Maurizio Taramasso

Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

OBJECTIVES Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion. BACKGROUND Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis. METHODS We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach. RESULTS A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events. CONCLUSIONS Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.

The Growing Clinical Importance of Secondary Tricuspid Regurgitation

Functional or secondary tricuspid regurgitation (STR) is the most frequent etiology of tricuspid valve pathology in Western countries. Surgical tricuspid repair has been avoided for years, because of the misconception that tricuspid regurgitation should disappear once the primary left-sided problem is treated; this results in a large number of untreated patients with STR. Over the past few years, many investigators have reported evidence in favor of a more aggressive surgical approach to STR. Consequently, interest has been growing in the physiopathology and treatment of STR. The purpose of this review is to explore the anatomical basis, pathophysiology, therapeutic approach, and future perspectives with regard to the management of STR.

A new technique for vascular access management in transcatheter aortic valve implantation

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty‐two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards‐Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards‐Sapien) or one (CoreValve). There were serious “on‐table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites.

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

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.

Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial

AIMS Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. CONCLUSIONS This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

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.

Transcatheter Treatment of Severe Tricuspid Regurgitation with the Edge-to-Edge: MitraClip Technique.

Background: Current surgical and medical treatment options for severe tricuspid regurgitation (TR) are limited, and additional interventional approaches are required. In the present observational study, the safety and feasibility of transcatheter repair of chronic severe TR with the MitraClip system were evaluated. In addition, the effects on clinical symptoms were assessed. Methods: Patients with heart failure symptoms and severe TR on optimal medical treatment were treated with the MitraClip system. Safety, defined as periprocedural adverse events such as death, myocardial infarction, stroke, or cardiac tamponade, and feasibility, defined as successful implantation of 1 or more MitraClip devices and reduction of TR by at least 1 grade, were evaluated before discharge and after 30 days. In addition, functional outcome, defined as changes in New York Heart Assocation class and 6-minute walking distance, were assessed. Results: We included 64 consecutive patients (mean age 76.6±10 years) deemed unsuitable for surgery who underwent MitraClip treatment for chronic, severe TR for compassionate use. Functional TR was present in 88%; in addition, 22 patients were also treated with the MitraClip system for mitral regurgitation as a combined procedure. The degree of TR was severe or massive in 88% of patients before the procedure. The MitraClip device was successfully implanted in the tricuspid valve in 97% of the cases. After the procedure, TR was reduced by at least 1 grade in 91% of the patients, thereof 4% that were reduced from massive to severe. In 13% of patients, TR remained severe after the procedure. Significant reductions in effective regurgitant orifice area (0.9±0.3cm2 versus 0.4±0.2cm2; P<0.001), vena contracta width (1.1±0.5 cm versus 0.6±0.3 cm; P=0.001), and regurgitant volume (57.2±12.8 mL/beat versus 30.8±6.9 mL/beat; P<0.001) were observed. No intraprocedural deaths, cardiac tamponade, emergency surgery, stroke, myocardial infarction, or major vascular complications occurred. Three (5%) in-hospital deaths occurred. New York Heart Association class was significantly improved (P<0.001), and 6-minute walking distance increased significantly (165.9±102.5 m versus 193.5±115.9 m; P=0.007). Conclusions: Transcatheter treatment of TR with the MitraClip system seems to be safe and feasible in this cohort of preselected patients. Initial efficacy analysis showed encouraging reduction of TR, which may potentially result in improved clinical outcomes.

First-in-man implantation of a tricuspid annular remodeling device for functional tricuspid regurgitation

Tricuspid regurgitation (TR) is a common finding in patients with left-sided disease, and is associated with poor outcome and predicts poor survival, heart failure, and reduced functional capacity [(1)][1]. It is common after mitral valve treatment in rheumatic or ischemic mitral regurgitation, if

Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.