Cristina Giannini

5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

OBJECTIVES The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). BACKGROUND There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. METHODS Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. RESULTS All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported. CONCLUSIONS TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.

2-year results of CoreValve implantation through the subclavian access: a propensity-matched comparison with the femoral access.

OBJECTIVES The goal of this study was to assess the procedural and 2-year results of the subclavian approach for transcatheter aortic valve implantation (TAVI) compared with those of the femoral approach by using propensity-matched analysis. BACKGROUND The subclavian approach with the CoreValve prosthesis (Medtronic, Inc., Minneapolis, Minnesota) represents an interesting opportunity when the femoral access is unfeasible. METHODS All consecutive patients enrolled in the Italian CoreValve Registry who underwent TAVI with the subclavian approach were included. Propensity score analysis was used to identify a matching group of patients undergoing femoral TAVI. RESULTS Subclavian approach was used in 141 patients (61% men; median age 83 years; median logistic European System for Cardiac Operative Risk Evaluation score 23.7%). The femoral group of 141 patients was matched for baseline clinical characteristics, except for peripheral artery disease. The 2 groups showed similar procedural success (97.9% vs. 96.5%; p = 0.47), major vascular complications (5.0% vs. 7.8%; p = 0.33), life-threatening bleeding events (7.8% vs. 5.7%; p = 0.48), and combined safety endpoint (19.9% vs. 25.5%; p = 0.26). The subclavian group showed lower rates of acute kidney injury/stage 3 (4.3% vs. 9.9%; p = 0.02), of minor vascular complications at the 18-F sheath insertion site (2.1% vs. 11.3%; p = 0.003), and of all types of bleeding events related to vascular complications. Survival at 2 years was 74.0 ± 4.0% in the subclavian group compared with 73.7 ± 3.9% in the femoral group (p = 0.78). The 2-year freedom from cardiovascular death was 87.2 ± 3.1% versus 88.7 ± 2.8% in the subclavian versus femoral group, respectively (p = 0.84). CONCLUSIONS The subclavian approach for TAVI is safe and feasible, with procedural and medium-term results similar to the femoral approach. Subclavian access should be considered a valid option not only when the femoral approach is impossible but also when it is difficult, albeit feasible.

Transcatheter valve-in-ring implantation after failure of surgical mitral repair

OBJECTIVES Redo surgery after failed mitral valve repair may be high risk, or contraindicated in patients with comorbidities. Because of this high risk, other interventional possibilities like transcatheter valve implantation might be of benefit. We report our experience with transcatheter mitral valve-in-ring implantation (TVIR) in high-risk patients after failure of surgical ring annuloplasty. METHODS From January 2010 to February 2012, following a multidisciplinary discussion, 17 high-risk patients underwent TVIR using Edwards SAPIEN XT prostheses, via either a transvenous transseptal (n = 8), or a transapical approach (n = 9). RESULTS Patients were aged 70 ± 16 years, in New York Association classes III/IV. Their mean logistic EuroSCORE was 36 ± 17% and mean Society of Thoracic Surgeons risk score 13 ± 9%. The mean time interval between surgery and repair failure was 7 ± 3 years. Annuloplasty rings were semi-rigid in 14 cases, flexible in 2, and rigid in 1. Manufacturers ring diameters were 26 mm in 4 patients, 27 mm in 1, 28 mm in 9, 30 mm, 31 mm and 34 mm in 1. The predominant failure mode was regurgitation in 12 cases and stenosis in 5. SAPIEN XT diameters were 26 mm in 15 patients, 23 mm and 29 mm in 1. Procedural success rate was 88% (15/17). Emergency surgery was needed in 1 patient due to acute dislodgement of the ring. The degree of mitral regurgitation was reduced to none or mild in all but 2 patients; final mean gradient was 7 ± 3 mmHg. Thirty-day survival was 82% (14/17 patients). At last follow-up (13 ± 5 months), survival rate was 71% (12/17). CONCLUSIONS These preliminary results suggest that TVIR is feasible, with low operative risk, and may provide short-term clinical and haemodynamic improvement in selected high-risk patients with failure of mitral ring annuloplasty.

