Corrado Tamburino

Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis

Background— There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. Methods and Results— A total of 663 consecutive patients (mean age 81.0±7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year. Conclusions— Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥2+ mainly impact late outcomes between 30 days and 1 year.

Incidence, Predictors, and Outcomes of Aortic Regurgitation After Transcatheter Aortic Valve Replacement Meta-Analysis and Systematic Review of Literature

OBJECTIVES This study was designed to establish the incidence, impact, and predictors of post-transcatheter aortic valve replacement (TAVR) aortic regurgitation (AR). BACKGROUND AR is an important limitation of TAVR with ill-defined predictors and unclear long-term impact on outcomes. METHODS Studies published between 2002 and 2012 with regard to TAVR were identified using an electronic search and reviewed using the random-effects model of DerSimonian and Laird. From 3,871 initial citations, 45 studies reporting on 12,926 patients (CoreValve [Medtronic CV Luxembourg S.a.r.l., Tolochenaz, Switzerland] n = 5,261 and Edwards valve [Edwards Lifesciences, Santa Ana, California] n = 7,279) were included in the analysis of incidence and outcomes of post-TAVR AR. RESULTS The pooled estimate for moderate or severe AR post-TAVR was 11.7% (95% confidence interval [CI]: 9.6 to 14.1). Moderate or severe AR was more common with use of the CoreValve (16.0% vs. 9.1%, p = 0.005). The presence of moderate or severe AR post-TAVR increased mortality at 30 days (odds ratio: 2.95; 95% CI: 1.73 to 5.02) and 1 year (hazard ratio: 2.27; 95% CI: -1.84 to 2.81). Mild AR was also associated with an increased hazard ratio for mortality, 1.829 (95% CI: 1.005 to 3.329) that was overturned by sensitivity analysis. Twenty-five studies reported on predictors of post-TAVR AR. Implantation depth, valve undersizing, and Agatston calcium score (r = 0.47, p = 0.001) were identified as important predictors. CONCLUSIONS Moderate or severe aortic regurgitation is common after TAVR and an adverse prognostic indicator of short- and long-term survival. Incidence of moderate or severe AR is higher with use of the CoreValve. Mild AR may be associated with increased long-term mortality. Therefore, every effort should be made to minimize AR by a comprehensive pre-procedural planning and meticulous procedural execution.

Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis

AIMS The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA). METHODS AND RESULTS From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 ± 18.1 mmHg (pre-TAVI) to 10.3 ± 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 ± 0.2 cm(2) (pre-TAVI) to 1.8 ± 0.4 cm(2) (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed. CONCLUSION This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up.

Expert review document part 2: methodology, terminology and clinical applications of optical coherence tomography for the assessment of interventional procedures.

This document is complementary to an Expert Review Document on Optical Coherence Tomography (OCT) for the study of coronary arteries and atherosclerosis.1 The goal of this companion manuscript is to provide a practical guide framework for the appropriate use and reporting of the novel frequency domain (FD) OCT imaging to guide interventional procedures, with a particular interest on the comparison with intravascular ultrasound (IVUS).1–4 In the OCT Expert Review Document on Atherosclerosis, a comprehensive description of the physical principles for OCT imaging and time domain (TD) catheters (St Jude Medical, Westford, MA, USA) was provided.1 The main advantage of FD-OCT is that the technology enables rapid imaging of the coronary artery, using a non-occlusive acquisition modality. The FD-OCT catheter (DragonflyTM; St Jude Medical) employs a single-mode optical fibre, enclosed in a hollow metal torque wire that rotates at a speed of 100 r.p.s. It is compatible with a conventional 0.014″ angioplasty guide wire, inserted into a short monorail lumen at the tip. The frequency domain optical coherence tomography lateral resolution is improved in comparison with TD-OCT, while the axial resolution did not change. These features, together with reduced motion artefacts and an increased maximum field of view up to 11 mm, have significantly improved both the quality and ease of use of OCT in the catheterization laboratory.3,4 However, the imaging depth of the FD-OCT is still limited to 0.5–2.0 mm.5 The main obstacle to the adoption of TD-OCT imaging in clinical practice is that OCT cannot image through a blood field, and therefore requires clearing or flushing of blood from the lumen.1 The 6 Fr compatible DragonflyTM FD-OCT catheter is so far the only one in the market, as two other systems from Volcano and Terumo, which …

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.

Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l'Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study.

AIMS Angiographic guidance for percutaneous coronary intervention (PCI) has substantial limitations. The superior spatial resolution of optical coherence tomography (OCT) could translate into meaningful clinical benefits. We aimed to compare angiographic guidance alone versus angiographic plus OCT guidance for PCI. METHODS AND RESULTS Patients undergoing PCI with angiographic plus OCT guidance (OCT group) were compared with matched patients undergoing PCI with angiographic only guidance (Angio group) within 30 days. The primary endpoint was the one-year rate of cardiac death or myocardial infarction (MI). A total of 670 patients were included, 335 in the OCT group and 335 in the Angio group. OCT disclosed adverse features requiring further interventions in 34.7%. Unadjusted analyses showed that the OCT group had a significantly lower one-year risk of cardiac death (1.2% vs. 4.5%, p=0.010), cardiac death or MI (6.6% vs. 13.0%, p=0.006), and the composite of cardiac death, MI, or repeat revascularisation (9.6% vs. 14.8%, p=0.044). Angiographic plus OCT guidance was associated with a significantly lower risk of cardiac death or MI even at extensive multivariable analysis adjusting for baseline and procedural differences between the groups (OR=0.49 [0.25-0.96], p=0.037) and at propensity-score adjusted analyses. CONCLUSIONS This observational study, the first ever formally to appraise OCT guidance for PCI decision-making, suggests that the use of OCT can improve clinical outcomes of patients undergoing PCI.

Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: Insights from a large multicenter registry

OBJECTIVES This study sought to evaluate the main baseline and procedural characteristics, management, and clinical outcomes of patients from a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) who suffered coronary obstruction (CO). BACKGROUND Very little data exist on CO following TAVI. METHODS This multicenter registry included 44 patients who suffered symptomatic CO following TAVI of 6,688 patients (0.66%). Pre-TAVI computed tomography data was available in 28 CO patients and in a control group of 345 patients (comparisons were performed including all patients and a cohort matched 1:1 by age, sex, previous coronary artery bypass graft, transcatheter valve type, and size). RESULTS Baseline and procedural variables associated with CO were older age (p < 0.001), female sex (p < 0.001), no previous coronary artery bypass graft (p = 0.043), the use of a balloon-expandable valve (p = 0.023), and previous surgical aortic bioprosthesis (p = 0.045). The left coronary artery was the most commonly involved (88.6%). The mean left coronary artery ostia height and sinus of Valsalva diameters were lower in patients with obstruction than in control subjects (10.6 ± 2.1 mm vs. 13.4 ± 2.1 mm, p < 0.001; 28.1 ± 3.8 mm vs. 31.9 ± 4.1 mm, p < 0.001). Differences between groups remained significant after the case-matched analysis (p < 0.001 for coronary height; p = 0.01 for sinus of Valsalva diameter). Most patients presented with persistent severe hypotension (68.2%) and electrocardiographic changes (56.8%). Percutaneous coronary intervention was attempted in 75% of the cases and was successful in 81.8%. Thirty-day mortality was 40.9%. After a median follow-up of 12 (2 to 18) months, the cumulative mortality rate was 45.5%, and there were no cases of stent thrombosis or reintervention. CONCLUSIONS Symptomatic CO following TAVI was a rare but life-threatening complication that occurred more frequently in women, in patients receiving a balloon-expandable valve, and in those with a previous surgical bioprosthesis. Lower-lying coronary ostium and shallow sinus of Valsalva were associated anatomic factors, and despite successful treatment, acute and late mortality remained very high, highlighting the importance of anticipating and preventing the occurrence of this complication.

Usefulness of the SYNTAX Score for Predicting Clinical Outcome After Percutaneous Coronary Intervention of Unprotected Left Main Coronary Artery Disease

