MitraClip Implantation for the Treatment of New-Onset Systolic Anterior Motion of the Mitral Valve After Transcatheter Aortic Valve Replacement.

New-onset systolic anterior motion of the anterior mitral valve leaflet in patients undergoing transcatheter aortic valve replacement is a rare pathophysiologic mechanism leading to postprocedural development of mitral regurgitation and, eventually, left ventricular outflow obstruction. We report the first human case of successful MitraClip implantation to treat new-onset systolic anterior motion of the mitral valve after transcatheter aortic valve replacement causing severe obstruction to left ventricular outflow that was unresponsive to standard medical therapy.

Percutaneous mitral valve repair with the MitraClip system in the elderly: One-year outcomes from the GRASP registry.

BACKGROUND: Although mitral regurgitation (MR) affects a relevant and increasing number of elderly, an optimal management of this high-risk population is challenging. METHODS AND RESULTS: The aim of this prospective, observational study was to compare one-year outcomes of MitraClip therapy in high surgical risk patients with moderate-to-severe or severe MR between patients aged <75 versus ≥75years. A total of 180 patients were included: 92 were <75years and 88 were ≥75years old. At one-year follow-up the primary efficacy endpoint (composite of death, surgery for mitral valve dysfunction and grade 3+ or 4+ MR) occurred in 41 patients (24.5%), with similar rates between those aged <75years (23.9%) and those ≥75years (25.2%), p=0.912. A total of 21 (12.2%) deaths were observed within 1year after the MitraClip procedure, without significant differences in cumulative mortality rates between elderly and younger patients (10.8% vs. 13.3%, respectively, p=0.574). Compared with baseline, the significant reduction in MR severity achieved after the procedure was sustained at one-year follow-up, in both elderly and younger patients and a significant improvement in NYHA functional class was observed in both groups. A total of 18 (10.0%) patients experienced a re-hospitalization for acute heart failure within one-year after the MitraClip procedure, with no significant differences between elderly and younger. At one-year follow-up both elderly and younger patients showed significant reductions in left ventricular volumes, with changes of similar extent between the two subgroups. CONCLUSIONS: MitraClip therapy can be considered a viable option also among subsets with more advanced age.

Impact of chronic kidney disease on outcomes after percutaneous mitral valve repair with the MitraClip system: insights from the GRASP registry.

AIMS: Our aim was to evaluate the impact of baseline chronic kidney disease (CKD) on clinical outcomes after percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS: Two hundred and fourteen consecutive patients dichotomised by the presence of baseline CKD (n=113) or no-CKD (n=101) had their clinical outcomes compared up to 12-month follow-up. The primary safety endpoint was the incidence of major adverse events and the primary efficacy endpoint was freedom from death, surgery for MV dysfunction, or grade ≥3+ MR. The primary safety endpoint was demonstrated in 12.4% vs. 2.0% in CKD and no-CKD patients, respectively (p=0.003). The primary efficacy endpoint at 12 months was significantly lower in CKD patients (65.8% vs. 84.2%, respectively, log-rank p=0.005). While MR reduction and NYHA functional class improvement were mostly sustained and equivalent up to 12 months in no-CKD patients, they were impaired in CKD patients. Baseline CKD was an independent predictor of the primary efficacy endpoint (adjusted HR 2.48, 95% CI: 1.29 to 4.79, p=0.006) and calcified leaflet predicted grade ≥3+ MR at 12 months (adjusted HR 6.56, 95% CI: 2.71 to 15.88, p<0.001). CONCLUSIONS: CKD patients had worse clinical outcomes compared with no-CKD patients post PMVR. CKD was an independent predictor of the primary efficacy endpoint, whereas calcified leaflet was an independent predictor of grade ≥3+ MR at 12 months.

Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry.

OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.

Gender-related clinical and echocardiographic outcomes at 30-day and 12-month follow up after MitraClip implantation in the GRASP registry.

OBJECTIVES: To assess the influence of patients' gender on the outcomes of percutaneous edge-to-edge mitral valve repair (PMVR) using the MitraClip system. BACKGROUND: Although gender-related differences have been extensively documented in patients who undergo surgery for moderate-to-severe (3+) and severe (4+) mitral regurgitation (MR), studies assessing whether these differences exist after PMVR are lacking. METHODS: Clinical and echocardiographic data through 12-month follow up from 171 consecutive patients whom underwent MitraClip implantation and were dichotomized by the gender (106 males and 65 females) were obtained. The primary safety endpoint was the incidence of major adverse events at 30 days and the primary efficacy endpoint was freedom from death, surgery for mitral valve dysfunction, or grade≥3+ MR at 12-month follow up. RESULTS: The primary safety endpoint was observed in four males (3.8%) and four females (6.2%) (P=0.358). Remarkable reduction in MR postprocedure was revealed in both groups, and these results were mostly sustained. Furthermore, left ventricle reverse remodeling and New York Heart Association (NYHA) functional class improvement were revealed in both groups, but females tended to demonstrate worse results over time (P=0.083). The primary efficacy endpoint obtained by Kaplan-Meier estimates was observed in 76.3 and 70.2%, respectively (log rank P=0.231). CONCLUSIONS: MitraClip implantation in patients with 3+ and 4+ MR is safe and efficacious until mid-term follow up, regardless of patients' gender. Despite improvement in NYHA functional class in both groups, female gender demonstrated a trend toward poorer results. Further validation of our findings is warranted.

