Pigtail catheter “propping” for MitraClip percutaneous transcatheter mitral valve repair

In recent years percutaneous therapy has emerged as a feasible and effective option for the treatment of mitral regurgitation, particularly in cases where the risks of conventional cardiac surgery are prohibitively high. To date the most widely used percutaneous approach is beating heart, edge‐to‐edge repair with the MitraClip device (Abbott Vascular‐Structural Heart, Menlo Park, CA). The technique requires simultaneous grasping and approximation of both mitral valve leaflets prior to securing and releasing the clip. However, this may be technically challenging or indeed impossible in patients with failure of coaptation, particularly when there is a large coaptation gap. We present an approach for overcoming this relatively common obstacle based on “propping” the anterior mitral valve leaflet toward its posterior counterpart with a diagnostic pigtail catheter to reduce the coaptation gap and to allow grasping of both leaflets without difficulty. © 2016 Wiley Periodicals, Inc.     

Pushing with the pigtail: A novel approach to placing the MitraClip in a patient with a severely restricted posterior mitral leaflet

The MitraClip is an US Food and Drug Administration‐approved device for inoperable patients with severe degenerative mitral regurgitation (MR) and is under investigation for use in patients with severe functional MR. Simultaneously grasping both leaflets of the mitral valve can be technically challenging, however, in patients with a restricted posterior leaflet. We present one such case in which a pigtail catheter, placed retrograde into the left ventricle, was able to push the ventricular surface of the posterior leaflet into closer approximation with the anterior leaflet, and facilitate successful clip placement. We provide this report in hopes that it will provide a useful strategy for interventionalists faced with this challenging situation. © 2014 Wiley Periodicals, Inc.     

First‐in‐human report of MitraClip G4 implantation for severe degenerative mitral regurgitation

The new MitraClip G4 device (Abbott Vascular) has been recently approved by Food and Drug Administration and is currently in limited release. A patient with a large mitral regurgitation (MR) jet but a relatively small mitral valve area (MVA) was not a surgical repair candidate nor an optimal MitraClip third‐generation device candidate. Therefore, we implanted the new G4 NTW device that resulted in significant MR reduction with a 57% reduction in MVA. To our knowledge, this is the first reported clinical use of the MitraClip G4 NTW device. We find that it may provide better results than a single NTR device and less reduction in MVA than two older generation devices. Further experience is needed to optimize patient selection for the four new G4 devices available.     

Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation.

INTRODUCTION: The Endovascular Valve Edge-to-Edge REpair STudies (EVEREST) are investigating a percutaneous technique for edge-to-edge mitral valve repair with a repositionable clip. The effects on the mitral valve gradient (MVG) and mitral valve area (MVA) are not known. METHODS: Twenty seven patients with moderate to severe or severe mitral regurgitation (MR) were enrolled. Echocardiography was performed preprocedure, at discharge, and at 1, 6, and 12 months. Mean MVG was measured by Doppler and MVA by planimetry and pressure half-time, and evaluated in a central core laboratory. Pre- and postclip deployment, simultaneous left atrial/pulmonary capillary wedge and left ventricular pressures were obtained in eight patients. RESULTS: Three patients did not receive a clip, six patients had their clip(s) explanted by 6 months (none for mitral stenosis), and four were repaired with two clips. Results are notable for a slight increase in mean MVG by Doppler postclip deployment (1.79 +/- 0.89 to 3.31 +/- 2.09 mm Hg, P < 0.01) and an expected decrease in MVA by planimetry (6.49 +/- 1.61 to 4.46 +/- 2.14 cm(2), P < 0.001) and by pressure half time (4.35 +/- 0.98 to 3.01 +/- 1.42 cm(2), P < 0.05). There were no significant changes in hemodynamic parameters postclip deployment by direct pressure measurements. There was no change in MVA by planimetry from discharge to 12 months (3.90 +/- 1.90 to 3.79 +/- 1.54 cm(2), P = 0.78). CONCLUSIONS: Echocardiographic and hemodynamic measurements after percutaneous mitral valve repair with the MitraClip show an expected decrease in mitral valve area with no evidence of clinically significant mitral stenosis either immediately after clip deployment or after 12 months of follow-up.     

