Filippo Figini

Transcatheter vs surgical aortic valve replacement in intermediate- surgical-risk patients with aortic stenosis: A propensity score-matched case-control study

BACKGROUND Limited real-world data comparing outcomes after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in intermediate-surgical-risk patients with aortic stenosis are available. METHODS We identified 182 consecutive patients who underwent TAVR via the transfemoral (TF) route (November 2007-February 2011) and 111 moderate-to-high-risk historical case controls undergoing SAVR (August 2003-July 2008). Using propensity score matching based on clinical characteristics and surgical risk scores, we compared clinical outcomes in 111 matched patients. Valve Academic Research Consortium definitions were applied for end point adjudication. RESULTS Baseline clinical characteristics, in particular Logistic European System for Cardiac Operative Risk Evaluation (23.2 ± 15.1 vs 24.4 ± 13.4) and Society of Thoracic Surgeons score (4.6 ± 2.3 vs 4.6 ± 2.6), were well matched between groups. Transfemoral TAVR was associated with more vascular complications (33.3% vs 0.9%, P < .001). On the other hand, acute kidney injury was more frequent after SAVR (8.1% vs 26.1%, P < .001). The rates of all-cause mortality in both TF-TAVR and SAVR groups was1.8% at 30 days (P = 1.00) and 6.4% and 8.1%, respectively, at 1 year (P = .80). At 1 year, the rate of cerebrovascular events was similar in the 2 groups (4.6% vs 9.1%, P = .19). CONCLUSIONS In this real-world cohort of intermediate-surgical-risk patients with aortic stenosis, TF-TAVR and SAVR were associated with similar mortality rates during follow-up but with a different spectrum of periprocedural complications. Furthermore, the survival rate after TF-TAVR in this group of elderly patients with intermediate Society of Thoracic Surgeons score was encouraging.

Comparison of incidence and predictors of left bundle branch block after transcatheter aortic valve implantation using the CoreValve versus the Edwards valve.

Conduction disorders and permanent pacemaker implantation are common complications in patients who undergo transcatheter aortic valve implantation (TAVI). The aim of this study was to assess the incidence and clinical significance of new bundle branch block in patients who underwent TAVI with the Medtronic CoreValve Revalving System (MCRS) or the Edwards SAPIEN valve (ESV). Data from 238 patients with no previous pacemaker implantation, left bundle branch block (LBBB) or right bundle branch block at baseline electrocardiography who underwent TAVI with either MCRS (n = 87) or ESV (n = 151) bioprostheses from 2007 to 2011 were analyzed. New-onset LBBB occurred in 26.5% patients (n = 63): 13.5% with the ESV (n = 20) and 50.0% with the MCRS (n = 43) (p = 0.001). Permanent pacemaker implantation was required in 12.7% of patients (n = 8) because of complete atrioventricular block (ESV n = 2, MCRS n = 4), LBBB and first degree atrioventricular block (MCRS n = 1) and new-onset LBBB associated with sinus bradycardia (MCRS n = 1). At discharge, LBBB persisted in 8.6% of ESV patients (n = 13) and 32.2% of MCRS patients (n = 28) (p = 0.001). On multivariate analysis, the only predictor of LBBB was MCRS use (odds ratio 7.2, 95% confidence interval 2.9 to 17.4, p <0.001). Persistent new-onset LBBB at discharge was not associated with overall (log-rank p = 0.42) or cardiovascular (log-rank p = 0.46) mortality. New-onset right bundle branch block was documented in 4.6% of patients (n = 11), with no statistically significant differences between the ESV and MCRS. In conclusion, new-onset LBBB is a frequent intraventricular conduction disturbance after TAVI with a higher incidence with the MCRS compared with the ESV. LBBB persists in most patients, but in this cohort, it was not a predictor of overall or cardiovascular mortality or permanent pacemaker implantation.

