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Gian Paolo Ussia,
Marco Barbanti,
Kunal Sarkar,
Miriam Cumbo, Patrizia Aruta,
Marilena Scarabelli,
Valeria Cammalleri,
Sebastiano Immè,
Anna Maria Pistritto,
Simona Gulino,
Wanda Deste,
Gaetano Zingali,
Valeria Garretto,
Massimiliano Mulè,
Salvatore Scandura,
Corrado Tamburino
[show abstract]
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ABSTRACT: Multislice computed tomography (MSCT) has generally been accepted as the most accurate modality fulfilling this purpose with good reproducibility. A major drawback of MSCT consists in the use of contrast dye, which may be unsafe in transcatheter aortic valve implantation (TAVI) patients who frequently are affected by renal failure. We sought to appraise the accuracy of intracardiac echocardiography (ICE) in measurements of structures in the aortic root in patients undergoing TAVI.
Aortic annulus and sinus of Valsalva diameters were measured using ICE, performed during standard invasive preprocedural assessment in 30 consecutive patients with severe aortic stenosis referred for TAVI. Multislice computed tomography was performed in all patients afterward, and aortic root measurements were made by an independent radiologist.
Effective ICE measurements were obtained in all patients, easily and without any complication. Mean aortic annulus diameters were 21.9 ± 1.8 mm using ICE, 22.0 ± 1.9 mm using MSCT (3-chamber [3-C] view) and 22.8 ± 1.8 mm using the mean of long-axis and short-axis (L-ax/S-ax) view MSCT (P = .192, ICE vs 3-C MSCT; P < .001, ICE vs L-ax/S-ax MSCT, respectively). Correlation between ICE and both MSCT measurements was good (r(2) = 0.83, P < .001; r(2) = 0.80, P < .001, respectively). Mean sinus of Valsalva diameters were 32.3 ± 3.3 mm using ICE and 32.5 ± 3.1 mm using 3-C MSCT view (P = .141). Even in this case, correlation between ICE and both MSCT measurements was excellent (r(2) = 0.96, P < .001).
In patients referred for TAVI, measurements of the aortic annulus and the sinus of Valsalva using ICE compare favorably with those made at MSCT. This approach might be a useful and reproducible strategy in patients with severe renal impairment to avoid the administration of contrast dye during MSCT.
American heart journal 04/2012; 163(4):684-9. · 4.65 Impact Factor
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Gian Paolo Ussia,
Marco Barbanti,
Kunal Sarkar, Patrizia Aruta,
Marilena Scarabelli,
Valeria Cammalleri,
Sebastiano Immè,
Anna Maria Pistritto,
Simona Gulino,
Massimiliano Mulè,
Wanda Deste,
Stefano Cannata,
Corrado Tamburino
[show abstract]
[hide abstract]
ABSTRACT: Prosthesis dislocation during transcatheter aortic valve implantation (TAVI) is a rare but important complication. There is scarce data on the performance of prosthesis in the aorta that have become dislocated from their intended anatomical position in the aortic annulus. We investigated the causes of dislocation during TAVI of the self-expanding CoreValve ReValving™ System (CRS) (Medtronic Inc., Minneapolis, MN, USA). This included midterm follow-up of patients experiencing this acute complication.
Among 176 consecutive patients undergoing TAVI with the CRS prosthesis, seven (3.9%) experienced acute valve dislocation. A comprehensive analysis of the mechanism of dislocation and clinical outcomes of patients experiencing this complication was performed. Based on the underlying mechanism, all cases of prosthesis displacement were classified into the following three groups: 1) accidental dislocation immediately after valve implantation (n=1; 14.3%); 2) dislocation during the snaring manoeuvre to reposition a low deployment of the CRS prosthesis (lower edge >10 mm) below the aortic annulus accompanied with haemodynamically significant regurgitation (n=4; 57.1%); 3) intentional dislocation performed with the snaring manoeuvre as a bailout in cases of coronary ostia impairment or severe prosthetic leak due to higher deployment for a suboptimal sealing of the device with valve calcifications (n=2; 28.6%). The majority of cases occurred during early experiences with the new Accutrak™ (Medtronic Inc., Minneapolis, MN, USA) delivery system. In six patients a second CRS was implanted in the appropriate position. The dislodged CRS functioned normally, without any evidence of structural deterioration, thrombosis or further distal migration and showed complete apposition against the aortic wall. No thromboembolic events were reported in any patient.
