Andrea Guidotti

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.

Percutaneous tricuspid valve therapies: the new frontier

Moderate-to-severe tricuspid regurgitation (TR) affects ∼1.6 million patients in the USA, of whom only 8000 undergo tricuspid surgery annually; this results in an extremely large number of untreated patients with significant TR. Therefore, there is a large unmet clinical need for patients with severe TR who are not referred for conventional surgery, mainly due to expected high surgical risk. Percutaneous procedures are an attractive alternative to surgery for patients deemed to be high-risk surgical candidates. Whereas over the past few years, the development and clinical use of percutaneous approaches to the aortic valve and mitral valve have been widespread, few data are available about the feasibility and the efficacy of the percutaneous tricuspid valve treatment. This review will explore the available technologies, which are today under evaluation and the preliminary clinical results.

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.

First-in-Man Transseptal Implantation of a “Surgical-Like” Mitral Valve Annuloplasty Device for Functional Mitral Regurgitation

Undersized annuloplasty is an established first-line therapy option for functional mitral regurgitation (MR) [(1)][1]. Percutaneous direct annuloplasty as a stand-alone therapy, as well as in combination with other transcatheter mitral interventions, aims to reproduce surgical annuloplasty [(2)][2

Afterload Mismatch After MitraClip Insertion for Functional Mitral Regurgitation

Afterload mismatch, defined as acute impairment of left ventricular function after mitral surgery, is a major issue in patients with low ejection fraction and functional mitral regurgitation (FMR). Safety and efficacy of MitraClip therapy have been assessed in randomized trials, but limited data on its acute hemodynamic effects are available. This study aimed to investigate the incidence and prognostic role of afterload mismatch in patients affected by FMR treated with MitraClip therapy. We retrospectively analyzed patients affected by FMR and submitted to MitraClip therapy from October 2008 to December 2012. Patients were assigned to 2 groups according to the occurrence of the afterload mismatch: patients with afterload mismatch (AM+) and without afterload mismatch (AM-). Of 73 patients, 19 (26%) experienced afterload mismatch in the early postoperative period. Among preoperative variables, end-diastolic diameter (71 ± 8 vs 67 ± 7 mm, p = 0.02) and end-systolic diameter (57 ± 9 vs 53 ± 7 mm, p = 0.04) were both significantly larger in AM+ group. An increased incidence of right ventricular dysfunction (68% vs 31%, p = 0.049) and pulmonary hypertension (49 ± 10 vs 40 ± 10 mm Hg, p = 0.0009) was found in AM+ group. Before hospital discharge, left ventricular ejection fraction (LVEF) became similar in both groups (31 ± 9% vs 33 ± 11%, p = 0.65). Long-term survival was comparable between the 2 groups (p = 0.44). A low LVEF in the early postoperative period (LVEF <17%) was significantly associated with higher mortality rate in long-term follow-up (p = 0.048). In conclusion, reduction of mitral regurgitation with MitraClip can cause afterload mismatch; however, this phenomenon is transient, without long-term prognostic implications.

Quality of life of elderly patients following valve surgery for chronic organic mitral regurgitation

OBJECTIVE Mitral valve surgery for organic mitral regurgitation (MR) in the elderly has been debated. In the elderly, quality of life is a better indicator of surgical success than survival. We assessed quality of life of elderly patients submitted to surgery for MR using the Minnesota Living with Heart Failure (MLHF) questionnaire. METHODS Between August 2003 and August 2006, 225 consecutive patients >70 years old underwent surgical treatment of organic MR. Mean age was 77 +/- 3.3 years (range 71-87 years). Mean EF was 50 +/- 11%. Degenerative disease was the most prevalent (77%) etiology. CABG was associated in 25% of patients. Mean Charlson score was 4.3 +/- 1.5 and 101 patients (45%) were NYHA class III and IV. Hospital survivors were followed up and quality of life by MLHF score was assessed. RESULTS Mitral repair and replacement were equally distributed in this population. Hospital mortality was 2.7%. Late survival was 91 +/- 1.9% at 3 years. MLHF was obtained from 204 patients at mean 2 +/- 1 years of follow-up. MLHF score was 38 +/- 18; there were 135 (66%) patients with MLHF >30. MLHF tended to increase with age at follow-up (p = 0.007). Multivariable predictors of MLHF were preoperative atrial fibrillation (p = 0.019), diabetes (p = 0.03), higher creatinine level (p = 0.0009), higher EuroSCORE (p = 0.02), residual mitral regurgitation grade at follow-up echocardiography (p < 0.0001) and systolic pulmonary artery pressure at follow-up (p = 0.04). Type of surgical treatment (repair vs replacement and choice of prosthesis) did not predict MLHF at follow-up, although those who had recurrent MR after repair had the highest scores compared to patients who had repair and durable result and those treated by replacement (MLHF was 51 +/- 21, vs 34 +/- 16, vs 39 +/- 18, respectively, p = 0.0013). CONCLUSIONS Quality of life following mitral valve surgery is suboptimal in more than half of elderly patients. MLHF score at follow-up is mostly related to preoperative conditions. Type of surgery does not influence MLHF score, however, quality of life is worse in patients with recurrent/residual MR following repair.

