Ralph Toelg

High-Speed Rotational Atherectomy Before Paclitaxel-Eluting Stent Implantation in Complex Calcified Coronary Lesions: The Randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) Trial

OBJECTIVES This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness. BACKGROUND DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown. METHODS The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months. RESULTS Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups. CONCLUSIONS Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.

Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial

BACKGROUND Absorbable scaffolds were designed to overcome the limitations of conventional, non-absorbable metal-based drug-eluting stents. So far, only polymeric absorbable scaffolds are commercially available. We aimed to assess the safety and performance of a novel second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) in patients with de-novo coronary artery lesions. METHODS We did this prospective, multicentre, non-randomised, first-in-man trial at 13 percutaneous coronary intervention centres in Belgium, Brazil, Denmark, Germany, Singapore, Spain, Switzerland, and the Netherlands. Eligible patients had stable or unstable angina or documented silent ischaemia, and a maximum of two de-novo lesions with a reference vessel diameter between 2·2 mm and 3·7 mm. Clinical follow-up was scheduled at months 1, 6, 12, 24, and 36. Patients were scheduled for angiographic follow-up at 6 months, and a subgroup of patients was scheduled for intravascular ultrasound, optical coherence tomography, and vasomotion assessment. All patients were recommended to take dual antiplatelet treatment for at least 6 months. The primary endpoint was in-segment late lumen loss at 6 months. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01960504. FINDINGS Between Oct 8, 2013, and May 22, 2015, we enrolled 123 patients with 123 coronary target lesions. At 6 months, mean in-segment late lumen loss was 0·27 mm (SD 0·37), and angiographically discernable vasomotion was documented in 20 (80%) of 25 patients. Intravascular ultrasound assessments showed a preservation of the scaffold area (mean 6·24 mm(2) [SD 1·15] post-procedure vs 6·21 mm(2) [1·22] at 6 months) with a low mean neointimal area (0·08 mm(2) [0·09]), and optical coherence tomography did not detect any intraluminal mass. Target lesion failure occurred in four (3%) patients: one (<1%) patient died from cardiac death, one (<1%) patient had periprocedural myocardial infarction, and two (2%) patients needed clinically driven target lesion revascularisation. No definite or probable scaffold thrombosis was observed. INTERPRETATION Our findings show that implantation of the DREAMS 2G device in de-novo coronary lesions is feasible, with favourable safety and performance outcomes at 6 months. This novel absorbable metal scaffold could be an alternative to absorbable polymeric scaffolds for treatment of obstructive coronary disease. FUNDING Biotronik AG.

Multi-vessel stenting during primary percutaneous coronary intervention for acute myocardial infarction. A single-center experience.

BackgroundRecanalization of the culprit lesion is the main goal of primary angioplasty for acute ST-segment elevation myocardial infarction (STEMI). Patients presenting with acute myocardial infarction and multivessel disease are, therefore, usually subjected to staged procedures, with the primary percutaneous coronary intervention (PCI) confined to recanalization of the infarct-related artery (IRA). Theoretically at least, early relief of stenoses of non-infarctrelated arteries could promote collateral circulation, which could help to limit the infarct size. However, the safety and feasibility of such an approach has not been adequately established.MethodsIn this single-center prospective study we examined 73 consecutive patients who had an acute STEMI and at least one or more lesions ≥ 70% in a major epicardial vessel other than the infarctrelated artery. In the first 28 patients, forming the multi-vessel (MV) PCI group, all lesions were treated during the primary procedure. In the following 45 patients, forming the culprit-only (CO) PCI group, only the culprit lesion was treated during the initial procedure, followed by either planned-staged or ischemiadriven revascularization of the non-culprit lesions. Fluoroscopy time and contrast dye amount were compared between both groups, and patients were followed up for one year for major adverse cardiac events (MACE) and other significant clinical events.ResultsThe two groups were well balanced in terms of clinical characteristics, number of diseased vessels and angiographic characteristics of the culprit lesion. In the MV-PCI group, 2.51 lesions per patient were treated using 2.96 ± 1.34 stents (1.00 lesions and 1.76 ± 1.17 stents in the CO-PCI group, both p < 0.001). The fluoroscopy time increased from 10.3 (7.2–16.9) min in the CO-PCI group to 12.5 (8.5–19.3) min in the MV-PCI group (p = 0.22), and the amount of contrast used from 200 (180–250) ml to 250 (200–300) ml, respectively (p = 0.16). Peak CK and CK-MB were significantly lower in patients of the MV-PCI group (843 ± 845 and 135 ± 125 vs 1652 ± 1550 and 207 ± 155 U/l, p < 0.001 and 0.01, respectively). Similar rates of major adverse cardiac events at one year were observed in the two groups (24% and 28% in multi-vessel and culprit treatment groups, p = 0.73). The incidence of new revascularization in both infarct- and noninfarct-related arteries was also similar (24% and 28%, respectively, p = 0.73).ConclusionWe may state from this limited experience that a multi-vessel stenting approach for patients with acute STEMI and multi-vessel disease is feasible and probably safe during routine clinical practice. Our data suggest that this approach may help to limit the infarct size. However, larger studies, perhaps using drug-eluting stents, are still needed to further evaluate the safety and efficiency of this procedure, and whether it is associated with a lower need of subsequent revascularization and lower costs.

