Recurrence of Functional Versus Organic Mitral Regurgitation After Transcatheter Mitral Valve Repair: Implications from Three-Dimensional Echocardiographic Analysis of Mitral Valve Geometry and Left Ventricular Dilation for a Point of No Return.

BACKGROUND: MitraClip implantation has become the standard transcatheter mitral valve repair (TMVR) technique for severe mitral regurgitation (MR). However, approximately one third of patients have poor outcomes, with MR recurrence at follow-up. The aim of this study was to investigate whether quantitative analysis of mitral valve (MV) geometry on three-dimensional (3D) echocardiography can identify geometric parameters associated with the recurrence of severe functional MR (FMR) versus organic MR (OMR) at 6-month follow-up after TMVR using the MitraClip. METHODS: Sixty-one patients with severe FMR (n = 45) or OMR (n = 16) who underwent transesophageal 3D echocardiography before and 6 months after TMVR were retrospectively analyzed. MV geometry was quantified using 3D echocardiography software. Vena contracta area (VCA) at 6-month follow-up was used to define two outcome groups: patients with good results with VCA < 0.6 cm2 (MR < 0.6) and those with MR recurrence with VCA ≥ 0.6 cm2 (MR ≥ 0.6). RESULTS: MR recurrence was found in 34% of all study patients (21 of 61). In patients with FMR, significant differences between MR < 0.6 and MR ≥ 0.6 were found at baseline for tenting index (1.13 vs 1.23, P = .004), tenting volume (2.8 vs 4.0 ml, P = .04), indexed left ventricular (LV) end-diastolic volume (68.0 vs 99.9 ml/m2, P = .001), and VCA (0.71 vs 1.00 cm2, P = .003); no significant parameters of MR recurrence were found in patients with OMR. Multivariate analysis identified indexed LV end-diastolic volume as the strongest independent determinant of MR recurrence. Receiver operating characteristic analysis identified a tenting index of 1.185 (area under the curve 0.79) and indexed LV end-diastolic volume of 88 ml/m2 (area under the curve 0.76) to best discriminate between MR < 0.6 and MR ≥ 0.6. CONCLUSIONS: MR recurrence after TMVR in patients with FMR is associated with advanced LV dilation and MV tenting before TMVR, which provides clinical implications for a point of no return beyond which progressive LV dilation with MV geometry dilation and tethering cannot be effectively prevented by TMVR. In contrast, no significant determinants of MR recurrence and progressive MV annular dilation could be identified in patients with OMR.

Combined Tricuspid and Mitral Versus Isolated Mitral Valve Repair for Severe MR and TR: An Analysis From the TriValve and TRAMI Registries.

OBJECTIVES: The aim of this study was to retrospectively compare the characteristics, procedural courses, and outcomes of patients presenting with concomitant mitral regurgitation (MR) and tricuspid regurgitation (TR) in the TriValve (Transcatheter Tricuspid Valve Therapies) and TRAMI (Transcatheter Mitral Valve Interventions) registries. BACKGROUND: Transcatheter mitral edge-to-edge valve repair (TMVR) has been shown to be successful in patients with severe MR. Lately, edge-to-edge repair has also emerged as a possible treatment for severe TR in patients at high risk for cardiac surgery. In patients with both severe MR and TR, the yield of concomitant transcatheter mitral and tricuspid valve repair (TMTVR) for patients at high surgical risk is unknown. METHODS: The characteristics, procedural data, and 1-year outcomes of all patients in the international multicenter TriValve registry and the German multicenter TRAMI registry, who presented with both severe MR and TR, were retrospectively compared. Patients in TRAMI (n = 106) underwent isolated TMVR, while those in TriValve (n = 122) additionally underwent concurrent TMTVR in compassionate and/or off-label use. RESULTS: All 228 patients (mean age 77 ± 8 years, 44.3% women) presented with significant dyspnea at baseline (New York Heart Association functional class III or IV in 93.9%), without any differences in the rates of pulmonary hypertension and chronic pulmonary disease. The proportion of patients with left ventricular ejection fraction <30% was higher in the TMVR group (34.9% vs. 18.0%; p < 0.001), while patients in the TMTVR group had lower glomerular filtration rates. At discharge, MR was comparably reduced in both groups. At 1 year, overall all-cause mortality was 34.0% in the TMVR group and 16.4% in the TMTVR group (p = 0.035, Cox regression). On multivariate analysis, TMTVR was associated with a 2-fold lower mortality rate (hazard ratio: 0.52; p = 0.02). The rate of patients in New York Heart Association functional class ≤II at 1 year did not differ (69.4% vs. 67.0%; p = 0.54). CONCLUSIONS: Concurrent TMTVR was associated with a higher 1-year survival rate compared with isolated TMVR in patients with both MR and TR. Further randomized trials are needed to confirm these results.

