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Percutaneous mitral valve-in-valve implantation is an emerging option in patients with surgical bioprosthesis failure or failing mitral annuloplasty and increased surgical risk. We present a case of transcatheter transvenous trans-septal mitral valve-in-ring (TMVinR) procedure, in a patient with severe left ventricular dysfunction and severe mitral regurgitation, after surgical mitral annuloplasty, managed with periprocedural mechanical circulatory support (MCS) with VA-ECMO.

Mitral annular calcification can pose a formidable surgical challenge in the setting of mitral valve replacement for mitral stenosis. Although there are reports of transapical valve-in-valve transcatheter mitral valve replacement in the setting of degenerated bioprosthetic mitral valve replacement, there is less experience with transcatheter mitral valve replacement for mitral annular calcification. This report describes a patient who previously received a transcatheter aortic valve replacement and then subsequently underwent a minimally invasive right thoracotomy for transcatheter mitral valve replacement with a successful result. We discuss technical pearls and operative considerations based on an extensive experience with minimally invasive valve surgery from a right mini-thoracotomy.

Current balloon expandable transcatheter valves have limited applicability to patients with “native” right ventricular outflow tracts (RVOT), meaning those who have had previous surgery and are left with large, compliant, irregular RVOT. The Alterra Adaptive PrestentTM is a self‐expanding, partially covered stent that was designed to internally reconfigure these types of RVOT, making them suitable for implantation of a commercially available balloon expandable heart valve, the SAPIEN 3. Herein, we describe the first human implant of this device.

Background: Transcatheter mitral valve replacement (TMVR) in deteriorated prostheses, rings or mitral annular calcification are being performed more frequently. Inadvertently, we are starting to see patients who develop severe aortic stenosis following TMVR. Simultaneous transcatheter aortic valve replacement (TAVR)/TMVR has been previously reported, but almost all are performed in the order of TAVR first then followed by TMVR.Methods: We included three patients who underwent TAVR following TMVR. The patients subsequently presented with symptomatic aortic stenosis or insufficiency. All procedures were performed from September 2015 to July 2017.Results: All cases underwent successful TAVR after TMVR. There were several technical points. First, a balloon expandable valve was used for the initial case, but because of the interaction between the balloon and TMVR valve, we elected to use self-expandable valves for the subsequent cases. Secondly, it is critical to confirm that the wire is not traversing...

The availability of polytetrafluoroethylene (PTFE) covered, self-expandable nitinol stents in 2001 considerably improved the patency, response rates and survival of the transjugular intrahepatic portosystemic shunt (TIPS). Side effects of portosystemic shunting such as hepatic encephalopathy (HE) and worsening of hepatic function, however, remained a problem. To reduce HE, underdilatation of nitinol stents has been practiced for many years. However, as shown recently, underdilatation was a flop since, due to their intrinsic memory, nitinol stents always expanded to reach their nominal diameter of 8 or 10 mm. To overcome this problem and to be able to perform permanent shunts with a smaller diameter of < 8 mm, we studied the usefulness of a balloon-expandable, covered, metallic stent which allowed adjustment to any diameter between 5 and 12 mm. Methods: 30 patients with cirrhosis and symptomatic portal hypertension were included. The mean Child-Pugh score was 8 ± 2.17 patients had refractory ascites, 9 patients variceal bleeding and four patients other indications for the TIPS. Results: The TIPS was successfully implanted in all patients within 69.6 ± 21.8 min. The shunt reduced the portosystemic pressure gradient by 57.5 ± 14.2% with a mean stent diameter of 7.4 ± 1.0 mm (5 -10.3 mm). During a mean follow-up of 330 ± 249 days, shunt revision was necessary in 5 patients (17%), four of them had insufficient response and received stent dilatation and one patient had stent misplacement requiring a parallel shunt. Three patients (10%) developed HE. Conclusions: The covered, balloon-expandable stent could be placed accurately and allowed creation of adapted shunts with smaller diameters as usual. This resulted in a comparatively low rate of HE.

Major injury of the innominate artery is traditionally treated with an open repair which is technically challenging, associated with large volumes of blood loss and prolonged operative times. Endovascular treatment with covered stent placement across the injury is an attractive alternative. However, placement of a single covered stent across the innominate artery bifurcation into one of its distal branches will not prevent bleeding because of retrograde perfusion from the unstented branch distal to the bifurcation. Here, we report a case of successful endovascular repair of one such injury involving the innominate artery bifurcation with ongoing extravasation into the mediastinum. The injury was successfully treated by utilizing 2 balloon-expandable covered stents placed in kissing fashion from the innominate artery into both of its distal branches. This technique of parallel covered stent placement across a bifurcation could effectively repair bifurcation injuries while maintaining patency of both distal branches.

