3D printing from transesophageal echocardiography for planning mitral paravalvular leak closure - feasibility study.

Introduction: Transcatheter closure of paravalvular leak (PVL) is still a demanding procedure due to the complex anatomy of PVL channels and risk of interference between the implanted occluder and surrounding structures. Efforts are made to improve procedural outcomes in transcatheter structural heart interventions by establishing treatment strategy in advance with the use of 3D-printed physical models based on data obtained from cardiac computed tomography (CT) studies. Aim: In this feasibility study 3D printing of PVL models based on data recorded during transesophageal echocardiography (TEE) examinations was evaluated. Material and methods: 3D-TEE data of patients with significant PVL around mitral valve prostheses were used to prepare 3D models. QLab software was used to export DICOM images in Cartesian DICOM format of each PVL with the surrounding tissue. Image segmentation was performed in Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the Polyjet printer with a transparent, rigid material. We measured dimensions of PVLs both in TEE recordings and printed 3D models. The results were correlated with sizes of occluding devices used to close the defects. Results: In 7 out of 8 patients, there was concordance between procedurally implanted occluders and pre-procedurally matched closing devices based on 3D-printed models. Conclusions: 3D-printing from 3D-TEE is technically feasible. Both shape and location of PVLs are preserved during model preparation and printing. It remains to be tested whether 3D printing would improve outcomes of percutaneous PVL closure.

Mitral Paravalvular Leak 3D Printing from 3D-Transesophageal Echocardiography.

BACKGROUND: Paravalvular leaks can be detected in almost 15% of patients after mitral valve prosthesis implantation. This complication can result in congestive heart failure and hemolysis. Despite advancements in non-invasive imaging, percutaneous closure of paravalvular leaks is not always successful. Therefore, efforts are made to improve treatment outcomes by using 3D-printed models of defects as pre-procedural support for interventional cardiologists. METHODS: Retrospectively, 3D-transesophageal echocardiography recordings of 8 patients with clinically significant mitral paravalvular leaks were analyzed. Qlab Software was used to export DICOM images of each paravalvular leak channel, including surrounding tissue. Image segmentation was performed in 3D Slicer, a free, open-source software package used for imaging research. Models were printed to actual size with the poly jet Stratasys Objet 30 printer with a transparent, rigid material. RESULTS: Duration of model preparation and printing, as well as the total cost, was calculated. Mean total time of model preparation was 430.5 ± 196 minutes. CONCLUSION: 3D-printing from 3D-transesophageal echocardiography is technically feasible. Both shape and location of paravalvular leaks are preserved during model preparation and printing. It remains to be tested if 3D-printing would improve outcomes of percutaneous paravalvular leaks closure.

Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry.

BACKGROUND: Transcatheter paravalvular leak closure (TPVLC) offers a viable alternative to reoperation but optimal technical strategy is still to be defined. We present a prospective TPVLC registry in which safety and efficacy of multi-plug, single-stage approach were assessed. METHODS: Patients with heart failure (HF) symptoms caused by PVL were qualified for TPVLC by Heart Team. Ante- or retrograde access was employed for mitral while retrograde only for aortic PVLs. Two to 4 AVP 3 devices were simultaneously implanted into each PVL. Endpoints were defined according to VARC-2. RESULTS: From 64 referred patients 49, with either mechanical valves (n = 30) or stented bioprostheses, were eligible for TPVLC. PVL location was mitral (n = 29) or aortic (n = 20). In aortic group acute procedural success (APS) ratio was 100% and no MACCEs occurred. In mitral group, first-attempt TPVLC was successful in 22 cases (4/4 in transapical and 18/25 in transseptal access). Second-attempt transapical procedure followed transseptal failure in 5 patients. Mitral TPVLC ultimately proved efficient in 89.7% with 76.5% APS. Cumulatively, TPVLC was accomplished in 46 subjects (93.9%) with 78% APS. When successful, it led to a significant decrease of NT-proBNP concentration and HF symptoms regression. Periprocedural safety endpoints were met in three patients and included non-disabling stroke, and two access site-related complications. In device failure group two patients died (end-stage HF) and two others were rehospitalized. CONCLUSION: TPVLC with simultaneous deployment of multiple AVP III occluders is feasible with high device success rate and no significant periprocedural complications. The clinical benefits of reduction of HF symptoms and hemolysis are evident after 30 days and persist up to 1 year without recurrence of PVL.