Effective percutaneous “edge‐to‐edge” mitral valve repair with mitraclip in a patient with acute post‐MI regurgitation not related to papillary muscle rupture

A 65‐year‐old woman was admitted to our institution for rest dyspnea and hypotension. EKG showed sinus tachycardia with signs of infero‐posterior STEMI. 2D‐echocardiogram showed severe left ventricular systolic dysfunction with a‐ diskynesia of the inferior and posterior walls and severe functional mitral regurgitation (MR). The patient underwent urgent coronary angiography that showed 3‐vessels disease with total occlusion of both first obtuse marginal (OM) branch of the left circumflex artery and right coronary artery (RCA) and critical stenosis of left anterior descending (LAD). Because of extremely high surgical risk, we performed a staged totally percoutaneous approach. First, we reopened the presumed culprit vessels (RCA and OM) and then, after 48 hr, we performed angioplasty of the LAD. Since revascularization provided no significant improvement in respiratory and hemodynamic parameters we performed a percutaneous mitral repair with Mitraclip. MR grade was reduced from severe to trivial with rapid improvement of the respiratory and hemodynamic parameters. The post‐procedural course was uneventful and the patient was discharged 7 days later. At the 30‐day and 6‐month follow‐up the patient remained asymptomatic in NYHA I functional class with no recurrence of MR. Acute MR due to post‐AMI mechanical complications is generally considered a contraindication to MitraClip implantation for several reasons. However, the present report shows that, in selected cases, the Mitraclip system may be successfully used to reduce the severity of acute MR secondary to AMI and may allow to reverse cardiogenic shock and/or refractory pulmonary congestion related to the acute regurgitation. © 2016 Wiley Periodicals, Inc.     

Repeated MitraClip procedure in patients with recurrent MR after a successful first procedure: Limitations and outcome

Objectives

The present study aimed to evaluate the outcome and potential limitations of a repeated MitraClip procedure (ReClip).

Background

The MitraClip procedure has emerged as a treatment option in high surgical risk patients suffering from severe mitral regurgitation (MR). However, despite successful initial repair a significant number of patients develops severe recurrent MR.

Methods

Patients undergoing a ReClip procedure in our institution were retrospectively identified. Baseline data and the procedural outcome were assessed to identify potential limitations of such procedures.

Results

Fifteen out of 234 patients undergoing a mitral‐valve repair with the MitraClip device (Abbott Vascular) underwent a ReClip due to recurrent MR. In 11 patients, a MR reduction of at least one degree without causing mitral valve stenosis (trans‐mitral mean gradient ≥5 mmHg) was achieved by performing a ReClip. After 1 year, two patients developed severe recurrent MR again. Pulmonary artery pressures significantly decreased after the procedure in individuals with successful repair (MR reduction of at least one degree and mitral valve mean gradient <5 mmHg).

Conclusion

A ReClip procedure may be feasible in patients with recurrent MR but the risk benefit ratio should be carefully balanced against other treatment options.     

One‐stop‐shop totally percutaneous approach for severe aortic and mitral regurgitation in cardiogenic shock

Patients presenting with cardiogenic shock and severe combined aortic and mitral regurgitation represent a major clinical challenge. Therapeutic options are limited in this setting as they are often deemed inoperable due to prohibitive risk for surgery, while mechanical circulatory support is usually contraindicated or technically challenging. Medical therapy, on the other hand, is associated with high‐mortality rates. Therefore, percutaneous therapies may represent an appealing alternative. Here, we present a “one‐stop‐shop” totally percutaneous approach for severe aortic and mitral regurgitation in a patient with cardiogenic shock.     

An unusual cause of recurrent mitral regurgitation after percutaneous mitral valve repair

Recurrent flail leaflet represents an infrequent cause of recurrent mitral regurgitation after MitraClip. This report presents a case of recurrent severe MR due to a ruptured chorda tendineae after edge‐to‐edge repair.     

Subacute hemolytic anemia after transcatheter edge‐to‐edge mitral valve repair: A case report

The MitraClip System is extensively used in high‐risk patients with symptomatic severe mitral regurgitation (MR). Some studies have identified complications associated with use of the MitraClip. We report the case of a 91‐year‐old woman with severe MR of a prolapsed posterior commissure. Two weeks after using the MitraClip, she developed hemolytic anemia. She was conservatively treated with blood transfusion and medical treatment; fortunately, her general condition did not deteriorate during the follow‐up period. To the best of our knowledge, this is the first report of hemolytic anemia after MitraClip implantation.     

