Vascular complications after percutaneous mitral valve repair and venous access closure using suture or closure device.

OBJECTIVE: The aim of this study was to assess the impact of different access-site closure strategies, suture or closure device (Proglide, Abbott Vascular), on vascular and bleeding complications after percutaneous mitral valve repair (MitraClip, Abbott Vascular). BACKGROUND: Considering the high-risk profile in patients receiving percutaneous mitral valve repair, complications related to the large 24 Fr access sheath and its relation to the closure technique have not been evaluated so far. METHODS AND RESULTS: Between 2009 and 2015, 277 consecutive high-risk patients with severe mitral valve regurgitation (MR) underwent percutaneous mitral valve repair at our institution using Z-suture (n = 150) or closure device (n = 127) to close the access-site. Duplex sonography was performed in all patients. The primary endpoint was access-site related complications according to the Valve Academic Research Consortium (VARC) criteria. Secondary outcomes were the incidence of bleeding complications and mortality. Access-site related VARC2 major and minor complications were comparable after closure with Z-suture or closure device (2,7% vs 3.1%, P = 0.81 and 15,3% vs 15.7%, P = 0.92). Three patients (2%) in the suture and four patients (3.1%) in the closure device group experienced unplanned endovascular intervention at the access site. Access-site related major bleeding was observed in 4 (2.7%) suture and 4 (3.1%) closure device treated patients (P = 0.81). No access site related mortality occurred. CONCLUSION: Both Z-suture and closure device use after percutaneous mitral valve repair are feasible and safe. However, there is no benefit of one strategy over the other according to VARC2 major and minor complications.

Predictors for long-term survival after transcatheter edge-to-edge mitral valve repair.

OBJECTIVES: To determine predictors for long-term outcome in high-risk patients undergoing transcatheter edge-to-edge mitral valve repair (TMVR) for severe mitral regurgitation (MR). BACKGROUND: There is no data on predictors of long-term outcome in high-risk real-world patients. METHODS: From August 2009 to April 2011, 126 high-risk patients deemed inoperable were treated with TMVR in two high-volume university centers. RESULTS: MR could be successfully reduced to grade ≤2 in 92.1% of patients (116/126 patients). Long-term clinical follow-up up to 5 years (95.2% follow-up rate) revealed a mortality rate of 35.7% (45/126 patients). Repeat mitral valve treatment (surgery or intervention) was needed in 19 patients (15.1%). Long-term clinical improvement was demonstrated with 69% of patients being in NYHA class ≤II. In a multivariable Cox regression analysis, the post-procedural grade of MR (hazard ratio [HR] 1.55 per grade, P = 0.035), the left ventricular ejection fraction (HR 0.58 for difference between 75th and 25th percentile, P = 0.031) and the glomerular filtration rate (HR 0.33 for 75th vs 25th percentile, P < 0.001) were independent predictors for long-term mortality. Patients with primary MR and a post-procedural MR grade ≤1 had the most favorable long-term outcome. CONCLUSIONS: This study determines predictors of long-term clinical outcome after TMVR and demonstrates that the grade of residual MR determines long-term survival. Our data suggest that it might be of benefit reducing residual MR to the lowest possible MR grade using TMVR-especially in selected high-risk patients with primary MR who are not considered as candidates for surgical MVR.

Long-term outcome of patients with severe biventricular heart failure and severe mitral regurgitation after percutaneous edge-to-edge mitral valve repair.

OBJECTIVE: To assess long-term outcome and parameters associated with poor and favorable outcome in patients with a left ventricular ejection fraction (LV-EF) ≤25% and severe mitral regurgitation (MR) after percutaneous edge-to-edge mitral valve repair (pMVR). BACKGROUND: There is no data on long-term outcome in this cohort of patients. METHODS: We analyzed all 34 patients with a LV-EF ≤25% and severe MR treated with pMVR in 2 university hospitals from 2009 to 2012. RESULTS: Mitral regurgitation could be successfully reduced to grade ≤2 in 30 patients (88%). Long-term follow-up (up to 5 years) revealed a steep decline of the survival curve reaching 50% already 8 month after pMVR. In contrast, estimated survival of the remaining patients showed a favorable long-term outcome. Patients deceased during the first year presented with higher right ventricular tricuspid pressure gradient (RVTG) (44.5 ± 8.4 mmHg vs. 35.2 ± 15.4 mmHg, P = 0.035) and worse RV-function (P = 0.014) prior to the procedure. One-year mortality of patients with pulmonary hypertension and depressed RV-function (n = 22) was very high (77%) compared to the remaining patients (n = 12, mortality rate of 0%, P = 0.0001). CONCLUSIONS: Although pMVR lead to a successful reduction of MR in patients with a LV-EF ≤25%, 1-year mortality in this cohort was very high. However, a subgroup of patients showed a favorable long-term outcome after pMVR. Especially the right ventricular parameters sustained RV-function and absence of pulmonary hypertension-easily assessed with echocardiography-might be used to identify this subgroup and encourage pMVR in these patients.

