Valeria Cammalleri

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 ≤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.

Dual Antiplatelet Therapy Versus Aspirin Alone in Patients Undergoing Transcatheter Aortic Valve Implantation

Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin is a widely accepted strategy in patients undergoing transcatheter aortic valve implantation (TAVI), but this approach is not evidence based. The goal of the present study was to determine whether DAPT in patients undergoing TAVI is associated with improved outcomes compared to aspirin alone. From May 2009 to August 2010, consecutive patients were randomized to receive a 300-mg loading dose of clopidogrel on the day before TAVI followed by a 3-month maintenance daily dose of 75 mg plus aspirin 100 mg lifelong (DAPT group) or aspirin 100 mg alone (ASA group). The primary end point was the composite of major adverse cardiac and cerebrovascular events, defined as death from any cause, myocardial infarction, major stroke, urgent or emergency conversion to surgery, or life-threatening bleeding. The cumulative incidence of major adverse cardiac and cerebrovascular events at 30 days and 6 months was 14% and 16%, respectively. No significant differences between the DAPT and ASA groups were noted at both 30 days (13% vs 15%, p = 0.71) and 6 months (18% vs 15%; p = 0.85). In conclusion, the strategy of adding clopidogrel to aspirin for 3 months after TAVI was not found to be superior to aspirin alone. These results must be confirmed in a larger randomized trial.

Quality of life assessment after percutaneous aortic valve implantation

AIMS To assess the NYHA class and the quality of life (QoL) scores after percutaneous aortic valve implantation (PAVI) with the 18-Fr CoreValve prosthesis. METHODS AND RESULTS From April 2007 until August 2008, 57 consecutive patients with aortic stenosis were evaluated for PAVI. Of these, 30 patients with successfully prosthesis implantation had more than 5-month follow-up. QoL assessment was realized with the SF-12v2 Health-Survey, a simple questionnaire designed for self-administration that provides easily interpretable scales for physical [physical component summary (PCS)] and mental [mental component summary (MCS)] health. The questionnaire was administered before and 5 months after PAVI. All 30 patients had a marked upgrading in haemodynamic and echocardiographic parameters (peak-to-peak gradient from 64 +/- 23 to 2 +/- 0.4; P < 0.001; aortic valve area index from 0.3 +/- 0.1 to 0.9 +/- 0.3; P < 0.001), with an improvement in New York Heart Association (NYHA) class at discharge and after 5 months. Mean pre-operative SF-12v2 scores showed a severe impairment of perceived quality of life compared with general Italian population >75 years, both for physical (PCS-baseline 28.5 vs. 37.9, P < 0.001) and mental scores (MCS-baseline 37.8 vs. 45.4, P < 0.001). After 5 months, a striking improvement in both scores (PCS 41.3-MCS 48.3; P < 0.001) was observed. CONCLUSION Our preliminary results show a marked short-term improvement in functional status and physical and mental health in patients underwent PAVI.

Comparison of Complications and Outcomes to One Year of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis

Comparisons of transcatheter aortic valve implantation (TAVI) to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis remain sparse or limited by a short follow-up. We sought to evaluate early and midterm outcomes of consecutive patients (n = 618) undergoing successful TAVI (n = 218) or isolated SAVR (n = 400) at 2 centers. The primary end point was incidence of Valvular Academic Research Consortium-defined major adverse cerebrovascular and cardiac events (MACCEs) up to 1 year. Control of potential confounders was attempted with extensive statistical adjustment by covariates and/or propensity score. In-hospital MACCEs occurred in 73 patients (11.8%) and was more frequent in patients treated with SAVR compared to those treated with TAVI (7.8% vs 14.0%, p = 0.022). After addressing potential confounders using 3 methods of statistical adjustment, SAVR was consistently associated with a higher risk of MACCEs than TAVI, with estimates of relative risk ranging from 2.2 to 2.6 at 30 days, 2.3 to 2.5 at 6 months, and 2.0 to 2.2 at 12 months. This difference was driven by an adjusted increased risk of life-threatening bleeding at 6 and 12 months and stroke at 12 months with SAVR. Conversely, no differences in adjusted risk of death, stroke and myocardial infarction were noted between TAVI and SAVR at each time point. In conclusion, in a large observational registry with admitted potential for selection bias and residual confounding, TAVI was not associated with a higher risk of 1-year MACCEs compared to SAVR.

