Clip Detachment Research Articles

Repeat Mitral Valve Interventions After Transcatheter Edge-to-Edge Repair: The COAPT Trial

The frequency and effectiveness of repeat mitral valve interventions (RMVI) after transcatheter edge-to-edge repair (TEER) for secondary mitral regurgitation (MR) are unknown. We aimed to examine the rate of and outcomes following RMVI after TEER in the COAPT trial.The COAPT tria randomized heart failure (HF) patients with severe secondary MR to TEER with the MitraClipTM device plus guideline-directed medical therapy (GDMT) versus GDMT alone. We evaluated the characteristics and outcomes of patients who had a RMVI during 4-year follow-up. A MitraClip implant was attempted in 293 patients randomized to TEER+GDMT, 10 of whom (underwent a RMVI procedure (9 repeat TEER and 1 surgical mitral valve replacement) after 4-years of follow-up (cumulative incidence 3.90%,95% CI 2.08-7.08; median 182 days after the initial procedure). Patients with RMVI had larger mitral annular diameters, fewer clips implanted and were more likely to have ≥3+ MR at discharge compared with those without RMVI. Reasons for RMVI included failed index procedure due to difficult transseptal puncture (n=2) or tamponade (n=1); residual or recurrent severe MR after an initially successful procedure (n=5); partial clip detachment (n=1); and site-assessed mitral stenosis (n=1). RMVI was successful in 8/10 (80%) patients. Patients who underwent RMVI had higher 4-year rates of HFH but similar mortality compared with those without RMVI. The annualized incidence rates of all HFH in patients who underwent RMVI were 234 events per 100 person years (95% CI 139-395) pre-RMVI and 46 per 100 person years (95% CI 25-86) post-RMVI as compared with 32 events per 100 patient years (95% CI 28-36) among patients not undergoing RMVI. The rate ratio of HFH was reduced after RMVI in patients undergoing RMVI (0.20, 95% CI 0.09-0.45).

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Prosthetic complications with mandibular bar-retained implant overdentures having distal attachments and metal frameworks: A 2- to 12-year retrospective analysis

Statement of problemLong-term reports on 2-implant-retained overdentures having metal frameworks and bars containing distal attachments are scarce. PurposeThe purpose of this retrospective study was to evaluate prosthetic complications with 2-implant-retained mandibular overdentures with metal frameworks having either screw- or cement-retained cantilevered bars with distal attachments. Material and methodsSeventy-three edentulous study participants who had been treated with mandibular overdentures with 2 implants were included. The parameters assessed were acrylic resin fractures (base fracture, fracture at midline), debonding of teeth, opposing prosthesis fracture, need for relining or rebasing, abutment and bar screw loosening and fracture, ball or bar attachment or clip wear, fracture or detachment, bar fracture, and implant loss. Statistical analysis was performed by using the Mann-Whitney U test as the data were not normally distributed. The categorical variables between the groups were analyzed by using the Fisher exact test (α=.05). ResultsTwenty-seven prostheses had a cement-retained bar, and 46 bars were screw-retained. Of 73 overdentures, 68 were metal-reinforced. The mean observation time was 5.9 years with a range between 2 and 12 years. The most common complication was wear of the Rhein 83 polymer attachment followed by bar screw loosening. The cumulative survival rate for overdentures was 91.9% at 6.8 years. The service life of cement-retained prostheses was significantly longer (P<.05). Bar, resin base, and mid-line fractures were only seen with cement-retained prostheses. The number of times an attachment change was required did not differ between cement- and screw-retained bars. Of 191 implants, 3 were lost, and the cumulative survival rate was 93.5% at 7.5 years. No significant difference was found between retention types in terms of implant loss (P>.05). ConclusionsBased on the participant population observed, the survival rates of 2-implant-retained mandibular overdentures and their implants in the medium term were high. Wear of the polymer attachment was commonly seen. Overdentures with cement-retained bars had bar or acrylic resin fractures. Mandibular 2-implant-retained overdentures with a screw-retained bar containing bilateral distal attachments had fewer prosthetic complications and high implant survival in the medium term.