Transapical endovascular implantation of neochordae using a suction and suture device

OBJECTIVE Neochordae implantation is a standard method for treatment of mitral valve prolapse. We describe a transcatheter technology enabling transapical endovascular chordal implantation. METHODS Six adult pigs were anesthetized. Two 10F sheaths were introduced in the femoral vessels for monitoring and intracardiac echo. After midline sternotomy, the pericardium was opened, the apex was punctured inside two 2-0 polypropylene purse strings. A 0.035 in J tipped guidewire was introduced in the left ventricle and an ultra stiff 14F sheath (guide catheter) inserted through the apex. A suction-and-suture device was introduced in the left ventricle. The mitral valve was crossed under echo guidance. Using suction, either the anterior (two cases) or posterior (four cases) leaflet was captured and a loop of 4-0 polypropylene was thrown at the edge of the leaflet. The loop, with a pledget, was exteriorized through the introducer. The introducer was removed and the purse-string tied. Under echo guidance, the neochordae suture was pulled and tied over a pledget to evoke leaflet tethering. The animals were sacrificed and gross anatomy reviewed. RESULTS Leaflet capture was feasible in the intended location in all cases. Following suture tethering, variable degrees of MR were obtained. At gross anatomy, the neochordae were positioned at 1-4mm from the leaflet free edge, and were firmly attached to the leaflets. CONCLUSIONS Transcatheter endovascular neochordae implantation is feasible. A prolapse model is needed to further demonstrate feasibility under pathologic conditions. The apical approach allows easy and direct route to transcatheter beating heart minimally invasive mitral repair.

Transcatheter direct mitral annuloplasty with Cardioband: feasibility and efficacy trial in an acute preclinical model.

AIMS The aim of the study was to report preclinical safety and feasibility of a new transcatheter direct mitral annuloplasty intervention in an acute animal model. METHODS AND RESULTS Twenty healthy pigs underwent Cardioband (Valtech Cardio, Or Yehuda, Israel) transcatheter implantation under intracardiac echocardiographic and fluoroscopic guidance. Through a neo inferior vena cava approach, transseptal access was arranged. The device was delivered into the left atrium using a multi-steerable catheter and fixed to the mitral annulus with multiple helix anchors. Following device cinching, reduction of annular size was evaluated. In all animals the device could be successfully implanted and displayed 100% function, with the average procedure duration and fluoroscopy times being 78±23 minutes and 27±9 minutes, respectively. In total, 246 anchors (average 12.3 per device) were delivered and optimal anchor placement was achieved in 95.1%, while inadequate anchor position (4%) and injury of the coronary sinus or atrium (0.8%) occurred in the rest. Following maximal cinching, diastolic transmitral flow velocity and coaptation lengths were markedly increased (p<0.001), whereas septolateral and intercommissural distances were significantly decreased (p<0.001), when compared to pre-contraction baseline, demonstrating efficient annular reduction by the device. CONCLUSIONS Transcatheter direct annuloplasty with a surgical-like adjustable device is feasible in the porcine animal model. The humanised porcine model has been instrumental in demonstrating feasibility and in establishing the procedural steps.

Transcatheter direct mitral valve annuloplasty with the Cardioband system for the treatment of functional mitral regurgitation.

Direct mitral valve annuloplasty is a transcatheter mitral valve repair approach that mimics the conventional surgical approach to treat functional mitral regurgitation. The Cardioband system (Valtech Cardio, Inc., Or-Yehuda, Israel) is delivered by a trans-septal approach and the implant is performed on the atrial side of the mitral annulus, under live echo and fluoroscopic guidance using multiple anchor elements. The Cardioband system obtained CE mark approval in October 2015, and initial clinical experiences are promising with regard to feasibility, safety and efficacy.