Martina Patanè

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.

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.

Early discharge after transfemoral transcatheter aortic valve implantation

Background The aim of this study was to assess the feasibility and the safety of early discharge (within 72 h) after transfemoral transcatheter aortic valve implantation (TAVI) and to identify baseline features and/or peri-procedural variables, which may affect post-TAVI length-of-stay (LoS) duration. Methods and results Patients discharged within 72 h of TAVI (early discharge group) were compared with consecutive patients discharged after 3 days (late discharge group). Propensity-matched cohorts of patients with a 2:1 ratio were created to better control confounding bias. Among 465 patients, 107 (23.0%) were discharged within 3 days of the procedure. Multivariable regression analysis of unmatched patients demonstrated that baseline New York Heart Association (NYHA) class IV (OR: 0.22, 95% CI 0.05 to 0.96; p=0.045) and any bleeding (OR: 0.31, 95% CI 0.74 to 0.92; p=0.031) were less likely to be associated with early discharge after TAVI. Conversely, the year of procedure (OR: 1.66, 95% CI 1.25 to 2.20; p<0.001) and the presence of a permanent pacemaker (PPM) before TAVI (OR: 2.80, 95% CI 1.36 to 5.75; p=0.005) were associated with a higher probability of early discharge. In matched populations, patients in the early discharge group reported lower incidence of in-hospital bleeding (7.9% vs 19.4%, p=0.014), major vascular complications (2.3% vs 9.1%, p=0.038) and PPM implantation (7.9% vs18.5%, p=0.021), whereas after discharge, at 30-day, no significant differences were reported between groups in terms of death (2.2% vs 1.7%, p=0.540), bleeding (0.0% vs 1.1%, p=0.444), PPM implantation (1.1% vs 0.0%, p=0.333) and re-hospitalisation (1.1% vs 1.1%, p=1.000). Conclusions Early discharge (within 72 h) after transfemoral TAVI is feasible and does not seem to jeopardise the early safety of the procedure, when performed in a subset of patients selected by clinical judgement. Patients undergoing TAVI in unstable haemodynamic compensation and patients experiencing bleeding after the procedure demonstrated to be poorly suitable to this approach, whereas increasing experience in post-TAVI management was associated with a reduction of LoS.

Optimized Screening of Coronary Artery Disease With Invasive Coronary Angiography and Ad Hoc Percutaneous Coronary Intervention During Transcatheter Aortic Valve Replacement

Background— We sought to describe an optimized approach to coronary artery disease (CAD) screening and management in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and Results— When invasive coronary angiography showed CAD, the treatment strategy and completeness of revascularization was determined based on coronary anatomy. TAVR was performed in the same setting if percutaneous coronary intervention (PCI) was uncomplicated; otherwise TAVR was postponed. A total of 604 patients undergoing CAD screening at the time of TAVR procedure were prospectively included in this study. Severe CAD was found in 136 patients (22.5%). Among patients with severe CAD, 53 patients (8.8%) underwent uncomplicated PCI. After PCI, TAVR was postponed in 2 patients (0.3%). In 83 patients (13.8%), coronary angiography showed severe CAD that was left untreated. After TAVR, all-cause and cardiovascular 30-day mortality rates were 2.4% and 1.4%, respectively. Disabling stroke, myocardial infarction, and life-threatening bleeding occurred in 0.5%, 0.8%, and 4.0% of patients, respectively. Acute kidney injury II or III rate was 3.3%. At 2 years, all-cause mortality rate was 14.1%. Disabling stroke and myocardial infarction occurred in 2.5% and 1.8% of patients, respectively. Patients undergoing TAVR and PCI in the same session had similar rate of the composite of death, disabling stroke, and myocardial infarction when compared with patients without CAD, and patients with severe CAD left untreated (TAVR+PCI: 10.4%; severe CAD left untreated: 15.4%; no-CAD: 14.8%; P=0.765). Conclusions— In patients undergoing TAVR, screening of CAD with invasive coronary angiography and ad hoc PCI during TAVR is feasible and was not associated with increased periprocedural risks. PCI followed by TAVR in the same session had similar outcomes than TAVR in which PCI was not performed.

Routine versus selective coronary artery bypass for left main coronary artery revascularization: The appraise a customized strategy for left main revascularization (CUSTOMIZE) study

