Mitral valve-in-valve and valve-in-ring procedures: Midterm outcomes in a French nationwide registry.

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

Comparison of prevalence and management of left atrial appendage thrombi under old and new anticoagulants prior to left atrial catheter ablation.

BACKGROUND: The prevalence and management of left atrial appendage (LAA) thrombi associated with new anticoagulants remain to be elucidated, especially prior to atrial fibrillation (AFib) ablation. This study sought to (1) compare the prevalence of LAA thrombi and/or severe LAA contrast under vitamin K antagonist (VKA) agents and novel oral anticoagulants (NOACs), (2) evaluate the rate of LAA thrombus resolution after anticoagulation modification, and (3) determine the predictive factors of LAA thrombi and severe LAA contrast in patients prior to LA AFib ablation. METHODS: Between January 2013 and March 2016, 576 consecutive patients referred for AFib ablation were included, and the prevalence of transesophageal echocardiography-detected thrombi was similar under NOACs (2.1%) and VKA agents (2.6%). RESULTS: Thrombus resolution was obtained in 50% of cases following anticoagulation modification. Through multivariate exact logistic regression analysis with relevant clinical and echocardiographic features, age (P<.001), LAA hypocontractility (P<.001), and left ventricular ejection fraction (P=.007) were found to be independently associated with the occurrence of LAA thrombus. The relevant factors independently associated with LAA thrombus or severe contrast were LAA hypocontractility (P<.001) and age (P<.001). CONCLUSIONS: The prevalence of transesophageal echocardiography-detected thrombi in patients referred for AFib ablation is similar under NOACs (2.1%) and VKA agents (2.6%). Under VKA therapy with 3-4 international normalized ratio, 50% of thrombi dissolved. Independent predictive factors of procedure contraindication included age, LAA hypocontractility, and left ventricular ejection fraction.

Sutureless aortic bioprosthesis valve implantation and bicuspid valve anatomy: an unsolved dilemma?

Interest is growing in the clinical use of sutureless (SU) valves. However, indications in some anatomical sub-settings, like bicuspid aortic valves (BAV), have been so far limited. We discuss herein our initial experience with the implantation of the 3f Enable SU bioprosthesis in patients with a BAV. Patients with a BAV were selected in our unit between March 2011 and September 2014 for a SU 3f Enable valve implantation. Twenty of the 198 patients who underwent a 3f Enable valve implantation in our unit had a BAV. Procedural success was 100 %, but reclamping was necessary in one (5 %) case. Median size of implanted bioprosthesis was 23 mm. After a mean follow-up of 13.8 ± 10.7 months, survival was 100 %. Two patients (10 %) showed an immediate grade 1 paravalvular leak (PVL) that progressed to grade 2 and 3+ (moderate/severe), respectively, during follow-up. Type of bicuspidy (Sievers classification) in these two patients was 0 and intraoperatively aortic annuli admitted the 25 mm calibrator. Among the 18 patients without PVL, no one had a type 0 large BAV. At 1 year, implantation of the 3f Enable SU bioprosthesis appears to be safe in patients with BAV type I and II, while in type 0 use of the SU valve seems to be safe only if the annular diameter is <25 mm. Larger studies are necessary to confirm our findings in order to clarify the indications for SU technology in the subset of bicuspid patients.

Aortic sutureless bioprosthesis implantation following degeneration of a SOLO stentless valve.

A case is presented of the early degeneration of a 21 mm SOLO stentless valve concomitant with severe mitral regurgitation (MR). Transcatheter valve-in-valve implantation was considered in this high-risk case (logistic EuroSCORE 29.3%), but was dismissed because of the risk of coronary occlusion, an absence of visual landmarks, and the impossibility to treat the MR. Following the implantation of a 27 mm Medtronic Hancock II mitral bioprosthesis, the leaflets of the SOLO valve were removed, and a 19 mm 3f Enable sutureless bioprosthesis delivered into the remaining sewing belt of the stentless valve. The total cross-clamp time was 64 min. No aortic paravalvular leakage was detected at discharge and early follow up (four months); the mean and peak transvalvular aortic gradients were 13 and 23 mmHg, respectively, and the left ventricular ejection fraction 60%. A sutureless strategy simplified the management of this high-risk case.

Sutureless 3F Enable Valve Replacement for Pure Aortic Regurgitation.