Percutaneous edge-to-edge repair of the mitral valve in patients with degenerative versus functional mitral regurgitation.

OBJECTIVES: To prospectively assess the outcome of percutaneous edge-to-edge repair in patients with degenerative versus functional mitral regurgitation (MR). BACKGROUND: The optimal patient population eligible for percutaneous edge-to-edge repair has yet to be defined. METHODS: We analyzed 119 patients treated by percutaneous edge-to-edge repair for symptomatic MR, 72 patients with degenerative and 47 patients with functional MR. The primary endpoints were defined as procedural success (MR grade reduction ≥1 grade) as well as a composite endpoint defined as freedom from MR 3+ or 4+, mitral valve reintervention and death 12 months after clip implantation. In patients with successful clip placement we further analyzed MR grade, New York Heart Association (NYHA) functional class, distance in the 6 min walking test and left ventricular volumes 12 months after clip implantation. RESULTS: The primary success rate of all intended clipping procedures was 83.3% for degenerative and 89.4% for functional MR (P = 0.42). Regarding the composite endpoint we observed an event free survival of 59.7% in patients treated for degenerative MR and 63.8% in patients treated for functional MR (P = 0.73). We observed a highly significant reduction in MR grade as well as improvement in NYHA functional status in both groups 12 months after clip implantation. However, there was a more pronounced MR grade reduction in patients treated for degenerative MR compared with patients treated for functional MR. CONCLUSIONS: Percutaneous edge-to-edge repair of the mitral valve is feasible and comparably effective in patients with degenerative and functional MR.

Three-dimensional echocardiographic optimization improves outcome in cardiac resynchronization therapy compared to ECG optimization: a randomized comparison.

AIMS: There is little consensus on optimal atrioventricular (AV) and ventricular-to-ventricular (VV) intervals in cardiac resynchronization therapy (CRT). The aim of this study was to examine a novel combination of Doppler echocardiography (DE) and three-dimensional echocardiography (3DE) for individualized AV- and VV-interval optimization compared to conventional electrocardiogram (ECG) optimization. METHODS: In this double-blind, randomized controlled trial, 77 patients (male: 57, age: 68 ± 10 years) with severely reduced ejection fraction (EF), New York Heart Association (NYHA) class III or IV, and wide QRS complex (>120 ms) have been included. Patients were randomized to either AV- and VV-interval optimization using DE and 3DE (group 1, n = 39) or ECG (group 2, n = 38). 3DE was performed in all patients for the evaluation of left ventricular (LV) dimensions, EF and systolic dyssynchrony index (SDI), and NYHA class obtained before CRT and after 3 months. Primary endpoint of the study was clinical response to CRT, defined as a reduction of NYHA class by ≥1 score. Secondary endpoints were change of EF, LV volumes, and SDI. RESULTS: There were significantly more responders in group 1 (82%) than in group 2 (58%, P = 0.021). Similarly, group 1 showed a larger increase in EF (7.0 ± 6.0% vs 3.4 ± 5.6%, P = 0.015) and a more pronounced reduction of SDI (-4.5 ± 5.9% vs -1.5 ± 5.6%, P = 0.039) than group 2. CONCLUSION: Compared with conventional ECG optimization, this novel echocardiographic optimization protocol resulted in a significantly higher response rate, improved LV systolic function, and may be used to select the optimal AV and VV intervals in CRT.

Implantation of a MitraClip between two previously implanted MitraClips to treat recurrent severe mitral regurgitation.

We first describe the implantation of a MitraClip (Abbott Vascular, Abbott Park, IL, USA) between 2 previously implanted MitraClips to treat recurrent mitral regurgitation (MR). An 82-year-old male patient presented with dyspnea New York Heart Association NYHA class III due to recurrent severe MR 18 months after primarily successful implantation of 2 MitraClips. The initial procedure was performed to treat severe MR due to prolapse and flail of the anterior leaflet and resulted in mild MR after implantation of 2 MitraClips. Concomitant diseases were persistent atrial fibrillation, moderate tricuspid valve regurgitation, and chronic kidney disease stage 3. Thus, the patient was not considered a suitable candidate for surgical treatment. Using fluoroscopic guidance, 2D- and 3D-transesophageal echocardiographies, we succeeded in placing a third clip between the previously implanted clips and reduced the severe MR to mild MR without increase in the mean gradient. No periprocedural complications were observed. Six months after the procedure the patient presented with mild MR and NYHA class I. .

