3D-Printing to Plan Complex Transcatheter Paravalvular Leaks Closure.

BACKGROUND: Percutaneous closure of paravalvular leak (PVL) has emerged as an alternative to surgical management in selected cases. Achieving complete PVL occlusion, while respecting prosthesis function remains challenging. A multimodal imaging analysis of PVL morphology before and during the procedure is mandatory to select an appropriate device. We aim to explore the additional value of 3D printing in predicting device related adverse events including mechanical valve leaflet blockade, risk of device embolization and residual shunting. METHODS: From the FFPP registries (NCT05089136 and NCT05117359), we included 11 transcatheter PVL closure procedures from three centers for which 3D printed models were produced. Cardiac CT was used for segmentation for 3D printed models (3D-heartmodeling, Caissargues, France). Technology used a laser to fuse very fine powders (TPU Thermoplastic polyurethane) into a final part-laser sintering technology (SLS) with an adapted elasticity. A simulation on 3D printed model was performed using a set of occluders. RESULTS: PVLs were located around aortic prostheses in six cases, mitral prostheses in four cases and tricuspid ring in one case. The device chosen during the simulation on the 3D printed model matched the one implanted in eight cases. In the three other cases, a similar device type was chosen during the procedures but with a different size. A risk of prosthesis leaflet blockade was identified on 3D printed models in four cases. During the procedure, the occluder was removed before release in one case. In another case the device was successfully repositioned and released. In two patients, leaflet impingement was observed post-operatively and surgical device removal had to be performed. CONCLUSION: In a case-series of complex transcatheter PVL closure procedures, hands-on simulation testing on 3D printed models proved its usefulness to plan and facilitate these challenging procedures.

Complex transcatheter left atrial appendage closure using a tailored trans-jugular approach simulated by 3D printing: a case report.

Background: Transcatheter left atrial appendage (LAA) closure (LAAc) is less feasible in patients with unusual LAA anatomy. Case summary: A 65-year-old woman with persistent atrial fibrillation was referred for LAAc. Transesophageal echocardiography (TEE) revealed spontaneous contrast in the LAA without formation of a thrombus; the LAA shape was tortuous and difficult to assess. A first LAAc procedure was unsuccessful given the unsuitable sheath position. Therefore, a soft three-dimensional (3D) model printing was performed by laser sintering and revealed excessive sheath kinking with an inferior approach, but successful deployment would be feasible using a superior approach. Successful trans-jugular implantation of a Watchman FLX 31 device in stable position without residual leakage was achieved during the subsequent procedure. At 3-month follow-up, and after cessation of oral anticoagulation, the patient's symptoms improved. Imaging demonstrated complete LAA occlusion and correct placement of the device along the LAA superior axis. Discussion: This is the first-reported clinical case of a complex transcatheter LAAc through a trans-jugular approach. Simulating the patient's anatomy with a laser sintering 3D-printed model showed why the transfemoral approach failed, validated the trans-jugular procedure, enabled selection of the simple curve access sheath that had the most direct trajectory towards the LAA, confirmed that transseptal puncture was possible, allowed determination of the angle of puncture, enabled selection of the most appropriate LAA device and had a very low cost compared with planning software or other printing methods.

Clinical outcomes of bioresorbable vascular scaffold to treat all-comer patients. Are patients with acute coronary syndrome better candidates for bioresorbable vascular scaffold?

BACKGROUND: Scaffold thromboses (ST) and adverse events and have been associated with bioresorbable vascular scaffolds (BVS) at long-term, but their mechanism remains unclear. We sought to evaluate patient and lesion characteristics associated with mid- to long-term outcomes in patients treated with BVS. METHODS: This is an observational single-center, single-arm, retrospective study evaluating the performance of BVS in an all-comer population, including complex lesions (chronic total occlusions, long lesions), small vessels, and acute coronary syndromes (ACS). RESULTS: From May 2013 to June 2015, we included 482 patients (580 lesions) that were treated with BVS implantation including 71.2% treated for ACS in the present analysis. Mean follow-up period was 816.2 ±â€¯242.6 days. The primary endpoint was device oriented cardiac events (DOCE), defined as a composite of target-lesion revascularization (TLR), ST, target vessel myocardial infarction (TVMI) and cardiac death. Using Kaplan-Meier methods, the DOCE and ST rates at 36 months were 9.4% and 2.3%, respectively. No ST occurred between 2 and 3 years and ST occurred after 3 years, in one patient. Using multivariate analysis, ACS was the only significant predictor of lower rates of DOCE (p = 0.04, HR: 0.47, 95% CI: 0.23-0.96). CONCLUSIONS: In this large all-comers real-world cohort, lesions treated with BVS had non-negligible rates of DOCE and ST, in line with previous published randomized trials. The occurrence of very late event was very low after 24 months. ACS patients had lower rates of DOCE.

