Intracoronary Pacing during "Chimney Technique" in Transcatheter Aortic Valve-in-Valve Implantation: An Alternative Temporary Rapid Ventricular Stimulation?

Temporary rapid ventricular pacing (TRVP) is required during transcatheter aortic valve implantation (TAVI) in order to reduce cardiac output and to facilitate balloon aortic valvuloplasty, prosthesis deployment, and post-deployment balloon dilation. The two most frequently used TRVP techniques are right endocardial (RE)-TRVP and retrograde left endocardial temporary rapid ventricular pacing (RLE)-TRVP. The first one could be responsible for cardiac tamponade, one of the most serious procedural complications during TAVI, while the second one could often be unsuccessful. Intracoronary (IC)-TRVP through a coronary guidewire has been described as a safe and efficient procedure that could avoid such complications. We describe two clinical cases in which IC-TRVP has been effectively used during valve-in-valve TAVI with coronary protection via the "chimney technique", after unsuccessful RLE-TRVP.

Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation.

OBJECTIVE: To investigate the predictors of moderate-to-severe aortic regurgitation (AR≥2+) after CoreValve implantation and evaluate the feasibility and safety of postdilatation in reducing the degree of AR. BACKGROUND: Although transcatheter aortic valve implantation is an alternative treatment for high surgical risk patients with severe aortic stenosis, post-implantation paravalvular AR remains a complication. METHODS: From July 2008 to July 2010, we enrolled 79 consecutive patients with severe aortic stenosis who underwent CoreValve implantation. RESULTS: On univariable analysis, the predictors of AR≥2+ immediately after CoreValve implantation were: larger annulus size, low implantation, prosthesis mismatch, chronic renal insufficiency, a history of heart failure, and peripheral vascular disease. On multivariable analysis, the independent predictors of AR≥2+ were: larger annulus diameter (OR 1.78, 95%CI 1.25-2.55; P = 0.002), low implantation (OR 3.67, 95%CI 1.01-13.35, P = 0.05), and peripheral vascular disease (OR 3.54, 95%CI 1.19-10.56, P = 0.02). Post-CoreValve implantation, AR ≥ 2 was seen in 40.5% (32/79). Twenty-one patients underwent postdilatation with improvement in AR grade in the majority (17/21). Of the four patients who did not respond to postdilatation, two underwent valve-in-valve implantation. In one patient, the valve was pulled more proximally by the snare technique. The remaining 10 patients were treated conservatively. CONCLUSION: The appropriate strategy for treating patients with AR≥2+ depends on the causes and severity of AR post-TAVI. This study suggests that we should carefully select the size of CoreValve prosthesis to prevent prosthesis mismatch, especially when implanted in larger annulus sizes. For valves implanted in the appropriate position, postdilatation appears effective in reducing the degree of AR.

One-Year Results Following a Pre-Specified ABSORB Implantation Strategy in ST-Elevation Myocardial Infarction (BVS STEMI STRATEGY-IT Study).

BACKGROUND: data from clinical experiences with Absorb bioresorbable scaffold (BRS) in STEMI raised concerns among clinicians about the device safety because a noteworthy scaffold thrombosis (ScT) rate was reported at early and long-term follow-up. Nevertheless, pre-specified technical suggestions of how to perform an optimal BRS procedure in STEMI were lacking. In this study we sought to assess the 1-year results following a pre-specified BRS implantation strategy in ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI (pPCI). METHODS: This is a prospective, multicenter study on 505 STEMI patients undergoing pPCI with Absorb following a dedicated implantation protocol. The primary end-point (a device oriented composite end-point (DOCE) of cardiac death, target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) within 30 days) was already reported. We here present DOCE, its singular components and ScT rates (secondary end-points) at 1-year. RESULTS: According to the study protocol direct Absorb implantation was feasible in 47 (9.3%) patients while post-dilatation was performed in 468 (92.7%) cases. The hierarchical DOCE rate at 1-year was 1.2% (0.4% cardiac death, 0.4% TV-MI and 0.8% ID-TLR) versus 0.6% at 30-day. Two episodes (0.4%) of ScT (one probable subacute and one late definite) were reported. At 1-year, 99.2% patients were on dual antiplatelet therapy (95% with ticagrelor or prasugrel). CONCLUSIONS: A pre-specified Absorb implantation strategy in STEMI patients was associated with persistent low DOCE and ScT rates at 1-year. Longer term follow-up is needed to assess the role of this strategy on preventing very-late events (NCT02601781).

