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.

Five-year follow-up of patients who underwent everolimus-eluting bioresorbable scaffold implantation.

OBJECTIVES: The aim of this study was to evaluate very long-term results after unrestricted everolimus-eluting bioresorbable scaffolds (BRS) implantation. BACKGROUND: Previous randomized studies mainly included selected patients differing from those seen during daily routine and long-term data from all-comers registries are sparse. METHODS: Consecutive patients undergoing BRS implantation were included in this observational, single center study. Clinical follow-up was conducted up to 5 years. Endpoint of interest was the composite of target lesion failure (TLF), including target-vessel myocardial infarction and target lesion revascularization and cardiac death. Furthermore, ARC-defined scaffold thrombosis (ScT) were assessed. RESULTS: A total of 176 patients with a median age of 64 (55 - 72) years were analyzed, of which 59.6% presented an acute coronary syndrome. A total of 183 mainly complex lesions (55.8%) were treated. At 5 years, the rate for TLF was 21.6%. Definite or probable ScT rate was 4.1%. The rate of ScT within the first year was 2.8% and afterwards 1.2%. Notably, no ScT was seen later than 2 years. CONCLUSIONS: Although this real-world registry displays high rates of clinical events during long-term follow-up, no ScT was seen after 2 years.

Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy.

AIMS: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure. METHODS AND RESULTS: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT. CONCLUSION: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.

Determinants of ST-segment elevation myocardial infarction as clinical presentation of acute coronary syndrome.

Antiplatelet agents and statin therapies are widely used in patients with known cardiovascular disease. Plaque rupture (PR) and plaque erosion (PE) are the most frequent underlying mechanisms of acute coronary syndromes (ACS). The conditions and medications that are associated with ST-segment elevation myocardial infarction (STEMI) following PR or PE have not been systematically studied. A total of 838 ACS patients (494 with STEMI, 344 with NSTE-ACS) who were diagnosed with PR or PE by optical coherence tomography were included. The patients were categorized into two groups based on underlying pathology, and the baseline characteristics and culprit plaque morphology associated with STEMI were investigated within each group. Among 838 patients, 467 (55.7%) had PR, and 371 (44.3%) were diagnosed with PE. Among patients with PR, older age, hyperlipidemia, no antiplatelet therapy, higher level of low-density lipoprotein cholesterol, and greater lipid burden and macrophage infiltration were associated with increased probability of STEMI. Among patients with PE, no dual antiplatelet therapy and no statin therapy were associated with increased probability of STEMI. The incidence of STEMI caused by PR was significantly lower on antiplatelet therapy (P < 0.001), and the incidence of STEMI caused by PE was significantly lower on antiplatelet therapy (P < 0.001) or on statin therapy (P < 0.001). Antiplatelet therapy is associated with lower probability of STEMI, regardless of underlying pathology, and statin therapy is associated with lower probability of STEMI in PE as clinical presentation of ACS. Statin therapy prior to the onset of acute coronary syndromes (ACS) may reduce the probability of plaque rupture. Antiplatelet therapy prior to the onset of ACS is associated with reduced probability of ST-segment elevation myocardial infarction (STEMI) following both plaque rupture and plaque erosion, and dual antiplatelet therapy offers additional protection compared to a single antiplatelet agent in plaque erosion. The combination of statin and antiplatelet therapy may have an additive effect on reducing the probability of STEMI caused by plaque erosion. Yellow: lipid pool(necrotic core); red: fibrin-rich thrombus; gray; platelet-rich thrombus.

Circadian variations in pathogenesis of ST-segment elevation myocardial infarction: an optical coherence tomography study.

Previous studies have reported a circadian variation in the onset of ST-segment elevation myocardial infarction (STEMI). However, underlying mechanisms for the circadian variation have not been fully elucidated. We investigated the relationship between onset of STEMI and the underlying pathology using optical coherence tomography (OCT). Patients with a diagnosis of STEMI were selected from a multicenter OCT registry. Patients were divided into 4 groups based on the estimated time of onset (00:00-05:59, 06:00-11:59, 12:00-17:59, or 18:00-23:59). Underlying pathologies of MI (plaque rupture, plaque erosion, and calcified plaque) were compared among the 4 groups. Among 648 patients, plaque rupture was diagnosed in 386 patients (59.6%), plaque erosion in 197 patients (30.4%), and calcified plaque in 65 patients (10.0%). A marked circadian variation was detected in the incidence of plaque rupture with a peak at 09:00, whereas it was not evident in plaque erosion or calcified plaque. The probability of plaque rupture significantly increased in the periods of 06:00-11:59 [odds ratio (OR) 2.13, 95% confidence interval (CI) 1.30-3.49, p = 0.002] and 12:00-17:59 (OR 2.10, 95% CI 1.23-3.58, p = 0.005), compared to the period of 00:00-05:59. This circadian pattern was observed only during weekdays (p = 0.010) and it was not evident during the weekend (p = 0.742). Plaque rupture occurred most frequently in the morning and this circadian variation was evident only during weekdays. Acute MI caused by plaque rupture may be related to catecholamine surge.

