Objectives The EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study (HRS) assessed the safety and effectiveness of the MitraClip device (Abbott Vascular, Santa Clara, California) in ...patients with significant mitral regurgitation (MR) at high risk of surgical mortality rate. Background Patients with severe MR (3 to 4+) at high risk of surgery may benefit from percutaneous mitral leaflet repair, a potentially safer approach to reduce MR. Methods Patients with severe symptomatic MR and an estimated surgical mortality rate of ≥12% were enrolled. A comparator group of patients screened concurrently but not enrolled were identified retrospectively and consented to compare survival in patients treated by standard care. Results Seventy-eight patients underwent the MitraClip procedure. Their mean age was 77 years, >50% had previous cardiac surgery, and 46 had functional MR and 32 degenerative MR. MitraClip devices were successfully placed in 96% of patients. Protocol-predicted surgical mortality rate in the HRS and concurrent comparator group was 18.2% and 17.4%, respectively, and Society of Thoracic Surgeons calculator estimated mortality rate was 14.2% and 14.9%, respectively. The 30-day procedure-related mortality rate was 7.7% in the HRS and 8.3% in the comparator group (p = NS). The 12-month survival rate was 76% in the HRS and 55% in the concurrent comparator group (p = 0.047). In surviving patients with matched baseline and 12-month data, 78% had an MR grade of ≤2+. Left ventricular end-diastolic volume improved from 172 ml to 140 ml and end-systolic volume improved from 82 ml to 73 ml (both p = 0.001). New York Heart Association functional class improved from III/IV at baseline in 89% to class I/II in 74% (p < 0.0001). Quality of life was improved (Short Form-36 physical component score increased from 32.1 to 36.1 p = 0.014 and the mental component score from 45.5 to 48.7 p = 0.065) at 12 months. The annual rate of hospitalization for congestive heart failure in surviving patients with matched data decreased from 0.59 to 0.32 (p = 0.034). Conclusions The MitraClip device reduced MR in a majority of patients deemed at high risk of surgery, resulting in improvement in clinical symptoms and significant left ventricular reverse remodeling over 12 months. (Pivotal Study of a Percutaneous Mitral Valve Repair System EVEREST II; NCT00209274 )
Abstract The most recent American College of Cardiology/American Heart Association heart valve guidelines recommend that prompt surgical correction of severe degenerative mitral valve regurgitation, ...ideally mitral valve repair, should be performed to decrease the risks of long-term mortality and heart failure risks associated with this condition. Mitral valve repair performed using a minimally invasive robotic approach can now be successfully carried out in nearly all cases of degenerative disease with very low risks of stroke or death. Experienced groups have further shown specific advantages of robotic mitral valve repair compared with conventional approaches, including reduced blood loss, lower risks of infection and atrial fibrillation, shorter hospital length of stay, quicker return to normal activities, and a superior cosmetic result. Herein, we discuss the current status of robotic mitral valve repair including indications, technical advances, safety, effectiveness, and durability.
Objective The Endovascular Valve Edge-to-Edge Repair Study (EVEREST II) is a prospective, multicenter, randomized controlled trial comparing percutaneous repair with the MitraClip device to mitral ...valve (MV) surgery in the treatment of mitral regurgitation. The present study analyzed the patient characteristics and treatment effects on mitral repair versus replacement. Methods Of 279 patients enrolled, 80 surgical patients underwent 82 MV operations and 178 underwent an initial MitraClip procedure, of whom 37 underwent a subsequent MV operation within 1 year of their index the MitraClip procedure. A logistic regression model was used to predict MV replacement according to valve pathology, etiology of mitral regurgitation, age, previous cardiac surgery, and treatment group. Results The rate of percutaneous or surgical MV repair at 1 year was 89% (158/178) in patients initially receiving the MitraClip device versus 84% (67/80) in the surgical patients ( P = .36). Surgical repair was performed after the MitraClip procedure in 20 (54%) of 37patients ( P < .001 vs surgery). In both the MitraClip device and surgery groups, MV replacement was significantly associated with anterior leaflet pathology ( P = .035). Logistic regression analysis showed that anterior leaflet pathology predicted MV replacement. In 5 (13.5%) of 37 patients undergoing surgery after MitraClip therapy, replacement was performed in part because of MV injury associated with the MitraClip procedure. Conclusions These data suggest that anterior leaflet pathology is strongly associated with MV replacement in patients undergoing either de novo MV surgery or surgery after MitraClip therapy. MitraClip therapy has a repair rate similar to surgery through 1 year but also imparts a risk of replacement of a potentially repairable valve.