Attachment of a migrated MitraClip to the left ventricular apex: A novel case report

Herein, we report a novel case of emergency surgical mitral valve replacement for severe mitral valve regurgitation (MR) following MitraClip implantation (Abbott Laboratories, Chicago, IL, USA). Recurrent MR was caused because of the migration of the clip due to the destruction of the mitral valve leaflets with Staphylococcus aureus infective endocarditis. Intra-operative transesophageal echocardiography revealed that the clip was stuck to the left ventricular apex. Although the device could not be removed surgically, surgical repair of the valve enabled the patient to recover without any further complications.     

The mitral‐to‐aortic flow‐velocity integral ratio in the real world echocardiographic evaluation of functional mitral regurgitation before and after percutaneous repair

Introduction

Percutaneous mitral valve repair (PMVR) using MitraClip system has emerged as a therapeutic option for patients with functional severe mitral regurgitation (FMR) at prohibitive risk for surgery. In this setting, the echocardiographic assessment of FMR severity is challenging because the traditional echocardiographic methods have important limitations. The aim of this study was to assess the accuracy and reliability of a simple Doppler index, the mitral/aortic flow velocity integral ratio (MAVIR), to evaluate residual FMR severity after PMVR.

Methods

Eighty‐five heart failure patients with functional MR and LV dysfunction (LVEF ≤ 40%) were included. FMR was quantified on the basis of traditional quantitative parameters of MR severity. MAVIR was expressed as the ratio of mitral and aortic time velocity integral (TVI) values. According to MR severity, 25 patients underwent MC implantation and at 6 months a complete echocardiographic follow‐up was performed.

Results

A significant linear relationship was found between MAVIR and both VC and EROA. A MAVIR ≥1.02 identified pts with severe MR with a sensitivity of 86.7% and a specificity of 90.9%. At the 6 months echocardiographic follow‐up after the MitraClip implantation, we observed a significant reduction of LAVI, LVED and LVES volume, while LVEF improved. Furthermore, MAVIR significantly decreased its decrease showed a significant linear relationship with LAVI reduction.

Conclusion

Our data show a close relationship between MAVIR and traditional indexes of MR severity in patients with FMR. This Doppler‐derived index seems applicable after PMVR where traditional echocardiographic index of MR severity shows significant limitations.

     

Cleft mitral leaflets and severe mitral regurgitation: Testing the limits of percutaneous mitral valve repair

Repair of mitral regurgitation (MR) with the MitraClip device (Abbot Vascular, Menlo Park, CA) to treat degenerative MR is associated with improved acute and long‐term outcomes. There is an increasing adoption of the device and operators are now testing the limits of the therapy even for unfavorable anatomies. Isolated cleft mitral leaflets are rare but represent a challenge to percutaneous repair. We present two cases of successful repair of severe MR and cleft mitral leaflets. In the first case, a 52‐year‐old male with a dilated cardiomyopathy and an ejection fraction (EF) of 15% presented in decompensated heart failure. Workup revealed a pseudo‐cleft anterior mitral leaflet and a cleft posterior leaflet. A strategy to treat the restricted posterior leaflet lateral of the posterior cleft with a provisional second clip resulted in trace residual MR with only one clip, and an EF improvement to 50% at 2‐month follow‐up. In the second case, an 80‐year‐old male with a history of obstructive CAD with a normal EF but severe MR and a restricted anterior leaflet presented with severe shortness of breath. An initial strategy to grasp the middle of the valve was unsuccessful due to the cleft. Instead, two clips were placed side‐by‐side on either side of the cleft resulting in trivial residual MR. Despite challenging anatomy percutaneous repair can allow for dramatic reduction in MR, resulting in significant left ventricular remodeling and improvement of EF and cardiac output.     

“The Starry Sky.” A new intraprocedural three‐dimensional echocardiographic technique

The NeoChord procedure is a micro‐invasive, trans‐ventricular, beating‐heart chordal replacement technique for patients with severe degenerative mitral valve regurgitation resulting from prolapsed or flail leaflets. Three dimensional transoesophageal echocardiographic guidance is crucial to assist the operator during the procedure. Equidistant placement of neochordae along the free edge of the prolapsing leaflet segment is important to ensure uniform stress distribution and to avoid damaging any of the previously placed neochordae. Lowering the image gain associated with the three‐dimensional surgical view of the mitral valve allows for signal attenuation of the native structures delineating the precise placement location of the neochordae.     