Dislocation of a CRS device can be managed effectively with the implantation of a second device in a standard fashion leaving the dislocated device safely in the aorta. Intentional repositioning of a CRS device in the aorta can be accomplished by experienced operators without any serious neurologic or vascular events in the post-procedure period or at midterm follow-up.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 03/2012; 7(11):1285-92. · 3.29 Impact Factor
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Corrado Tamburino,
Marco Barbanti,
Davide Capodanno,
Carmelo Mignosa,
Maurizio Gentile, Patrizia Aruta,
Anna Maria Pistritto,
Claudio Bonanno,
Salvatore Bonura,
Alessandra Cadoni,
Simona Gulino,
Maria Concetta Di Pasqua,
Valeria Cammalleri,
Marilena Scarabelli,
Massimiliano Mulè,
Sebastiano Immè,
Giuliana Del Campo,
Gian Paolo Ussia
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ABSTRACT: 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.
The American journal of cardiology 02/2012; 109(10):1487-93. · 3.58 Impact Factor
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Gian Paolo Ussia,
Valeria Cammalleri,
Kunal Sarkar,
Salvatore Scandura,
Sebastiano Immè,
Anna Maria Pistritto,
Anna Caggegi,
Marta Chiarandà,
Sarah Mangiafico,
Marco Barbanti,
Marilena Scarabelli,
Massimiliano Mulè, Patrizia Aruta,
Corrado Tamburino
[show abstract]
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ABSTRACT: 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.
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.
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.
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.
International journal of cardiology 09/2011; 155(2):194-200. · 7.08 Impact Factor
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Gian Paolo Ussia,
Marilena Scarabelli,
Massimiliano Mulè,
Marco Barbanti,
Kunal Sarkar,
Valeria Cammalleri,
Sebastiano Immè, Patrizia Aruta,
Anna Maria Pistritto,
Simona Gulino,
Wanda Deste,
Davide Capodanno,
Corrado Tamburino
[show abstract]
[hide abstract]
ABSTRACT: 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.
The American journal of cardiology 09/2011; 108(12):1772-6. · 3.58 Impact Factor
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Gian Paolo Ussia,
Marco Barbanti,
Valeria Cammalleri,
Marilena Scarabelli,
Massimiliano Mulè, Patrizia Aruta,
Anna Maria Pistritto,
Sebastiano Immè,
Davide Capodanno,
Kunal Sarkar,
Simona Gulino,
Corrado Tamburino
[show abstract]
[hide abstract]
ABSTRACT: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. Quality-of-life (QoL) is a critical measure of effectiveness of TAVI in this patient population. In this prospective study, we sought to assess one year changes in QoL in patients who underwent TAVI.
From June 2007 to July 2010, 149 consecutive patients underwent TAVI using the 18 Fr CoreValve (Medtronic Inc, Minneapolis, MN, USA) or the Edwards SAPIEN XT heart valve (Edwards Lifescience, Irvine, CA, USA) at our institution. Of these, 143 patients with successful prosthesis implantation comprised the study population. The SF-12v2 Health-Survey questionnaire provides scales for physical (physical component summary [PCS]) and mental (mental component summary [MCS]) health. Among patients included in the present analysis, device success was obtained in 138 patients (96.5%). Mean preprocedural SF-12v2 scores showed an important upgrading after TAVI: PCS improved from 28.3 to 44.0 at five months and 42.4 at 12 months (p<0.001). MCS increased from 38.0 to 47.3 at five months and 48.2 at 12 months (p<0.001). Both the physical and mental score summaries at follow-up of these post-TAVI patients were not significantly different from the anticipated thresholds of the general Italian population over the age of 75 years. NYHA functional class improvement was reported in all patients.
Our results showed a marked mid-term improvement in functional status and physical and mental health in patients who underwent TAVI.
EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 09/2011; 7(5):573-9. · 3.29 Impact Factor
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[show abstract]
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ABSTRACT: 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%.