Safety of a conservative strategy of permanent pacemaker implantation after transcatheter aortic CoreValve implantation

BACKGROUND Conduction abnormalities are frequent after transcatheter aortic valve implantation with the CoreValve (Medtronic, Minneapolis, MN) and are often treated with liberal permanent pacemaker (PPM) implantation. Our aim was to assess the 1-year outcome of a conservative approach to pacing and to identify its predictors. METHODS We analyzed 275 consecutive patients without a PPM before transcatheter aortic valve implantation who underwent successful CoreValve implantation at our 3 centers, sharing a conservative approach to pacing. RESULTS Of the 47 patients (17.1%) who developed postprocedural complete atrioventricular block, 14 recovered spontaneous atrioventricular conduction <72 hours and did not receive a PPM. Sixty-six patients (24.0%) received a PPM before discharge, and 74 more patients (26.9%) developed a new left bundle-branch block (LBBB). Independent predictors of PPM implantation were as follows: lower CoreValve implantation below the aortic annulus (odds ratio [OR] 1.16/mm, 95% CI 1.03-1.30, P = .01), right bundle-branch block (OR 3.72, 95% CI 1.5-9.2, P = .004), left anterior hemiblock (OR 2.34, 95% CI 1.1-5.1, P = .03), and longer PR interval (OR 1.02/ms, 95% CI 1.00-1.04, P = .03). One-year survival was similar between patients who received a PPM and patients who did not receive a PPM (P = .90), with no case of sudden death in the latter group, and between patients with a new LBBB not receiving a PPM and patients without postprocedural LBBB (P = .37). CONCLUSION A high CoreValve implantation level and avoidance of prophylactic pacing in patients with new LBBB without persistent bradyarrhythmias allowed for a relatively low rate of PPM implantation. This conservative approach spared unwarranted pacing and did not affect 1-year survival.

Early Left Ventricular Mechanics Abnormalities in Prehypertension: A Two-Dimensional Strain Echocardiography Study

BACKGROUND Prehypertension predicts established hypertension. In this study, the aim was to analyze left ventricular (LV) mechanics in borderline prehypertensive (pre-HT) and hypertensive (HT) subjects through two-dimensional (2D)-strain echocardiography and then evaluate possible relations between cardiac parameters and insulin metabolism (homeostasis model assessment of insulin resistance (HOMA(IR)). METHODS Seventy-four consecutive newly diagnosed, untreated HT were divided, on the basis of their office blood pressure (BP) measurements, confirmed by ambulatory BP monitoring (ABPM), in 41 borderline pre-HT (ABPM: 122.5 +/- 6.7/76.2 +/- 5.2 mm Hg) and 33 never-treated mild HT (ABPM: 138.3 +/- 7.3/87.6 +/- 7.1 mm Hg). Thirty-three healthy normotensive (NT) controls (ABPM: 114.8 +/- 6.3/73.1 +/- 6.1 mm Hg) (P < 0.0001) were also studied (NT). All subjects performed 2D color Doppler and pulsed-wave tissue Doppler imaging (PW-TDI). RESULTS Left ventricular mass (LVM) was significantly higher in pre-HT (39.2 +/- 8.7 g/m(2.7)) and in HT (43.6 +/- 8.5 g/m(2.7)) compared with NT (30.9 +/- 7.4 g/m(2.7)) (P < 0.0001). A mild LV diastolic dysfunction was found both with Doppler mitral flow velocity and PW-TDI at mitral annulus level analysis. Longitudinal 2D strain in pre-HT (-18.9% +/- 3.4) and in HT (-18.0% +/- 3.3) was significantly lower than in NT (-23.9% +/- 3.0) (P < 0.002). These LV abnormalities were associated with systolic ABPM, LVM, and HOMA(IR). CONCLUSIONS Early abnormalities of LV longitudinal systolic deformation were found both in pre-HT and HT, together with a mild LV diastolic dysfunction. In both groups this early cardiac systolic and diastolic dysfunction is associated to insulin resistance, systolic pressure load, and cardiac remodeling.