Successful percutaneous mitral valve leaflet repair for primary mitral regurgitation results in functional improvement and positive cardiac reverse remodelling

Abstract Funding Acknowledgements Type of funding sources: None. Background Percutaneous mitral valve leaflet repair can be an effective treatment for primary mitral regurgitation (MR) patients deemed high-risk for surgery. Accurate assessment of cardiac reverse remodelling is essential to optimise future patient selection. Cardiovascular magnetic resonance (CMR) is the reference standard for cardiac volumetric assessment and compared to transthoracic echocardiography (TTE) provides superior reproducibility in MR quantification. Prior CMR studies have analysed cardiac reverse remodelling following percutaneous intervention in combined cohorts of primary and secondary MR patients. However, as aetiology of MR can significantly impact outcomes, focused studies are warranted. Purpose Assess cardiac reverse remodelling and quantify changes in MR following percutaneous mitral valve leaflet repair for primary MR using the reference standard (CMR). Methods 12 patients with at least moderate-severe MR on TTE were prospectively recruited to undergo CMR imaging and 6-minute walk tests (6MWT) at baseline and 6 months following percutaneous mitral valve leaflet repair (MitraClip). CMR protocol involved: left-ventricular (LV) short axis cines (bSSFP, SENSE-2, 10mm, no gap), transaxial right-ventricular (RV) cines (bSSFP, SENSE-2, 8mm, no gap), two and four chamber cines and aortic through-plane phase contrast imaging, planned at the sino-tubular junction. MR was quantified indirectly using LV and aortic stroke volumes. Results 12 patients underwent percutaneous mitral valve leaflet repair (MitraClip) for posterior mitral valve leaflet prolapse, however 1 patient declined follow up after single-leaflet clip detachment resulting in 11 patients (age 83 ± 5years, 9 male) completing follow up imaging. At 6-months: significant improvements occurred in New York Heart Association functional class (Table 1) and 6MWT distances (223 ± 71m to 281 ± 65m, p = 0.005) and significant reductions occurred in indexed left ventricular end-diastolic volumes (LVEDVi) (118 ± 21ml/m2 to 94 ± 27ml/m2, p = 0.001), indexed left ventricular end-systolic volumes (58 ± 19ml/m2 to 48 ± 21ml/m2, p = 0.007) and quantitated MR volume (55 ± 22ml to 24 ± 12ml, p = 0.003) and MR fraction (49 ± 9.4% to 29 ± 14%, p= &amp;lt;0.001). There were no statistically significant changes in left ventricular ejection fraction (LVEF), right ventricular dimensions/ejection fraction or bi-atrial dimensions (Table 1). All patients demonstrated decreased LVEDVi and quantified MR (Figure 1). Conclusion Successful percutaneous mitral valve leaflet repair for primary MR results in reduction in MR, positive LV reverse remodelling, preservation of LVEF, and functional improvements. Larger CMR studies are now required to further guide optimal patient selection.

Long-term outcomes of over-the-scope clip for refractory gastrointestinal diseases

Background The Over-The-Scope Clip (OTSC) can effectively treat refractory gastrointestinal diseases. However, most reports have focused on short-term effectiveness. We examined clinical outcomes of the deployed clips and long-term characteristics. Material and methods Of 47 patients with OTSC treatment, 35 with follow-up periods of ≥3 months were retrospectively examined. The indications were 11 bleedings, 17 perforations, and seven fistulas. The observation period was defined as medium-term (3 to <12 months) or long-term (≥12 months). The primary outcome was the clinical success rate without disease recurrence. The secondary outcomes were the complication rate, survival duration, and clip retention rate. Results The medium- and long-term clinical success rates were 100% during the observation period (median, 44 months; range, 3–78 months). The complication rate was 2.9% (n = 1). The median survival time was 1,634 days for bleeding, 1,757 days for perforation, and 444 days for fistulas. The overall clip retention rates were 56.4%, 38.1%, 30.9%, and 25.9% after one, six, and 12 months and at the final follow-up, respectively. The average clip retention duration was 244 days in bleeding, 656 days in perforations, and 188 days in fistulas. Conclusions Regardless of clip detachment, the OTSC can be effective in long-term.