Patient selection for MitraClip therapy impaired left ventricular systolic function

Mitral regurgitation (MR) is a disabling disease associated with poor prognosis and high incidence of clinical events if left untreated. To reduce the invasiveness of the surgical approach, different types of transcatheter procedures are becoming available. The MitraClip procedure (Abbott Vascular Inc. Menlo Park, CA, USA) is yet the only catheter-based procedure available in clinical practice at the moment. The device has been evaluated in a number of preclinical studies, registries and in FDA approved clinical trials. (EVEREST trial, ACCESS-EU trial). Indication and timing of intervention is a crucial step in the diagnostic-therapeutic pathway of patients with mitral regurgitation. The aim of this review is to clarify the potential of MitraClip in clinical practice, particularly focusing on patient selection for this novel therapy. Patient selection and overall decision making is strongly influenced by anatomical and clinical factors. Decision-making in degenerative MR (DMR) vs. functional (FMR) can be quite different. Generally, MitraClip is effective in treating either type II or IIIb dysfunction (at the moment FMR is the main indication for MitraClip in Europe, according to the ACCESS registry data). The relative role of MitraClip and surgery in the management of patients with MR is still unclear. From the global initial experience, MitraClip therapy could be complementary to surgery in those patients at high risk for surgery who have ideal anatomical characteristics for implantation. The procedure is quite predictable in patients with favorable anatomy. In patients with suboptimal anatomy, if the risk of surgery is too high, MitraClip could be still indicated sometimes. Our preliminary experience suggests that in patients with DMR, the EVEREST anatomical criteria are strong predictors of early and mid-term success. According to it, MitraClip therapy is appropriate in those DMR patients with high surgical risk and ideal anatomy for clip implantation according to the EVEREST criteria. In FMR refractory to medical therapy and resynchronization therapy, MitraClip could be considered as first option therapy, particularly in those patients with comorbidities, or advanced age, being the operative risk of surgery above 5% in this population. In the future, novel devices, improved knowledge, more efficient imaging and transcatheter mitral prosthetic valve implantation may expand the indications to those patients currently not treated by MitraClip for anatomical unsuitability, and may improve the results both in term of early efficacy and long term durability.     

Redo MitraClip mitral valve repair after a late single leaflet detachment

Percutaneous mitral valve repair with the MitraClip^® (Abbott, Abbott Park, IL) can reduce mitral regurgitation (MR) and improve symptoms and quality of life in patients with severe mitral regurgitation. While this therapy is safe, there have been reports of single leaflet detachment where the MitraClip remains attached only to one leaflet of the mitral valve after deployment. Most of these cases occur within the first month of the procedure but there have been reports of late detachment occurring after this period. This case report describes a patient with severe functional MR who underwent an initial successful MitraClip procedure with implantation of two clips but subsequently developed late detachment of one clip. It also discusses the challenges and feasibility of performing a repeat MitraClip procedure in these patients. © 2013 Wiley Periodicals, Inc.     

Mitral regurgitation following PASCAL mitral valve repair system: A single arm meta-analysis

Major consequences of untreated severe mitral regurgitation (MR) includes heart failure, ventricular remodeling and pulmonary hypertension leading to significant morbidity and mortality. MitraClip is the most widely used device for treatment of severe MR. To overcome some of the shortcomings of MitraClip, novel devices like PASCAL mitral valve repair system are developed. We performed a single arm meta-analysis for patients with severe mitral regurgitation (MR) undergoing PASCAL mitral valve repair system. The results showed that 93.8% patients had reduction in MR grade, with an average operative time of 88 min and an average increase of 86.33 m in 6-min walk test.     

Edge-to-Edge Mitral Valve Repair With Extended Clip Arms: Early Experience From a Multicenter Observational Study

ObjectivesThe aim of this study was to investigate the technical success and efficacy of mitral valve edge-to-edge repair using extended clip arms.BackgroundA new iteration of the MitraClip system, the MitraClip XTR, was introduced in 2018 with the aim of addressing technical limitations observed with previous versions.MethodsPatients having received at least 1 new implant for the treatment of symptomatic mitral regurgitation (MR) were eligible for this study.ResultsAmong the 107 patients (mean age 76 ± 9 years, 69% men) included in this study, the etiology of MR was balanced, with one-half (n = 53 [50%]) classified as secondary and the remaining 54 patients having either primary (n = 40 [37%]) or mixed (n = 14 [13%]) disease. The mean number of devices implanted was 1.5 ± 0.6. Multiple device implantation was required in 46 patients (43%). Single-leaflet device attachment occurred in 4 patients and leaflet injury in 2 additional patients, requiring surgical conversion in 4 patients. Among the 102 patients discharged alive without mitral valve surgery, 95 (93%) had MR ≤2+ and 79 (77%) had MR ≤1+. The mean transmitral gradient increased from 1.9 ± 1.0 mm Hg at baseline to 3.5 ± 1.8 mm Hg at discharge (p < 0.001).ConclusionsTechnical success with the new mitral valve repair system with extended clip arm was achieved in 93% of the patients. MR ≤2+ was obtained in 95 patients (93%) and MR ≤1+ in 79 (77%). The main reasons for procedural failure were acute single-leaflet device attachment associated with leaflet damage or isolated leaflet injury and often required surgical correction.     