Latest Developments in Robotic Percutaneous Coronary Intervention.

Interventional cardiovascular medicine has seen constant progress over the last few decades. Since the first angiograms and percutaneous transluminal coronary angioplasty were carried out, this progress has been tremendous and has led to a substantial decline in cardiovascular morbidity and mortality. The purpose of this article is to report and review the latest developments and evidence in robotics-assisted percutaneous coronary intervention (rPCI) and its potential future applications, opportunities, and limitations. Contemporary evidence shows that rPCI can lead to a significant reduction in radiation exposure as well as medical hazards for cardiologists. Rates of device and procedural success remain high and there is no evidence of a disadvantage for the patient. The accuracy of implantation with a reduced geographic mismatch is a further advantage that can result in a higher quality of treatment. Even in complex coronary lesions and procedures, rPCI seems to be safe and efficient. The latest developments include telestenting over hundreds of kilometers from a remote platform. Currently, the main limitations are the absence of large-scale randomized trials for the valid assessment of the benefits and disadvantages of rPCI as well as the technical limitations of the currently available rPCI systems. rPCI is a forward-looking innovation in cardiology that is applicable to a wide range of coronary interventions. Despite the present lack of knowledge and the limited data concerning the outcome for the patient, the available literature reveals promising results that should lead to improvements for physicians and patients.

Relative risk of plaque erosion among different age and sex groups in patients with acute coronary syndrome.

Postmortem studies reported plaque erosion is frequent in young women. Recent in vivo studies failed to show age and sex differences in the plaque erosion prevalence. The aim of this study was to investigate the prevalence of plaque erosion by age and sex among acute coronary syndromes (ACS) patients. From 1699 ACS patients, 1083 with plaque erosion or rupture were analyzed. Patients were categorized as 5 age groups (≤ 50, 51-60, 61-70, 71-80, ≥ 81 years). Overall prevalence of plaque erosion was similar between males and females (p = 0.831). Males age ≤ 50 had higher (p = 0.018) and age 71-80 had lower (p = 0.006) prevalence of plaque erosion. Females age 61-70 had higher (p = 0.021) and age 71-80 had lower (p = 0.045) prevalence of plaque erosion. In advanced age groups (≥ 71 years), rupture was the dominant etiology in both sexes. In multivariate analysis of males, age ≤ 50 demonstrated a trend to increase (OR 1.418, 95% CI 0.961-2.093, p = 0.078) the erosion risk. Females age ≤ 70 independently increased (OR 2.138, 95% CI 1.249-3.661, p = 0.006) the risk for erosion. The prevalence of plaque erosion was similar between males and females. Plaque erosion risk was increased in the males age ≤ 50 and in the females age ≤ 70 among ACS patients.

Fractional flow reserve and frequency of PCI in patients with coronary artery disease.