Impact of intervention strategies after failed Mitraclip therapy on mid-term outcome

Abstract Introduction Procedural failure after MitraClip (MC) therapy has a decisive prognostic influence and Re-treatment after acute procedure failure (APF) remains complex due to the generally high-risk patients. The aim of this work is to analyze the mid-term outcome between the surgical and the percutaneous interventional treatment routes according to APF from our High Volume Center. Methods Retrospective analysis of patients (pts.) consecutively treated with MC in the period from 9/2009 - 5/2019 with residual mitral regurgitation (rMR) that is still higher in the case of symptomatic APF (NYHA 3–4). Outcome analysis in primary (PMR) and secondary MR (SMR) with subsequent percutaneous (group Reclip) vs. surgical treatment (group surgery). Results Of a total of 824 pts., 63 (73±10 years, 20 women [31,7%]) showed APF (MR&amp;gt;2) peri / postinterventionally. Mitraclip reintervention was performed in 36 pts. (26 SMR, 10 PMR), while 27 (13 SMR, 14 PMR) underwent surgery. Mitral valve replacement (MVR) was surgically performed on 21 pts. (11 PMR, 10 SMR), while reconstruction (MVrec) was performed on n=6 (3 PMR, 3 SMR). The mechanism of the rMR in the surgery group, n=14 (51.9%) was a pure sail injury (LT) or a partial clip detachment (PCD) or a combination of both, n=9 (33.3%) a severe rMI, n=3 (11.1%) device endocarditis and n=1 (3.7%) a technical device problem. In the reclip group n=15 (41.7%) showed an LT and / or a PCD and n=21 (58.3%) a severe rMR. Thirty-day mortality was 13.9% (n=5 deaths) in the ReClip-group (n=4 SMR, n=1 PMR) an 18.5% in the surgical group (n=5 deaths; all SMR patients). In the midterm FU over 18 months (Figure 1), the surgically treated patients with SMR showed a significantly higher mortality rate than in patients with PMR (p=0.002). In the Reclip intervention group, no significant difference between treated PMR and SMR patients can be objectified (p=0.995). The comparison between surgery / reclip in the PMR group shows no significance, whereas a trend (p=0.148) in favor of the reclip can be distinguished between surgery / reclip in SMR in the outcome. Conclusion Surgically treated patients after AFP with an SMR as index etiology show a very poor short and medium-term survival both in comparison to the PMR patients and to the two reclip groups. With the combination of AFP and SMR, the reclip treatment can be regarded as the primary treatment option despite the lack of statistical significance compared to surgery. In return, surgery combined with AFP and PMR offers a viable alternative and can be favored over the reclip procedure in younger patients. Kaplan-Meier plot of the 4 intervention groups Funding Acknowledgement Type of funding source: None

Reinterventions after transcatheter edge to edge mitral valve repair: Is early clipping warranted?

Reintervention after transcatheter edge to edge repair using MitraClip is still challenging. We aimed to report our experience in reinterventions after MitraClip procedures and describe the outcomes. From 2012 to 2020, 167 patients had a transcatheter edge to edge repair; 10 of them needed reinterventions. At the time of the first MitraClip, the median EuroSCORE was 4.29 (2.62-7.52), and the ejection fraction was 30 (20-40)%. Emergency mitral valve replacement (MVR) was performed in two patients, elective MVR in three, cardiac transplantation in two, and repeat clipping in threepatients. The median time from MitraClip to the reintervention was 4.5 (2-13) months. One patient required extracorporeal membrane oxygenation support after elective MVR. Repeat clipping failed to control mitral regurgitation grade in all patients. Clip detachment was reported in five patients (50%). The median follow-up after the reintervention was 19.5 (9-75) months, and mortality occurred in two patients who had repeat clipping (20%). MVR after MitraClip is feasible with low morbidity and mortality. Repeat mitral valve clipping had a high failure rate. Mitral repair was not feasible in all patients in our series, and the use of MitraClip to delay surgical interventions may not be feasible if mitral repair is an option.