Short-Term Results of Transapical Transcatheter Mitral Valve Implantation for Mitral Regurgitation

Background

Mitral regurgitation (MR) is the most common valvular heart disease, and mitral valve surgery is the gold standard therapy for severe MR. Many patients with severe MR are not referred for surgery because of old age, comorbidities, or severe left ventricular dysfunction. Transcatheter mitral valve implantation may be a better therapeutic option for these high-risk patients with severe symptomatic MR.

Objectives

This study sought to describe the first-in-man series of transapical mitral valve implantation for mitral regurgitation with the TIARA device.

Methods

Extensive preclinical ex vivo and animal studies were conducted with the transapical mitral valve implantation of the Tiara system. The first 2 cases of human implantation were successfully performed in a 73-year-old man and a 61-year-old woman with severe functional MR. Both patients were in New York Heart Association class IV heart failure with depressed left ventricular ejection fraction, pulmonary hypertension, and additional comorbidities.

Results

The valve was implanted uneventfully in both patients. General anesthesia and transapical access were used. Patients were hemodynamically stable with no need for cardiopulmonary bypass. Immediately after implantation, systemic arterial pressure and stroke volume increased and pulmonary pressure decreased dramatically. There were no intraoperative complications, and both patients were extubated in the operating room. Post-procedural echocardiograms at 48 h, 1 month, and 2 months demonstrated excellent prosthetic valve function with a low transvalvular gradient and no left ventricular outflow tract obstruction. There was a trivial paravalvular leak in the first patient at 48 h, which was completely resolved at subsequent studies; no paravalvular leak occurred in the second patient.

Conclusions

Transapical transcatheter mitral valve implantation is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent. Transcatheter mitral valve implantation may become an important treatment option for patients with severe MR who are at high operative risk.     

Avances en el tratamiento percutáneo de la insuficiencia mitral

Percutaneous techniques for the treatment of mitral regurgitation have aroused much interest in recent years. Percutaneous mitral annuloplasty can be performed indirectly by using devices implanted in the coronary sinus or directly by using a retrograde approach. However, as yet, the results of these techniques are scarce and some devices have a high complications rate. The most frequent percutaneous mitral valve repair technique consists of mitral leaflet plication by implanting 1 or more percutaneous clips (MitraClip) in an imitation of the Alfieri surgical technique. Clinical experience with this device is broader than that with any other. The MitraClip device is associated with improved mitral regurgitation in a high percentage of carefully-selected patients. However, the single randomized study performed to date (EVEREST) showed its efficacy to be less than that of surgical repair and we await the results of new randomized studies that should clarify which patient-type can benefit most from this technique. Other left ventricular remodeling devices, tendinous cord implantation, and leaflet ablation are currently undergoing preclinical development or first-in-human experimentation. Finally, the development of biological prostheses for percutaneous mitral valve replacement is at an early stage. Many promising experiments at the preclinical phase and initial experiments in humans will very probably multiply in the near future. However, the true role of this technique in treating mitral valve disease will have to be evaluated in appropriately designed randomized controlled studies.     

Successful repositioning of apically tethered transcatheter mitral valve replacement in the off‐bypass,beating heart

A 73‐year‐old man with severe, symptomatic secondary mitral regurgitation (MR) underwent successful transcatheter mitral valve replacement using the Tendyne? mitral valve system. The device was deployed from the left ventricular (LV) apex and secured in position by a tether attached to an epicardial pad. Three days postoperatively, the patient developed hemolytic anemia and a paravalvular leak (PVL) associated with indentation of the LV apex. Adjustment of the tether tension and placement of an epicardial disc under the pad resulted in reduction in the PVL, and resolution of the hemolytic anemia.