Association of tricuspid regurgitation with clinical and echocardiographic outcomes after percutaneous mitral valve repair with the MitraClip System: 30-day and 12-month follow-up from the GRASP Registry.

AIM: The aim of this study was to evaluate the association of baseline tricuspid regurgitation (TR) on the outcomes after percutaneous mitral valve repair (PMVR) with the MitraClip system. METHODS AND RESULTS: Data from 146 consecutive patients with functional mitral regurgitation (MR) were obtained. Two different groups, dichotomized according to the degree of pre-procedural TR (moderate/severe, n = 47 and none/mild, n = 99), had their clinical and echocardiographic outcomes through 12-month compared. At 30-day, the primary safety endpoint was significantly higher in moderate/severe TR compared with none/mild TR (10.6 vs. 2.0%, P = 0.035). Marked reduction in MR grades observed post-procedure were maintained through 12 months. Although NYHA functional class significantly improved in both groups compared with baseline, it was impaired in moderate/severe TR compared with the none/mild TR group (NYHA > II at 30 day: 33.3 vs. 9.2%, P < 0.001; at 1 year: 38.5 vs. 12.3%, respectively, P = 0.006). Left ventricle reverse remodelling and ejection fraction improvement were revealed in both groups. The primary efficacy endpoint at 12-month determined by freedom from death, surgery for mitral valve dysfunction, or grade ≥ 3+ MR was comparable between groups, but combined death and re-hospitalization for heart failure rates were higher in the moderate/severe TR group. Multivariable Cox regression analysis demonstrated that baseline moderate/severe TR and chronic kidney disease were independent predictors of this combined endpoint. CONCLUSIONS: Although PMVR with MitraClip led to improvement in MR, TR, and NYHA functional class in patients with baseline moderate/severe TR, the primary safety endpoint at 30-day was impaired, while moderate/severe TR independently predicted death and re-hospitalization for heart failure at 12-month.

Late MitraClip procedure after left atrial appendage occlusion: indication and procedure description.

We report the first human case of percutaneous edge-to-edge mitral valve repair using MitraClip System (Abbott Vascular, Abbott Park, IL) in a patient, who previously underwent left atrial appendage closure with PLAATO™ System (ev3. Inc., Plymouth, MN). The procedure was successfully performed using the standard MitraClip technique, in the catheterization laboratory, with transesophageal echocardiographic and fluoroscopic guidance. We showed that a double percutaneous procedure for stroke prevention and mitral regurgitation treatment might be a valid approach in selected patients ineligible for chronic anticoagulation therapy and at high risk for conventional cardiac surgery.

One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry).

The aim of this study was to report on the 30-day and 1-year outcomes of percutaneous mitral valve repair with the MitraClip technique in patients with grade ≥3+ mitral regurgitation (MR) at high risk for conventional surgical therapy enrolled in the prospective Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation (GRASP) registry. Acute device success was defined as residual MR ≤2+ after clip implantation. The primary safety end point was the rate of major adverse events at 30 days. The primary efficacy end point was freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 30 days and 1 year. A total of 117 patients were treated. Eighty-nine patients (76%) presented with functional MR and 28 patients (24%) with organic MR. Acute device success was observed in all patients. Device implantation time significantly diminished with experience and varied significantly between cases with 1 versus ≥2 clips. No procedural mortality was recorded. Major adverse events occurred in 4 patients at 30 days (4.3%). Deterioration to MR ≥3+ was recorded in 25% of patients with degenerative MR and 7% of those with functional MR at 1 year. No surgery for mitral valve dysfunction occurred within 1 year. Freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR was 96.4% and 75.8% at 30 days and 1 year, respectively. No significant differences were noted in the primary efficacy end point between patients with degenerative MR and those with functional MR. In conclusion, percutaneous mitral valve repair with the MitraClip technique was shown to be safe and reasonably effective in 117 patients from a real-world setting.

Multifrequency ultrasound-assisted liposuction: 5 years of experience.