A 79-year-old woman with severe mitral annular calcification was scheduled for mitral valve replacement. A SAPIEN 3 valve was implanted in mitral position using an open surgical approach. Immediately after cardiopulmonary bypass, bleeding from an unidentified source was encountered. Cardiopulmonary bypass was emergently resumed and a laceration of the left ventricular apex due to the valve delivery system was detected. Risk factors specific to the open surgical approach include a decompressed ventricle, decreased annulus to apical distance, and the absence of continuous fluoroscopic and echocardiographic imaging. These create a clinical scenario where risk of ventricular perforation is increased compared with traditional intravascular transcatheter valve delivery.

Transcatheter aortic valve replacement (TAVR) has become standard therapy for patients with severe aortic stenosis who are deemed at least intermediate risk for surgical valve replacement. Over the past decade, several technological advances have taken place to improve the quality and safety of these devices. The current commercially available valves are broadly grouped into balloon expandable and self-expandable valves. The latest iteration of the self-expandable valve is Medtronic’s repositionable valve known as the Evolut PRO system. In this review, we highlight the evidence behind the use of TAVR, improvement in devices over previous generations, clinical evidence behind the CoreValve Evolut PRO system, and the future of TAVR.

Transcatheter mitral valve replacement (TMVR) using balloon-expandable valves has become an alternative therapy for selected patients with mitral valve disease. Up to now, the transapical approach has been the preferred route, but the transseptal approach is becoming increasingly popular due to its reduced invasiveness and increased safety. However, transseptal TMVR procedures are technically challenging, and little is known about the screening process required before this therapy. The authors provide operators with a step-by-step approach from the screening process to follow-up care for transseptal TMVR procedures.

Objectives This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days. Background Deployment of these THV showed promising initial clinical results. However, no comparative data are available. Methods Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311). Results In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3. Conclusions Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.

Device landing zone (DLZ) calcification is an important determinant of procedural success in transcatheter aortic valve implantation (TAVI). To evaluate the impact of DLZ calcification on procedural outcome with different types of transcatheter heart valves (THVs). Aortic valve calcium density (AVCdens) was determined by non-contrast-enhanced computed tomography in 1232 patients undergoing transfemoral TAVI. We stratified the outcome data according to the extent of AVCdens (mild, moderate, severe) and compared balloon-expandable (BE) with self-expanding (SE) THV. Moreover, THVs were subdivided according to their radial force (BE: high; SEmod: moderate; SElow: low). With BE THV, PVR ≥2° (2.1 vs. 7.9%; p

Purpose: To evaluate the safety and efficacy of a next-generation balloon-expandable stent-graft for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries. Methods: A prospective, multicenter, single-arm safety and efficacy study ( ClinicalTrials.gov identifier: NCT02080871) of the VBX Stent Graft for treatment of de novo or restenotic lesions in the iliac arteries was conducted under an Investigational Device Exemption at 26 US sites and 1 New Zealand center. The study eligibility criteria were established with the aim of enrolling more “real-world” patients compared with previous iliac stent studies supporting Food and Drug Administration approval. The study enrolled 134 patients (mean age 66±9.5 years; 79 men) with 213 iliac lesions. Three-quarters of the population (101, 75.4%) had Rutherford category 3 ischemia, and 43 (32.1%) patients presented with TASC II C/D lesions. The primary endpoint was a composite of device- or procedure-related death within 30 days, myocardial infarction within 30 days, target lesion revascularization (TLR) within 9 months, and amputation above the metatarsals in the treated leg within 9 months. Results: In all, 234 devices were implanted in 213 lesions with 100% technical success; 57 (42.5%) patients received kissing stents at the aortic bifurcation. No devices exhibited a discernable change in length after final deployment as determined by independent core laboratory quantitative angiographic analysis. At 9 months, 3 (2.3%) of 132 patients (1 lost to follow-up, 1 unrelated death) experienced a major adverse event (3 TLRs) related to the primary endpoint. At 9 months, there were no device-related serious adverse events or unanticipated adverse device effects. Conclusion: The next-generation balloon-expandable stent-graft demonstrated notable 9-month safety and efficacy in treating iliac occlusive disease in patients reflecting common clinical practice.