1635 Catch me if you can: a rare case of two-staged MitraClip detachment

Abstract Case report A 74-year-old man presented with acute heart failure and chronic obstructive pulmonary disease exacerbation. His medical history revealed: anterior myocardial infarction in 2005, treated with primary PCI of left anterior descending coronary artery followed by triple coronary artery bypass, atrial fibrillation, hypertension, diabetes mellitus and obesity. Transthoracic and transesophageal echocardiography (TEE) showed severe functional ischemic mitral regurgitation (MR) with multiple jets, the main one involving the A2-P2 scallops due to asymmetric tethering of the posterior leaflet. The vena contracta diameter (VC) was 8 mm, the effective regurgitant orifice area (EROA) 0.53 cm². Global left ventricular (LV) function was preserved with inferior-posterior wall akinesis. After "Heart Team" discussion, due to high surgical risk, the patient was referred for percutaneous mitral valve repair (PMVR) using MitraClip (MC) system (Abbott Vascular, Illinois). One clip (MC-XTR) was placed at the A3-P3 segments; subsequently, prior to releasing a second clip (MC-XTR), the first one partially detached from the posterior leaflet (Fig A). A third clip (MC-NTR) was implanted medially. The grasp was challenging but at the end of the procedure, the first clip appeared stable and marked reduction of MR was achieved (Fig B). 7 days later, the patient became symptomatic for resting dyspnea and worsened his clinical status. A control 2D-3D TEE revealed a complete detachment of the first implanted clip, visible distally into the LV, trapped in the mitral valve subchordal apparatus (Fig C). This resulted in massive MR (VC: 12 mm, EROA: 0.91 cm²) with an eccentric posteriorly directed regurgitant jet (Fig D). The patient underwent emergency surgical retrieval of the migrated clip, and removal of the torn mitral valve anterior leaflet. The other two clips were also removed (Fig E), and a bioprosthetic mitral valve was implanted. The procedure was completed uneventfully and the patient is in stable conditions at 2-months follow-up. Discussion The constant stretching and whip effect of the mitral leaflets captured between the clips arms, used in PMVR, can lead to complications. Partial clip detachment is a rare adverse event described in ∼0.7-4.9% of patients within 30 days after MC intervention*. We experienced a two-staged MC detachment that is an even rarer complication and requires emergency surgery. In addition, we highlights the usefulness of 3D TEE for early diagnosis and better imaging characterization in patients who develop complications after MC procedure. No conflict of interest. *Puls M, Lubos E, Boekstegers P, von Bardeleben RS, Ouarrak T, Butter C, Zuern CS, Bekeredjian R, Sievert H, Nickenig G, Eggebrecht H, Senges J, Schillinger W. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from German transcatheter mitral valve interventions registry. Eur Heart J 2016;37:703-12. Abstract 1635 Figure.

Long-term assessment of over-the-scope clip (OTSC) behavior after gastric application

Background: The aim of this study was to assess the long-term behavior of the over-the-scope clip (OTSC) after gastric application.Material and methods: A database of all patients who had OTSC placement with regular follow-up at a tertiary hospital between November 2013 and September 2016 was retrospectively analyzed. The incidence, time, and related adverse events of clip attachment and detachment were recorded. The relationship between the position of the clip and detachment was assessed by Fisher's exact test.Results: Seventy-two patients who had gastric OTSC placement due to iatrogenic perforations by endoscopic interventions were included in the study. The overall incidence of clip detachment was 27.8% (20/72). Fisher's exact test confirmed a significant association between clip detachment rate and clip position (p = .005): cardia 50% (3/6); gastric fundus 13.2% (5/38); gastric body 75% (9/16); and gastric antrum 25% (3/12). Except for one patient (5%; 1/20) who experienced minor gastric hemorrhage, there were no complications related to spontaneous clip detachment. There was no delayed bleeding, perforation, or obstruction due to clips staying in place in the long-term.Conclusions: Long-term gastric clip attachment appears to be safe even if spontaneous detachment occurs.