Impact of cardiac comorbidities on early and 1-year outcome after percutaneous mitral valve interventions: data from the German transcatheter mitral valve interventions (TRAMI) registry.

AIMS: The use of the MitraClip system has gained widespread acceptance for the treatment of patients with mitral regurgitation (MR) who are not suitable for the conventional surgery. This study sought to investigate the early and 1-year outcome after MitraClip therapy of patients with MR and cardiac comorbidities. METHODS AND RESULTS: Outcomes through 12-month follow-up of patients (n = 528) who underwent MitraClip implantation were obtained from the German transcatheter mitral valve interventions (TRAMI) registry. The majority of these patients (n = 409, 77.5 %) also suffered from coronary artery disease (CAD). Patients with a dilated cardiomyopathy (DCM, n = 65, 12.3 %) or concomitant valvular aortic disease (AV, n = 54, 10.2 %) were less frequent. Although the prevalent pathogenesis was functional MR, patients with DCM had significantly more frequent a functional MR (96.9 %) compared to patients with CAD (74.9 %) or AV (62.5 %, p < 0.001). Technical success was achieved in 97.5 % of patients. Procedural echocardiograms demonstrated in the vast majority of patients a reduction from severe MR III to mild MR I with no difference between the groups (p = 0.83). The peri-procedural complication rate was very low. At 30-day and 12-month follow-up, the majority of patients were in NYHA functional class II or lower. The rate of death, stroke, and myocardial infarction (MACCE) was comparable in the three patient groups during 12-month follow-up (DCM 26.9 %, CAD 30.3 % and AV 27.5 %, p = 0.85). CONCLUSIONS: The MitraClip implantation is feasible and safe even in high-risk patients with MR and cardiac comorbidities.

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

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Silent cerebral ischemia after thoracic endovascular aortic repair: a neuroimaging study.

BACKGROUND: The risk of clinically apparent, periprocedural stroke after thoracic endovascular aortic repair (TEVAR) due to dislodgement and embolization of aortic debris from intravascular manipulation of guidewires, catheters, and large-bore delivery systems ranges between 2% and 6% and has been associated with increased postoperative mortality. The rate of clinically silent cerebral ischemia is yet unknown, but may be even higher. METHODS: Nineteen patients (13 male, 6 female) who underwent TEVAR were included into this descriptive study. Periprocedural apparent and silent cerebral ischemia was assessed by daily clinical neurologic assessment and serial cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) at baseline and 5 days (median, interquartile range: 3.5) after the procedure. RESULTS: The TEVAR was successful in all patients without immediate clinically apparent neurologic deficits. Postinterventional cerebral DW-MRI detected a total of 29 new foci of restricted diffusion in 12 of 19 TEVAR patients (63%). Lesions were usually multiple (1 to 6 lesions per patient) and ranged in size between 15 mm3 and 300 mm3; 16 lesions were found in the left hemisphere, 13 lesions in the right hemisphere. Overstenting of the left subclavian artery was performed in 8 cases, but was not associated with lateralization of lesions. There were no additional apparent neurologic events during the in-hospital period. CONCLUSIONS: Thoracic endovascular aortic repair resulted in a high incidence of new foci of restricted diffusion on cerebral DW-MRI in a pattern suggestive of periprocedural embolization. Although multiple lesions per patients were found, these lesions were not associated with apparent neurologic deficits during the in-hospital period. Further developments in TEVAR should be directed toward reducing the risk of periprocedural cerebral embolization.

The new St Jude Trifecta versus Carpentier-Edwards Perimount Magna and Magna Ease aortic bioprosthesis: is there a hemodynamic superiority?