Long-Term Outcomes After MitraClip Implantation According to the Presence or Absence of EVEREST Inclusion Criteria.

Numerous patients are treated with the MitraClip, although they do not fulfill the stringent inclusion criteria of the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) trials. The outcome of those patients is not well known. Therefore, we compared the long-term outcome after MitraClip treatment between patients who matched (group 1) and did not match (group 2) the EVEREST criteria. One hundred thirty-four consecutive patients were treated from September 2009 to July 2012: 59 patients (44%) in group 1 versus 75 patients (56%) in group 2. Investigated end points were acute procedural success (for group 1 vs 2: 97% vs 95%; p = 0.694), all-cause mortality (28% vs 27%; p = 0.656), reintervention (RI) rate (11% vs 37%; p = 0.010), and improvement in mitral regurgitation (MR) (-1.3 ± 1 vs -1.5 ± 1, p = 0.221) and in New York Heart Association functional class (-0.7 ± 1 vs -0.9 ± 0.8, p = 0.253) during the follow-up of 33 months (27.9 to 38.3). The morphologic extent of a flail leaflet was an independent predictor for RI. In conclusion, although the overall outcome was comparable between both groups, recurrent symptomatic MR with need for RI was higher in group 2, mainly because of complex valve pathologies: especially flail width >15 mm and gap ≥10 mm. Improvements in the interventional strategy are warranted for reducing the need for RI in patients with primary MR.

Right ventricular thrombus formation in a patient with arrhythmogenic right ventricular dysplasia following radiofrequency ablation.

A middle-aged female suffering from ARVD presented for routine follow-up 8 weeks after right ventricular radiofrequency ablation of recurring ventricular tachycardia. Echocardiography revealed two right ventricular thrombi in the scar area of right ventricular radiofrequency ablation. Ablation-related thromboembolic events should be considered as possible complication in patients suffering from ARVD.

Acute and Midterm Outcome After MitraClip Therapy in Patients With Severe Mitral Regurgitation and Left Ventricular Dysfunction.

The clinical outcome of patients with severe primary and secondary mitral regurgitation (MR) and heart failure or significantly reduced left ventricular ejection fraction (LVEF) who underwent percutaneous mitral valve repair (pMVR) is yet not well known. This study compares midterm outcome of patients with severe left ventricular dysfunction (EF ≤30%) versus patients with slightly or moderately reduced or normal LVEF (EF >30%) after pMVR. One hundred thirty-six consecutive patients were enrolled: 42 patients displayed severe left ventricular dysfunction, group 1 (logistic EuroSCORE I 27.7 ± 21.8%; secondary MR in 37 patients), and 94 patients displayed slightly or moderately reduced or normal LVEF, group 2 (logistic EuroSCORE I 17 ± 18.2%; secondary MR in 21 patients). The primary efficacy endpoint was death of any cause, repeat mitral valve intervention, and/or New York Heart Association class ≥III, which was reached in 31% of patients in group 1 versus 40% in group 2 (p = 0.719) at a median follow-up of 371 days. MR, graded by transthoracic echocardiography, was reduced in both groups (p <0.001) and New York Heart Association class improved in each group (p <0.001), with no differences between groups (p >0.05). In conclusion, at midterm follow-up, the pMVR provided significant clinical benefits with comparable results achieved both in patients with significantly reduced and in patients with moderately reduced to normal LVEF. Thus, pMVR represents a feasible and effective treatment in high-risk patients who otherwise have limited therapeutic options and no safe option to reduce MR.

Dangerous liaison: successful percutaneous edge-to-edge mitral valve repair in patients with end-stage systolic heart failure can cause left ventricular thrombus formation.

