Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial.

BACKGROUND: The optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT). METHODS: ROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA. RESULTS: The mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm3 vs. 0.61 ± 0.33 mm3; p = 0.68; IVL: 0.64 ± 0.19 mm3 vs. 0.68 ± 0.22 mm3; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL. CONCLUSION: RA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL.

Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

Fusion imaging guided implantation of a Tricento transcatheter heart valve for severe tricuspid regurgitation.

We report the case of a 64-year-old patient with history of chronic kidney disease on dialysis who was repeatedly hospitalized due to hydropic decompensation. Right heart failure with secondary severe tricuspid regurgitation was diagnosed. An interventional approach was recommended due to the heavy calcification of the sinus venosus and the perioperative risk (EuroScore II 3.2%) and taking into account the explicit request of the patient. After analysis of a full-cycle computed tomography, the patient was eligible for the implantation of the Tricento transcatheter heart valve. The custom-made prosthesis was implanted successfully using periprocedural transoesophageal guidance supported by fusion imaging that integrates live co-registration. After implantation of the valve prosthesis, the primary result was excellent. The patient was discharged without further complications shortly after the procedure and her status is being closely monitored.

First-in-Man Lithoplasty of a LIMA Bypass With ECMO Support in a Last-Remaining Vessel.

We report the case of a 70-year-old patient with history of chronic heart disease who underwent bypass surgery twice beforehand and was admitted due to non-ST segment elevation myocardial infarction. Angiography showed degeneration of all bypass grafts except the LIMA bypass, which showed significant ostial stenosis with severe calcification. Peri-operative risk was computed to be as high as 12.3% (STS Score). An interventional strategy was chosen: the very high-risk procedure was performed safely under the protection afforded by venoarterial ECMO and cardiac surgeons on standby using a coronary intravascular lithoplasty (IVL) balloon. After implantation of a drug eluting stent, the primary angiogram showed a satisfactory result. The patient was discharged without further complications short after the procedure and is closely followed-up.

Mitral valve leaflet repair with the new PASCAL system: early real-world data from a German multicentre experience.

AIMS: To examine the clinical experience and practical use of the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA, USA) and to report some of the first clinical results. METHODS AND RESULTS: A total of 18 consecutive patients with severe, symptomatic mitral regurgitation (MR) were included in this German multicentre registry. All patients underwent clinical, echocardiographic, and laboratory assessment prior to the PASCAL procedure and before hospital discharge. MR was classified as functional in 6 patients, degenerative in 2, and combined in 10. All except one received a single PASCAL implant. The preprocedural severe MR present in all patients was reduced: grade 0 in 4 (22.2%), grade I in 11 (61.1%), grade II in 3 (16.7%). The v-wave was significantly reduced from 31.7 ± 9.5 to 18 ± 7.7 mmHg (p < 0.001). Independent leaflet capture, performed in 4 (22.2%) of the patients, wide clasps, and the 10-mm central spacer are features of the PASCAL device to optimize mitral leaflet repair. There were no periprocedural complications. CONCLUSION: PASCAL is a safe and effective mitral valve repair device for the treatment of severe MR. Device-specific features allow valve repair tailored to the individual anatomy of the underlying mitral pathology in each patient.

Galectin-3 and ST2 as predictors of therapeutic success in high-risk patients undergoing percutaneous mitral valve repair (MitraClip).