Comparison of Results of Transcatheter Aortic Valve Implantation in Patients With Severely Stenotic Bicuspid Versus Tricuspid or Nonbicuspid Valves

Data on transcatheter aortic valve implantation (TAVI) for severe bicuspid aortic valve (BAV) stenosis and how this compares to that for tricuspid aortic valve (TAV) stenosis are limited. Twenty-one consecutive patients with BAV were treated with the Edwards or CoreValve bioprosthesis from November 2007 to December 2012 at San Raffaele Scientific Institute and Clinical Institute S. Ambrogio, Milan, Italy. Results were compared with a cohort of patients with TAV (n=447) treated with the same bioprostheses over the same period. Procedural 1- and 12-month outcomes were examined as defined by the Valve Academic Research Consortium criteria. Patients with BAV were younger (76.7±7.1 vs 79.8±7.4 years, p=0.06) and with a larger aortic annulus (25.0±1.8 vs 23.6±2.1 mm, p=0.01). Device success (85.7% vs 94.4%, p=0.10) was lower in patients with BAV. Although the 30-day composite safety end point (23.8% vs 21.0%, p=0.76) was similar between the 2 groups, mortality rate at 30 days was higher (14.2% vs 3.6%, p=0.02) in the BAV group. Cardiovascular mortality at 1 year did not differ significantly between the 2 groups (10.5% vs 7.4%, p=0.62). In conclusion, transcatheter aortic valve implantation in high surgical risk patients with severe BAV stenosis appears to be feasible with mid-term cardiovascular mortality similar to that for patients with TAV. Early survival and device success, however, were lower for patients with BAV demonstrating that further studies are required to identify which subset of patients with BAV is best suited for transcatheter treatment.

Comparison of early clinical outcomes between ABSORB bioresorbable vascular scaffold and everolimus-eluting stent implantation in a real-world population.

To compare the early clinical outcomes between ABSORB bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) and cobalt chromium everolimus‐eluting stents in real‐world patients with mostly complex disease.

Transcatheter valve-in-valve implantation with the Edwards Sapien in patients with bioprosthetic heart valve failure: The Milan experience

AIMS Reoperation for bioprosthetic heart valve failure is associated with significant morbidity and mortality, particularly in high-risk patients. Transcatheter valve-in-valve (VIV) implantation may offer a less invasive alternative. The aim of this study was to report our initial experience with transcatheter VIV implantation to treat degenerated tissue valves. METHODS AND RESULTS VIV implantation with the Edwards SAPIEN transcatheter heart valve (THV; Edwards Lifesciences Inc, Irvine, CA, USA) was performed in 18 high-risk patients (STS 8.2±5.2%; logistic EuroSCORE 37.4±20.8%) with symptomatic bioprosthetic failure (17 aortic, one mitral). Valve Academic Research Consortium (VARC) definitions were applied for endpoint adjudication. Transfemoral access was the preferred vascular approach (16 patients, with the mitral VIV delivered anterogradely through the femoral vein; one transaxillary and one transapical). The majority (83%) of procedures were performed under local anaesthesia and sedation. Device success was achieved in all but one patient who had a final transaortic gradient ≥20mmHg. Acute kidney injury occurred in three patients (Stage 3 in 1), life-threatening or major bleeding in four patients, while major vascular complications occurred in one patient. Permanent pacemaker implantation was required in two patients. There were no deaths or neurological events at 30-day follow-up. At a median follow-up of 11 months (interquartile range 6-16), the mortality rate was 5.6% and all patients were in NYHA class II or lower. CONCLUSIONS Transcatheter implantation of the Edwards THV within a degenerated aortic bioprosthesis, performed predominantly via the transfemoral route, is feasible and associated with good periprocedural and clinical outcomes in high-risk surgical patients.

Incidence, Management, and Outcomes of Cardiac Tamponade During Transcatheter Aortic Valve Implantation: A Single-Center Study

OBJECTIVES The aim of this study was to explore the incidence, causes, and outcomes of cardiac tamponade in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND Use of TAVI is increasing, but the procedure is vulnerable to complications, given the cohort of patients. Cardiac tamponade is a possible complication, and there is a scarcity of data on the incidence and outcomes of cardiac tamponade during TAVI. METHODS All patients who sustained cardiac tamponade during or post-TAVI between 2007 and 2012 were included in the study. RESULTS Of 389 patients who underwent TAVI, 17 (4.3%) had cardiac tamponade. The mean age was 82.3 ± 3.7 years, and most were women (n = 12, 70.6%). Causes of cardiac tamponade were right ventricular perforation by temporary pacemaker (9 patients, 52.9%), annular rupture or aortic dissection (4 patients, 23.5%), and tear in the left ventricular free wall caused by Amplatz stiff wire or catheters (4 patients, 23.5%). Mortality occurred in 4 patients (23.5%), and all had tamponade caused by injury to the high-pressured left-sided circulation (left ventricle and aorta). Most patients (n = 14, 82.4%) sustained cardiac tamponade during the procedure-2 patients (11.7%) within 24 h, and 1 patient after 24 h. CONCLUSIONS Cardiac tamponade during TAVI is not frequent but is associated with high mortality rates especially when left-sided structures are involved. Meticulous handling of the equipment and improvements in the safety of currently used devices could further reduce the occurrence of this complication.