A 56-Year-Old Man With Cardiac Tamponade and Eosinophilia.

CASE PRESENTATION: A 56-year-old man was admitted to the ICU with chest pain, cough, hemoptysis, increasing dyspnea, and orthopnea for 1 week. The patient reported an 8-kg weight loss over the last month and recurrent wheezing episodes for approximately 1 year. He had a history of tobacco smoking and excessive alcohol consumption, both of which he stopped 15 years ago. His medical history included high BP treated with amlodipine and an episode of drug-induced angioedema 8 years ago. He had no history of recent travel.

Simplifying the assessment of coronary artery stenosis by enhancing instantaneous wave free ratio.

BACKGROUND: Instantaneous wave free ratio (iFR) does not require adenosine, but has a relatively wide intermediate range where functional assessment remains inconclusive. In this pilot study, we sought to enhance iFR through with the use of intracoronary (IC) saline (iFRs) and contrast media (iFRc) and determine whether these techniques correlated well with fractional flow reserve (FFR). METHODS: Patients with coronary artery stenosis (CAS) associated with an iFR in the intermediate zone (≥0.86 and ≤0.93) were prospectively assessed with resting distal coronary pressure/aorta pressure (Pd/Pa), iFR, iFRs, iFRc and FFR. RESULTS: A total of 40 coronary lesions were studied (40 patients). Pearson correlation coefficients for FFR and iFR, FFR and iFRs, FFR and iFRc were respectively: 0.57 (P=0.0002), 0.80 (P<0.0001) and 0.77 (P<0.0001). Receiver-operating characteristic (ROC) curve analysis showed similar area under the curve (AUC) of iFRs and iFR [0.90 (95% CI: 0.76-1) vs. 0.89 (95% CI: 0.79-0.99), P=0.89]. Youden's index established cut-off values of ≤0.90 for iFR (sensitivity =91%, specificity =74%) and ≤0.78 for iFRs (sensitivity =73%, specificity =100%). In contrast, the AUC of iFRc was superior to the AUC of iFR [0.99 (95% CI: 0.98-1), P=0.049]. iFRc showed excellent accuracy and established cut-off values of ≤0.81 in predicting an FFR value of ≤0.80 (sensitivity =100%, specificity =93%). CONCLUSIONS: When iFR is in the intermediate zone, functional assessment of CAS by iFR is enhanced with the use of contrast media but not saline. This pilot study could be hypothesis generating for further study to enhance iFR specificity and sensibility.

Clampless myocardial revascularization on a healed iatrogenic aortic dissection.

Iatrogenic aortic dissection is an infrequent complication of cardiac catheterization (0.03-0.06%) associated with up to 19% of mortality at 30 days. It was reported to mostly occur when using a 6-Fr guiding catheter to cannulate the right coronary artery. This life-threatening complication usually requires early surgical management and close imaging monitoring and control of systolic blood pressure. This case report describes a patient with iatrogenic aortic dissection during cardiac catheterization in symptomatic coronary artery disease. Conservative management of the limited non-progressive aortic dissection was chosen followed by surgical revascularization with a clampless technique, despite the recent aortic injury.

Bioresorbable vascular scaffold to treat in-stent restenosis: Single-center experience.

AIMS: The management of patients with in-stent restenosis (ISR) is still a major clinical challenge even in the era of drug-eluting stents (DES). Recent studies have demonstrated acceptable clinical outcomes for the everolimus-eluting bioresorbable vascular scaffold (BVS) ABSORB™ in patients with stable coronary artery disease but data are scarce on its use in patients with ISR. We report the long-term results of our preliminary experience with this novel approach at our institution. METHODS AND RESULTS: We investigated the safety and efficacy of BVS implantation to treat ISR. 34 consecutive patients (37 lesions) underwent PCI for ISR with BVS implantation between May 2013 and June 2015 at our institution and were included in the current analysis. Follow-up was available in 91.9% of the patients. Mean follow-up period was 801.9 ± 179 days. One patient had definite scaffold thrombosis (ScT) 2 months after stent implantation which was treated with DES. Five patients (six lesions) experienced target lesion revascularization (TLR). The composite endpoint rate of TLR, ScT, myocardial infarction, and death occured in 6/37 lesions at follow-up (16.2%). CONCLUSIONS: These real-world data using BVS in patients with ISR demonstrates that ISR treatment with ABSORB™ BVS is feasible but could have slightly higher target lesion failure rates as compared to DES. This proof of concept could be hypothesis-generating for larger randomized controlled studies.

Initial clinical experience with the GORE® CARDIOFORM ASD occluder for transcatheter atrial septal defect closure.