BACKGROUND Current guidelines recommend coronary artery bypass grafting (CABG) as the first choice of revascularization in patients with unprotected left main coronary artery (ULMCA) disease. We tested the hypothesis that a non guideline-driven approach to ULMCA revascularization which uses percutaneous coronary intervention (PCI) by default and CABG in selected patients may be as safe as the traditional guideline-driven approach. METHODS Between March 2002 and December 2008, PCI has been used as a default strategy for ULMCA revascularization in Center 1 (non guideline-driven [NGD] group), whereas CABG has been used as a default strategy in Center 2 (guideline-driven [GD] group). RESULTS A total of 838 patients with ULMCA disease were included. Of these 67.1% and 32.9% were treated in the NGD and GD groups, respectively. A significant higher risk of major adverse cardiac events (MACE) (hazard ratio [HR] 1.60, 95% confidence interval [CI] 1.10-2.33, p=0.014) and target vessel revascularization (HR 2.44, 95% CI 1.26-4.72, p=0.008) occurred at 24 months in the NGD group as compared with GD Group. Adjustment by means of propensity score did not result in substantial changes with regard to the subcomponent safety and efficacy endpoints. Conversely, the composite of MACE was no longer significant according to all types of statistical adjustment. CONCLUSIONS In a large registry of patients with ULMCA disease undergoing revascularization in current clinical practice, an approach based on PCI and the selective use of CABG gives results which are not inferior to those of a traditional approach guided by the current guidelines.

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.

Early and Mid-Term Outcomes of Transcatheter Aortic Valve Replacement Using the New Generation Self-Expanding Corevalve Evolut R Device

ABSTRACT Background: To assess early and mid-term efficacy of transcatheter aortic valve replacement (TAVR) using the new-generation CoreValve Evolut R (Medtronic Inc., Galway, Ireland). Methods: This is a prospective, single-center study. All consecutive patients undergoing TAVR with 23-, 26-, 29-, 34-mm Evolut R valve were included. In a secondary analysis, patients undergoing Evolut R implantation were compared using the propensity score method with a historical cohort of patients who underwent CoreValve implantation in our institution. Results: From March 2015 to September 2017, a total of 320 patients with a median age of 81.1 years (IQR 77–84) and mean STS score of 4.9 ± 3.1% were treated. Device success was obtained in 300 patients (93.8%). Effective recapture and repositioning of the valve due to initial suboptimal deployment was accomplished in 40 patients (12.5%). Post-TAVR transthoracic echocardiogram showed a reduction in mean gradient from 49.1 ± 18.2 mmHg to 7.6 ± 0.4 mmHg (p < 0.001). Moderate paravalvular regurgitation (PVR) was observed in 4.2% patients. No patient had severe PVR. At 30-day, all-cause and cardiovascular mortality rates were 2.2% and 1.9%, respectively; disabling stroke occurred in 5 patients (1.6%). Life-threatening and major bleeding occurred in 16 (5.0%) and 42 (13.1%) patients, respectively. Pacemaker implantation rate was 12.6%. Compared with the CoreValve, Evolut R use was associated with higher device success (92.8% vs. 79.7%, p < 0.001) and lower rates of moderate or severe PVR (2.1% vs. 14.4%, p < 0.001), minor vascular complications (4.9% vs. 14.5%, p < 0.001), and pacemaker implantation (13.5% vs. 21.0%, p = 0.026). Conclusion: In this prospective, single-center study, TAVR using the new-generation self-expanding Evolut R system, was associated with high device success rate, excellent hemodynamics, and low early complications rates.

Transcatheter Aortic Valve Implantation: Abbott Portico

The Portico (St. Jude Medical) valve (Fig. 24.1a) is a self-expanding transcatheter aortic prosthesis that was clinically evaluated in the Portico CE trial. In this prospective, multicenter study, safety, and performance of the Portico system (23 and 25 mm valves delivered through 18 Fr transfemoral resheathable delivery system) were tested on 100 patients with severe symptomatic aortic stenosis, 50 for each valve size. The results through 12 months showed that the Portico system produces clinically significant and sustained improvements in patient outcomes. Additionally, this study establishes an excellent safety profile at 30 days with the Portico system in terms of mortality, permanent pacemaker rate, moderate/severe paravalvular leak (PVL), major stroke rate, and major vascular complications. The good hemodynamic results were sustained up to 12 months, with the mean aortic gradient constantly stable at about 9.9 mmHg and valve area at 1.6 cm2. The functional NYHA class remained improved and remained stable at follow-up [1].

Transcatheter Aortic Valve Implantation: Edwards SAPIEN 3

The Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) is the last generation balloon-expandable transcatheter aortic valve, which incorporates features to reduce vascular complications and paravalvular regurgitation (PVR) and to improve precise and easy positioning.

Transcatheter Aortic Valve Implantation: Other Devices

Supported by favorable data from first-generation devices, TAVI has undergone rapid technological advancements. The focus on these innovations was on limiting complications found with early TAVI devices such as paravalvular regurgitation, conduction disturbances, valve malpositioning, and the impossibility of repositioning and retrieving the prosthesis. Innovations were achieved both on device designs and on delivery system technologies. Some second-generation devices have already received the CE Mark (Sapien 3, Edwards Lifesciences; CoreValve Evolut R, Medtronic; Portico™, St. Jude Medical, St. Paul, MN, USA; ACURATE neo™, Symetis, Ecublens, Switzerland; Lotus™, Boston Scientific, Marlborough, MA, USA), while other devices are in early clinical evaluation but have yet to receive the CE Mark.