Tricuspid Clipping during LVAD Support: First in Human Report

Purpose Transcatheter mitral valve edge-to-edge repair using the MitraClip system (Abbott Vascular, USA) has been used for several years in high-risk patients with isolated severe mitral regurgitation. Clipping of the tricuspid valve using the MitraClip system was introduced recently.Tricuspid regurgitation requiring valve repair is frequent in the context of LVAD support. To our knowledge a transfemoral clipping of tricuspid valve during LVAD support using the MitraClip system has not been performed so far and is here reported for the first time. Methods A 56-year old woman developed severe tricuspid regurgitation 4 weeks after LVAD implantation. The logistic EuroScore was 28.36%. We found a sufficient right ventricular function (TAPSE 24 mm, S´ 7-11 cm/s, FAC 46 %). Indication for tricuspid clipping was done after evaluating anatomical conditions. A clip delivery system was introduced via transfemoral approach (24/22 french) into the right atrium. Thereafter guiding catheter was angulated slightly in “plus” and “anterior” directions to position the guiding catheter vertically to the tricuspid valve. The next step of the maneuver consisted of advancing the MitraClip device into the right atrium, opening both arms, centering and advancing the system into the right ventricle. By retracting the MitraClip device both leaflets (anterior and septal) were grasped and closed to coapt the tricuspid leaflets. After an effective reduction of tricuspid regurgitation had been achieved, the clip was deployed. The clip delivery system and guiding catheter were withdrawn. Results Reconstruction of the two- and three-dimensional transesophageal echocardiographic dataset documented a significant echocardiographic improvement with an effective reduction of tricuspid regurgitation from grade III° to grade I° without any stenosis. The patient tolerated the procedure very well and was discharged 3 days after the implantation. 6 months after implantation the patient is doing well with a tricuspid regurgitation grad I°. No clip detachment was found. Conclusion In conclusion, it has been shown that transfemoral tricuspid valve repair using the MitraClip system during LVAD support could be a feasible, safe and well-tolerated therapy for this special indication without renewed surgical intervention.

Operational modal analysis and Bayesian model updating of a standing seam metal roofing system

Clip detachment is found to be a common failure mode for metal roofs. It leads to the stiffness reduction at some supports of the metal roof and alter its dynamic characteristics. Therefore, it is possible to detect the damage of clips by monitoring the modal properties. To assess the dynamic properties of metal roofs, part of a full-scale standing seam metal roof was constructed on a supporting steel frame in the laboratory. Modal parameters were identified from the measured acceleration responses using frequency domain decomposition method (FDD). The finite element model of the system was developed, and the clip stiffness was estimated by Markov chain Monte Carlo (MCMC)-based Bayesian model updating method. Both the modal identification and model updating results are reported in detail. The results presented in this paper are valuable and important for the development of a structural health monitoring system for metal roofing system.

Operational modal analysis and Bayesian model updating of a standing seam metal roofing system

Clip detachment is found to be a common failure mode for metal roofs. It leads to the stiffness reduction at some supports of the metal roof and alter its dynamic characteristics. Therefore, it is possible to detect the damage of clips by monitoring the modal properties. To assess the dynamic properties of metal roofs, part of a full-scale standing seam metal roof was constructed on a supporting steel frame in the laboratory. Modal parameters were identified from the measured acceleration responses using frequency domain decomposition method (FDD). The finite element model of the system was developed, and the clip stiffness was estimated by Markov chain Monte Carlo (MCMC)-based Bayesian model updating method. Both the modal identification and model updating results are reported in detail. The results presented in this paper are valuable and important for the development of a structural health monitoring system for metal roofing system.