BACKGROUND: The use of ultrasound in liposuction was first introduced by Kloehn. The ultrasound frequencies used in this technology have a high degree of selectivity for fat cells, thus reducing blood loss, postoperative edema, and ecchymosis and avoiding contour irregularities. The authors report their 5 years of experience with a multifrequency ultrasound generator and describe their series with the aim to focus attention on the problems linked with ultrasound use. METHODS: A total of 797 patients were selected to receive ultrasound assisted liposuction (UAL). Accurate preoperative planning was conducted for all the patients before admission to the surgical quarter. Liposuction was performed using general anesthesia for 538 patients (63 %), peripheral anesthesia for 220 patients (25.76 %), and local anesthesia for 96 patients (11.24 %). The ultrasound generator device was set by choosing the better working protocol (continuous or pulsed mode) according to the tissue characteristics, and the frequency test was performed. A photo of the patient was taken before surgery and at every follow-up visit to estimate the results and to have an objective evaluation of the outcome. The patient's opinion of the results also was recorded using a graduated scale. RESULTS: The results were excellent in 204 cases (25.4 %), good in 356 cases (44.6 %), moderate in 174 cases (22 %), and poor in 63 cases (8 %). CONCLUSIONS: For body contour improvement, UAL is an essential procedure. The introduction of multifrequency UAL, or rather the possibility of using the better working frequency during the treatment, allows better results, thus improving patient outcome. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article.

Left cardiac chambers reverse remodeling after percutaneous mitral valve repair with the MitraClip system.

BACKGROUND: Successful mitral valve surgical repair, decreasing volume overload, has been shown to provide reverse left ventricular (LV) and/or left atrial remodeling in most patients. Percutaneous mitral valve repair with the MitraClip system (Abbott, Abbott Park, IL) has been associated with favorable clinical outcomes in patients with mitral regurgitation at high risk of surgery. However, specific data on left cardiac chambers reverse remodeling after such procedures are limited. METHODS: This was a prospective observational study of consecutive patients at high risk of surgery, with moderate-to-severe or severe mitral regurgitation undergoing MitraClip system implantation. Follow-up echocardiography was performed at 6 months. The evaluated parameters were the LV end-diastolic and end-systolic volume indexes, LV sphericity index, LV ejection fraction, and left atrial volume index. Reverse LV remodeling was defined as a decrease of 10% in the LV end-diastolic volume index. RESULTS: The study population included 44 patients: 14 with degenerative and 30 with functional mitral regurgitation. At 6 months of follow-up, significant reductions in the median and interquartile range of the sphericity index (from 0.57 [interquartile range 0.54-0.62] to 0.54 [interquartile range 0.50-0.58]; P < .001), LV end-diastolic volume index (from 79.4 mL/m(2) [interquartile range 63.0-102.2] to 60.7 mL/m(2) [50.8-84.4]; P < .001), and LV end-systolic volume index (from 49.3 mL/m(2) [interquartile range 28.2-70.5] to 28.9 mL/m(2) [interquartile range 22.2-55.8]; P < .001) were observed. The LV ejection fraction improved significantly (from 38.0% [interquartile range 30.0-55.0%] to 46.0% [interquartile range 35.0-58.0%]; P < .001) from baseline to 6 months. Minor differences in the left atrial volume index were observed. Reverse remodeling, according to the specified definition, was observed in 77.3% of the patients. CONCLUSIONS: The present study reports positive LV reshape effects after mitral valve repair with the MitraClip system, showing significant improvements in LV size and function.

[Percutaneous repair of mitral regurgitation: a new tool in the armamentarium for advanced heart failure?]. / Correzione percutanea dell'insufficienza mitralica: un nuovo strumento nell'armamentario per lo scompenso cardiaco?

Mitral regurgitation (MR) is the second most common heart valve disease worldwide, requiring surgical intervention in Europe. The current gold-standard treatment is surgical repair or replacement. Despite clear international guidelines, many patients do not undergo surgical intervention due to comorbidities, real or perceived high risk for cardiac surgery. The treatment of patients with functional MR in advanced heart failure has unsatisfactory results in terms of long-term survival as shown by retrospective small surgical experiences even if there is weak evidence for beneficial effects on left ventricular remodeling and functional capacity. Nevertheless, the appropriateness and timing of valve surgery in patients with advanced heart failure remain controversial. Based on these results, the focus of research has shifted in recent years to the development of percutaneous approaches to treat severe MR, in order to restore valve function in a minimally invasive fashion. Currently, various percutaneous techniques are under investigation in clinical trials and others have been developed, based on the surgical principles of mitral valve repair. This article focuses on the percutaneous mitral valve repair procedure using the MitraClip system (Abbott Vascular, Abbott Park, Illinois, USA). This approach that reproduces the edge-to-edge technique described by Alfieri, is safe and effective in improving functional class and reducing rehospitalization rates for heart failure patients.

Percutaneous mitral valve repair in patients with prior cardiac surgery.

