxel-eluting bifurcation stent, BiOSS® Expert is feasible and successful. The long-term clinical results are satisfactory in this high-risk patient population.

First-in-man study of paclitaxel-eluting stent BiOSS (Bifurcation Optimisation Stent System) dedicated for coronary bifurcation stenoses: three months results.

BACKGROUND: The best treatment strategy for coronary bifurcation stenosis is still unknown. Dedicated bifurcation stents are the most promising solution. AIM: To evaluate the safety and short-term efficacy of a new stent dedicated for coronary bifurcation stenosis. METHODS: A new bifurcation optimisation stent system (BiOSS, Balton, Poland) is made of 316L stainless steel and is coated with a mixture of biodegradable lactate polymer and paclitaxel (1 µg/mm(2)). The stent consists of two parts, with different diameters according to Murray law connected by two 1.5 mm long bridges. BiOSS is mounted on a dedicated bifurcation balloon (Bottle, Balton, Poland) with markers of the proximal and the distal stent edge, and a third marker at the mid part showing the proximal end of its smaller distal part. The stent delivery is a rapid exchange system. Provisional T-stenting is the obligatory strategy. In order to optimise the result, Bottle balloon (nominal pressure: 10 atm) is inflated with mid marker positioned at the side branch ostium. Double antiplatelet therapy was planned for 12 months. Forty five patients with non-left main bifurcation stenosis (the n-LMB group), as well as 15 patients with left main (LM) bifurcation stenosis (the LMB group), were included in the prospective, feasibility and safety assessment registry. An intravascular ultrasound control is obligatory for all LM patients and strongly recommended for the remaining patients. Patients with ST-elevation myocardial infarction (STEMI) and Medina type 001 bifurcation lesions were excluded from the registry. The primary end-points of the study were: death, MI, in-stent thrombosis and target lesion revascularisation (in-hospital and one, three, six, and 12 months after the intervention). An angiographic control is planned at nine months in all patients. Here, we present the results of a three-month follow-up. RESULTS: The average age of the enrolled patients (63% males) was 67 ± 11 years. Thirty five (58%) patients had hypertension, and 16 (27%) were diabetic (five on insulin treatment). Almost half of the patients (29, 48%) had previous non-ST- -elevation acute coronary syndrome treated with percutaneous coronary intervention. Six (10%) patients had previous coronary artery bypass grafting. In the LMB group (n = 15), there were: six with Medina type 111; five with type 010; three with type 110; and one with type 011 bifurcation lesions. In the n-LMB group (n = 45), the dominant vessel was left anterior descending (n = 26, 58%), followed by left circumflex (n = 15, 33%) and right coronary artery (n = 4, 9%). Medina type 111 lesions were present in 48% of patients. Intravascular ultrasound was performed in 37 (62%) cases. All BiOSS stents were implanted successfully (avg. pressure 12 atm), without any periprocedural complications. There were only seven (14%) cases with a second stent implanted within a side branch. There were four periprocedural increases of troponin interpreted as MI. At one month and at three months, all patients were uneventful (out-of hospital MACE rate 0%). CONCLUSIONS: The BiOSS bifurcation dedicated stent is a feasible device, with promising safety and short-term clinical effectiveness/profile.

Comparative intravascular ultrasound analysis of ostial disease in the left main versus the right coronary artery.

BACKGROUND: Significant aorto-ostial disease is difficult to evaluate with angiography and sometimes even with intravascular ultrasound (IVUS). METHODS: We used IVUS to compare ostial lesions in the left main coronary (LMCA, n = 45) versus the right coronary artery (RCA, n = 50). IVUS measurements were performed each 1 mm beginning within the ostium and continuing to the distal reference segment. Negative remodeling was defined as a remodeling index (lesion/distal reference arterial area) < 0.95. RESULTS: Patient age was 66 +/- 11 years in the LMCA group and 66 +/- 11 years in the RCA group; 56% of the LMCA ostial lesions and 46% of RCA ostial lesions were in males, and 35% of the LMCA ostial lesions and 20% of the RCA ostial lesions were in diabetics. With the exception of a smaller minimum lumen area (p < 0.0001) and distal reference plaque burden (p = 0.002) in ostial RCA lesions and a larger eccentricity index in ostial LMCA lesions (p = 0.001), both sites were remarkably similar. Both ostial LMCA and RCA lesions were short, had modest amounts of calcium, had modest plaque burdens, but had a marked frequency of negative remodeling (84% in LMCA and 86% in RCA; p = 1.0). CONCLUSION: IVUS morphometry is similar in ostial LMCA and RCA lesions; negative remodeling is the dominant contributor to lumen compromise in both locations.