Of 165 patients who underwent TAVI using the 18-French Medtronic CoreValve (N = 153) and the Sapien Edwards™ (N = 12) at our Institution between June 2007 and September 2010, we identified those with LES < 20%, with prosthesis implantation (n = 84), and reported on their clinical outcome compared with patients with LES ≥ 20% (n = 78). The primary endpoint was the incidence of overall death and major adverse cerebrovascular and cardiac events (MACCE) at 30-day and midterm follow-up stratifying patients by clinical characteristics.
At 30-day, a significant higher incidence of MACCE (20.8% vs. 6.0%, odds ratio [OR] 4.08 95% confidence interval [CI] 1.42-11.74, P = 0.009) and death (15.6% vs. 2.4%, OR 7.45 95% CI 1.61-34.48, P = 0.010) was reported in the LES ≥ 20% group as compared with the LES < 20% group, respectively. The 12-month MACCE rates was (27.1% vs. 11.4%, hazard ratio [HR] 2.47 95% CI 0.93-6.63, P = 0. 071) for LES ≥ 20% and LES < 20% patients, respectively (mortality rates was 25.7% vs. 6.8% HR 4.21 95% CI 1.24-14.30, P = 0.021).
This study tends to suggest that current mortality reported after TAVI could be significantly affected by the very-high risk profile of the population which currently undergoes this procedure, making comparison with surgical series rather unreliable.
Catheterization and Cardiovascular Interventions 04/2011; 79(1):132-40. · 2.29 Impact Factor
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Gian Paolo Ussia,
Marilena Scarabelli,
Massimiliano Mulè,
Marco Barbanti,
Valeria Cammalleri,
Sebastiano Immè, Patrizia Aruta,
Anna Maria Pistritto,
Alessandro Carbonaro,
Wanda Deste,
Paolo Sciuto,
Giovanni Licciardello,
Valeria Calvi,
Corrado Tamburino
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ABSTRACT: 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.
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.
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.
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. © 2010 Wiley-Liss, Inc.
Catheterization and Cardiovascular Interventions 11/2010; 76(5):757-66. · 2.29 Impact Factor
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Gian Paolo Ussia,
Marco Barbanti,
Sebastiano Immè,
Marilena Scarabelli,
Massimiliano Mulè,
Valeria Cammalleri, Patrizia Aruta,
Anna Maria Pistritto,
Davide Capodanno,
Wanda Deste,
Maria Concetta Di Pasqua,
Corrado Tamburino
[show abstract]
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ABSTRACT: 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.
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.
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 cm(2) (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%).
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.
Catheterization and Cardiovascular Interventions 09/2010; 76(3):440-9. · 2.29 Impact Factor
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[show abstract]
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ABSTRACT: To provide data on feasibility, safety and efficacy of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve implantation (TAVI). Background. There are no data on BAV use as a bridge to TAVI in patients at high risk of periprocedural complications.
Between June 2007 to May 2009, 83 consecutive patients with symptomatic severe aortic stenosis (48 female, 35 male) aged from 65 to 88 years (mean age 81 +/- 5 years) were treated with TAVI. Early hemodynamic and clinical outcomes of patients undergoing palliative BAV before TAVI (BAV Group, n = 43) were compared with those of patients who directly underwent TAVI (no-BAV Group, n = 40).
Patients in the BAV group had worse baseline clinical characteristics than those in the no-BAV group, with higher rates of congestive heart failure, New York Heart Association (NYHA) functional class III or IV and a higher EuroSCORE. In the BAV group, significant changes were found after valvuloplasty with regard to NYHA functional class, mean pressure gradient and aortic valve area. Peak-to-peak transvalvular pressure gradient and left ventricular systolic pressure also decreased immediately after BAV. Before TAVI, no differences in either clinical status or hemodynamic data were observed between patients who underwent BAV and those who did not.
Bridging to TAVI with BAV is a feasible and reasonably safe approach to offer temporary relief in selected high-risk patients with symptomatic severe aortic stenosis and a high chance of periprocedural complications.
The Journal of invasive cardiology 04/2010; 22(4):161-6. · 1.84 Impact Factor