BACKGROUND AND AIM OF THE STUDY: The safety of percutaneous mitral valve repair with the MitraClip system has been documented. However, few data are available on high-risk patients not amenable to surgery. The aim of this study was to evaluate the outcomes of patients with prior cardiac surgery undergoing MitraClip therapy (Abbott, Abbott Park, Chicago, IL, USA) for severe mitral regurgitation. METHODS: We reported two cases of percutaneous treatment of severe mitral regurgitation performed in patients who had previously undergone cardiac surgery with the implantation of mechanical prosthetic aortic valve. RESULTS: In both the reported cases a sustained reduction in mitral regurgitation severity was obtained at two-year follow-up, with a relevant improvement in terms of clinical status and quality of life. CONCLUSIONS: Percutaneous mitral valve repair using the MitraClip system represents a viable treatment choice for severe mitral regurgitation in high-risk patients who have previously undergone cardiac surgery.

Echocardiographic-based treatment of functional tricuspid regurgitation.

OBJECTIVES: Functional tricuspid regurgitation (FTR) worsens over time, and its natural history is unfavorable. An aggressive surgical strategy, using the echocardiographic systolic dimensions of the tricuspid annulus (sysTA), can be helpful to reduce the detrimental late effects of FTR. METHODS: From March 2006 to February 2008, 298 patients, with at least FTR grade 1+, underwent mitral valve surgery. Of these 298 patients, 167 underwent tricuspid repair (treated group [T], moderate-or-greater FTR in 108 and mild in 59, with sysTA > 24 mm) and 137 did not (untreated group [UT], moderate-or-greater FTR in 16 and mild in 115; 81 with sysTA > 24 mm and 34 with sysTA of ≤ 24 mm). The 256 survivors underwent echocardiographic examination at a mean follow-up of 13 ± 8 months. RESULTS: Preoperatively, at discharge, and at the follow-up examination, the mean FTR grade was 1.11 ± 0.32, 0.87 ± 0.49, and 1.03 ± 0.57 (P = NS) in the UT group and 2.11 ± 0.92, 0.45 ± 0.36, and 0.48 ± 0.32 (P < .001) in the T group. A total of 24 patients had FTR grade 2 or greater, 16 (14.5%) in the UT group and 8 (5.5%) in the T group (P = .026). In the UT group, 10 of 16 patients had sysTA of 25 to 28 mm and 6 of 10 had sysTA greater than 28 mm. No patient with mild FTR and sysTA of 24 mm or less had an increased FTR grade. Globally, 12 patients (10.9%) had an increased FTR grade in the UT group versus none in the T group (P < .001). Patients with postoperative atrial fibrillation had less residual FTR if annuloplasty had been performed (1.6 ± 0.7 vs 0.91 ± 0.63, P = .005). CONCLUSIONS: An aggressive strategy for FTR correction, using the sysTA, was able to reduce the FTR grade 1 year after surgery, but mitral surgery alone could not.

Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting.

AIMS: This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip system (Evalve, Inc., Menlo Park, CA, USA). METHODS AND RESULTS PATIENTS: were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < or =2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of >2 units of blood, ventilation for >48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days. CONCLUSION: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.

Spontaneous coronary artery dissection: a report of two atypical cases.

Spontaneous coronary artery dissection is a rare pathology that has no exact incidence, etiology, pathogenesis and evolution in literature. We report two cases of two women with coronary artery dissection, uncommon clinical presentation of acute coronary syndrome and without identifiable risk factors. A review of the literature and the management of this condition are presented.

A simple method to obtain the correct length of the artificial chordae in complex chordal replacement.

BACKGROUND: Different techniques have been proposed to measure the correct length of artificial chordae. We herein describe a new simple method to measure the chordal length in complex chordal replacement. METHOD: Chordal replacement was used by us for two different purposes: (1) to maintain the correct chordal length for the anterior leaflet (AL) and (2) to eliminate any movement of the posterior leaflet (PL) to fix it. To reach this goal, the AL is pulled up to the maximum extent and the new chordae are tied 5 mm higher than the related border. On the contrary, in the PL the new chordae are tied at the level of the related border. RESULTS: From March 2006 to March 2007, at the University of Catania, this technique was used in 32 patients (16 for correction of PL prolapse, 6 patients for correction of AL prolapse, and in 10 patients for correction of both leaflets prolapse). The number of chordae per patients was 8.6 for the PL and 6.8 for the AL. No patient died or had major complications. After a mean follow-up of 5 +/- 2 months, two-dimensional echocardiography showed that all the patients had no or trivial mitral regurgitation (MR). The echocardiogram showed a correct movement of the new chordae. CONCLUSIONS: This technique allows to easily establish the length of the new chordae of the AL and, if necessary, of the PL in complex mitral valve repair.