OBJECTIVES: The Trifecta valve (St Jude Medical, St Paul, Minn) is a new bioprosthetic heart valve designed for supra-annular aortic valve replacement. We compared the hemodynamic performance of the Trifecta against the Perimount-Magna and Magna-Ease valve prostheses (Edwards Lifesciences, Irvine, Calif) in a nonrandomized, observational, single-center study. METHODS: A total of 346 consecutive patients with aortic valve disease underwent aortic valve replacement between January 2003 and November 2011, with implantation of the Trifecta (group 1, n = 121), the Perimount-Magna (group 2, n = 126), or the Magna Ease bioprosthesis (group 3, n = 99). Clinical and hemodynamic data were prospectively recorded and compared. Hemodynamic performance was evaluated by transthoracic echocardiography, including mean pressure gradient (MPG) and aortic valve area (AVA) at baseline, discharge, and 6-month follow-up. A multivariate model of covariance analysis was constructed to further compare the primary study end points of MPG and AVA at 6-month follow-up. RESULTS: For all valve sizes, unadjusted MPGs did not differ (P = .08), but AVAs differed (P < .001) between groups at 6-month follow-up. After final adjustment by a multivariate model of covariance analysis, neither the MPGs (P = .16) nor the AVAs (P = .92) at 6 months postoperatively were influenced by the type of prosthesis used. CONCLUSIONS: The present observational study is the first to compare the new Trifecta valve with well-established supra-annular aortic valve bioprostheses from a hemodynamic perspective. Although mean pressure gradients and aortic valve areas seem to be advantageous at 6-month follow-up with the new Trifecta valve, after multivariate covariance analysis, no influence of prosthesis type on mean pressure gradient or aortic valve area could be demonstrated.

Acute outcomes after MitraClip therapy in highly aged patients: results from the German TRAnscatheter Mitral valve Interventions (TRAMI) Registry.

AIMS: The influence of age on baseline demographics and outcomes of patients selected for MitraClip has not been previously investigated. METHODS AND RESULTS: Baseline demographics and acute outcomes in 1,064 patients from the German TRAMI registry were stratified by age (525 patients ≥76 years and 539 patients <76 years). In elderly patients, logistic EuroSCORE was higher (25[15-40]% vs. 18[10-31]%, p<0.0001) and the proportion of women was greater (47.2% vs. 29.3%, p<0.0001). Elderly patients were more likely to have preserved left ventricular ejection fraction >50% (40.1% vs. 21.8%, p<0.0001) and degenerative mitral regurgitation (DMR, 35.3% vs. 25.6%, p<0.01). Age was the most frequent reason for non-surgical treatment in the elderly (69.4% vs. 36.1%, p<0.0001). The intrahospital MACCE (death, myocardial infarction, stroke) was low in both groups (3.5% vs. 3.4%, p=0.93) and the proportion of non-severe mitral regurgitation at discharge was similar (95.8% vs. 96.4%, p=0.73). A logistic regression model did not reveal any significant impact of age on acute efficacy and safety of MitraClip therapy. In both groups, the majority of patients were discharged home (81.8% vs. 86.2%, p=0.06). CONCLUSIONS: Elderly and younger patients have similar benefits from MitraClip therapy. Age was the most frequent cause for denying surgery in elderly patients.

Critical importance of unsuspected findings detected by intraoperative transesophageal echocardiography for decision making during cardiac surgery.

AIMS: To report the frequency of unsuspected pathologies detected by presurgical and/or postsurgical intraoperative transesophageal echocardiography (IOTEE) and its impact on the extent of cardiac surgery and the number of pathologies remaining unoperated. METHODS AND RESULTS: In a 2-year study period, 469 patients (male/female = 273/196; age 68.0 ± 11.9 years) with presurgical and/or postsurgical IOTEE out of 2,035 patients submitted for cardiac surgery were analyzed retrospectively. Presurgical IOTEE was performed in all patients referred to valve surgery or suspicious valve disease or valve diseases with open surgical decision. Postsurgical IOTEE was performed in all patients after valve surgery. Pathologies relevant for surgery were defined as valve disease of moderate degree or higher or structural disease like shunt lesions. In 464 patients (98.9 %), a total number of 757 IOTEEs were successfully performed including 351 presurgical and 384 postsurgical studies, 1-s presurgical IOTEE, 20-s postsurgical, and one-third postsurgical IOTEE. Surgically relevant unsuspected findings were detected in 33.0 % of presurgical IOTEE leading to alteration of surgery in 27.6 %. Relevant pathologies detected by postsurgical IOTEE were found in 7.8 % as remnant valvular dysfunction of the operated valve and in 12.3 % related to other structures. Relevant pathologies detected by postsurgical IOTEE finally remained unoperated in 21.2 % of patients with only postsurgical IOTEE versus only 10.7 % (p < 0.05) of patients with both presurgical and postsurgical IOTEE. CONCLUSION: We found an alarming high number of unsuspected pathologies by IOTEE causing substantial alterations of surgery. Beyond this, whether patients received presurgical IOTEE or not made a significant difference on the number of pathologies left unoperated.

Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. METHODS AND RESULTS: Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. CONCLUSIONS: Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Towards real-time cardiovascular magnetic resonance guided transarterial CoreValve implantation: in vivo evaluation in swine.