Comparison of Hospital Mortality With Intra-Aortic Balloon Counterpulsation Insertion Before Versus After Primary Percutaneous Coronary Intervention for Cardiogenic Shock Complicating Acute Myocardial Infarction

Primary percutaneous coronary intervention (PCI) and intra-aortic balloon pump counterpulsation (IABP) are established treatment modalities in acute myocardial infarction complicated by cardiogenic shock. We hypothesized that the insertion of the IABP before primary PCI might result in better survival of patients with cardiogenic shock compared to postponing the insertion to after primary PCI. We, therefore, retrospectively studied 48 patients who had undergone primary PCI with IABP because of cardiogenic shock complicating acute myocardial infarction (26 patients received the IABP before and 22 patients after primary PCI). No significant differences were present in the baseline clinical characteristics between the 2 groups. The mean number of diseased vessels was greater in the group of patients treated with the IABP before primary PCI (2.8 +/- 0.5 vs 2.3 +/- 0.7, p = 0.012), but the difference in the number of treated vessels was not significant. The peak creatine kinase and creatine kinase -MB levels were lower in patients treated with the IABP before primary PCI (median 1,077, interquartile range 438 to 2067 vs median 3,299, interquartile range 695 to 6,834, p = 0.047, and median 95, interquartile range 34 to 196 vs median 192, interquartile range 82 to 467, p = 0.048, respectively). In-hospital mortality and the overall incidence of major adverse cardiac and cerebrovascular events were significantly lower in the group of patients receiving the IABP before primary PCI (19% vs 59% and 23% vs 77%, p = 0.007 and p = 0.0004, respectively). Multivariate analysis identified renal failure (odds ratio 15.2, 95% confidence interval 3.13 to 73.66) and insertion of the IABP after PCI (odds ratio 5.2, 95% confidence interval 1.09 to 24.76) as the only independent predictors of in-hospital mortality. In conclusion, the results of the present study suggest that patients with cardiogenic shock complicating acute myocardial infarction who undergo primary PCI assisted by IABP have a more favorable in-hospital outcome and lower in-hospital mortality than patients who receive IABP after PCI.

Long-term clinical outcome of rotational atherectomy followed by drug-eluting stent implantation in complex calcified coronary lesions

To assess long‐term outcome after rotational atherectomy (RA) is followed by drug‐eluting stent (DES) implantation in complex calcified coronary lesions.

Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial

Abstract Aims Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. Methods and results The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and—if subjects consented—at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: −0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: −0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. Conclusion The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. ClinicalTrials.gov identifier NCT01960504.