Meta-Analysis of the Usefulness of Mitraclip in Patients With Functional Mitral Regurgitation

Midterm outcomes for patients presenting with heart failure and functional mitral regurgitation (MR) treated with Mitraclip remain unclear. Pubmed, Medline, and Google Scholar were systematically searched for studies enrolling patients with severe-moderate MR who underwent Mitraclip implantation. All events after at least 6 months were the primary safety end point (including death, rehospitalization for heart failure, and reinterventions), whereas change in the ejection fraction, left ventricular volumes, arterial pulmonary pressure, and left atrial diameters were considered as secondary end points. Meta-regression analysis was performed to evaluate the effect of baseline clinical and echocardiographic parameters on efficacy outcomes: 875 patients were included in 9 studies; 1.48 clips (1.3 to 1.7) for patients were implanted, and after a median follow-up of 9 months (6 to 12), 409 patients (78% [75% to 83%]) were in class New York Heart Association I/II and 57 (11% [8% to 14%]) still had moderate-to-severe MR. Overall adverse events occurred in 137 (26% [20% to 31%]) of the patients and 78 (15% [1% to 17%]) of them died; 6-minute walk test improved by 100 m (83 to 111), whereas a significant reduction in left ventricular volumes and systolic pulmonary pressure was reported. At meta-regression analysis, an increase in left ventricle systolic volumes positively affected reduction of volumes after Mitraclip, whereas atrial fibrillation reduced the positive effect of the valve implantation on ejection fraction on end-diastolic and -systolic volumes. In conclusion, Mitraclip represents an efficacious strategy for patients with heart failure and severe MR. It offers a significant improvement in functional class and in cardiac remodeling, in patients with severely dilated hearts as well, although its efficacy remains limited in the presence of atrial fibrillation.

A Prospective Randomized Trial of Thrombectomy Versus No Thrombectomy in Patients With ST-Segment Elevation Myocardial Infarction and Thrombus-Rich Lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) Trial

OBJECTIVES The aim of this study was to evaluate whether thrombectomy during primary percutaneous coronary intervention (pPCI) in patients with high thrombus burden improves myocardial reperfusion and reduces infarct size. BACKGROUND Thrombectomy aims at reducing distal thrombotic embolization during pPCI, improving myocardial reperfusion and clinical outcome. METHODS We randomized 208 patients with high thrombus burden in a 1:1 ratio to either pPCI with thrombectomy (Group T) or standard pPCI (Group S). Thrombectomy was performed with either rheolytic or manual aspiration catheters. Three-month magnetic resonance imaging was performed to assess infarct size and transmurality and microvascular obstruction (MVO). The primary endpoints were ST-segment elevation resolution (STR) >70% at 60 min and 3-month infarct size. RESULTS The baseline profile was similar between groups, except for a higher rate of initial Thrombolysis In Myocardial Infarction flow grade 3 in Group S (p = 0.002). Group T showed a significantly higher rate of STR (57.4% vs. 37.3%; p = 0.004) and of final myocardial blush 3 (68.3% vs. 52.9%; p = 0.03). Group T and Group S did not differ with regard to infarct size (20.4 ± 10.5% vs. 19.3 ± 10.6%; p = 0.54) and transmurality (11.9 ± 12.0% vs. 11.6 ± 12.7%; p = 0.92), but Group T showed significantly less MVO (11.4% vs. 26.7%; p = 0.02) and a higher prevalence of inhomogeneous scar (p < 0.0001). One-year freedom from major adverse cardiac events was similar between groups. CONCLUSIONS Thrombectomy as an adjunct to pPCI in patients with high thrombus load yielded better post-procedural STR and reduced MVO at 3 months but was not associated with a reduction in infarct size and transmurality. Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous (Coronary Intervention; NCT01472718).

Abnormal right ventricular mechanics in early systemic hypertension: a two-dimensional strain imaging study

AIMS To analyse the relationship between increasing systemic blood pressure (BP) and right ventricular (RV) function as assessed by two-dimensional strain imaging. METHODS AND RESULTS Longitudinal peak strain and strain rate (SR) were sampled by speckle-tracking methodology at the RV free wall and interventricular septum (IVS) and RV and left ventricular (LV) structure and function were evaluated by conventional echo-Doppler sonography in 89 never-treated, non-obese subjects with office BP values varying from the optimal to mildly hypertensive range. Data were analysed by 24 h systolic BP (SBP) tertiles (cut-offs: 117 and 130 mmHg, n = 29, 30, and 30, respectively), thus partitioning subjects with optimal BP from those with high-normal and mildly increased values. RV peak systolic strain and early diastolic SR decreased in the mid-BP third without further changes in the upper tertile. IVS thickened gradedly by increasing systemic 24 h SBP; posterior wall remodelled to a lesser extent and poorly related to BP load and LV mass index did not change. RV and IVS systolic and diastolic strain indices associated inversely with increasing septal thickness. Conventional right and left indices of global ventricular function, left atrial size, and estimated systolic pulmonary pressure did not differ. CONCLUSION Two-dimensional strain-assessed RV function is sensitive to increased systemic BP, even at levels below the conventional diagnostic limits for arterial hypertension. Subclinical RV systolic and diastolic abnormalities paralleled BP-driven septal remodelling, perhaps as a reflection of the crucial role played by IVS in RV function.