BACKGROUND AND AIM: We present our experience in the use of the sutureless valve in patients undergoing aortic valve replacement for pure aortic regurgitation. METHODS: Out of 167 patients who underwent sutureless aortic valve implantation with a Medtronic 3f Enable prosthesis in our unit between March 2011 and February 2014, 12 (7.1%) received a sutureless valve for pure aortic regurgitation. RESULTS: Mean age, logistic EuroSCORE, and left ventricular ejection fraction were 72 ± 5 years, 6.3 ± 2.9%, and 52.5 ± 15.3%, respectively. The sutureless valve could be successfully implanted in all cases; nine patients had a full sternotomy (associated coronary artery bypass graft in four cases and associated mitral surgery in five), one patient had a ministernotomy, and two had a thoracoscopic approach. Average cross-clamping and cardiopulmonary bypass times were 90 ± 30 and 127 ± 51 minutes, respectively. At the outpatient echocardiography, average mean gradient was 10.54 ± 4.99 mmHg and a grade I-II paravalvular leakage (PVL) was detected in the first patient of the cohort (ministernotomy approach). At a mean follow-up of 11.1 ± 5.5 months, average mean gradient was 9.75 ± 2.87 mmHg, no new PVL was detected, and the known PVL was stable. No pacemaker implantation was required. CONCLUSIONS: Implantation of the 3f Enable sutureless valve is technically possible with pure aortic regurgitation in selected patients. Multicenter investigations are necessary to assess the mid-term benefits of such a device in this subset of patients.

Sutureless Valve Implantation in Sievers Type 0 Bicuspid Annuli: A Word of Caution.

AIM: We describe a series of 3f Enable sutureless prostheses implanted in bicuspid valves. METHODS: Between March 2011 and April 2014, five patients with Sievers type 0 bicuspid valves were selected to receive the sutureless 3f Enable prosthesis . Exclusion criteria were: intraoperative calibration of the aortic annulus >27 mm, left ventricle ejection fraction <50%, age <70 years. RESULTS: All the implantations could be performed without the necessity to re-deploy the prosthesis . The perioperative transesophageal echocardiogragram detected two moderate paravalvular leakages (PVL) in two patients who received a large size of prosthesis (25 and 27 mm, respectively). The two leakages, at a follow-up of 32 and 24 months, respectively, increased to grade II and II +. No PVL appeared in the other three patients. CONCLUSION: This experience should warn about the inadequate performance of the 3f Enable valve in Sievers type 0 large aortic bicuspid annuli. In this subset any minor intraoperative residual leakage should not be accepted.

Pre-participation cardiovascular evaluation in Pacific Island athletes.

BACKGROUND: Pre-participation cardiovascular evaluation (PPE) aims to detect cardiac disease with sudden cardiac death (SCD) risk. No study has focused on Pacific Island athletes. METHODS: A total of 2281 Pacific Island athletes were studied with (i) a questionnaire on family, personal history and symptoms, (ii) a physical examination and (iii) a 12-lead ECG. RESULTS: 85% presented a normal history and examination. A positive family history was 1.4-1.9 fold higher in Melanesians, Polynesians and Métis than in Caucasians, while a positive personal history, abnormal symptoms and abnormal examination was 1.3 fold higher in Melanesians and Métis than in others. Neither gender nor training level had a bearing on these results. Melanesians had higher T wave inversions (TWIs) in V2-V4 leads but had no CV abnormalities. Lateral or infero-lateral TWIs were found in 6 male and in 5 highly trained athletes and cardiomyopathies were diagnosed in 3/6 athletes. Overall, 3.9% athletes were found to have a CV abnormality and 0.8% had a risk of SCD. Polynesians and males were more at risk than the others while the level of training made no difference. In athletes at risk of SCD, the main detected CV diseases were cardiomyopathies, Wolff-Parkinson-White (WPW) and severe valve lesions of rheumatoid origin. CONCLUSIONS: PPE revealed that 3.9% presented CV abnormalities. A risk of SCD was found in 0.8% with cardiomyopathies, WPW, and severe valve lesions of rheumatoid origin. Melanesians, Polynesians and male of high level of training were more at risk than others.

Impact of very high pressure stent deployment on angiographic and long-term clinical outcomes in true coronary bifurcation lesions treated by the mini-crush stent technique: A single center experience.