OBJECTIVES We herein aimed to compare acute 30-day outcomes of latest-generation self-expandable and balloon-expandable transcatheter heart valves. METHODS From 2012 through 2016, 104 consecutive patients (study group, 69.2% female, 81.7 ± 5.5 years, logEuroSCORE I 15.9 ± 9.3%) received transfemoral transcatheter aortic valve implantation using the Symetis ACURATE neo® transcatheter heart valve. A control group of patients after transfemoral transcatheter aortic valve implantation with the Edwards Sapien 3™ transcatheter heart valve was retrieved from our database and matched to the study group. Data were retrospectively analysed according to updated Valve Academic Research Consortium definitions. RESULTS Device success was 94.2% (98 of 104) and 98.1% (102 of 104) in study and control groups, respectively (P = 0.157). All-cause 30-day mortality was 3.9 (4 of 104) vs 0.9% (1 of 104) (P = 0.317). Resultant transvalvular peak/mean gradients and effective orifice area were 14.2 ± 5.7 vs 22.6 ± 6.8 mmHg (P

Over the last decade, transcatheter aortic valve implantation (TAVI) has emerged as the treatment of choice for patients with symptomatic severe aortic valve stenosis at a prohibitive or high risk for surgical valve replacement. Since its introduction in 2002 and establishment of the retrograde transfemoral access route in 2005, TAVI procedures underwent several refinements (1-3). Improved prosthesis design and delivery systems, as well as the systematic use of multimodality imaging for accurate patient selection and valve positioning have significantly improved the efficacy and safety of TAVI devices over the last years. Although TAVI is currently approved for the treatment of inoperable or high surgical risk patients with severe symptomatic AS, increased operator experience and improved valve systems have expanded the use of TAVI towards patients with intermediate or lower risk (4-6). However, so far, because of the lack of large scale and randomized data, the expansion of the use of TAVI to lower risk populations warranted careful individual clinical evaluation and decision-making.

Background Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. Methods and results We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069 ). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p p p p p = 0.01), and the combined endpoint “early safety” was met significantly less with ES3 (10% vs. 21% with CV, p = 0.03). Conclusions Transfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2.

Background Though several anatomical characteristics have been reported separately as risk factors for paravalvular leak (PVL) and landing zone (LZ) complications after transcatheter aortic valve replacement (TAVR), multivariate risk models are needed. Methods Patients that underwent balloon-expandable TAVR with multidetector cardiac computed tomography (MDCT) sizing were studied. MDCT images were analyzed and the association between anatomical factors and ≥mild PVL, ≥moderate PVL, and LZ complications (annular rupture, requirement of new permanent pacemaker, and coronary obstruction) was determined, and subsequently competing predictive models were developed and validated. Results A total of 316 consecutive TAVR patients were included. Median age was 82.0 years (74.0–87.0) and STS score was 8.3% (5.4–10.9). Factors associated with ≥mild PVL included TAVR with Sapien/Sapien XT vs. Sapien 3 (OR = 2.50, 95% CI = 1.24–5.07), LVOT nontubularity (OR = 1.02, 95% CI = 1.01–1.04), LZ calcification (OR = 1.01, 95% CI = 1.00–1.01), and low cover index (OR = 0.94, 95% CI = 0.91–0.96). Factors associated with LZ complications included LZ calcification (OR = 1.01, 95% CI 1.00–1.01), leaflet asymmetry (OR = 1.01, 95% CI 1.01–1.02), and cover index (OR = 1.09, 95% CI 1.03–1.14). Predictive models for ≥mild PVL (AUC = 0.71, 95% CI = 0.66–0.77), ≥moderate PVL (AUC = 0.75, 95% CI = 0.65–0.84), and LZ complications (AUC = 0.77, 95% CI = 0.67–0.87) were created using procedural details and anatomical data from the MDCT. Clinical variables were not included as they were poorly correlated with the occurrence of PVL and LZ complications. For each outcome, the area under the curve (AUC) of the multivariate model was superior to the model consisting only of individual factors. Conclusions A model using procedural/anatomical characteristics derived from MDCT predicts ≥mild PVL, ≥moderate PVL, and LZ complications post-TAVR. Incorporation of anatomical risks into clinical practice may help stratify patients before TAVR. © 2017 Wiley Periodicals, Inc.

Objectives: The aim of this study was to determine the incidence, characteristics, and treatment outcomes of patients diagnosed with clinical transcatheter heart valve thrombosis.Background...

