Nicola Buzzatti

Mitraclip therapy and surgical mitral repair in patients with moderate to severe left ventricular failure causing functional mitral regurgitation: a single-centre experience †

OBJECTIVES Surgical mitral repair is the conventional treatment for severe symptomatic functional mitral regurgitation (FMR). Mitraclip therapy is an emerging option for selected high-risk patients with FMR. The aim of this study was to report the outcomes of patients who underwent a surgical mitral repair and Mitraclip therapy for FMR in our experience. METHODS From March 2000 and April 2011, 143 patients with FMR were treated in our institution: 91 patients (63.6%) underwent surgical mitral repair (49% ischaemic; 51% idiopathic) and 52 (36.4%) underwent Mitraclip implantation (71% ischaemic; 29% idiopathic). Associated procedures in the surgical group were myocardial revascularization in 35%, tricuspid repair in 25% and atrial fibrillation ablation in 26%. Follow-up was 100% complete (median 18; 6.4-45 months for surgery and 8.5; 4-12 months for Mitraclip). RESULTS Mitraclip patients were older (P = 0.04), had higher log EuroSCORE (P < 0.0001), lower LVEF (P = 0.006) and higher left ventricular diameter (P = 0.01 for left ventricular end-diastolic diameter and P = 0.05 for left ventricular end-systolic diameter). Major postoperative infection or sepsis occurrence was higher in the surgical group (16.3 vs. 3.8%; P = 0.01), while no differences were observed in terms of acute renal failure, cardiogenic shock, cerebrovascular accident and acute myocardial infarction. Length-of-stay was 11 days (IQR: 7-19 days) for surgery and 5 days (IQR: 4-9 days) for MitraClip (P < 0.0001). In-hospital mortality was 6.6% for surgery (6/91) and 0% for Mitraclip (P = 0.01). Surgery was identified as a predictor of in-hospital death (OR: 2.61; P = 0.01). Residual MR ≥ 3+ at discharge was 0% for surgery and 9.6% for Mitraclip (P = 0.002). At follow-up, actuarial survival at 1 year was 88.9 ± 3.5% for surgery and 87.5 ± 7% for Mitraclip (P = 0.6). Actuarial freedom from MR ≥ 3+ at 1 year was 79.1 ± 8% for MitraClip and 94 ± 2% for surgery (P = 0.01). At last follow-up, most of the survivors were in NYHA class I-II. CONCLUSIONS Mitraclip therapy is a safe therapeutic option in selected high-risk patients with FMR, and it is associated with a lower hospital mortality and shorter length-of-stay compared with surgery, in spite of worse preoperative conditions. Early and 1-year rates of recurrent MR are higher with Mitraclip. Further studies are needed to determine the long-term clinical impact.

Clinical outcomes of MitraClip for the treatment of functional mitral regurgitation.

AIMS The aim of this study was to report medium-term outcomes of MitraClip implantation in inoperable or high-risk surgical candidates with functional mitral regurgitation (FMR) in our single-centre experience. From October 2008, 109 consecutive patients with FMR underwent MitraClip implantation (mean age 69±9 years; 82% NYHA Class III-IV). Logistic EuroSCORE was 22±16%. Comorbidities included: chronic renal failure (47%), diabetes (22%), COPD (28%). Mean EF was 28±11%; LVEDD was 68±8 mm. Procedural success was 99% and 30-day mortality was 1.8%. At discharge, 87% patients had MR ≤2+. At 12 months, EF was 34.7±10.4% (p=0.002 compared to preoperative value). Actuarial survival at three years was 74.5±7%. Actuarial freedom from MR ≥3+ at 2.5 years was 70±6%. At one-year follow-up, 86% of patients were in NYHA Class I-II. Preoperative pro-BNP level ≥1,600 pg/ml was identified as an independent risk factor of mortality at follow-up. MitraClip therapy for FMR is a valuable alternative to surgery in high-risk patients. Higher preoperative pro-BNP level is a risk factor for mortality at follow-up. Although patients treated in current practice are high-risk, the procedure remains safe and effective in selected patients.