Aortic Regurgitation and Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation A Serial Cardiac Magnetic Resonance Imaging Study

Background—Aortic regurgitation (AR) after transcatheter aortic valve implantation (TAVI) has been associated with poor outcomes, but little is known about how it evolves over time. We evaluated left ventricular (LV) function, remodeling, and the occurrence and evolution of AR after TAVI by using cardiac MRI. Methods and Results—Forty-three patients treated with transfemoral TAVI underwent cardiac MRI 1 week and 6 months after TAVI. LV volumes and function were assessed by using standard cine MRI sequences. Phase-contrast imaging was performed to quantify the degree of AR. The mean age of the evaluated patients was 80 years, and 65% of patients were women. At baseline MRI, the median LV ejection fraction was 58.1%, which improved significantly at follow-up to 63.4% (P<0.0001). A significant reduction of LV end-diastolic volume (149.7±41.4–140.1±43.9 mL; P=0.014) and of LV mass (156.3±32.8–142.7±39.3 g; P<0.001) was observed. Over time, aortic regurgitant fraction increased slightly but significantly from 5.2% to 7.8% (P=0.04). Subgroup analysis revealed that significant changes of LV ejection fraction, volumes, and mass only occurred in patients with no or mild AR at baseline MRI, whereas those parameters remained unchanged in patients with AR more than or equal to grade II. Conclusions—By using cardiac MRI in patients with TAVI, a significant improvement of LV function, volume, and mass can be documented. Mild-to-moderate AR is commonly seen, and AR shows a small increase over time. More-than-mild AR seems to prevent LV functional and structural recovery after TAVI.

Stuck rotablator: the nightmare of rotational atherectomy.

AIMS Rotational atherectomy (RA) is frequently performed to modify complex fibrocalcific coronary lesions with high procedural success. A stuck rotablator is a rare but life-threatening complication. However, its description remains sporadic and it has never been systematically analysed. The aim of this analysis is to present our experience and summarise the available literature about stuck rotablator, and to identify risk factors and possible management strategies for this complication. METHODS AND RESULTS We analysed our experience of 442 RA procedures and identified four cases of stuck rotablator. Two of these cases were rotablations in freshly implanted stents. All cases were managed percutaneously. We further analysed the available literature and identified a total of 11 reports with 14 cases of a stuck rotablator burr; seven were managed surgically and seven with endovascular approaches. Based on our experience and the literature review we developed an algorithm to guide operators while managing this complication. CONCLUSIONS Entrapment of a rotablation burr is a rare but very serious complication of RA. Operators performing RA should be aware of this risk and be prepared to manage it adequately. In our experience, the risk seems to be higher when rotablating freshly implanted underexpanded stents.

Longitudinal Deformation of Contemporary Coronary Stents: An Integrated Analysis of Clinical Experience and Observations from the Bench

OBJECTIVE  To report clinical experience with longitudinal stent deformation (LSD) and observations from the bench. BACKGROUND  LSD was recently reported with thin-strut coronary stents. Whether it is related to a particular stent or constitutes a class-effect remains debatable. METHODS After 2 cases of LSD were reported, information was sent to operators to warn of this event and identify possible cases. All cases were reviewed to ensure LSD had occurred. Simultaneously, bench testing was conducted to identify the susceptibility of stents to longitudinal compression and whether LSD detection is influenced by fluoroscopic stent visibility. RESULTS  Between July 2010 and November 2011, 2,705 coronary interventions were performed with 4,588 stents (Promus Element = 41.6%, Xience Prime = 24.4%). Six patients with LSD were identified, all with Promus Element (0.31%). Wire bias was a predisposing factor in 4 cases. All patients were treated with postdilatation and/or additional stenting. No adverse events occurred (mean 5.8 months). In bench testing, LSD occured in all examined stents, but at different levels of applied force (weight). Most shortening at 50 g was observed with Promus Element (38.9%), as was the best visibility of LSD on x-ray images. With postdilatation all stents showed some re-elongation. CONCLUSION In our practice LSD was a rare observation only seen with the Promus Element stent. When subjected to longitudinal compression in a bench test all contemporary stents can be compressed. Compression of Promus Element occurs at a lower force, but it is the only stent where deformations are detected with x ray. Postdilatation can partially improve LSD.

Rotational atherectomy before paclitaxel‐eluting stent implantation in complex calcified coronary lesions: Two‐year clinical outcome of the randomized ROTAXUS trial

In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel‐eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long‐term data of prospective head‐to‐head comparisons between both treatment strategies have been reported.