BACKGROUND: Fractional flow reserve (FFR) guided percutaneous coronary intervention (PCI) has been validated in patients with stable coronary artery disease (CAD) but has not yet been verified under specific conditions such as heart failure or microvascular dysfunction. The aim of the present study was to examine the influence of specific patient comorbidities on FFR values and thus the frequency of PCI in patients with intermediate coronary stenosis. METHODS: A total of 652 patients with CAD and intermediate coronary stenosis who were assessed for FFR were included in this retrospective study. In a subgroup analysis, specific comorbidities such as heart failure with non-ST-segment-elevated acute coronary syndrome (NSTE-ACS), heart failure, diabetes mellitus, atrial fibrillation (AF), and left ventricular hypertrophy (LVH) were considered. RESULTS: In all lesions with an FFR ≤ 0.80 (n = 227/808, 28.1%), PCI was performed using drug-eluting stents. Pathological FFR values (FFR ≤ 0.80) before PCI were most frequently observed in the left anterior descending artery (LAD; n = 168/418, 39.9%) followed by the right coronary artery (RCA; n = 37/178, 20.7%) and the left circumflex artery (LCX; 22/223, 9.8%). The comorbidities NSTE-ACS (p = 0.28), heart failure with reduced ejection fraction (HFrEF; p = 0.63), heart failure with preserved ejection fraction (HFpEF; p = 0.3719), diabetes mellitus (p = 0.177), or LVH (p = 0.407) had no major impact on the occurrence of pathological FFR values; there was also no association between FFR and the occurrence of lesions in the different target vessels. CONCLUSION: The occurrence of pathological FFR values, most frequently documented in the LAD, was the same in patients with or without HFrEF, HFpEF, diabetes mellitus, AF, and LVH, demonstrating that these comorbidities did not influence FFR values and, thus, the indication for PCI.

OCT-assessment of scaffold resorption: Analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.

BACKGROUND: The aim of this study was to analyze individual differences in resorption of bioresorbable vascular scaffolds (BRS) through optical coherence tomography (OCT) analysis and to identify factors potentially influencing the resorption process. METHODS: Between April 2016 and July 2017 clinically driven invasive coronary angiography and OCT examinations were performed in 36 patients who had previously been treated with a total of 48 BRS (ABSORB BVS, Abbott Vascular, Santa Clara, CA). For each scaffold, a new BRS-RESORB-INDEX (BRI) was calculated. RESULTS: The mean time interval since implantation was 789 ± 321 days. In OCT, BRS struts remained detectable in all 48 BRS. Normalized light intensity as a marker for the resorption of BRS struts increased with time in a linear fashion (Spearman Rho: p < .001, correlation coefficient = .90; R2 [linear] = .91). Multivariable analysis identified diabetes (BRI of patients with diabetes vs. patients without diabetes: 0.34 ± 0.13 vs. 0.58 ± 0.22; p = .002) and presence of Peri-strut low intensity areas (PSLIA, BRI of 10 patients with PSLIA vs. 26 patients without PSLIA: 0.44 ± 0.21 vs. 0.61 ± 18; p = .027) as independent predictors for a prolonged BRS resorption, whereas the resorption rate in ACS patients (STEMI, NSTEMI, and unstable angina; n = 13) was significantly higher as compared to patients without ACS (0.62 ± 0.17 vs. 0.43 ± 0.24; p = .012). CONCLUSION: In humans, BRS resorption rate is significantly influenced by numerous factors. Our data suggest that diabetes and PSLIA are associated with a prolonged resorption process, whereas in ACS patients, BRS resorption appears to be significantly faster.

A multicenter post-marketing evaluation of the Elixir DESolve® Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

OBJECTIVES: To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. BACKGROUND: The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. METHODS: One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. RESULTS: The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. CONCLUSIONS: Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed.

Overlapping implantation of bioresorbable novolimus-eluting scaffolds: an observational optical coherence tomography study.

Overlapping implantation of bioresorbable vascular scaffolds is frequently necessary, but its influence on vessel and scaffold structure has not been thoroughly analyzed previously. The aim of this study was to analyze the acute effects of overlapping implantation on BRS as determined by optical coherence tomography (OCT). A total of 38 patients with de novo coronary artery stenoses who underwent OCT in the context of implantation of novolimus-eluting BRS (DESolve, Elixir Medical Corporation, Sunnyvale, California, USA) were investigated. In 15 patients, overlapping implantation of two BRS was performed, while 23 patients with implantation of one single BRS served as the control group. OCT data were retrospectively analyzed regarding acute scaffold implantation results. There were no significant differences between the overlap and control group in terms of residual in-scaffold area stenosis, scaffold area, mean or minimal lumen area, eccentricity index, incomplete scaffold apposition area or malapposition. While strut fracture was slightly more frequent in BRS with overlap its incidence was low overall. In patients with overlapping BRS, overlap segments did not display smaller lumen areas than segments without overlap (mean lumen area overlap: 8.16 ± 2.97 mm2 vs. no overlap: 7.70 ± 2.55 mm2; p = 0.71; minimal lumen area overlap: 6.83 ± 2.71 mm2 vs. no overlap: 6.17 ± 2.58 mm2; p = 0.37). Acute mechanical performance of novolimus-eluting BRS is not impaired by overlapping implantation. It can be assumed that vessel expansion compensates for the double scaffold layer in the overlap area resulting in a similar lumen area in overlap areas and in those with a single strut layer.