Objective The study objective was to review our first 300 consecutive robotic-assisted mitral repairs performed from June 2005 to October 2012 and to compare the surgical outcomes of our previously ...reported initial 120 cases with the subsequent 180 procedures. Methods Our initial 120 robotic-assisted mitral repairs were previously reported, and we now compare our early experience with the recent 180 consecutive procedures for a total of 300 robotic-assisted mitral repairs. There was no patient selection. Every patient in need of isolated mitral valve repair underwent this procedure. All patients received an annuloplasty band and 1 or more of the following: leaflet resection, secondary chordal transposition, or polytetrafluoroethylene neochordal replacement and edge-to-edge repair. Results All 300 patients had preoperative echocardiographic findings of severe mitral regurgitation. There were no differences ( P = not significant) between the initial and the recent cohorts for preoperative characteristics, including age (58.4 ± 10.5 years vs 59.9 years), female gender (35.8% vs 36.1%), ejection fraction (61.9% vs 60.6%), congestive heart failure (35.0% vs 36.7%), creatinine (0.94 mg/dL vs 0.98 mg/dL), and New York Heart Association class. The incidence of anterior and posterior leaflet prolapse was similar in both groups, whereas Barlow syndrome was higher in group 2 (5.8% vs 27.8%). There was 1 (0.33%) hospital mortality and no deaths in the last 180 cases. Overall, 8 patients (2.7%) required subsequent mitral valve replacement via a median sternotomy, 6 (5.0%) in the first group and 2 (1.1%) in the second group ( P = .06). One patient in each group had mitral valve re-repair through a right mini-thoracotomy, and 1 patient in the first group required a mitral valve replacement via a mini-thoracotomy during the original procedure. Two of the 180 patients had documented cerebrovascular accident, but both fully recovered clinically. There was no cerebrovascular accident in the last 120 patients. Crossclamp times decreased from 116 minutes to 91 minutes in the second group despite starting a training program with a junior associate performing part of the procedure at the console in the last 100 cases. Post-pump echocardiograms showed no/trace mitral regurgitation in 86.1% of the last 180 patients and mild mitral regurgitation in 11.1%. Follow-up echocardiography for the last 180 patients from 1 month to more than 1 year showed no/trace mitral regurgitation in 64.6% of patients and mild mitral regurgitation in 23.1% of patients. Seven patients (10.8%) had moderate mitral regurgitation, and 1 patient (1.5%) had severe mitral regurgitation. Conclusions The majority of complications and reoperations occurred early in our experience, especially using the first-generation da Vinci robot (Intuitive Surgical Inc, Sunnyvale, Calif). The newer da Vinci Si HD system with the addition of an adjustable left atrial roof retractor together with increased experience has made robotic-assisted mitral repair of all types of degenerative mitral valve pathology reproducible. The training of young surgeons in a stepwise fashion in high-volume centers will help to avoid the complications encountered during the introduction of this technology.
Abstract Percutaneous edge-to-edge repair using the MitraClip system causes reduction of mitral valve area (MVA). However, its clinical impact is not fully elucidated. This study assessed the impact ...of postprocedural MVA reduction on pulmonary hypertension and outcomes. A total of 92 patients with grades 3 to 4+ mitral regurgitation (MR) who underwent MitraClip therapy were retrospectively reviewed. Using intraprocedural 3-dimensional transesophageal echocardiography (3DTEE), postprocedural MVA was obtained by 2 optimized planes through the medial and lateral orifices of the repaired valve. MVA was reduced by 60.1% immediately after MitraClip procedure (p <0.001). Postprocedural MVA correlated moderately with mean transmitral pressure gradient (TMPG) in the majority of patients (r = −0.56, p < 0.001), but discordance of MVA and TMPG was observed in 40% of patients. In multivariable linear regression analysis, postprocedural MVA ≤1.94 cm2 was independently associated with a blunted decrease of systolic pulmonary artery pressure at 1-month follow-up (β-estimate -4.63, 95% confidence interval -9.71 to -0.15, p = 0.042). Postprocedural MVA ≤1.94 cm2 was an independent predictor of all-cause mortality and heart failure hospitalization after MitraClip (hazard ratio 4.28, 95% confidence interval 1.56 to 11.7, p = 0.005) even after adjustment for age, gender, atrial fibrillation, etiology of MR, left ventricular systolic function, preexisting pulmonary hypertension, and residual MR. After further adjustment for TMPG ≥5 mm Hg, postprocedural MVA ≤1.94 cm2 remained predictive for adverse outcomes (p = 0.048). In conclusion, the intraprocedural assessment of MVA by 3DTEE can predict hemodynamic response and postprocedural prognosis after MitraClip therapy.