Background—The SYNTAX score (SXscore) has been proposed recently as a valuable tool to characterize the coronary vasculature prospectively with respect to the number of lesions and their functional impact, location, and complexity. However, the prognostic value of SXscores in patients undergoing percutaneous coronary intervention of the left main artery has not been validated. Methods and Results—We applied the SXscore in 255 consecutive patients who underwent percutaneous coronary intervention for left main disease and explored its performance with respect to their clinical outcome. Univariate and multivariate Cox proportional hazard regression analyses were performed to evaluate the relation between the SXscore and the incidence of cardiac mortality, the primary end point of the study, and major adverse cardiac events (MACE). At 1 year, the SXscore significantly predicted the risk of cardiac death (hazard ratio, 1.12/unit increase; 95% CI, 1.06 to 1.18; P<0.001) and MACE (hazard ratio, 1.59/unit increase; 95% CI, 1.02 to 2.48; P=0.043). After adjustment for potential confounders, a higher SXscore remained significantly associated with cardiac mortality (adjusted hazard ratio, 1.15; 95% CI, 1.05 to 1.26; P=0.003) and MACE (adjusted hazard ratio, 1.06; 95% CI, 1.02 to 1.10; P=0.005). C-indexes for SXscores in terms of cardiac death and MACE were 0.83 and 0.64, respectively. Using classification tree analysis, discrimination levels of 34 and 37 were identified as the optimal cutoff to distinguish between patients at low and high risk of cardiac death and MACE, respectively. Conclusions—The SXscore is a useful tool to predict cardiac mortality and MACE in patients undergoing percutaneous revascularization of the left main coronary artery.

Percutaneous coronary intervention versus coronary artery bypass graft surgery in left main coronary artery disease: a meta-analysis of randomized clinical data

OBJECTIVES The purpose of this study was to determine the safety and efficacy of percutaneous coronary intervention (PCI) compared with coronary artery bypass graft (CABG) in patients with left main coronary artery (LMCA) disease. BACKGROUND Previous meta-analyses of PCI versus CABG in LMCA disease mainly included nonprospective, observational studies. Several new randomized trials have recently been reported. METHODS We identified 1,611 patients from 4 randomized clinical trials for the present meta-analysis. The primary endpoint was the 1-year incidence of major adverse cardiac and cerebrovascular events (MACCE), defined as death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke. RESULTS PCI was associated with a nonsignificantly higher 1-year rate of MACCE compared with CABG (14.5% vs. 11.8%; odds ratio [OR]: 1.28; 95% confidence interval [CI]: 0.95 to 1.72; p = 0.11), driven by increased TVR (11.4% vs. 5.4%; OR: 2.25; 95% CI: 1.54 to 3.29; p < 0.001). Conversely, stroke occurred less frequently with PCI (0.1% vs. 1.7%; OR: 0.15; 95% CI: 0.03 to 0.67; p = 0.013). There were no significant differences in death (3.0% vs. 4.1%; OR: 0.74; 95% CI: 0.43 to 1.29; p = 0.29) or MI (2.8% vs. 2.9%; OR: 0.98; 95% CI: 0.54 to 1.78; p = 0.95). CONCLUSIONS In patients with LMCA disease, PCI was associated with nonsignificantly different 1-year rates of MACCE, death, and MI, a lower risk of stroke, and a higher risk of TVR compared with CABG.

Usefulness of SYNTAX score to select patients with left main coronary artery disease to be treated with coronary artery bypass graft.

OBJECTIVES The purpose of our study was to investigate the utility of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) score in aiding patient selection for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in a large contemporary registry of patients undergoing revascularization of left main coronary artery. BACKGROUND The SYNTAX score has been developed as a combination of several validated angiographic classifications aiming to grade the coronary lesions with respect to their functional impact, location, and complexity. METHODS Between March 2002 and December 2008, 819 patients with left main coronary artery disease underwent revascularization in 2 Italian centers. We compared clinical outcomes of PCI versus CABG in patients with SYNTAX score < or =34 and patients with SYNTAX score >34. RESULTS The rates of 2-year mortality were similar between CABG and PCI in the group of patients with SYNTAX score < or =34 (6.2% vs. 8.1%, p = 0.461). Among patients with SYNTAX score >34, those treated with CABG had lower rates of mortality (8.5% vs. 32.7%, p < 0.001) than those treated with PCI. After statistical adjustment, revascularization by PCI resulted in a similar risk of death compared with CABG in patients with SYNTAX score < or =34 (hazard ratio: 0.81, 95% confidence interval: 0.33 to 1.99, p = 0.64) and in a significantly higher risk in patients with SYNTAX score >34 (hazard ratio: 2.54, 95% confidence interval: 1.09 to 5.92, p = 0.031). CONCLUSIONS A SYNTAX score threshold of 34 may usefully identify a cohort of patients with left main disease who benefit most from surgical revascularization in terms of mortality.