OBJECTIVES: To report the initial clinical experience with a novel atrial septal defect (ASD) closure device, the GORE® CARDIOFORM ASD Occluder (GCO). BACKGROUND: Transcatheter closure has become the treatment of choice for secundum ASD. A wide range of occluder devices are available, but concern has been raised about the risk of cardiac erosion associated with rigid devices and future access to the left atrium METHODS: Retrospective chart review of patients treated with the GCO at three Canadian centers. Primary outcomes were procedural success and residual shunting at follow-up, as well as 30-day major adverse events. Secondary outcomes included new onset atrial arrhythmias, wire frame fractures (WFF), and all cause mortality. Clinical, echocardiographic, procedural data, and follow-up outcome variables were collected in each participating hospital. RESULTS: Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO and were included in the study cohort. Procedural success was achieved in 22 of 26 patients (85%) and no major procedural complications were observed. Two patients (8%) presented new onset atrial tachyarrhythmia during early follow-up (0-30 days). Follow-up echocardiography (median of 119 days [IQR: 92-146]) demonstrated no residual shunt in all implanted patients. After a median clinical follow-up of 174 days (IQR: 135-239), one patient died of an unrelated cause, there were no documented major adverse cardiovascular events. Fluoroscopic imaging of the device was performed in 20 patients (91%), and WFF was noted in five cases. No clinical consequence or device dysfunction was observed in these patients. CONCLUSIONS: In this first-in-man multicenter study, the GCO was safe and effective for ASD closure, with no major adverse events or residual shunt at follow-up. © 2017 Wiley Periodicals, Inc.

From tricuspid to double orifice Morphology: Percutaneous tricuspid regurgitation repair with the MitraClip device in congenitally corrected-transposition of great arteries.

Edge to edge transcatheter mitral valve repair with MitraClip (Abbott Vascular, Menlo Park, CA) is increasing for high-risk surgical patients with significant mitral regurgitation. Patients with congenitally corrected transposition of the great arteries (CCTGA) presenting with tricuspid valve regurgitation of a systemic right ventricle may represent particularly challenging candidates for MitraClip given their anatomy. We report the case of a 67-year-old gentleman with CCTGA and severe tricuspid regurgitation who was referred for MitraClip implantation after heart team consensus. Successful implantation of one clip was performed, achieving a significant reduction of the regurgitation. Similarly, favorable findings were confirmed at 6 months, 1 and 2 years follow-up and the patient had no recurrent heart failure admissions after 2-year follow-up. We describe the technical considerations and the importance of 3D-transoesophageal echocardiography for performing the MitraClip of a trileaflet systemic atrioventricular valve. © 2016 Wiley Periodicals, Inc.

Epidemiology, Management Strategies, and Outcomes of Patients With Chronic Total Coronary Occlusion.

Factors influencing the management of patients with chronic total occlusion (CTO) are poorly described. We sought to analyze the clinical and angiographic variables influencing the decision-making process of patients with CTO. Consecutive patients with at least 1 coronary artery CTO were included and categorized as managed either by percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), or medical therapy (MT). Patients with previous CABG were excluded. The CTO SYNTAX score (CTO-SS) was defined as the ratio between the score attributed to the CTO lesion in the SYNTAX score calculation and the total SYNTAX score. Independent predictors of management strategies were sought. A total of 510 patients were included (CTO incidence: 20%): 9% were treated with PCI, 34% with CABG, and 57% with MT. SYNTAX score was lowest in PCI (14.8 [11.0 to 18.5]) and highest in CABG (31.5 [25.0 to 38.8], p <0.0001). PCI was attempted more often in patients with higher CTO-SS (i.e., those with higher contribution to the overall SYNTAX score from the CTO lesion; 88% had a CTO-SS >0.5). Conversely, CABG was preferred in subjects with lower CTO-SS (61% had a CTO-SS ≤0.5, p <0.0001). Age, ejection fraction, SYNTAX score, and age of the CTO were independent predictors of revascularization. At mid-term follow-up, unsuccessful revascularization or MT was independently associated with death (hazard ratio 7.2, p = 0.0005). In conclusion, CTOs are frequently documented in clinical practice. However, less than a half is revascularized. Management strategies are influenced by angiographic variables such as the SYNTAX score and the newly proposed CTO-SS.

Atrial septal defect closure with left ventricular dysfunction.

Atrial septal defects are one of the most common congenital heart diseases in adults that may result in significant left to right shunt. Secundum atrial septal defects can remain unrecognised until adult age and cause haemodynamic changes with or without symptoms. Transcatheter ASD closure is the gold standard; however, in those patients with left ventricular dysfunction there may be increased risk of complications due to acute changes in left-sided pressures. In this review, we discuss the clinical aspects of ASD closure in the setting of LV dysfunction and discuss methods to evaluate risk and strategies to minimise complications.