Clinical manifestations of heart failure abate with transcatheter aortic paravalvular leak closure using Amplatzer vascular plug II and III devices.

OBJECTIVES: To evaluate the transcatheter paravalvular leak closure (TPVLC) aptitude to reduce manifestations of heart failure caused by aortic paravalvular leak (PVL). BACKGROUND: TPVLC is a valuable alternative to reoperation. While technical feasibility of the method is well established, data on long-term clinical outcome are less abundant. METHODS: We launched a prospective registry of patients with clinically significant aortic PVL. They were scheduled for TPVLC with Amplatzer vascular plug (AVP) II and III devices serving as occluders. The efficacy and safety were monitored at 6-month follow-up exam. RESULTS: The occluder deployment reached a success rate of nearly 90%. Following the procedure, we recorded significant improvement both in terms of patient functional capacity and echocardiographic determinants of left ventricular performance. Simultaneously, NT-proBNP plasma concentration and hemolysis markers decreased. Only local complications related to puncture site occurred. CONCLUSIONS: Heart failure caused by aortic PVL can be safely and efficiently treated with TPVLC using AVP II and III devices as occluders.

A case of multiple giant right coronary artery aneurysms.

Coronary artery aneurysm is a rare congenital or acquired anomaly. The commonest location of coronary artery aneurysms is the right coronary artery and they are found slightly more often in males. We report an unusual case of multiple and extremely large aneurysms, therefore potentially at risk of rupture or thrombosis.

Sinus of Valsalva aneurysm.

Bicuspid aortic valve is one of the most common congenital cardiac anomalies and it may be accompanied by other cardiovascular anomalies. Sinus of Valsalva aneurysm is a rare anomaly in adult population, but it coexists with bicuspid aortic valve quite often. This report describes a 57 years-old patient who had a bicuspid aortic valve accompanied by unruptured Valsalva sinus aneurysm with significant left anterior narrowing and who underwent successful surgery with ascending aorta and aortic valve replacement as well as coronary by-pass grafting.

Early and long-term results of unprotected left main coronary artery stenting: the LE MANS (Left Main Coronary Artery Stenting) registry.

OBJECTIVES: The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. BACKGROUND: PCI is an increasingly utilized method of revascularization in patients with ULMCA. METHODS: This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. RESULTS: Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction <50% was the only independent risk factor influencing long-term survival. CONCLUSIONS: Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

Acute and late outcomes of unprotected left main stenting in comparison with surgical revascularization.

OBJECTIVES: The purpose of this study was to compare the early and late results of percutaneous and surgical revascularization of left main coronary artery stenosis. BACKGROUND: Unprotected left main coronary artery (ULMCA) stenting is being investigated as an alternative to bypass surgery. METHODS: We randomly assigned 105 patients with ULMCA stenosis to percutaneous coronary intervention (PCI; 52 patients) or coronary artery bypass grafting (CABG; 53 patients). The primary end point was the change in left ventricular ejection fraction (LVEF) 12 months after the intervention. Secondary end points included 30-day major adverse events (MAE), major adverse cardiac and cerebrovascular events (MACCE), length of hospitalization, target vessel failure (TVF), angina severity and exercise tolerance after 1 year, and total and MACCE-free survival. RESULTS: A significant increase in LVEF at the 12-month follow-up was noted only in the PCI group (3.3 +/- 6.7% after PCI vs. 0.5 +/- 0.8% after CABG; p = 0.047). Patients performed equally well on stress tests, and angina status improved similarly in the 2 groups. PCI was associated with a lower 30-day risk of MAE (p < 0.006) and MACCE (p = 0.03) and shorter hospitalizations (p = 0.0007). Total and MACCE-free 1-year survival was comparable. Left main TVF was similar in the 2 groups. During the 28.0 +/- 9.9-month follow-up, there were 3 deaths in the PCI group and 7 deaths in the CABG group (p = 0.08). CONCLUSIONS: Patients with ULMCA disease treated with PCI had favorable early outcomes in comparison with the CABG group. At 1 year, LVEF had improved significantly only in the PCI group. After more than 2 years, MACCE-free survival was similar in both groups with a trend toward improved survival after PCI.