Management of implant failure during transcatheter aortic valve implantation

Background: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub‐optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. Methods: Of 110 patients who underwent TAVI using the third generation 18‐French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid‐term follow up. Results: Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under‐expansion conditioning moderate to severe peri‐valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri‐valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm2 (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). Conclusions: Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid‐term clinical and echocardiographic results.

Postprocedural management of patients after transcatheter aortic valve implantation procedure with self‐expanding bioprosthesis

Background: Transcatheter aortic valve implantation (TAVI) carries higher risk of post‐procedural adverse events than conventional percutaneous cardiovascular interventions. We report our experience about postoperative management protocol adopted in our Division. Methods: One hundred and ten patients underwent TAVI and 108 were transferred to the cardiac intensive care unit (CICU) after procedure. During the first 48 hours, vital parameters were monitored continuously. Close attention was given to rhythm and atrio‐ventricular conduction disturbances, systemic blood pressure, fluid balance and vascular accesses. Results: The most common complications were renal impairment (21.3%), femoral artery pseudo‐aneurysms (FAP) (11%), new complete atrioventricular block (20.3 %), cerebral vascular accident (4.5%) and cardiac perforation due to temporary pacemaker lead (1.8%). Ultrasound‐guided compression repair was considered the first line treatment for FAP, but in 6 cases surgical treatment was immediately performed due to the rapid expansion of FAP. Complete atrio‐ventricular block occurred in 22 patients (20.3 %) within the first 24 hours after TAVI and a permanent pacemaker was implanted in 21 patients (19.1%). Acute kidney injury occurred in 18 patients (35%) with pre‐procedural chronic renal failure and in 5 patients (9%) without preoperative renal dysfunction. Conclusions: After TAVI, cardiovascular complications are common and therefore accurate standardized management of patients in CICU during the first 48 hours is mandatory to early detect and manage complications and to decrease the rate of adverse events and the length of in‐hospital stay.

Quality of life following percutaneous mitral valve repair with the MitraClip System

BACKGROUND Percutaneous valve repair with MitraClip System is an emerging alternative for high surgical risk patients with severe mitral regurgitation (MR). QoL is a critical measure of effectiveness of this procedure. We sought to evaluate quality of life (QoL) and NYHA class following this novel procedure. METHODS The study included 39 consecutive patients who underwent mitral valve repair with the MitraClip System, both for functional (64%) and degenerative (36%) MR. All patients received the SF-12v2 questionnaire pre-procedure and at 6 months follow-up to assess the physical and mental health. RESULTS Acute procedural success was obtained in 100%. Three patients experienced minor procedural complications. At follow-up 86% of patients had MR ≤ 1+ and 14% experienced a moderate MR. Mean pre-procedural SF-12v2 scores of our patients showed a severe impairment of perceived QoL, both for physical and mental scores; after six months a striking improvement in physical (PCS 35.44 vs 44.67, p<0.0001) and mental (MCS 38.07 vs 46.94, p<0.0001) aspect of QoL was observed. Furthermore, physical and mental status upgrading was higher in patients with functional MR. NYHA functional class improved in all patients. CONCLUSION Our results show an early marked improvement in functional status and physical and mental health in patients underwent percutaneous mitral valve repair with the MitraClip System.

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 closure of left atrial appendage to prevent embolic events in high-risk patients with chronic atrial fibrillation†

Percutaneous closure of the left atrial appendage (LAA) is a novel alternative for the treatment of patients with atrial fibrillation (AF) and with a high risk of stroke who are not eligible for long‐term anticoagulation therapy. The aim of this study was to asses the safety, feasibility, and long‐term efficacy of this procedure.

Early‐ and mid‐term outcomes of transcatheter aortic valve implantation in patients with logistic EuroSCORE less than 20%: A comparative analysis between different risk strata

Background: Transcatheter Aortic Valve Implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. The European consensus document recommended TAVI for prohibitive‐risk patients not eligible for conventional surgery (prohibitive risk defined as expected mortality ≥ 20% calculated with the Logistic EuroScore (LES) in association with clinical judgment). To date, there is lack of clarity on data about outcomes of TAVI in lower risk patients. We sought to evaluate the outcomes of patients undergoing TAVI with LES ≥ 20% in comparison with patients with LES < 20%.