Percutaneous Aortic Valve Replacement: Current Status and Future Perspective

Surgical valve replacement is the definitive therapy for patients with critical aortic stenosis (AS). However, the risk of surgery may be higher in elderly patients with significant comorbidities. Six years after the first in man, percutaneous aortic valve implantation (PAVI) for the treatment of AS currently represents a dynamic field of research and development. Two devices have a CE marked and are under clinical investigation for PAVI, the Edwards-Sapien valve mounted within a balloon-expandable stent and the self-expanding CoreValve. Since the first in-man PAVI by Alain Cribier in 2002, well over 1000 high-risk patients with severe symptomatic AS have been treated using PAVI (as of January 2008). The currently available results suggest that the technique is feasible and provides hemodynamic and clinical improvement for up to two years in patients with critical AS at high risk or with contraindications for surgery. Pending questions concern mainly safety and long-term durability

Percutaneous Mitral Valve Repair: is There a Future?

Percutaneous mitral valve repair was introduced a few years ago for patients with symptomatic severe mitral regurgitation and can use two different approaches. The first approach is the edge-to-edge technique, which creates a double mitral valve orifice. The second approach is mitral annuloplasty, which is achieved by introducing a constraining device in the coronary sinus located in the vicinity of the mitral annulus. Preliminary results of percutaneous mitral valve repair are encouraging and show the feasibility of these techniques, which though should be carefully evaluated in comparison with surgery and standard contemporary medical treatment

Percutaneous mitral valve repair: the beginning of the end or the end of the beginning?

The new percutaneous mitral valve repair techniques are at an early stage. Preliminary series show that they are feasible; however, they need to be further evaluated in comparison with contemporary treatment to accurately assess their efficiency. Potential applications may benefit high-risk patients after thorough evaluation

Impact of Degree of Commissural Opening After Percutaneous Mitral Commissurotomy on Long-Term Outcome

ObjectivesWe sought to evaluate the prognostic value of the degree of commissural opening (CO) on outcome.BackgroundCommissural opening is the main mechanism by which the mitral valve area (MVA) increases after percutaneous mitral commissurotomy (PMC) but its impact on long-term outcome has never been evaluated.MethodsOf 1,024 consecutive patients with severe MS who underwent PMC, degree of CO was prospectively evaluated in 875 patients (age 48 ± 13 years, female 83%, New York Heart Association (NYHA) functional class III/IV 75%) with good immediate PMC results (MVA ≥1.5 cm2 and no mitral regurgitation >2/4). These 875 patients were divided into 3 groups: both commissures only partially opened or not split (Group 1, n = 189), 1 commissure completely split (Group 2; n = 459), and both commissures completely split (Group 3; n = 227). During a follow-up of 55 ± 28 months, following clinical end points were collected: death, cardiovascular death, need for mitral valve surgery or repeat dilation, and NYHA functional class.ResultsBefore PMC, patients in Group 1 were older, more often in NYHA functional class III/IV, but MVA and mean gradient were not different (p ≥ 0.50). Immediately after PMC, there were significant differences between groups with regard to mean gradient (Group 1, 5.1 ± 2.1 mm Hg; Group 2, 4.5 ± 1.7 mm Hg; Group 3, 4.0 ± 1.6 mm Hg; p < 0.0001) and MVA (Group 1, 1.8 ± 0.2 cm2; Group 2, 1.9 ± 0.2 cm2; Group 3, 2.1 ± 0.3 cm2; p < 0.0001). The 10-year rate of good functional results (survival without need for mitral surgery or repeat dilation and NYHA functional class I or II at last follow-up) was significantly higher in Group 3 (76 ± 5%) than in Groups 1 and 2 (39 ± 8% and 57 ± 11%, respectively; p < 0.0001). In multivariable analysis, either the degree of CO or the MVA was an independent predictor of good late functional results (p < 0.05).ConclusionsComplete CO is associated with larger MVA, smaller gradients, and functional improvement. The degree of CO provides important prognostic information and thus should be systematically evaluated during and after PMC and considered as a complementary measure of the procedural success in addition to the MVA, not always easy to assess

