Project description:Transapical off-pump mitral valve repair (MVr) with NeoChord implantation has become widely applied in Europe for patients presenting with severe mitral regurgitation due to leaflet prolapse or flail. The procedure is performed under real-time 2D- and 3D-transesophageal echocardiography (TEE) for both implantation and neochordae tension adjustment allowing real-time monitoring of hemodynamic recovery. Preoperative anatomic and echocardiographic selection criteria, procedure refinement, as well as innovative ex-vivo surgical simulator training have been developed and strategically employed in the past few years, to generate a robust precision-based procedural framework with significantly enhanced operator use, patient safety and clinical outcomes. The procedure has evolved into a reproducibly successful and safe approach, which complements existing surgical treatment strategies available to eligible patients with chronic severe degenerative mitral regurgitation.
Project description:IntroductionNowadays micro-invasive-procedures (off-pump, beating-heart) for mitral valve repair (MVRe) are abruptly expanding with the potential to be adopted as a valuable alternative to surgery. In the present manuscript, the authors review the available technologies intended to treat mitral regurgitation (MR) through transapical approach, including annuloplasty and chordal-repair options.AnnuloplastyTo date, Valcare Amend is the only transapical MV ring to have been implanted in patients. The device allows for stabilization of the annulus through a complete semirigid d-shaped ring. The first-in-human successful procedure was performed in 2016 by our Group and subsequent clinical experience included a total of 14 implanted patients. Currently, the technology is under clinical trial evaluation to validate the efficacy and safety profile of the device.Chordal repairBeating-heart chordal implantation via transapical approach is a current feasible, safe and reproducible option. Neochord DS1000 is the most widely used technology in the field, with a solid procedural experience and good results in well-selected patients. Its clinical use has been validated in Europe since 2012, while it is still under clinical investigation in the United States. Harpoon MVRe system is a novel technology, recently CE-mark approved for clinical use.Discussion and conclusionsTransapical micro-invasive technologies are current viable therapies to treat MR in selected patients. Although there are still several limitations that preclude an extensive use of such procedures, their results are promising in well-selected patients. Embracing transcatheter MVRe therapies should guide the cardiac surgeon through the new revolution of micro-invasive MV tailored repair.
Project description:BackgroundTranscatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty.Methods and materialBetween March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria.ResultsThe mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups.ConclusionDespite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.
Project description:AimsTranscatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices.Methods and resultsA total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.ConclusionsTMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.
Project description:BackgroundTranscatheter mitral valve-in-ring replacement (TMViR) is an emerging alternative for patients with recurrent mitral regurgitation (MR) after a prior failed annuloplasty ring. However, intraoperative common issues and complications remain to be addressed.Case summaryWe describe the case of a 67-year-old male patient who underwent surgical mitral concomitant tricuspid annuloplasty repair 7 years ago who developed recurrent severe MR (New York Heart Association functional class IV). To avoid a high-risk surgical reoperation, we chose to perform a TMViR using an innovative dedicated device-the Mi-thos system-via a transapical approach. A patient-specific, 3-dimensional printed model was used to guide the procedure to avoid potential challenges. The procedure was performed successfully, and the patient exhibited symptomatic improvement.ConclusionsThis case report highlights the first use of the innovative Mi-thos system in a TMViR procedure. The findings demonstrate the feasibility and safety of utilizing the Mi-thos system, guided by 3-dimensional printing technology, for patients who have experienced recurrent mitral regurgitation MR following a failed annuloplasty ring.
Project description:Introduction: Transcatheter mitral valve-in-valve (ViV) & valve-in-ring (ViR) are relatively novel therapeutic alternatives for patients with degenerated bioprostheses or failed annuloplasty rings whose reoperative risk is too high. The predominant procedural access for both procedures is transapical or transseptal. However, whether there are differences in outcomes of this procedure using transseptal versus transapical access has not yet been defined. Methods: We conducted a systematic review of all published articles from MEDLINE and EMBASE to explore the outcomes of these two procedural approaches. Results:total of 55 studies including 183 patients (154 ViV and 29 ViR) were included. Patients that underwent ViV (101 transapical and 53 transseptal) using the transseptal approach required more iatrogenic atrial septal defect (ASD) closure (19% versus 0.0 %; P < 0.001) and hence had a lower device success rate (68% versus 89%; P = 0.001). However, there was no significant difference between the two groups in procedural success and all-cause mortality at 30 days. Overall severe bleeding complications (major or life threatening) were not different the two groups (3.7% versus 7.9%; P = 0.321). In the ViR group (19 transapical and 10 transseptal), no difference in procedural success, device success or 30-day outcomes were identified between transseptal and transapical groups, although sample size was small. Conclusion: In conclusion, mitral ViV and ViR using the two different procedural approaches appear to confer equal and reasonable 30-day outcomes.
Project description:Transcatheter valve implantation continues to grow worldwide and has been used principally for the nonsurgical management of native aortic valvular disease-as a potentially less invasive method of valve replacement in high-risk and inoperable patients with severe aortic valve stenosis. Given the burden of valvular heart disease in the general population and the increasing numbers of patients who have had previous valve operations, we are now seeing a growing number of high-risk patients presenting with prosthetic valve stenosis, who are not potential surgical candidates. For this high-risk subset transcatheter valve delivery may be the only option. Here, we present an inoperable patient with severe, prosthetic valve aortic and mitral stenosis who was successfully treated with a trans catheter based approach, with a valve-in-valve implantation procedure of both aortic and mitral valves.
Project description:BackgroundFailed mitral bioprosthesis has conventionally been treated with redo surgical mitral valve replacement (SMVR). Transcatheter mitral valve-in-valve implantation (TM-VIVI) is emerging as an alternative to SMVR in high-risk patients. We report our experience with transapical TM-VIVI using the J-Valve system.MethodsFrom May 2020 to January 2021, 21 patients with a failed mitral bioprosthesis underwent transapical TM-VIVI without concomitant procedures at Guangdong Provincial People's hospital. The mean age was 74.62 years. All patients were heavily symptomatic with severe mitral regurgitation and increased trans-prosthetic gradient. The Society of Thoracic Surgeons predicted risk of mortality (STS PROM) and European System for Cardiac Operative Risk Evaluation II (EuroScore II) scores were used and predicted high mortality (STS PROM, 12.91%±9.94%; EuroScore II, 12.04%±10.5%). All the procedures were performed in a hybrid room.ResultsThe success rate was 100% with no conversion to median sternotomy and no intraprocedural death. The mean ventilation time and intensive care unit (ICU) stay were 25±21.44 minutes and 4.14±7.08 days, respectively. No major postoperative complications were observed, except 1 patient suffered pneumonia and required tracheostomy. All patients recovered well. Postoperative echocardiography revealed excellent hemodynamics with no residual mitral regurgitation in 19 patients and mild regurgitation in 2 patients. In a subgroup analysis, no significant differences among procedural and postoperative outcomes were detected in patients with previous aortic-mitral double valve replacement (DVR) compared to other patients.ConclusionsOur results demonstrate the safety and feasibility of transapical TM-VIVI using the J-Valve system, even in patients following DVR.