Alfonso Ielasi

5-year outcomes following percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass graft for unprotected left main coronary artery lesions: The Milan experience

OBJECTIVES We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions. BACKGROUND Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG. METHODS All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed. A propensity analysis was performed to adjust for baseline differences between the 2 cohorts. RESULTS We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: 0.162 to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: 0.146 to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: 0.151 to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: 1.825 to 11.371; p = 0.0004). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: 0.825 to 3.054; p = 0.18). CONCLUSIONS At 5-year clinical follow-up, there was still no difference in the occurrence of major adverse cardiac and cerebrovascular events between elective PCI with DES implantation and CABG in unprotected left main coronary artery lesions in this single-center experience. There was an advantage of PCI in the composite end point of death, MI, and/or stroke, whereas a benefit in the need for reintervention was still found in CABG.

Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

OBJECTIVES Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion. BACKGROUND Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis. METHODS We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach. RESULTS A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events. CONCLUSIONS Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.

A new technique for vascular access management in transcatheter aortic valve implantation

Objectives: To describe results from a novel percutaneous technique designed to minimize the risk of hemorrhage in the event of a major complication during transcatheter aortic valve implantation. Background: Vascular access management is a major challenge in transfemoral TAVI due to the large introducer sheathes required. Methods: Fifty‐two pts underwent TAVI between November 2007 and March 2009. Of these, 37 received an Edwards‐Sapien Valve (23 mm valve: 17/37; 26 mm valve: 20/37) whilst 15 patients received a CoreValve (26 mm valve: 6/15; 29 mm valve: 9/15). Using a crossover technique, the opposing femoral artery was cannulated with a 7Fr long sheath. This allowed contralateral passage of a balloon and inflation in the proximal iliac. The sheath was then removed and Prostar sutures tied in a dry field. Balloon optimization of the puncture site was performed as required. Results: In three subjects, elective surgical repair was undertaken due to excessive femoral arterial calcification. In the remaining 49, the crossover technique was employed and closed with two Prostar devices (Edwards‐Sapien) or one (CoreValve). There were serious “on‐table” complications in seven patients, six due to the large introducer sheathes used in the TAVI procedure—iliac avulsion, two iliac dissections, iliac perforation, common femoral perforation and scrotal hematoma. All were repaired safely by combined surgical and endovascular techniques, using the crossover technique to ensure patient stability. All made a good recovery and were independently ambulant at discharge. Conclusion: Using crossover balloon inflation as an adjunct to Prostar closure may be helpful for managing TAVI vascular access sites.

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.

Incidence, predictors, management, immediate and long-term outcomes following grade III coronary perforation

OBJECTIVES The aim of this study was to evaluate the incidence, predictors, management, and clinical outcomes in patients with grade III coronary perforation during percutaneous coronary intervention. BACKGROUND Grade III coronary perforation is a rare but recognized complication associated with high morbidity and mortality. METHODS From 24,465 patients undergoing percutaneous coronary intervention from May 1993 to December 2009, 56 patients had grade III coronary perforation. RESULTS Most lesions were complex: 44.6% type B2, 51.8% type C, and 28.6% chronic total occlusions, and within a small vessel (≤ 2.5 mm) in 32.1%. Glycoprotein IIb/IIIa inhibitors were administered in 17.9% of patients. The device causing perforation was intracoronary balloon in 50%: 53.6% compliant, 46.4% noncompliant; intracoronary guidewire in 17.9%; rotablation in 3.6%; and directional atherectomy in 3.6%. Following perforation, immediate treatment and success rates, respectively, were prolonged balloon inflation 58.9%, 54.5%; covered stent implantation 46.4%, 84.6%; coronary artery bypass graft surgery (CABG) and surgical repair 16.0%, 44.4%; and coil embolization 1.8%, 100%. Multiple methods were required in 39.3%. During the procedure (n = 56), 19.6% required cardiopulmonary resuscitation and 3.6% died. In-hospital (n = 54), 3.7% required CABG, 14.8% died. The combined procedural and in-hospital myocardial infarction rate was 42.9%, and major adverse cardiac event rate was 55.4%. At clinical follow-up (n = 46) (median: 38.1 months, range 7.6 to 122.8), 4.3% had a myocardial infarction, 4.3% required CABG, and 15.2% died. The target lesion revascularization rate was 13%, with target vessel revascularization in 19.6%, and major adverse cardiac events in 41.3%. CONCLUSIONS Grade III coronary perforation is associated with complex lesions and high acute and long-term major adverse cardiac event rates.

Long‐term prognosis of medically treated patients with functional mitral regurgitation and left ventricular dysfunction

To assess long‐term prognosis in patients with functional mitral regurgitation (FMR) and left ventricular (LV) dysfunction, receiving current standard pharmacological therapy.