Is Surgical or Catheter-based Interventions an Option After an Unsuccessful Mitral Clip?

The objective of this study was to assess the results of catheter-based and surgical reinterventions in primary mitral regurgitation after failed MitraClip therapy. We report on 21 consecutive symptomatic patients with primary mitral regurgitation (median age 78 years) who underwent either repeat MitraClip therapy (n = 7) or mitral valve surgery (n = 14) after failure of the index procedure with 1-2 MitraClip implantations. At the time of reinterventions, 193 (interquartile range [IQR]: 32-622) days after the index procedure, patients had recurrent or persistent grade 3 mitral regurgitation. Early mortality at 30 days was 4.8%. Cardiac-related survival at 2 years was 85.4% (4 cardiac and 4 noncardiac deaths). Three of 7 patients with percutaneous reintervention were converted to surgery at 34, 52, and 56 days because repeat MitraClip therapy was ineffective because of pre-existing clip detachment or leaflet tear. Final therapy was biological mitral valve replacement in 14 of 21 patients (66.7%); 4 were treated with percutaneous repeat MitraClip repair (19%), and in 3 patients, surgical repairs were performed (14.3%). At follow-up with a median of 708 days, New York Heart Association class had improved significantly to class 2 (IQR: 1.0-2.5) (P = 0.0004), and the left ventricular end-diastolic diameter had decreased from 56 (IQR: 52-59) mm to 51 (48-58) mm (P = 0.0378), respectively. Recurrence of significant mitral regurgitation was absent in all but 1 patient with unsuccessful repeat MitraClip therapy who was deemed inoperable. Our data show that both repeat MitraClip and also mitral valve surgery are feasible and safe alternatives in patients without an excessively increased perioperative risk. We conclude that whenever leaflet insertion is not compromised, repeat catheter-based repair is a reasonable redo concept; in the remaining cases, surgery should be offered to the patient.

Procedural and Clinical Results of the New MitraClip® NT after Percutaneous Edge to Edge Repair of Mitral Valve Regurgitation

Objective: The MitraClip® NT (MC-NT) as an updated version aim to facilitate improved maneuvering of the guide catheter and more efficient leaflet capture due to technical improvements of the delivery system and clip material. We evaluate procedural results and 12-month clinical outcomes of the new MC-NT device and compare them with the previous MitraClip® MC. Methods: We analyzed a total population of 231 patients from our Ulm - Transcatheter Mitral Valve Repair registry. To adjust for differences of baseline characteristics a propensity-score matching was performed (N=142). 30-day endpoints were analyzed in accordance with the Mitral Valve Academic Research Consortium (MVARC). For both devices 12-month clinical results (MACCE, mortality, and heart failure rehospitalization) were evaluated. Results: Acute technical success was achieved in 100% with both device groups. Device, procedure and fluoroscopy time were comparable in both treatment groups. In-hospital mortality was 2.8% in the MC-NT group and 4.2% in the MC group (p=0.65). After 30 days single-leaflet clip detachment was observed in 2.8% in the MC-NT group compared to 1.4% (p=0.56). Mitral regurgitation was reduced to the same extent in both treatment groups (1.6 ± 0.6 vs. 1.6 ± 0.5 in MC-NT group, p=0.57) with comparable rates of recurrent moderate to severe mitral regurgitation after 30 days and during 12-month follow-up. Clinical results up to 12 months and improvement of New York Heart Association functional class were comparable in both device groups (3.1 ± 0.7 to 2.1 ± 0.9 vs. 3.2 ± 0.6 to 2.1 ± 0.9, p=0.75). Conclusion: The new MitraClip® NT as an updated version presents itself as an efficacious and safe device, but all in all failed to prove superiority compared to the original MitraClip® in terms of procedural and clinical results.