BACKGROUND: Real-time cardiovascular magnetic resonance (rtCMR) is considered attractive for guiding TAVI. Owing to an unlimited scan plane orientation and an unsurpassed soft-tissue contrast with simultaneous device visualization, rtCMR is presumed to allow safe device navigation and to offer optimal orientation for precise axial positioning. We sought to evaluate the preclinical feasibility of rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis. METHODS: rtCMR-guided transfemoral (n = 2) and transsubclavian (n = 6) TAVI was performed in 8 swine using the original CoreValve prosthesis and a modified, CMR-compatible delivery catheter without ferromagnetic components. RESULTS: rtCMR using TrueFISP sequences provided reliable imaging guidance during TAVI, which was successful in 6 swine. One transfemoral attempt failed due to unsuccessful aortic arch passage and one pericardial tamponade with subsequent death occurred as a result of ventricular perforation by the device tip due to an operating error, this complication being detected without delay by rtCMR. rtCMR allowed for a detailed, simultaneous visualization of the delivery system with the mounted stent-valve and the surrounding anatomy, resulting in improved visualization during navigation through the vasculature, passage of the aortic valve, and during placement and deployment of the stent-valve. Post-interventional success could be confirmed using ECG-triggered time-resolved cine-TrueFISP and flow-sensitive phase-contrast sequences. Intended valve position was confirmed by ex-vivo histology. CONCLUSIONS: Our study shows that rtCMR-guided TAVI using the commercial CoreValve prosthesis in conjunction with a modified delivery system is feasible in swine, allowing improved procedural guidance including immediate detection of complications and direct functional assessment with reduction of radiation and omission of contrast media.

The role of imaging in percutaneous mitral valve repair.

Percutaneous, transcatheter mitral valve repair has recently been introduced and various strategies--loosely based on surgical techniques--are currently under clinical and preclinical evaluation. Since percutaneous mitral valve repair techniques are rather specific regarding both the underlying cause of mitral regurgitation and patient anatomy, careful preinterventional imaging using various techniques is required for appropriate patient selection and essential for procedural success. While echocardiography is the dominant imaging modality for determination of mitral regurgitation severity and etiology, other imaging modalities like contrast-enhanced multidetector computed tomography, magnetic resonance imaging, and fluoroscopy/angiography may play an important role in the preinterventional evaluation process. In addition, imaging is of utmost importance for procedural guidance and the combined use of various imaging modalities, commonly fluoroscopy and echocardiography, is needed in the catheterization laboratory to ensure safety and efficacy of mitral valve repair procedures. Finally, imaging is essential for an adequate patient follow-up aiming to control stable device positioning, persistency of the geometric modifications induced, and continuous reduction of mitral regurgitation. This review highlights the role of various imaging techniques during preinterventional evaluation, procedural guidance and follow-up in the setting of percutaneous mitral valve repair with special focus on edge-to-edge leaflet repair and indirect annuloplasty via the coronary sinus as the best-studied approaches to date.

Recurrent infective endocarditis with uncommon Gram-negative Pasteurella multocida and Pseudomonas aeruginosa: a case report.

Infective endocarditis (IE) due to Gram-negative bacteria is a rare occurrence, with a relative frequency of less than 10% compared to that caused by Gram-positive bacteria. Herein is presented the fatal case of a 66-year-old man who had undergone mechanical aortic valve replacement 10 years previously, and developed aortic valve IE after sepsis with Pasteurella multocida caused by a cat bite at the left medial ankle. In addition, the patient suffered five months later from mitral and aortic valve endocarditis caused by Pseudomonas aeruginosa. Recurrent surgical therapy was mandatory. This unique case of recurrent Gram-negative IE shows that the condition must still be regarded as complex and often fatal, despite adequate medical and surgical treatment.

[Mitral valve prolapse: identification of high-risk patients and therapeutic management]. / Mitralklappenprolaps: Identifikation von Patienten mit erhöhtem Risiko und therapeutisches Management.

Mitral valve prolapse shows a wide spectrum from a benign anatomic variant to a progressive disease with severe cardiovascular morbidity and mortality. Echocardiography is the most important tool for diagnosis and risk stratification. Predictors for high risk are significant thickening of mitral leaflet of > 5 mm ("classic" prolapse), moderate to severe mitral regurgitation and reduced left ventricular function. These patients have an increased risk of infective endocarditis, cerebral ischemia and sudden cardiac death. Because of the risk for the development of severe mitral regurgitation requiring surgery short follow-up intervals are necessary. In mitral prolapse syndrome cardiac clinical signs (palpitation, rhythm disorders, syncope, etc.) are associated with a prolapse that can be treated symptomatically with drugs after exclusion of other causes and significant mitral regurgitation requiring surgery.