Periprocedural and Short-Term Outcomes of Transfemoral Transcatheter Aortic Valve Implantation With the Sapien XT as Compared With the Edwards Sapien Valve

OBJECTIVES The aim of this study was to analyze the short-term outcomes after transcatheter aortic valve implantation with the Edwards Sapien THV (ESV), compared with the Sapien XT THV (SXT) (Edwards Lifesciences, Irvine, California). BACKGROUND The SXT has been recently commercialized in Europe, but there are no studies analyzing the efficacy and safety of SXT, compared with ESV. METHODS All consecutive patients (n = 120) who underwent transcatheter aortic valve implantation in our center via the transfemoral approach with either ESV (n = 66) or SXT (n = 54). Valve Academic Research Consortium endpoints were used. RESULTS Mean age was 80 ± 8 years, and mean Logistic-European System for Cardiac Operative Risk Evaluation was 24.9 ± 17.0. The ilio-femoral artery minimal lumen diameter was smaller in patients treated with the SXT (7.27 ± 1.09 mm vs. 7.94 ± 1.08 mm, p = 0.002). Device success was high in both groups (96.3% vs. 92.4%, p = 0.45). Major vascular events were 3-fold lower in the SXT group (11.1% vs. 33.3%, relative risk: 0.40, 95% confidence interval: 0.28 to 0.57; p = 0.004). Life-threatening and major bleeding events were not significantly different between groups (18.5% vs. 27.3% and 35.2% vs. 40.9%, respectively). The SXT group had a lower 30-day Valve Academic Research Consortium combined safety endpoint (20.4% vs. 45.5%; relative risk: 0.44, 95% confidence interval: 0.24 to 0.80; p = 0.004). The 30-day mortality was 1.7% (n = 2). At 30 days, mean transaortic gradient was approximately 10 mm Hg in both groups and the aortic regurgitation was mild-to-moderate in 70.2% of SXT and 76.3% of ESV. CONCLUSIONS The new SXT valve has the same short-term performance as the ESV but seems to be associated with a lower risk of major vascular complications and thus has a broader clinical application.

Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosis.

OBJECTIVES This study sought to evaluate the long-term angiographic and clinical outcomes after the treatment of drug-eluting stent in-stent restenosis (DES-ISR) based on the angiographic pattern of restenosis. BACKGROUND Long-term outcomes after percutaneous treatment of DES-ISR are unclear. METHODS This study performed a retrospective analysis of 481 consecutive de novo DES-ISR lesions (n = 392) treated percutaneously between August 2002 and July 2007. The lesions were divided based on the pattern of restenosis: focal (305; 63.4%), diffuse (120; 24.9%), and occlusive (56; 11.6%). RESULTS The majority (65%) of patients had angina or ischemia on presentation and 13% had an acute coronary syndrome. Angiographic follow-up after treatment of DES-ISR was available in 65.5% of lesions. A second angiographic restenosis occurred in 29.1% of the focal group, 45.8% (p = 0.007) of the diffuse, and 65.6% (p < 0.0001) of the occlusive. The pattern of DES-ISR predicted the pattern of recurrence: occlusive reoccluded in 66.7%; diffuse recurred as diffuse or occlusive in 57.9%; focal as focal in 67.2%. During a median follow-up of 2.97 years (interquartile range: 2.37 to 3.89), major adverse cardiac events occurred in 32.8% of patients with no significant differences among the focal, diffuse, and occlusive groups (30.9%, 38.7%, 31.1%; p = 0.38). Diffuse restenosis was associated with a significantly higher target lesion revascularization rate compared with focal (27.1% vs. 15.8%; p = 0.008). A disparity between restenosis (65.6%) and target lesion revascularization (18.5%) rates for occlusive DES-ISR suggests that as many recurrent restenoses were occlusive, they were not retreated. CONCLUSIONS DES-ISR identifies a high-risk cohort that is at an increased risk of events, in particular repeat revascularization, during long-term follow-up. The initial pattern of restenosis is the most important predictor of recurrent restenosis or the need for subsequent reintervention.

Management and Long-Term Prognosis of Spontaneous Coronary Artery Dissection

The optimal management and short- and long-term prognoses of spontaneous coronary artery dissection (SCAD) remain not well defined. The aim of this observational multicenter study was to assess long-term clinical outcomes in patients with SCAD. In-hospital and long-term outcomes were assessed in 134 patients with documented SCAD, as well as the clinical impact and predictors of a conservative rather than a revascularization strategy of treatment. The mean age was 52 ± 11, years and 81% of patients were female. SCAD presented as an acute coronary syndromes in 93% of patients. A conservative strategy was performed in 58% of patients and revascularization in 42%. On multivariate analysis, distal versus proximal or mid location of dissection (odds ratio 9.27) and basal Thrombolysis In Myocardial Infarction (TIMI) flow grade 2 or 3 versus 0 or 1 (odds ratio 0.20) were independent predictors of conservative versus revascularization strategy. A conservative strategy was associated with better in-hospital outcomes compared with revascularization (rates of major adverse cardiac events 3.8% and 16.1%, respectively, p = 0.028); however, no significant differences were observed in the long-term outcomes. In conclusion, in this large observational study of patients with SCAD, angiographic features significantly influenced the treatment strategy, providing an excellent short- and long-term prognosis.

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.