Integrated reverse left and right ventricular remodelling after MitraClip implantation in functional mitral regurgitation: an echocardiographic study

AIMS The aim of the present study was to investigate the changes of left and right ventricular (RV) dimensions and function after MitraClip implantation in high-risk surgical patients with severe functional mitral regurgitation (MR). METHODS AND RESULTS Study population included 35 patients with functional MR. All the patients underwent clinical and echocardiographic evaluation at baseline, before discharge and at 6-month follow-up. The mean age was 75 years (63-81), 65.7% (n = 23) was male with a mean logistic EuroSCORE of 20%. Percutaneous mitral valve repair acronym (PMVR) resulted in significantly reduced MR and improved in New York Heart Association functional class. Echocardiography revealed improvement in left ventricular (LV) size and function since discharge with further improvement at 6 months. During the follow-up, a significant improvement in RV function was also observed by the baseline values. At baseline, before discharge and 6 months, respectively, the tricuspid annulus plane systolic excursion (TAPSE) was 16.8 ± 3.9, 18.7 ± 3.4, and 19.3 ± 4.5 mm (P = 0.001); the systolic pulmonary artery pressure (SPAP) was 50.1 ± 6.8, 41.2 ± 6.8, and 38.1 ± 6.8 mmHg (P < 0.0001); and the systolic velocity at the tricuspid annular (RV-Sm) was 8.8 ± 2.9, 10.4 ± 3.5, and 17.7 ± 3.1 cm (P < 0.0001). CONCLUSION MitraClip implantation induces a significant reverse remodelling of LV, with reduction in both diastolic and systolic LV volumes and an increase in the cardiac index. The concomitant reduction in LV filling pressure, obtained after MitraClip implantation, reflects nearly immediately on the haemodynamics of the right sections. In fact, since discharge, we observed both a reverse remodelling of the right sections, with a significant reduction in SPAP, and a significant increase in longitudinal RV systolic function as shown by the increase in TAPSE and RV-Sm.

Comparison of Percutaneous Mitral Valve Repair Versus Conservative Treatment in Severe Functional Mitral Regurgitation.

Percutaneous mitral valve repair (PMVR) using the MitraClip System is feasible and entails clinical improvement even in patients with high surgical risk and severe functional mitral regurgitation (MR). The aim of this study was to assess survival rates and clinical outcome of patients with severe, functional MR treated with optimal medical therapy (OMT) compared with those who received MitraClip device. Sixty patients treated with OMT were compared with a propensity-matched cohort of 60 patients who underwent PMVR. Baseline demographics and echocardiographic variables were similar between the 2 groups. The mean age of patients was 75 years, and 67% were men. The median logistic EuroSCORE and EuroSCORE II were 17% and 6%, respectively, because of the presence of several co-morbidities. The mechanism of MR was functional in all cases with an ischemic etiology in 52% of patients. Median left ventricle ejection fraction was 34%. All the patients were symptomatic for dyspnea with 63% and 12% in the New York Heart Association class III and IV, respectively. In PMVR group, the procedure was associated with safety and very low incidence of procedural complications with no occurrence of procedural and inhospital mortality. After a median follow-up of 515 days (248 to 828 days), patients treated with PMVR demonstrated overall survival, survival freedom from cardiac death and survival free of readmission due to cardiac disease curves higher than patients treated conservatively (log-rank test p = 0.007, p = 0.002, and p = 0.04, respectively). In conclusion, PMVR offers a valid option for selected patients with high surgical risk and severe, functional MR and entails better survival outcomes compared with OMT.