BACKGROUND: Percutaneous coronary intervention (PCI) for bifurcation lesions (BL) using 2 stents technique is known to be associated with high rates of procedural failure especially on the side branch (SB) mainly due to stent incomplete apposition. Stent deployment at very high pressure (SDHP) may lead to better stent expansion and apposition. However, SDHP may also be at the origin of deeper wall injury resulting into major cardiac adverse events. No data are available on evaluation of SDHP in BL treated by a mini-crush stent technique. METHODS: One hundred and thirteen consecutive patients underwent PCI for BL (Medina 1, 1, 1) using a mini-crush stent technique with SDHP defined as ≥20atm. An angiographic follow-up was performed at 6 month and clinical follow-up was obtained at a median of 3 years. RESULTS: Stent deployment mean pressures were 20±1.4atm (range 20-25) in the main vessel (MV) and 20±1.5atm (range 20-25) in SB. Simultaneous final kissing balloon was used in 92% of cases. PCI was successful in 100%. Angiographic follow-up was obtained in 83% of patients. Restenosis rate was 13% (12% restenosis in the SB) with only one case (0.8%) of SB probable thrombosis. Another case of late stent thrombosis occurred at a 3 years clinical follow-up. CONCLUSION: Compared with previously published studies in which stents were deployed at lower pressure, SDHP does not increase the restenosis rate in BL using mini-crush stent technique but seems to reduce the rate of stent thrombosis.

Substantial superiority of Niobe ES over Niobe II system in remote-controlled magnetic pulmonary vein isolation.

BACKGROUND: Catheter ablation of atrial fibrillation (AFib) primarily relies upon pulmonary vein isolation (PVI), but such procedures are associated with significant X-ray exposure. The newer Epoch system has been developed so as to enable more precise magnetic navigation whilst limiting X-ray exposure. OBJECTIVES: This study was aimed at quantifying both exposure time and X-ray reduction with the newer Epoch system compared to Niobe II during AFib ablation procedures. METHODS: From November 2011 to November 2013, our last 92 consecutive patients treated with the Niobe ES (Epoch Solution; 4th generation magnetic navigation technology) system were compared with the first 92 consecutive patients treated using the Niobe II system (3rd generation magnetic navigation technology) for symptomatic drug-refractory AFib. RESULTS: Mean patient age was 59±11years (20% female), and the study population was affected by either symptomatic paroxysmal (65.2%) or persistent (34.8%) AFib. Median procedure time was 2±0.5h and median total X-ray exposure 12.3±6.4min. Procedure time (1.9±0.4 vs. 2.7±1h, p<0.0001) and X-ray duration (12±4 vs. 15±7min, p=0.001) were significantly lower with Niobe ES than with the Niobe II system. X-ray ablation exposure time was also significantly lower with the Niobe ES system than with the Niobe II system (2.9±2 vs. 4±3.5min; p=0.01). Through multivariate analysis, the only predictive factors influencing both procedure duration and X-ray exposure were found to be the Niobe ES system use and LA size. CONCLUSIONS: Our study was the first to demonstrate that the new Niobe ES magnetic robotic system substantially reduced overall operating, fluoroscopy, and ablation times during AFib ablation procedure.

Transcatheter leadless cardiac pacing: The new alternative solution.

INTRODUCTION: A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS: Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION: This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

Unusual complication during a percutaneous coronary intervention for a bifurcation lesion using T and Protrusion technique.

Our case reports the first migration of a stent already deployed at high pressure in the main vessel during a 2-stent strategy for a bifurcation lesion using T and protrusion technique. The Kissing balloon was not optimal and could have led to an insufficient strut/cell opening and then to LAD stent pulled back into the artery tree. This case report highlights the importance of an optimal Kissing Balloon in two stent bifurcation technique.

First in Human Totally Endoscopic Perceval Valve Implantation.

Totally endoscopic cardiac operations for coronary procedures and atrial septal defect repair have demonstrated improved quality of life, but they have required longer cross-clamp times compared with open operations. Although transcatheter valve implantation remains appropriate for inoperable patients, the totally endoscopic approach could be an effective treatment for lower risk patients, including complete removal of the stenotic aortic valve, while minimizing surgical chest wall trauma, and providing excellent early quality of life. Totally endoscopic aortic valve replacement procedures were previously performed with the 3f Enable bioprosthesis. We present the first case, to our knowledge, of Sorin Perceval implantation.

Two Hundred Consecutive Implantations of the Sutureless 3f Enable Aortic Valve: What We Have Learned.