BACKGROUND: Percutaneous mitral valve repair (PMVR) is an interventional treatment option in patients with severe mitral regurgitation (MR) and at high risk for open-heart surgery. Currently, limited information exists about predictors of procedural success after PMVR. Galectin-3 (Gal-3) and suppression of tumorigenicity 2 (ST2) induce fibrotic alterations in severe MR and heart failure. We sought to examine the predictive value of Gal-3 and ST2 as specific indicators of therapeutic success in high-risk patients undergoing PMVR. HYPOTHESIS: We hypothesize that extended cardiac fibrotic alterations might have impact on successful MR reduction after the MitraClip procedure. METHODS: A total of 210 consecutive patients undergoing PMVR using the MitraClip system were included in this study. Procedural success was defined as an immediate reduction of MR by ≥2 grades, assessed by echocardiography. Venous blood samples were collected prior to PMVR and at 6 months follow-up for biomarker analysis. RESULTS: After PMVR there was a significant reduction in the severity of MR (MR grade: 3 ±0.3 vs 1.6 ±0.6, P <0.001). Low baseline Gal-3 levels (PMVRsuccess : 22.0 ng/mL [IQR, 17.3-30.9] vs PMVRfailure : 30.6 ng/mL [IQR, 24.8-42.3], P <0.001) and ST2 levels (PMVRsuccess : 900.0 pg/mL [IQR, 619.5-1114.5] vs PMVRfailure : 1728.0 pg/mL [IQR, 1051.March 1, 1930], P < 0.001) were associated with successful MR reduction after PMVR. Also, ROC analysis identified low baseline Gal-3 and ST2 levels as predictors of therapeutic success after PMVR (AUCGal-3 :0.721 [IQR, 0.64-0.803], P < 0.001; AUCST2 : 0.807 [IQR, 0.741-0.872], P < 0.001). CONCLUSIONS: There was an association between low Gal-3 and ST2 plasma levels and successful MR reduction in patients with severe MR undergoing PMVR using the MitraClip system.

Specific biomarkers of myocardial inflammation and remodeling processes as predictors of mortality in high-risk patients undergoing percutaneous mitral valve repair (MitraClip).

BACKGROUND: Specific matrix metalloproteinases (MMP-2, MMP-9) and inflammatory biomarkers (hsCRP, IL-6) were found to be consistently up-regulated in severe mitral valve regurgitation (MR) and are associated with mortality in heart failure patients. The aim of the present study was to examine the prognostic value of biomarkers of cardiac inflammation and remodeling processes in predicting mortality in patients with MR undergoing percutaneous mitral valve repair (PMVR). HYPOTHESIS: We hypothesize that increased cardiac inflammation and extracellular matrix turnover is predictive for mortality in patients with severe mitral regurgitation undergoing MitraClip. METHODS: A total of 210 consecutive patients undergoing PMVR were included. PMVR was performed according to standard clinical practice. Venous blood samples for biomarker analyses were collected prior to and 6 months after PMVR. Physiological parameters, medication use, safety events, and all-cause mortality were followed over 12 months. RESULTS: PMVR was performed successfully in all patients. Twelve months after PMVR there was an effective reduction in the severity of MR (P < 0.001), and an improvement in New York Heart Association class (P < 0.01) was documented. Elevated inflammatory biomarkers (AUChsCRP : 0.738 [IQR, 0.626-0.849], P = 0.001; AUCIL-6 : 0.811 [IQR, 0.724-0.899], P = 0.001) and biomarkers reflecting cardiac remodeling processes (AUCMMP-2 : 0.723 [IQR, 0.641-0.804], P = 0.001; AUCMMP-9 : 0.618 [IQR, 0.534-0.701], P = 0.01) were predictors of adverse cardiac events and mortality in patients with congestive heart failure undergoing PMVR. CONCLUSIONS: The present study is the first to identify biomarkers reflecting inflammation (hsCRP, IL-6) and cardiac remodeling processes (MMP-2, MMP-9) as predictors of mortality in high-risk patients undergoing PMVR.

Outcome of thrombus aspiration in STEMI patients: a propensity score-adjusted study.