Percutaneous mitral annuloplasty through the coronary sinus: An anatomic point of view

ObjectiveWe assessed the anatomic relationships among the mitral annulus, coronary sinus, and circumflex artery in human cadaver hearts.MethodsPercutaneous posterior mitral annuloplasty has been proposed to treat functional mitral regurgitation on the basis of the proximity of the coronary sinus to the mitral annulus. However, concern remains about the ability to perform a trigone-to-trigone posterior annuloplasty and the potential for compromise of the circumflex coronary artery. Ten hearts were studied after injection of expansible foam into the coronary sinus and circumflex artery. The mitral annulus perimeter, posterior intertrigonal (T1–T2) and intercommissural (C1–C2) distance, and coronary sinus projection on the native annulus (S1–S2) were measured. The spatial geometry of the coronary sinus was correlated with the circumflex artery route and the distance with the native mitral annulus.ResultsThe projection of coronary sinus annuloplasty achieves at best a commissure-to-commissure annuloplasty 14.5 (6–24) mm behind each trigone: T1–T2: 74 (56–114) mm, C1–C2: 62.2 (48–80) mm, S1–S2: 59.5 (40–80) mm. The coronary sinus was distant from the native annulus (8–14 mm at the coronary sinus ostium, 13.7–20.4 mm at the middle of the coronary sinus, 6.9–14 mm at the level of the great coronary vein). The circumflex artery was located between the coronary sinus and the mitral annulus in 45.5% of cases.ConclusionsThis anatomic study highlights the 3-dimensional structure of the coronary sinus and its distance from the native mitral annulus and fibrous trigones. Human anatomic studies are mandatory for the further development of percutaneous mitral repair technology

Multicenter Evaluation of Edwards SAPIEN Positioning During Transcatheter Aortic Valve Implantation With Correlates for Device Movement During Final Deployment

ObjectivesThis study sought to evaluate the exact location of Edwards SAPIEN (Edwards Lifesciences, Irvine, California) devices in different stages of implantation and to quantify possible operator-independent device movement during final deployment.BackgroundAccurate device positioning during transcatheter aortic valve implantation is crucial in order to achieve optimal results.MethodsThis multicenter study consisted of 68 procedures with reliable pacemaker capture. Device positions were assessed using fluoroscopic images and the C-THV system (Paieon Medical, Rosh Ha'Ayin, Israel).ResultsThe location after implantation was significantly higher than in the final stage of rapid pacing: 16.7 ± 16.3% of device height below the plane of the lower sinus border versus 32.6 ± 13.8%, p < 0.0001. Operator-independent device-center upper movement during final deployment was 2 ± 1.43 mm, range: −1.3 to 4.6 mm. Device movement was asymmetrical, occurring more in the lower part of the device than in its upper part (3.2 ± 1.4 mm vs. 0.75 ± 1.5 mm, p < 0.001), resulting in device shortening. Multivariate analysis revealed that moderate and severe aortic valve calcification had 49% higher upward movement than mild calcification (p = 0.03), and aortic sinus volume was negatively correlated with movement size (r = −0.35, p = 0.005). This movement was independent of device version (SAPIEN vs. SAPIEN XT), procedural access (transfemoral vs. transapical), and interventricular septum width.ConclusionsThe final Edwards SAPIEN position is mostly aortic in relation to the lower sinus border. There is an operator-independent upward movement of the device center during the final stage of implantation. Anticipated upward movement of the device should influence its positioning before final deployment

SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve

AIMS: Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA). METHODS AND RESULTS: Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6\u2009\ub1\u20096.7\u2009years, 52% male) were enrolled in 80 centres from 10 European countries. At 1\u2009year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1\u2009year. CONCLUSION: In SOURCE 3, we observe a low complication rate and mortality at 1\u2009year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956