BACKGROUND: In this article we present a consecutive single-center experience of implantation of the Medtronic 3f Enable aortic valve (Medtronic Inc, Minneapolis, MN). METHODS: Between March 2011 and October 2014, 200 consecutive patients (mean age, 76.4 ± 5.9 years; logistic EuroScore, 7.8% ± 7.0%) in our unit received the 3f Enable valve. This is a retrospective analysis of this prospective monocentric cohort. RESULTS: The 3f Enable valve could be implanted in all the scheduled 141 isolated aortic valve replacement (AVR) procedures (14 full sternotomies, 73 ministernotomies, 44 minithoracotomies, and 10 thoracoscopic approaches) and 59 combined procedures (all using full sternotomy). Reclamping was necessary in 7 (3.5%) patients (paravalvular leakage [PVL] was ≥ grade 1 because of undersizing or prosthetic misalignment); mean cross-clamp and cardiopulmonary bypass (CPB) times were 65 ± 31 and 91 ± 39 minutes, respectively. Sixteen (8%) patients required early implantation of a pacemaker (PM). At a mean follow-up of 12.6 ± 8.1 months, mean transvalvular gradient and effective orifice area (EOA) were 9.8 ± 4.4 mm Hg and 1.87 ± 0.6 cm(2), respectively. Mild PVL was present in 7 (3.5%) patients and moderate PVL was present in 5 (2.5%) patients. No device migration was registered, and no moderate PVL was detected in the last 100 patients of the cohort. Overall, 3-year survival was 78%. CONCLUSIONS: The 3f Enable valve shows excellent results regarding PVL but in our experience required a learning curve and a refinement of the technique of implantation. Use of the prosthesis was possible in various less invasive approaches.

Sutureless 3f Enable Valve Implantation in a Failing Bio-Bentall Conduit.

We report the case of a 61-year-old man who underwent a Bentall procedure with a BioValsalva conduit for an acute type A aortic dissection. Two years later the patient presented at our institution with severe aortic regurgitation caused by the rupture of one cusp of the bioprosthesis (Elan valve) included in the conduit. A transcatheter valve-in-valve option was discussed by the heart team but was dismissed in favor of a sutureless 3f Enable valve implantation into the failing bioprosthesis after leaflet removal. This strategy simplified the surgical procedure and provided excellent postoperative hemodynamics at follow-up.

Robotic magnetic navigation for ablation of human arrhythmias.

Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation. As ongoing developments will likely improve results and procedure times, this technology will become one of the most modern technologies for treating arrhythmias. Based on the literature, this review summarizes the advantages and limitations of robotic magnetic navigation for ablation of human arrhythmias.

Mid-term results of mitral valve repair for ischemic mitral regurgitation with ETlogix ring: A single-center study.

BACKGROUND: Ischemic mitral regurgitation (IMR) is a common complication of coronary artery disease and represents an independent predictor of mortality. In the IMR the pattern of mitral valve annular dilatation is asymmetrical: this can explain the long-term incidence of recurrent mitral regurgitation after surgical annular size reduction with a symmetrical ring. The aim of this study is to analyze early and mid-term results of mitral valve repair (MVR) with the CMA IMR ETlogix ring, specifically developed for the surgical correction of IMR. METHODS: Retrospectively, we studied 157 consecutive patients who underwent MVR with the CMA ETlogix ring for the treatment of grade ≥2 IMR in our center between June 2006 and December 2012. We reported clinical and echocardiographic early and mid-term results of this surgical technique. RESULTS: Postoperative 30days mortality was 6.3%. Postoperative echocardiography evaluation at discharge revealed the absence of residual MR in 70%, mild MR in 26.5% and moderate MR in 3.5% of patients respectively. Median echographic follow-up time was 28 (3-84) months: survival rate was 92.1% at 32months; free from mitral valve reoperation rate was 97.5% and grade >2 MR recurrence free survival rate was 96.6%. CONCLUSION: There are a few reports in the literature concerning the mid-term results of IMR surgical correction with CMA Etlogix ring. Our study, taking into account a large series of patients and an important follow-up period, demonstrates the effectiveness of this surgical repair technique reporting a low mid-term incidence of recurrent MR.

Proof of Concept of an Endoscopic Sutureless Valve Sizer.