Computed tomography-based evaluation of aortic annulus, prosthesis size and impact on early residual aortic regurgitation after transcatheter aortic valve implantation

OBJECTIVES Computed tomography (CT) is an increasingly utilized method for the evaluation of patient suitability for transcatheter aortic valve implantation (TAVI). The aim of this study was to analyse the role of CT in the choice of prosthesis and the prevention of residual aortic regurgitation (RAR). METHODS From November 2007 to September 2010, 115 patients (median age 81 years, inter-quantile range (IQR) 76-85; median ejection fraction 55%, IQR 45-60; median logistic EuroSCORE 19.7, IQR 11.0-32.1) undergoing TAVI were evaluated with a pre-procedural CT. An aortic complex was evaluated with multi-planar reconstructions, and we defined significant early RAR as RAR ≥ 2, and prosthesis/annulus mismatch (PAM) as the ratio between prosthesis size and mean annular size. All analyses were conducted for the whole sample and then separately for the two types of prosthesis implanted. RESULTS An Edwards-SAPIEN(®) prosthesis was implanted in 62 patients (54.7%), and a Medtronic CoreValve(®) in 52 (45.2%). Aortic annulus minimum and maximum diameters were 22.6 ± 2.1 and 26.0 ± 2.3 mm, respectively. The aortic annulus diameter and the length of the free edge of the aortic cusps were linearly related to a 1:1 ratio (P < 0.0001). Significant RAR (34 patients, 30%) appeared directly related to the annulus diameters (particularly maximum and medium diameters, P = 0.0003 and P = 0.0010, respectively) and cusp length (P = 0.0007) but inversely correlated with PAM (P = 0.0006). Prosthesis/annulus oversizing was associated with a reduction in RAR, with a cut-off of 7% as the limit below which RAR increases; moreover, we observed different cut-off values for the Edwards and CoreValve prostheses, although statistical significance was not reached for the CoreValve (respectively, 2% with P < 0.0001, 11% with P = 0.16). No association was found between PAM and possible PAM-related complications. CONCLUSIONS CT evaluation prior to TAVI showed that RAR was directly correlated with aortic root dimensions (particularly maximum and medium annulus diameters and cusp lengths) and inversely correlated with PAM. Oversizing the prosthesis by at least 7% reduces the risk of RAR. CT is an essential and invaluable tool in the assessment of patients undergoing TAVI.

Long-Term Results (≤18 Years) of the Edge-to-Edge Mitral Valve Repair Without Annuloplasty in Degenerative Mitral Regurgitation Implications for the Percutaneous Approach

Background— To assess the long-term results of the edge-to-edge mitral repair performed without annuloplasty in degenerative mitral regurgitation (MR). Methods and Results— From 1993 to 2002, 61 patients with degenerative MR were treated with an isolated edge-to-edge suture without any annuloplasty. Annuloplasty was omitted in 36 patients because of heavy annular calcification and in 25 for limited annular dilatation. A double-orifice repair was performed in 53 patients and a commissural edge-to-edge in 8. Hospital mortality was 1.6%. Follow-up was 100% complete (mean length, 9.2±4.21 years; median, 9.7; longest, 18.1). Survival at 12 years was 51.3±7.75%. At the last echocardiographic examination, MR ≥3+ was demonstrated in 33 patients (55%). At 12 years, freedom from reoperation was 57.8±7.21% and freedom from recurrence of MR ≥3+ was 43±7.6%. Residual MR >1+ at hospital discharge was identified as a risk factor for recurrence of MR ≥3+ (hazard ratio, 3.8; 95% confidence interval, 1.7–8.2; P=0.001). In patients with residual MR ⩽1+ immediately after surgery, freedom from MR ≥3+ at 5 and 10 years was 80±6% and 64±7.58%, respectively. Conclusions— In degenerative MR, the overall long-term results of the surgical edge-to-edge technique without annuloplasty are not satisfactory. Early optimal competence (residual MR ⩽1+) was associated with higher freedom from recurrent severe regurgitation.