Management of Mitral Clip Detachment in an Elective Mitral Valve Clipping

Management of Mitral Clip Detachment in an Elective Mitral Valve Clipping

Effects of Mechanical Ventilation on Heart Geometry and Mitral Valve Leaflet Coaptation During Percutaneous Edge-to-Edge Mitral Valve Repair.

This study sought to evaluate a ventilation maneuver to facilitate percutaneous edge-to-edge mitral valve repair (PMVR) and its effects on heart geometry. In patients with challenging anatomy, the application of PMVR is limited, potentially resulting in insufficient reduction of mitral regurgitation (MR) or clip detachment. Under general anesthesia, however, ventilation maneuvers can be used to facilitate PMVR. A total of 50 consecutive patients undergoing PMVR were included. During mechanical ventilation, different levels of positive end-expiratory pressure (PEEP) were applied, and parameters of heart geometry were assessed using transesophageal echocardiography. We found that increased PEEP results in elevated central venous pressure. Specifically, central venous pressure increased from 14.0 ± 6.5 mm Hg (PEEP 3 mm Hg) to 19.3 ± 5.9 mm Hg (PEEP 20 mm Hg; p < 0.001). As a consequence, the reduced pre-load resulted in reduction of the left ventricular end-systolic diameter from 43.8 ± 10.7 mm (PEEP 3 mm Hg) to 39.9 ± 11.0 mm (PEEP 20 mm Hg; p < 0.001), mitral valve annulus anterior-posterior diameter from 32.4 ± 4.3 mm (PEEP 3 mm Hg) to 30.5 ± 4.4 mm (PEEP 20 mm Hg; p < 0.001), and the medio-lateral diameter from 35.4 ± 4.2 mm to 34.1 ± 3.9 mm (p = 0.002). In parallel, we observed a significant increase in leaflet coaptation length from 3.0 ± 0.8 mm (PEEP 3 mm Hg) to 5.4 ± 1.1 mm (PEEP 20 mm Hg; p < 0.001). The increase in coaptation length was more pronounced in MR with functional or mixed genesis. Importantly, a coaptation length >4.9 mm at PEEP of 10 mm Hg resulted in a significant reduction of PMVR procedure time (152 ± 49 min to 116 ± 26 min; p = 0.05). In this study, we describe a novel ventilation maneuver improving mitral valve coaptation length during the PMVR procedure, which facilitates clip positioning. Our observations could help to improve PMVR therapy and could make nonsurgical candidates accessible to PMVR therapy, particularly in challenging cases with functional MR.

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry.

To analyze risk and outcomes of complications during and after MitraClip implantation using multicenter data from the prospective German Transcatheter Mitral Valve Interventions (TRAMI) registry. Data of 828 patients (mean age: 76.0 [71-81] years, 327 (40%) females) undergoing MitraClip implantation in Germany between 2010 and 2013 were analyzed. Most patients (85%) underwent elective procedures with on average implantation of 1.4 ± 0.6 clips. Emergent cardiac surgery was not required; a single patient died intraoperatively. During the in-hospital period, complications occurred in 215 (25.9%) patients, of which 106 (12.8%) were considered major. Major bleeding complications were among the most frequent major complications (7.4%), while rates of pericardial tamponade (1.9%) and clip-specific complications (embolization: 0%, partial clip detachment: 1.9%) were low. In-hospital death, stroke or myocardial infarction (MACCE) occurred in 2.2, 0.9, and 0% patients, respectively. Patients with complications appeared to be older and more critically ill pre-interventionally; in-hospital mortality was significantly higher as compared to those without procedural complications. MitraClip implantation appears to be a safe treatment option with low rates of MACCE and clip-specific complications. Nevertheless, MitraClip therapy is not without complications. Careful patient selection and improvements in preventing peri-procedural bleeding have the potential of reducing post-procedural complications and improving outcomes.