OBJECTIVE: In this paper, we present an endoscopic expandable sizer conceived to allow thoracoscopic aortic valve replacement with a sutureless prosthesis using a dynamic sizing of the aortic annulus. METHODS: Ten aortic torsos were prepared using a five-trocar thoracoscopic setting. Once the aortotomy was performed and the aortic valve leaflets removed, the technical feasibility of the endoscopic sizing (introduction into the trocar, expansion into the aortic annulus, determination of the valve size, and retraction) with the device was assessed. In case of successful thoracoscopic sizing, endoscopic implantation of a sutureless valve (five LivaNova Perceval prosthesis and five Medtronic 3f Enable bioprosthesis) was performed. Before ascending aorta closure, we assessed the appropriate sealing of the bioprosthesis in the native annulus with camera visualization and a nerve hook inspection. RESULTS: All the 10 endoscopic sizings were technically feasible. The scheduled aortic sutureless valve implantations were successfully performed. In all cases, fitting and placement of the sutureless bioprosthesis in the flaccid heart was satisfactory, with no paraprosthetic leakage detectable by the nerve hook. CONCLUSIONS: The use of the endoscopic expandable sizer is technically possible. In this early-stage test in the flaccid heart, selection of the valve size was satisfactory during thoracoscopic sutureless aortic bioprosthesis implantation. Further laboratory evaluation with fluid dynamics (aortic root pressurization) will be performed before a clinical study is started.

Closed chest human aortic valve removal and replacement: Technical feasibility and one year follow-up.

BACKGROUND: Minimally invasive aortic valve replacement has so far required a minithoracotomy or a ministernotomy. We present here the first series of totally endoscopic aortic valve replacement (TEAVR). METHODS: Between June 2013 and April 2015, 14 consecutive patients (12 males, mean age=76 ± 5.4 years) with a mean EuroSCORE II of 2.72 ± 0.03% underwent TEAVR. A five trocar setting was used in all patients: after ablation of the native valve, a Nitinol stented sutureless 3f Enable Medtronic valve, compressed into the main working trocar, was introduced into the thorax and then expanded in the aortic root. RESULTS: Among the 14 patients, a thoracoscopic approach was successful in 13 (92.8%) and conversion into an open surgery using the right anterior minithoracotomy was necessary to close the aortotomy in one case. Mean cross-clamping and cardiopulmonary (CPB) times were 112 ± 18 and 161 ± 31 min, respectively. All patients left the surgical unit within 8 days after the operation without any paravalvular leakage. There was no paravalvular regurgitation, conductive block or any major adverse event at a mean follow-up of 10 ± 4 months (range 2-16). CONCLUSIONS: TEAVR is feasible and safe in a selected subset of patients. Closed chest surgery has the potential to become the future approach of the isolated aortic valve replacement in low risk patients but further technical refinement and larger studies are necessary to reduce operative durations and enhance reproducibility.

Restenosis after percutaneous coronary intervention for coronary chronic total occlusion. The central role of an optimized immediate post-procedural angiographic result.

BACKGROUND: Factors of restenosis after percutaneous coronary intervention (PCI) for chronic total coronary occlusion (CTO) have not been fully explored. In particular, although the last ACC/AHA guidelines on PCI suggest that a minimum diameter stenosis of 10% with an optimal goal of as close to 0% as possible should be the new benchmark for lesions treated by stenting, angiographic success of PCI for CTO remains in the literature most often defined as a <30% residual diameter stenosis. Whether an optimized immediate post-PCI angiographic result (OAR) defined by a minimal diameter stenosis as close to 0% is associated with a lower restenosis rate in this subset of coronary lesions remains unknown. METHODS: Therefore, we assessed by quantitative coronary analysis (QCA) both the immediate post-PCI and 6-month follow-up angiographic results of 170 successfully treated true CTO. RESULTS: Post-PCI QCA immediate residual diameter stenosis was <30% in all 170 CTOs and OAR defined as a ≤10% residual stenosis was achieved in 133 (78%). Global binary restenosis rate was 21% in the 170 lesions. Restenosis rates were 46% and 14% in the non-OAR group and in the OAR group, respectively (p<0.0001). Multivariate analysis showed that a non-OAR, a younger age and a retrograde approach were independent factors of restenosis. CONCLUSION: Thus, an optimized immediate angiographic result with a minimal diameter stenosis as close to 0% as possible appears to be associated with a lower rate of restenosis after CTO PCI.