The use of thrombus aspiration (TA) prior to primary percutaneous coronary intervention (PPCI) has undergone a radical change in intervention guidelines. The clinical implications, however, are still under scrutiny. This study investigated the clinical effects and outcome of TA before PPCI in patients with ST-segment elevation myocardial infarction (STEMI). Overall 1027 patients with STEMI were analyzed in this retrospective, propensity score-adjusted, multicenter study. The primary endpoints were in-hospital and long-term mortality. There were 418 patients in the TA group and 609 in the conventional PPCI group. The in-hospital mortality rate was significantly higher in the TA group (8.7 vs. 5.0%; P = 0.03). During long-term follow-up [median follow-up duration 689 days (IQR 405-959)] the mortality rates were similar (TA 14.3%, conventional PPCI 15.0%; P = 0.85). Survival analysis for the complete observation period revealed no significant benefit of TA [hazard ratio (HR) 1.12; 97.5% CI 0.90-0.71; P = 0.63]. There were also no significant differences between the groups in the following secondary endpoints: composite of cardiovascular death and non-fatal reinfarction at discharge (P = 0.39), post-PPCI thrombolysis in myocardial infarction flow-grade-3 (P = 0.14), left ventricular ejection fraction (P = 0.47), and non-fatal reinfarction during follow-up (P = 0.17). Rehospitalization rate (1.82 vs. 10.3%; P < 0.0001) and Canadian Cardiovascular Society (CCS) grading (P = 0.02) during follow-up were significantly lower in the TA group. In our cohort the in-hospital mortality rate was significantly higher for TA patients, but during long-term follow-up the mortality rates did not differ. The incidence of rehospitalization and CCS grading were lower in the TA-treated patients.

Endocarditis after interventional repair of the mitral valve: Review of a dilemma.

BACKGROUND: The MitraClip procedure can be an alternative treatment option for patients with high surgical risk for whom surgical treatment is contraindicated. Patients with prosthetic material have an increased risk for infective endocarditis. HYPOTHESIS: Incidence, treatment and outcome of patients with endocarditis after interventional mitral valve repair are not known. METHODS: We searched for articles using PubMed using the terms "interventional mitral valve repair", "mitraclip" and "endocarditis". We have also searched for case reports in major congresses. Furthermore, we report two cases. RESULTS: Four cases of IE after MitraClip were found in addition to our cases. The leading cause is a bacterial infection, typically with staphylococcal bacteria. Approximately two thirds of these patients underwent surgery. Short-term outcome seems to be reasonable for these patients. During the early postoperative period and if Staphylococcus aureus can be cultivated mortality seems to be significantly elevated. CONCLUSION: IE after MitraClip procedure is a dilemma. While surgical bail-out seems to be the favorable treatment option, patients were rejected conventional surgery in first place due to their high operative risk. Best treatment recommendation must be made on an individual basis. Predisposing factors should be conscientiously addressed prior to the procedure.

Detector developments at DESY.

With the increased brilliance of state-of-the-art synchrotron radiation sources and the advent of free-electron lasers (FELs) enabling revolutionary science with EUV to X-ray photons comes an urgent need for suitable photon imaging detectors. Requirements include high frame rates, very large dynamic range, single-photon sensitivity with low probability of false positives and (multi)-megapixels. At DESY, one ongoing development project - in collaboration with RAL/STFC, Elettra Sincrotrone Trieste, Diamond, and Pohang Accelerator Laboratory - is the CMOS-based soft X-ray imager PERCIVAL. PERCIVAL is a monolithic active-pixel sensor back-thinned to access its primary energy range of 250 eV to 1 keV with target efficiencies above 90%. According to preliminary specifications, the roughly 10 cm × 10 cm, 3.5k × 3.7k monolithic sensor will operate at frame rates up to 120 Hz (commensurate with most FELs) and use multiple gains within 27 µm pixels to measure 1 to ∼100000 (500 eV) simultaneously arriving photons. DESY is also leading the development of the AGIPD, a high-speed detector based on hybrid pixel technology intended for use at the European XFEL. This system is being developed in collaboration with PSI, University of Hamburg, and University of Bonn. The AGIPD allows single-pulse imaging at 4.5 MHz frame rate into a 352-frame buffer, with a dynamic range allowing single-photon detection and detection of more than 10000 photons at 12.4 keV in the same image. Modules of 65k pixels each are configured to make up (multi)megapixel cameras. This review describes the AGIPD and the PERCIVAL concepts and systems, including some recent results and a summary of their current status. It also gives a short overview over other FEL-relevant developments where the Photon Science Detector Group at DESY is involved.