Optical coherence tomography: influence of contrast concentration on image quality and diagnostic confidence.

OCT requires intracoronary injection of contrast agent to remove blood from the coronary lumen during data acquisition, which is a possible limitation of this method. Aim of this study was to analyze the influence of iodine concentration on image quality and diagnostic certainty of optical coherence tomography (OCT). OCT sequences acquired using contrast agent with a reduced concentration of 150 mg iodine/ml and a standard concentration of 350 mg iodine/ml were analyzed. Cross-sectional images with a spacing of 10 mm were evaluated regarding image quality and diagnostic confidence. A total of 67 OCT sequences acquired in 24 patients were analyzed. 31 sequences were acquired using contrast agent with a concentration of 150 mg iodine/ml and 36 sequences with a concentration of 350 mg iodine/ml. The percentage of remaining blood streaks in the cross sections was significantly lower for 350 mg iodine/ml compared to 150 mg iodine/ml (19 ± 21 vs. 34 ± 26%, p = 0.013). Contrast with 350 mg iodine/ml showed a significantly higher percentage of completely flushed pullback length as compared to 150 mg iodine/ml (78 ± 24 vs. 58 ± 27%, p = 0.004). Diagnostic certainty was significantly higher for 350 mg iodine/ml than for 150 mg iodine/ml (Likert scale average 1.4 ± 0.7 vs. 2.1 ± 1.2, p < 0.001; Likert scale: 1 = absolutely confident, 2 = confident with slight doubts, 3 = doubtful/not confident, 4 = non-diagnostic). Regarding image quality and diagnostic certainty, contrast agent with a concentration of 350 mg iodine/ml is superior to 150 mg iodine/ml.

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.

Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison.

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

First case report of fully robotically assisted lithotripsy in heavily calcified left main stenosis.

Background: Percutaneous coronary intervention (PCI) is the standard-of-care treatment for left main stenosis as an alternative to bypass surgery. In addition, severe coronary lesion calcification can be modified by intravascular lithotripsy (IVL). However, with PCI and debulking treatment options, there are inherent limitations. PCI poses an increased health burden for the treating physician that is associated with wearing a heavy, lead-lined apron and being exposed to radiation. To overcome these issues, a robotically assisted angioplasty system (rPCI) was established that enables the operator to perform PCI remotely in routine clinical procedures. Furthermore, IVL have not been used remotely. Case summary: Here, we report the use of this technique for treating a heavily calcified left main stenosis in an 82-year-old male with previously diagnosed two-vessel coronary artery disease, progressive symptoms of dyspnoea at high cardio-vascular risk profile. The decision of the local heart team declined surgery. To the best of our knowledge, this is the first report of successful rPCI combined with IVL. Discussion: In the case presented, rPCI was feasible and safe even in a complex lesion of the left main coronary artery requiring IVL. rPCI is a revolutionary new technique that may be applied to various types of coronary artery lesions.

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.

Early Clinical Experience With the TRICENTO Bicaval Valved Stent for Treatment of Symptomatic Severe Tricuspid Regurgitation: A Multicenter Registry.

BACKGROUND: Patients with severe tricuspid regurgitation present late and are often ineligible for surgery or transcatheter repair systems. Transfemoral venous implantation of a bicaval valved stent has been proposed as therapeutic option in selected patients. The aim of this study was to summarize the early procedural and clinical outcomes of the novel TRICENTO system for the treatment of patients with symptomatic severe tricuspid regurgitation. METHODS: All consecutive patients treated with the custom-made TRICENTO implant at the participating centers were included in this retrospective multicentre registry. RESULTS: A total of 21 high-risk patients (mean age 76±7 years; 67% female) with severe or higher grade tricuspid regurgitation were analyzed. The majority of the patients were in New York Heart Association class III/IV (95%), had peripheral edema (95%), and previous hospitalization for right heart failure (67%). Technical success was 100%, and there was no case of in-hospital mortality. During follow-up (median 61 days), symptomatic improvement was observed (65% in New York Heart Association class I/II; P<0.001). Computed tomography revealed asymptomatic fractures of the TRICENTO prosthesis in 3 patients. Cardiac magnetic resonance imaging obtained in 7 patients showed a significant decrease (252±65 mm3 at baseline versus 216±58 mm3 at follow-up, P=0.006) of right ventricular end-diastolic volume. The overall-survival rate was 76% at 1 year. CONCLUSIONS: The present data indicate the feasibility of transfemoral bicaval valved stent implantation for the treatment of severe tricuspid regurgitation. Functional improvement and signs of right ventricular reverse remodeling were observed. Stent fractures did not impair valve function, but require refinement of prosthesis design and careful assessment of eligibility criteria.