Surgical treatment of paravalvular leak: Long-term results in a single-center experience (up to 14 years)

OBJECTIVES The aim of this study is to report the long-term outcomes (median follow-up time, 7 years; range, 1 month to 14 years) of patients who underwent surgery for paravalvular leak in our single-center experience. METHODS From October 2000 to November 2007, 122 consecutive patients underwent surgery for symptomatic paravalvular leak (40 patients with aortic paravalvular leak; 82 with mitral paravalvular leak). In 7 patients (5.7%, all mitral), surgery was performed on the beating heart through a right thoracotomy. In 35% of patients, multiple paravalvular leaks were present. RESULTS The mean age of patients was 62 ± 11 years, and European System for Cardiac Operative Risk Evaluation II was 7.2% ± 6%. Most of the patients were in New York Heart Association functional class III or IV (60%). Symptomatic hemolysis was present in 31% of the patients, and 41% of the patients had more than 1 previous cardiac operation. Paravalvular leak repair was feasible in 79 patients (65%), whereas in 43 patients (35%) prosthesis re-replacement was required. Thirty-day mortality was 10.7% (13/122 patients; 5% for aortic paravalvular leak and 13% for mitral paravalvular leak; P = .1); 2 patients (1.6%) with residual severe mitral paravalvular leak underwent successful redo surgery before discharge. Median length of stay was 7 days. Overall actuarial survival was 39% ± 6% at 12 years; freedom from cardiac death was 54% ± 7% at 12 years. Only 1 patient underwent redo surgery during follow-up. Multivariable analysis identified preoperative chronic renal failure (hazard ratio, 2.6; 95% confidence interval, 1.4-4.9; P = .03) and more than 1 previous cardiac reoperation (hazard ratio, 2.3; 95% confidence interval, 1.3-4; P = .03) as independent predictors of death at follow-up. CONCLUSIONS The operative mortality of surgical treatment of paravalvular leak is still high. Long-term outcomes remain suboptimal in these challenging patients, especially in the presence of multiple previous cardiac operations and associated co-pathologies. These results support the importance of alternative therapeutic options.

Conventional surgery and transcatheter closure via surgical transapical approach for paravalvular leak repair in high-risk patients: results from a single-centre experience.

OBJECTIVES Paravalvular leaks (PVL) occur in up to 17% of all surgically implanted prosthetic valves. Re-operation is associated with high morbidity and mortality. Transcatheter closure via a surgical transapical approach (TAp) is an emerging alternative for selected high-risk patients with PVL. The aim of this study was to compare the in-hospital outcomes of patients who underwent surgery and TA-closure for PVL in our single-centre experience. METHODS From October 2000 to June 2013, 139 patients with PVL were treated in our Institution. All the TA procedures were performed under general anaesthesia in a hybrid operative room: in all but one case an Amplatzer Vascular Plug III device was utilized. RESULTS Hundred and thirty-nine patients with PVL were treated: 122 patients (87.3%) underwent surgical treatment (68% mitral PVL; 32% aortic PVL) and 17 patients (12.2%) underwent a transcatheter closure via a surgical TAp approach (all the patients had mitral PVL; one case had combined mitral and aortic PVLs); in 35% of surgical patients and in 47% of TAp patients, multiple PVLs were present. The mean age was 62.5 ± 11 years; the Logistic EuroScore was 15.4 ± 3. Most of the patients were in New York Heart Association (NYHA) functional class III-IV (57%). Symptomatic haemolysis was present in 35% of the patients, and it was particularly frequent in the TAp (70%). Many patients had >1 previous cardiac operation (46% overall and 82% of TAp patients were at their second of re-operation). Acute procedural success was 98%. In-hospital mortality was 9.3%; no in-hospital deaths occurred in patients treated through a TAp approach. All the patients had less than moderate residual valve regurgitation after the procedure. Surgical treatment was identified as a risk factor for in-hospital death at univariate analysis (OR: 8, 95% CI: 1.8-13; P = 0.05). Overall actuarial survival at follow-up was 39.8 ± 7% at 12 years and it was reduced in patients who had >1 cardiac re-operation (42 ± 8 vs. 63 ± 6% at 9 years; P = 0.009). CONCLUSIONS A transcatheter closure via a surgical TAp approach appears to be a safe and effective therapeutic option in selected high-risk patients with PVL and is associated with a lower hospital mortality than surgical treatment, in spite of higher predicted risk. Long-term survival remains suboptimal in these challenging patients.