Coronary chronic total occlusions: mid-term comparison of clinical outcome following the use of the guided-STAR technique and conventional anterograde approaches.

Aim: There are limited data on the mid‐term safety following the use of the guided‐subintimal tracking and re‐entry (guided‐STAR) technique for the treatment of chronic total occlusions (CTO) and concerns have arisen about a potential increased risk of stent thrombosis (ST). Objectives: The aim of this study was to evaluate the mid‐term safety in terms of cardiac death and ST after recanalization using the contrast guided‐STAR technique when compared to conventional anterograde CTO recanalization (CA‐CTO). Methods and Results: This retrospective study analyzed 355 consecutive patients with successful angiographic recanalization (residual stenosis <20% and TIMI flow grade ≥2) of CTO lesion. Seventy‐four (20.8%) underwent guided‐STAR and 281 (79.2%) had CA‐CTO. Survival rates were estimated using the Kaplan‐Meier method. Compared to CA‐CTO patients, the rate of the following clinical, angiographic, and procedural characteristics were significantly higher in guided‐STAR patients: hypercholesterolemia (84 vs. 67%, P = 0.004), previous CABG (41.3 vs. 15.7%, P < 0.0001), three‐vessel disease, (62.7 vs. 47%, P = 0.019), right coronary artery CTO (62.7 vs. 41.6%, P = 0.002), stent length (68.15 vs. 54.05 mm, P < 0.0001). A drug‐eluting stent was implanted in the majority of cases (89.2% guided‐STAR vs. 93.5% CA‐CTO). At a median follow‐up of 779 days (IQR 495–1035), there were no significant differences in cardiac survival (97.2 vs. 97.5%, Log‐rank P = 0.912) and cumulative ARC ST rates (2.8 vs. 1.8%, Log‐rank P = 0.610) for guided‐STAR and CA‐CTO patients, respectively. The rate of restenosis was significantly higher in the guided‐STAR group compared to the CA‐CTO group (54 vs. 30%, Log‐rank P < 0.0001). The adjusted Cox proportional‐hazard analysis for procedural technique showed that the only significant independent predictor of restenosis was the stent length (HR, 1.017; 95% CI, 1.008–1.027; P < 0.0001). Conclusion: At mid‐term follow‐up, the guided‐STAR was not inferior to CA‐CTO in terms of safety. The only significant independent predictor of restenosis was the stent length.

Clinical and Angiographic Outcomes After Percutaneous Recanalization of Chronic Total Saphenous Vein Graft Occlusion Using Modern Techniques

Poor long-term outcomes after percutaneous coronary intervention (PCI) in chronic total occlusion (CTO) of saphenous vein grafts (SVGs) have been reported. However, limited data are available evaluating the use of modern techniques in this group. The aim of the present study was to assess the efficacy and long-term outcomes of PCI in SVG CTO with the routine use of embolic protection devices and drug-eluting stents. A retrospective cohort analysis was conducted of all consecutive patients undergoing PCI to SVG CTO from May 2002 to July 2009 at 2 centers. The indication for PCI was the presence of angina or silent ischemia with evidence of inducible ischemia after functional testing in the territory supplied by the SVG, despite optimal medical therapy. We identified 34 patients with SVG CTO. Of the 34 patients, 23 (68%) underwent successful SVG recanalization with stent implantation. An embolic protection device was used in 78% and 95% of stents implanted were drug-eluting stents. No in-hospital major adverse cardiac events occurred in the successful PCI group; one myocardial infarction occurred in the unsuccessful group. At follow-up (median 18.0 months, interquartile range 10.4 to 48.3), 1 case of myocardial infarction had occurred in the successful group. The in-stent restenosis rate was 68% (n = 13), of which 77% were focal, with target vessel revascularization in 61%. In conclusion, despite the relatively low procedural success rates, the clinical outcomes after successful PCI to SVG CTO with modern techniques were favorable. The repeat revascularization rates were high; however, graft patency was achievable in most after reintervention.