Local paclitaxel delivery as a treatment of persistent, recurrent in-stent restenosis -- safety assessment.

INTRODUCTION: In-stent restenosis still remains a serious clinical problem. Local intramural drug delivery (LDD -- Local Drug Delivery) seems to be an interesting alternative to drug-eluting stents (DES). AIM: The aim of the study was to assess the safety and effectiveness of local intramural paclitaxel administration in the treatment of recurrent in-stent restenosis (ISR). METHODS: Five patients were enrolled in the study (3 men, mean age 50+/-7 years) with at least a second episode of ISR within the same stent. Percutaneous coronary angioplasty was performed on a total of 11 vessel segments. Remedy delivery catheters (Boston Scientific) were used for balloon angioplasty. Inflation pressure was calibrated to obtain a balloon/vessel lumen ratio of 1.1:1. Then the pressure was lowered to 3 atmospheres and 100 microg of paclitaxel diluted in 2 ml of 0.9% NaCl was given over 60 seconds under the pressure of 2-3 atmospheres. This dose was used for each 10 mm of lesions. Control coronary angiography was performed six months after the procedure. RESULTS: In all patients effective target vessel revascularisation was achieved. No adverse events were observed in the periprocedural period or during the 6-month follow-up period. Control angiography revealed ISR in three segments (27.2%) and in-stent late lumen loss of 0.21+/-0.93 mm. CONCLUSIONS: Local intramural paclitaxel delivery is a safe and effective method of ISR treatment. The optimal paclitaxel dose should be established in further studies.

Stent implantation for the unprotected left main coronary artery. The long-term outcome of 62 patients.

INTRODUCTION: Stent implantation for the unprotected left main coronary artery (ULMCA) is regarded as controversial and coronary heart disease with LMCA stenosis still remains a basic indication for bypass surgery. Although there is no doubt that the risk of stent implantation for LMCA lesions is low, there are still limited data on long-term outcomes. There have been no reports so far answering the question whether ULMCA stenting ensures adequate coronary blood flow in the vessel. AIM: Assessment of the effect of LMCA flow restoration with stenting on the coronary flow reserve assessed by an exercise test, as well as on left ventricular function and angina in patients followed for 12 months after the procedure. METHODS: The study population included 62 patients (17 women and 45 men) aged 61.4+/-11.1 (35-84 years) who underwent coronary angioplasty with elective ULMCA stenting. In all patients, serial echocardiography (before and 1, 3, 6, and 12 months after the procedure) and the exercise test according to the Bruce protocol (1, 3, 6, 12 months after the procedure) were carried out. Routine coronary angiography was performed 3 to 6 months after the procedure. Fifty-nine patients (95.2%) survived a 12-month period. In 24 (38.7%) patients major adverse cardiac events (MACE) occurred. In-stent restenosis was observed in 13 patients; in 11 of them repeated PCI was performed and 2 of them underwent CABG. One patient after repeated PCI required CABG. RESULTS: Severity of angina, evaluated according to the CCS scale, decreased significantly in the 12-month follow-up period as compared with the preprocedural period (p <0.00001). The mean baseline left ventricular ejection fraction was 51.6+/-12.5%. It increased to 53.8+/-12.8% (p <0.02) at 6 months and remained at this level at 12 months. The mean exercise test time was 7.0+/-3.4 minutes in the first month after ULMCA stenting, and in the sixth and the twelfth month of follow-up it increased to 7.6+/-3.4 minutes (p <0.002) and 7.8+/-3.2 minutes (p <0.05), respectively. The metabolic equivalent task (MET) value did not change significantly during the observation period. CONCLUSIONS: Restoration of the physiological blood flow in the unprotected left main coronary artery with stent implantation is associated with a significant reduction of angina, significant improvement of the left ventricular systolic function and preservation of exercise capacity in long-term follow-up.