We present a case of emergency mitral valve replacement with the first — to the best of our knowledge — use of Melody balloon expandable stented bioprosthesis in a 2-years-old patient with acute endocarditis, subsequent mitral (bicuspid) valve incompetence after aggressive infective destruction, with the symptoms of critical multiorgan failure. The patient with a history of rapid deterioration after 2-weeks-long septicemia in the course of acute endocarditis was operated for life-saving indications. Melody valve was expanded over 16 mm TyShak balloon and implanted into a mitral position (Melody-MVR) with good result. Based on actual knowledge concerning heart valves reconstructions and institutional experience we conclude that infected mitral valve in children should be primary repaired, nevertheless Melody valve could be reasonable considered as a mitral prosthesis in patients with non-reparable conditions.

Background Transcatheter aortic valve replacement (TAVR) has been an alternative less invasive therapy for high-surgical risk/inoperable patients with aortic valve stenosis (AS) in Japan. We report 5-year outcomes of the first pivotal clinical trial of TAVR in Japan (PREVAIL JAPAN).Methods and Results:A total of 64 patients with AS who were considered unsuitable candidates for surgery were enrolled at 3 centers in Japan (mean age: 84.3±6.1 years, female: 65.6%, STS score: 9.0±4.5%). Transfemoral approach (TF) and transapical approach (TA) was performed in 37 patients and 27 patients, respectively. At 5 years, freedom from all-cause death was 52.7% (TF: 51.3%, TA: 56.3%). Risk of all stroke at 5-year was 15.8% (TF: 8.9%, TA: 25.5%) and risk of major adverse cardiac and cerebrovascular events at 5 years was 58.0% (TF: 51.3%, TA: 69.2%). Mild or greater aortic regurgitation (AR) at 1 week was not associated with increased all-cause death at 5 years (69.1%) compared with none or trace AR (48.3%) (P=0.184). Patients with high STS score (>8) had higher mortality rate than those with low STS scores (≤8). Conclusions The 5-year data from PREVAIL JAPAN show the clinical benefit of TAVR and suggest that balloon-expandable TAVR is an effective treatment option for Japanese patients with severe AS who are not suitable for surgery. (Funded by Edwards Lifesciences Limited; ClinicalTrials.gov number, NCT01113983.).

We read with great interest the paper by Faurie et al. ([1][1]) regarding the performance of left ventricular (LV) stimulation via the delivery guidewire compared with standard right ventricular (RV) stimulation in transcatheter aortic valve replacement (TAVR) with balloon expandable valves. In the

We implanted two sinus Superflex DS© stents in a systemic non-stenotic arterial duct of a newborn with hypoplastic left heart syndrome. Forty-eight hours later an important collapse of the stent was detected and treated with a balloon expandable stent. Sinus Superflex DS© has been specifically designed for systemic ducts. This complication generates doubts about its radial force in this scenario.

A 75-year-old man with a history of peripheral artery disease and bilateral iliofemoral stent implantation 2 years previously was referred to our center for recurrent claudication. Pre-therapeutic computed tomographic angiography identified severe right common iliac artery stent restenosis related

Transcatheter aortic valve replacement (TAVR) has emerged as a life-saving and effective alternative to surgical valve replacement in high-risk, elderly patients with severe calcific aortic stenosis. Despite its early promise, certain limitations and adverse events, such as suboptimal placement and valve migration, have been reported. In the present study, it was aimed to evaluate the effect of various TAVR deployment locations on the procedural outcome by assessing the risk for valve migration. The deployment of a balloon-expandable Edwards SAPIEN valve was simulated via finite element analysis in a patient-specific calcified aortic root, which was reconstructed from CT scans of a retrospective case of valve migration. The deployment location was parametrized in three configurations and the anchorage was quantitatively assessed based on the contact between the stent and the native valve during the deployment and recoil phases. The proximal deployment led to lower contact area between the native leaflets and the stent which poses higher risk for valve migration. The distal and midway positions resulted in comparable outcomes, with the former providing a slightly better anchorage. The approach presented might be used as a predictive tool for procedural planning in order to prevent prosthesis migration and achieve better clinical outcomes.

Currently, there are no recommendations regarding the selection of valve type for a transcatheter heart valve (THV)-in-THV procedure. A supra-annular valve design may be superior in that it results in a larger effective orifice area and may have a lower chance of valve thrombosis after THV-in-THV. In this report, we describe the use of a supra-annular valve strategy for an early degenerated THV.

Background: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. Methods: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. Results: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10–599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P =0.005), cardiovascular death (relative risk, 0.82; corrected P =0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P P Conclusions: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.