Mechanics of mitral valve edge-to-edge-repair and MitraClip procedure.

The edge-to-edge repair (ETER) technique has been used as a stand-alone procedure, or as a secondary procedure with ring annuloplasty for degenerative, functional mitral regurgitation, or for mitral regurgitation of other kinds of valvular etiologies. The percutaneous MitraClip technique based on ETER has been used in patients who are inoperable or at high surgical risk. However, adverse events such as residual mitral regurgitation, and clip detachment or fracture indicate that the mechanics underlying these procedures is not well understood. Therefore, current studies on mitral valve functionality and mechanics related to the ETER and MitraClip procedures are reviewed to improve the efficacy and safety of both procedures. Extensive in vivo, in vitro, and in silico studies related to ETER and MitraClip procedures along with MitraClip clinical trial results are presented and discussed herein. The ETER suture force and the mitral valve tissue mechanics and hemodynamics of each procedure are discussed. A quantitative understanding of the interplay of mitral valve components and as to biological response to the procedures remains challenging. Based on mitral valve mechanics, ETER or MitraClip therapy can be optimized to enhance repair efficacy and durability.

Abstract 13699: A True World Picture - Surgical Revision After Percutaneous Mitral Valve Repair With the Mitraclip Device

Background: Transcatheter mitral valve (MV) repair is of increasing interest facing however questionable mid term results. We herein report MV reference center experience of 18 patients who underwent MV surgery after failed percutaneous MV repair with MitraClip device (Evalve, Menlo Park, CA). Methods: Between June 2010 and October 2013, a total of 141 patients with severe mitral regurgitation (MR) underwent MitraClip procedure at Heart Center Leipzig. 11 patients (7.8%) needed surgical treatment for failed MV repair with the MitraClip device. For the same reasons we admitted 7 patients who underwent MitraClip procedure in other cardiac surgery centers. Mean EuroScore II of the patients was 23,51 (5,17-60,14). Results: From the group of 18 patients undergoing surgical treatment after MitraClip repair, 14 patients (77.7%) received one or more clip-implants and 4 patients (22.2%) suffered from failed MitraClip implantation. All patient were symptomatic (n=9, 50% - NYHA III; n=9, 50% - NYHA IV). The primary indications for surgery were: partial clip detachment (n=11, 61.1%), failed MitraClip implantation (n=4, 22.2%), recurrent MR greater than moderate (2+) (n=3, 16.6%), acute mitral valve endocarditis (n=1, 5.5%), mitral ring and clip detachment (n=1, 5.5%). 13 patients (72.2%) underwent MV replacement, 3 patients (16.6%) received left-ventricular assist device (LVAD), 2 patients (11.1%) underwent MV repair. One-month mortality reached 27,8% (n=5), and the overall mortality reached 50% (n=9). Conclusions: MV repair was feasible in only 2 cases (11.1%). Despite the high operative risk, surgical treatment after percutaneous MV repair failure with the MitraClip device is an option to be considered.

Percutaneous mitral repair with MitraClip system; safety and efficacy; initial Egyptian experience

To evaluate the feasibility, efficacy, and safety of the MitraClip system in patients with severe MR. Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by the use of a MitraClip device. Five patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines between March 2013 and May 2013 and underwent percutaneous mitral repair with the MitraClip system with 6 months follow up after the procedure. The primary acute safety endpoint was freedom from major adverse events (MAEs) at 30 days. The primary efficacy endpoint was acute procedural success defined as clip implant with the reduction of MR to equal or less than grade II, based on current guidelines. No transseptal complications were reported (0%). There was no procedural mortality. No patients experienced MAE at 30 days. No cases of clip detachment or embolization were observed. Acute procedural success was achieved in all treated patients (100%). There was an improvement in the severity of MR in all patients as assessed acutely. Acute MR reduction by 3 grades was achieved in 2 patients and by 2 grades in 3 patients (reduction ⩾2 grades in 100%). Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favorable short-term safety and efficacy results.