An Intense and Short-Lasting Burst of Neutrophil Activation Differentiates Early Acute Myocardial Infarction from Systemic Inflammatory Syndromes

Background Neutrophils are involved in thrombus formation. We investigated whether specific features of neutrophil activation characterize patients with acute coronary syndromes (ACS) compared to stable angina and to systemic inflammatory diseases. Methods and Findings The myeloperoxidase (MPO) content of circulating neutrophils was determined by flow cytometry in 330 subjects: 69 consecutive patients with acute coronary syndromes (ACS), 69 with chronic stable angina (CSA), 50 with inflammation due to either non-infectious (acute bone fracture), infectious (sepsis) or autoimmune diseases (small and large vessel systemic vasculitis, rheumatoid arthritis). Four patients have also been studied before and after sterile acute injury of the myocardium (septal alcoholization). One hundred thirty-eight healthy donors were studied in parallel. Neutrophils with normal MPO content were 96% in controls, >92% in patients undergoing septal alcoholization, 91% in CSA patients, but only 35 and 30% in unstable angina and AMI (STEMI and NSTEMI) patients, compared to 80%, 75% and 2% of patients with giant cell arteritis, acute bone fracture and severe sepsis. In addition, in 32/33 STEMI and 9/21 NSTEMI patients respectively, 20% and 12% of neutrophils had complete MPO depletion during the first 4 hours after the onset of symptoms, a feature not observed in any other group of patients. MPO depletion was associated with platelet activation, indicated by P-selectin expression, activation and transactivation of leukocyte β2-integrins and formation of platelet neutrophil and -monocyte aggregates. The injection of activated platelets in mice produced transient, P-selectin dependent, complete MPO depletion in about 50% of neutrophils. Conclusions ACS are characterized by intense neutrophil activation, like other systemic inflammatory syndromes. In the very early phase of acute myocardial infarction only a subpopulation of neutrophils is massively activated, possibly via platelet-P selectin interactions. This paroxysmal activation could contribute to occlusive thrombosis.

Comparison of VerifyNow-P2Y12 test and Flow Cytometry for monitoring individual platelet response to clopidogrel. What is the cut-off value for identifying patients who are low responders to clopidogrel therapy?

BackgroundDual anti-platelet therapy with aspirin and a thienopyridine (DAT) is used to prevent stent thrombosis after percutaneous coronary intervention (PCI). Low response to clopidogrel therapy (LR) occurs, but laboratory tests have a controversial role in the identification of this condition.MethodsWe studied LR in patients with stable angina undergoing elective PCI, all on DAT for at least 7 days, by comparing: 1) Flow cytometry (FC) to measure platelet membrane expression of P-selectin (CD62P) and PAC-1 binding following double stimulation with ADP and collagen type I either in the presence of prostaglandin (PG) E1; 2) VerifyNow-P2Y12 test, in which results are reported as absolute P2Y12-Reaction-Units (PRU) or % of inhibition (% inhibition).ResultsThirty controls and 52 patients were analyzed. The median percentage of platelets exhibiting CD62P expression and PAC-1 binding by FC evaluation after stimulation in the presence of PG E1 was 25.4% (IQR: 21.4–33.1%) and 3.5% (1.7–9.4%), respectively. Only 6 patients receiving DAT (11.5%) had both values above the 1st quartile of controls, and were defined as LR. Evaluation of the same patients with the VerifyNow-P2Y12 test revealed that the area under the receiver-operating-characteristic (ROC) curve was 0.94 (95% CI: 0.84–0.98, p < 0.0001) for % inhibition and 0.85 (0.72–0.93, p < 0.005) for PRU. Cut-off values of ≤ 15% inhibition or > 213 PRU gave the maximum accuracy for the detection of patients defined as having LR by FC.ConclusionIn conclusion our findings show that a cut-off value of ≤ 15% inhibition or > 213 PRU in the VerifyNow-P2Y12 test may provide the best accuracy for the identification of patients with LR.