Early Outcomes of 2 Mitral Valve Transcatheter Leaflet Approximation Devices: A Propensity Score-Matched Multicenter Comparison.

BACKGROUND: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking. OBJECTIVES: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems. METHODS: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE). RESULTS: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562). CONCLUSIONS: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome.

Clinical presentation does not affect acute mechanical performance of the Novolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography.

INTRODUCTION: Initial trials of bioresorbable vascular scaffolds (BVS) have mostly excluded patients presenting with acute coronary syndrome (ACS). However, these patients might benefit from a BVS platform, in particular as they are often younger and have been less frequently treated than patients with chronic disease. AIM: To compare the acute performance of a Novolimus eluting BVS in ACS and non-ACS patients using optical coherence tomography (OCT) in patients presenting with acute or chronic coronary syndrome. MATERIAL AND METHODS: The final OCT pullback of 79 patients (34 with ACS, 45 non-ACS) was analysed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. RESULTS: OCT showed a minimum lumen area (non-ACS vs. ACS) of 6.2 ±2.1 vs. 5.6 ±1.5 mm2 (p = 0.21). Mean residual area stenosis was 14.5% vs. 19.5% (p = 0.39). The mean eccentricity index did not differ significantly (0.78 ±0.13 vs. 0.78 ±0.06; p = 0.42). There was a non-significant tendency for more fractures in the non-ACS group (22.2% vs. 5.9%; p = 0.07). Prolapse area was comparable (4.4 ±7.4 mm2 vs. 5.2 ±10.9 mm2; p = 0.62). CONCLUSIONS: This is the first study to investigate the acute mechanical performance of a Novolimus-eluting BVS in patients with different clinical presentations using OCT. We found that clinical presentation did not determine acute mechanical performance as assessed by the final OCT pullback. There was evidence of more mechanical complications in terms of fractures and a higher percentage of incomplete strut apposition in the group of patients with chronic coronary syndrome.

Acute Mechanical Performance of Magmaris vs. DESolve Bioresorbable Scaffolds in a Real-World Scenario.

Background: After the bioresorbable PLLA-based vascular scaffold (Absorb BVS) was taken from the market due to its high adverse event rates, a magnesium-based scaffold (Magmaris) was introduced. Objective: To compare the acute performance of the sirolimus-eluting magnesium alloy Magmaris scaffold with that of the novolimus-eluting PLLA-based DESolve scaffold in terms of appropriate scaffold deployment using optical coherence tomography (OCT). Methods and Results: Data from the final OCT pullback of 98 patients were included (19 Magmaris, 79 DESolve) and analyzed at 1-mm intervals. The following indices were calculated: mean and minimal area, residual area stenosis, incomplete strut apposition, tissue prolapse, eccentricity index, symmetry index, strut fracture, and edge dissection. OCT showed a minimum lumen area for Magmaris vs. DESolve of 6.6 ± 1.6 vs. 6.0 ± 1.9 (p = 0.06). Scaffolds with residual area stenosis >20% were predominantly seen in the DESolve group (15.8 vs. 46.8%; p = 0.01). The mean eccentricity index did differ significantly (0.74 ± 0.06 vs. 0.63 ± 0.09; p < 0.001). No fractures were observed for Magmaris scaffolds, but 15.2% were documented for DESolve BRS (p < 0.001). Incomplete scaffold apposition area was significantly higher in the DESolve group (0.01 ± 0.02 vs. 1.05 ± 2.32 mm2; p < 0.001). Conclusion: This is the first study to compare the acute mechanical performance between Magmaris and DESolve in a real-world setting. The acute mechanical performance of Magmaris BRS seems to be superior to that of DESolve BRS, whereas OCT showed a good acute mechanical performance for both BRS in terms of generally accepted imaging criteria.