Mitral Replacement or Repair for Functional Mitral Regurgitation in Dilated and Ischemic Cardiomyopathy: Is it Really the Same?

BACKGROUND This was a study to compare the results of mitral valve (MV) repair and MV replacement for the treatment of functional mitral regurgitation (MR) in advanced dilated and ischemic cardiomyopathy (DCM). METHODS One-hundred and thirty-two patients with severe functional MR and systolic dysfunction (mean ejection fraction 0.32 ± 0.078) underwent mitral surgery in the same time frame. The decision to replace rather than repair the MV was taken when 1 or more echocardiographic predictors of repair failure were identified at the preoperative echocardiogram. Eighty-five patients (64.4%) received MV repair and 47 patients (35.6%) received MV replacement. Preoperative characteristics were comparable between the 2 groups. Only ejection fraction was significantly lower in the MV repair group (0.308 ± 0.077 vs 0.336 ± 0.076, p = 0.04). RESULTS Hospital mortality was 2.3% for MV repair and 12.5% for MV replacement (p = 0.03). Actuarial survival at 2.5 years was 92 ± 3.2% for MV repair and 73 ± 7.9% for MV replacement (p = 0.02). At a mean follow-up of 2.3 years (median, 1.6 years), in the MV repair group LVEF significantly increased (from 0.308 ± 0.077 to 0.382 ± 0.095, p < 0.0001) and LV dimensions significantly decreased (p = 0.0001). On the other hand, in the MV replacement group LVEF did not significantly change (from 0.336 ± 0.076 to 0.31 ± 0.11, p = 0.56) and the reduction of LV dimensions was not significant. Mitral valve replacement was identified as the only predictor of hospital (odds ratio, 6; 95% confidence interval, 1.1 to 31; p = 0.03) and overall mortality (hazard ratio, 3.1; 95% confidence interval, 1.1 to 8.9; p = 0.02). CONCLUSIONS In patients with advanced dilated and ischemic cardiomyopathy and severe functional MR, MV replacement is associated with higher in-hospital and late mortality compared with MV repair. Therefore, mitral repair should be preferred whenever possible in this clinical setting.

Long-term outcomes of tricuspid valve replacement after previous left-side heart surgery †

OBJECTIVES To assess long-term outcomes of tricuspid valve replacement (TVR) after previous left-side heart surgery. METHODS We reviewed reoperative TVR after left-side heart surgery performed at our institution between March 1997 and June 2012. In-hospital data were retrieved from our institutional database or medical records; follow-up was performed through telephone call, surviving patients being asked to provide a recent (≤6 months) echocardiogram. RESULTS Reoperative TVR was performed in 117 patients. Preoperative characteristics included: mean age 63.7 years, median logistic EuroSCORE (LES) 11.8, New York Heart Association (NYHA) class >2 in 79.5% of patients, right ventricle (RV) dysfunction >mild in 23.9% of patients and mean systolic pulmonary artery pressure (sPAP) 48.4 mmHg. A mechanical prosthesis was implanted in 5.1% of patients. A right thoracotomy was preferred to median sternotomy in 8.6% of cases. Isolated-TVR (I-TVR) was performed in 52.1% of patients, a beating-heart approach being used in 85.2% of I-TVR cases. Postoperative RV failure occurred in 46.1% of patients. Median length-of-stay was 11.5 days. Thirty-day mortality was 6.0% overall and 8.2% in the I-TVR group. Higher preoperative LES (P = 0.002), ascites (P = 0.004), RV dysfunction (P = 0.033) and sPAP (P = 0.046) were associated with acute mortality. No significant difference in acute outcomes was observed between beating and arrested-heart I-TVR, except for postoperative median length-of-stay (9 vs 28 days, respectively, P = 0.007). Among survivors median follow-up time was 5.1 years. Five-year and 10-year freedom from cardiac death were 79.4 and 61.0%, freedom from tricuspid reoperation were 97.3 and 87.5%, freedom from bioprosthesis degeneration were 92.8 and 74.3%, respectively. Five-year and 10-year survival in the I-TVR subgroup were respectively 74.4 and 61.6%. Higher preoperative sPAP was associated with increased follow-up mortality (P = 0.048). At the last follow-up, NYHA class I-II was found in 86.1% of surviving patients. CONCLUSIONS In selected cases, TVR is currently feasible with low acute mortality, especially if performed in the absence of ascites, significant RV dysfunction and pulmonary hypertension. Long-term mortality remains more difficult to predict, although it appeared to be also associated with higher preoperative pulmonary pressure. The global high-complexity profile of these patients is likely to impair long-term outcomes.