AIMS: To evaluate the characteristics and clinical outcome of patients with new formation of left ventricular (LV) thrombus after percutaneous edge-to-edge mitral valve repair. METHODS AND RESULTS: Between 2009 and 2012 we intended to treat 150 patients with severe mitral regurgitation (MR) with percutaneous edge-to-edge mitral valve repair in our centre. Post-procedural transthoracic echocardiographic examinations scheduled during the hospital stay revealed the new formation of LV thrombi in three out of 150 patients. All three patients suffered from end-stage systolic heart failure with a LV ejection fraction (LVEF) below 20% and were successfully treated in terms of MR reduction (reduction of at least two MR grades). No thrombus formation was observed in patients with a LVEF >20% treated in our centre (a total of 136 patients). The frequency of new LV thrombus formation in the cohort of patients with a LVEF ≤20% treated in our centre was 21% (three out of 14 patients). CONCLUSIONS: New formation of LV thrombus was detected in patients with severely depressed LVEF (≤20%) after successful reduction of MR following percutaneous edge-to-edge mitral valve repair. This phenomenon could be a play of chance, but percutaneous edge-to-edge mitral valve repair using the MitraClip¨ system is a new procedure. Special care is needed when performing new procedures, and the unexpected post-procedural finding of LV thrombus formation in approximately 20% in this cohort is worth reporting.

Three-dimensional transoesophageal echocardiography for the assessment of clip attachment to the leaflets in percutaneous edge-to-edge repair of the mitral valve.

AIMS: Single leaflet clip attachment (SLA) is a prevalent complication in percutaneous edge-to-edge repair of the mitral valve, leading to the recurrence of significant mitral regurgitation. The objective of this retrospective analysis was to evaluate a novel 3-D transoesophageal echocardiographic method for the assessment of clip attachment to the mitral leaflets. METHODS AND RESULTS: We analysed a total of 87 patients treated for symptomatic mitral regurgitation. In 47 patients, clip attachment to the leaflets was assessed by conventional 2-D transoesophageal echocardiography supported by biplane TEE images (biplane TEE group). In 40 patients, clip attachment to the leaflets was assessed by the intraprocedural 3-D volume method in addition to the conventional method (volumetric TEE group). The primary endpoint was defined as clip complications consisting of SLA and clip displacement at any time after clip implantation. Clip complications occurred in nine patients (19.1%) in the biplane TEE group and in two patients (5%) in the volumetric TEE group (p=0.06). Regarding the grade of mitral regurgitation, in the follow-up period we observed a more pronounced deterioration in the biplane TEE group than in the volumetric TEE group. CONCLUSIONS: These findings suggest that the additional use of 3-D volumetric transoesophageal echocardiography for the assessment of clip attachment to the mitral leaflets may contribute to a reduced rate of subsequent clip complications.

Acute beneficial hemodynamic effects of a novel 3D-echocardiographic optimization protocol in cardiac resynchronization therapy.

BACKGROUND: Post-implantation therapies to optimize cardiac resynchronization therapy (CRT) focus on adjustments of the atrio-ventricular (AV) delay and ventricular-to-ventricular (VV) interval. However, there is little consensus on how to achieve best resynchronization with these parameters. The aim of this study was to examine a novel combination of doppler echocardiography (DE) and three-dimensional echocardiography (3DE) for individualized optimization of device based AV delays and VV intervals compared to empiric programming. METHODS: 25 recipients of CRT (male: 56%, mean age: 67 years) were included in this study. Ejection fraction (EF), the primary outcome parameter, and left ventricular (LV) dimensions were evaluated by 3DE before CRT (baseline), after AV delay optimization while pacing the ventricles simultaneously (empiric VV interval programming) and after individualized VV interval optimization. For AV delay optimization aortic velocity time integral (AoVTI) was examined in eight different AV delays, and the AV delay with the highest AoVTI was programmed. For individualized VV interval optimization 3DE full-volume datasets of the left ventricle were obtained and analyzed to derive a systolic dyssynchrony index (SDI), calculated from the dispersion of time to minimal regional volume for all 16 LV segments. Consecutively, SDI was evaluated in six different VV intervals (including LV or right ventricular preactivation), and the VV interval with the lowest SDI was programmed (individualized optimization). RESULTS: EF increased from baseline 23±7% to 30±8 (p<0.001) after AV delay optimization and to 32±8% (p<0.05) after individualized optimization with an associated decrease of end-systolic volume from a baseline of 138±60 ml to 115±42 ml (p<0.001). Moreover, individualized optimization significantly reduced SDI from a baseline of 14.3±5.5% to 6.1±2.6% (p<0.001). CONCLUSIONS: Compared with empiric programming of biventricular pacemakers, individualized echocardiographic optimization with the integration of 3-dimensional indices into the optimization protocol acutely improved LV systolic function and decreased ESV and can be used to select the optimal AV delay and VV interval in CRT.