...many of these recommendations are based on expert consensus. The defining principle is that this effort is a joint, institutionally-based activity for cardiologists and cardiac surgeons (1,4). ......the specialty that provides some of these components will vary from program to program.
Preexisting pulmonary hypertension (PH) is associated with poor outcomes after surgical mitral valve repair for functional mitral regurgitation (FMR). However its clinical impact on MitraClip therapy ...remains unknown. The aim of this study was therefore to evaluate the impact of preexisting PH on MitraClip therapy for patients with FMR. Ninety-one consecutive patients who had FMR and who underwent the MitraClip procedure were studied. They were divided into 2 groups on the basis of pulmonary artery systolic pressure: the PH group (n = 48) and the non-PH group (n = 43). PH was defined as pulmonary artery systolic pressure >50 mm Hg using Doppler echocardiography. Procedural success (defined as magnetic resonance reduction to grade 2+ or less) and 30-day mortality were similar in the 2 groups. At 12 months, New York Heart Association functional class had improved to class I or II in most patients in the PH (from 2.9% to 94.3%) and non-PH (from 9.4% to 96.9%) groups. The mean pulmonary artery systolic pressure of the PH group significantly decreased from baseline but remained higher than that of the non-PH group (50.8 ± 15.3 vs 36.7 ± 11.6 mm Hg, p <0.001). After a mean of 25.0 ± 16.9 months of follow-up, Kaplan-Meier analysis demonstrated significantly higher all-cause mortality in the PH group. In Cox regression analysis, preexisting PH was the most powerful predictor of all-cause mortality (hazard ratio 3.731, 95% confidence interval 1.653 to 8.475, p = 0.002). In conclusion, MitraClip therapy reduced FMR and alleviated symptoms with an excellent early safety profile in the PH and non-PH groups. However, preexisting PH was associated with worse all-cause mortality.
Objectives This study sought to compare the regenerative potency of cells derived from healthy and diseased human hearts. Background Results from pre-clinical studies and the CADUCEUS ...(CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction) trial support the notion that cardiosphere-derived cells (CDCs) from normal and recently infarcted hearts are capable of regenerating healthy heart tissue after myocardial infarction (MI). It is unknown whether CDCs derived from advanced heart failure (HF) patients retain the same regenerative potency. Methods In a mouse model of acute MI, we compared the regenerative potential and functional benefits of CDCs derived from 3 groups: 1) non-failing (NF) donor: healthy donor hearts post-transplantation; 2) MI: patients who had an MI 9 to 35 days before biopsy; and 3) HF: advanced cardiomyopathy tissue explanted at cardiac transplantation. Results Cell growth and phenotype were identical in all 3 groups. Injection of HF CDCs led to the greatest therapeutic benefit in mice, with the highest left ventricular ejection fraction, thickest infarct wall, most viable tissue, and least scar 3 weeks after treatment. In vitro assays revealed that HF CDCs secreted higher levels of stromal cell-derived factor (SDF)-1, which may contribute to the cells' augmented resistance to oxidative stress, enhanced angiogenesis, and improved myocyte survival. Histological analysis indicated that HF CDCs engrafted better, recruited more endogenous stem cells, and induced greater angiogenesis and cardiomyocyte cell-cycle re-entry. CDC-secreted SDF-1 levels correlated with decreases in scar mass over time in CADUCEUS patients treated with autologous CDCs. Conclusions CDCs from advanced HF patients exhibit augmented potency in ameliorating ventricular dysfunction post-MI, possibly through SDF-1–mediated mechanisms.
Preamble With the evolution of transcatheter valve replacement, an important opportunity has arisen for cardiologists and surgeons to collaborate in identifying the criteria for performing these ...procedures. ...Additional Supporting Information may be found in the online version of this article. According to the ACC, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/ entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.
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