Mitral Transcatheter Technologies

Mitral valve regurgitation (MR) is often diagnosed in patients with heart failure and is associated with worsening of symptoms and reduced survival. While surgery remains the gold standard treatment in low-risk patients with degenerative MR, in high-risk patients and in those with functional MR, transcatheter procedures are emerging as an alternative therapeutic option. MitraClip® is the device with which the largest clinical experience has been gained to date, as it offers sustained clinical benefit in selected patients. Further to MitraClip implantation, several additional approaches are developing, to better match with the extreme variability of mitral valve disease. Not only repair is evolving, initial steps towards percutaneous mitral valve implantation have already been undertaken, and initial clinical experience has just started.

MitraClip therapy and surgical edge-to-edge repair in patients with severe left ventricular dysfunction and secondary mitral regurgitation: mid-term results of a single-centre experience†.

OBJECTIVES To compare the surgical and percutaneous edge-to-edge (EE) repair in patients with severe left ventricular (LV) dysfunction and secondary mitral regurgitation (MR). METHODS We reviewed the prospectively collected data of the first 120 consecutive patients (age: 65 ± 9.8 years, EF: 28 ± 8.2%) treated with surgical (65 patients) or percutaneous (55 patients) EE repair for severe secondary MR in our institution. Age (P = 0.005) and logistic European System for Cardiac Operative Risk Evaluation (P < 0.0001) were significantly higher in the MitraClip group. LVEF (P = 0.37), end-diastolic (P = 0.83) and end-systolic (P = 0.68) volumes and systolic pulmonary artery pressure (SPAP) (P = 0.58) were similar. The follow-up was 100% complete [median: 4 years; interquartile range (IQR): 2.2-7.2]. RESULTS The length of hospital stay was 10 days (IQR: 8-13) for surgery and 5 days (IQR: 3.9-7.8) for MitraClip (P < 0.0001). Hospital mortality (3 vs 0%, P = 0.49) and freedom from cardiac death at 4 years (80.8 ± 4.9% vs 79.1 ± 5.9%, P = 0.9) were not significantly different in the surgical and MitraClip group, respectively. Residual MR ≥ 2+ at hospital discharge was 7.6% for surgery and 29% for MitraClip (P = 0.002). At 4 years, freedom from MR ≥ 2+ (74.9 ± 5.6% vs 51.4 ± 7.4%, P = 0.01) and freedom from MR ≥ 3+ (92.8 ± 3.4% vs 68.1 ± 7%, P = 0.002) were both significantly higher in the surgical group. Multivariate analysis identified the use of MitraClip as an independent predictor of recurrence of MR ≥ 2+ [Hazard ratio (HR): 2.1, 95% confidence interval (CI): 1.1-3.9, P = 0.02] as well as of MR ≥ 3 (HR: 6.1, 95% CI: 1.5-24.3, P = 0.01). In the surgical group, no predictors of cardiac mortality were identified. In the MitraClip group, left ventricular end-diastolic diameter (HR: 1.1, 95% CI: 1-1.2, P = 0.005) and SPAP (HR: 1, 95% CI: 1-1.1, P = 0.005) were independent predictors of cardiac death at the follow-up. CONCLUSIONS MitraClip therapy is a safe therapeutic option in selected high-risk patients with secondary MR and relevant comorbidities. The surgical EE provides higher efficacy both postoperatively and at the mid-term follow-up.