Meta-analysis of angiographic versus intravascular ultrasound parameters of drug-eluting stent efficacy (from TAXUS IV, V, and VI).

Both quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) are currently used to assess in-stent restenosis. This study aimed to use standardized imaging and clinical follow-up to compare QCA parameters with several IVUS parameters to evaluate their strengths and weaknesses for detecting in-stent restenosis in a drug-eluting stent population. A subset of patients from the TAXUS IV, V, and VI studies was evaluated. The subset, which included 216 TAXUS-treated patients and 191 bare-metal stent-treated patients, had complete IVUS and QCA performed at baseline and follow-up. As expected, all QCA and IVUS parameters were consistent with less intimal hyperplasia in TAXUS patients than controls. The overall incidence of QCA binary restenosis was 14.0%, which was 9.3% in TAXUS-treated patients and 19% in bare-metal stent-treated patients (p = 0.0008). Regression analysis showed that QCA late lumen loss and percentage of diameter stenosis correlated only moderately with the various IVUS measures of neointimal hyperplasia for the combined group of patients (TAXUS + bare-metal stent), as well as for the TAXUS-treated and bare-metal stent-treated patients separately. However, in general, correlations within the control (bare-metal stent) group tended to be stronger than within the TAXUS group. The strongest correlation was between QCA percentage of diameter stenosis and IVUS percentage of intimal hyperplasia in the overall group and the control group. The strongest IVUS predictor of QCA binary restenosis at 9 months was maximum percentage of intimal hyperplasia, with an overall C = 0.91 and p <0.001. In conclusion, the QCA and IVUS parameters used to evaluate drug-eluting stent efficacy showed a moderate correlation with IVUS percentage of intimal hyperplasia, reliably predicting QCA binary in-stent restenosis.

Repeated stenting of recurrent in-stent restenotic lesions: intravascular ultrasound analysis and clinical outcome.

BACKGROUND: Stents are used to treat the first and even successive episodes of in-stent restenosis (ISR). METHODS: In 18 patients (19 lesions), intravascular ultrasound (IVUS) was performed after placement of a stent for a nonrestenotic lesion after the second stent was used to treat the first episode of ISR and after the third stent was used to treat the second episode of ISR. The duration between the first and second stent was 355 +/- 374 days, and between the second and third stent was 330 +/- 279 days. The duration of follow up after the third stent was 307 +/- 145 days. High-pressure inflation (> 14 atm) was performed for 69% (11/16) of patients when treating the first episode of ISR, and all patients when treating the re-ISR (p = 0.018). RESULTS: Nevertheless, vessel area and final minimal stent area (MSA) did not increase with successive restenting, and the ratio of minimum stent diameter to nominal stent size suggested that chronic stent underexpansion persisted. MSA > 5 mm2 was noted in 54% after the first stent, 35% after the second stent, and 42% after the third stent (p = 0.6). After the third stent, the rate of target lesion revascularization was 26% (5/19) and target vessel revascularization was 37% (7/19); there was 1 nonfatal myocardial infarction. Thus, the overall rate of major adverse cardiac events was 42%. CONCLUSION: While serial restenting a recurrent ISR lesion was not associated with progressive decrease in MSA, it was still associated with chronic stent underexpansion and a high rate of adverse events. Attention should be directed to achieving better stent expansion to minimize subsequent recurrences.