Frequency of slow coronary flow following successful stent implantation and effect of Nitroprusside.

Nitroprusside (NTP) is used for the treatment of slow coronary flow (SCF) after coronary interventions. The wide variation in dosage, route, and timing of its administration in the reported studies prevents an objective assessment of its efficacy. We report the incidence and response to a standardized NTP protocol of SCF after successful stent implantation. Selective intracoronary administration of incremental doses (initial bolus of 80 microg incremented by 40 microg) of NPT was assessed in 21 patients who developed SCF in a series of 2,212 consecutive patients who underwent successful stent placement from January to October 2005. SCF was observed only in patients treated for acute myocardial infarction (AMI; 11.5%, 12 of 105) or saphenous vein graft (SVG) stenosis (8.2%, 9 of 109). An intracoronary bolus of nitroglycerin did not restore normal Thrombolysis In Myocardial Infarction (TIMI) flow in any patient. The first 80-microg dose of NTP restored normal TIMI flow in 58% of patients (7 of 12) with AMI and in 44% of patients (4 of 9)with SVG stenosis. The maximal dose (120/160 microg) restored normal TIMI flow in all remaining patients with AMI but in only 1 additional patient with SVG stenosis. At the end of the procedure, the percent decrease in corrected TIMI frame count was significantly larger in patients with AMI (-44+/-10%) than in those with SVG stenosis (-24+/-16%, p=0.02). In a large consecutive series of successful stent procedures, SCF was found only in patients with ST-elevation AMI (11.5%) or with a stenosed SVG (8.2%). In conclusion, the standardized protocol of intracoronary NTP administration succeeded in normalizing SCF in all patients with AMI but in only 5 of 9 patients with SVG stenosis. This latter subgroup requires other therapeutic strategies.

Computed tomography-based evaluation of aortic annulus, prosthesis size and impact on early residual aortic regurgitation after transcatheter aortic valve implantation.

OBJECTIVES: Computed tomography (CT) is an increasingly utilized method for the evaluation of patient suitability for transcatheter aortic valve implantation (TAVI). The aim of this study was to analyse the role of CT in the choice of prosthesis and the prevention of residual aortic regurgitation (RAR). METHODS: From November 2007 to September 2010, 115 patients (median age 81 years, inter-quantile range (IQR) 76-85; median ejection fraction 55%, IQR 45-60; median logistic EuroSCORE 19.7, IQR 11.0-32.1) undergoing TAVI were evaluated with a pre-procedural CT. An aortic complex was evaluated with multi-planar reconstructions, and we defined significant early RAR as RAR ≥ 2, and prosthesis/annulus mismatch (PAM) as the ratio between prosthesis size and mean annular size. All analyses were conducted for the whole sample and then separately for the two types of prosthesis implanted. RESULTS: An Edwards-SAPIEN(®) prosthesis was implanted in 62 patients (54.7%), and a Medtronic CoreValve(®) in 52 (45.2%). Aortic annulus minimum and maximum diameters were 22.6 ± 2.1 and 26.0 ± 2.3 mm, respectively. The aortic annulus diameter and the length of the free edge of the aortic cusps were linearly related to a 1:1 ratio (P < 0.0001). Significant RAR (34 patients, 30%) appeared directly related to the annulus diameters (particularly maximum and medium diameters, P = 0.0003 and P = 0.0010, respectively) and cusp length (P = 0.0007) but inversely correlated with PAM (P = 0.0006). Prosthesis/annulus oversizing was associated with a reduction in RAR, with a cut-off of 7% as the limit below which RAR increases; moreover, we observed different cut-off values for the Edwards and CoreValve prostheses, although statistical significance was not reached for the CoreValve (respectively, 2% with P < 0.0001, 11% with P = 0.16). No association was found between PAM and possible PAM-related complications. CONCLUSIONS: CT evaluation prior to TAVI showed that RAR was directly correlated with aortic root dimensions (particularly maximum and medium annulus diameters and cusp lengths) and inversely correlated with PAM. Oversizing the prosthesis by at least 7% reduces the risk of RAR. CT is an essential and invaluable tool in the assessment of patients undergoing TAVI.

Very long-term outcomes following drug-eluting stent implantation for unprotected left main coronary artery stenosis: a single center experience.

INTRODUCTION AND OBJECTIVES: Encouraging results at long-term follow-up have been reported from non-randomized registries and randomized trials following percutaneous coronary intervention with drug-eluting stent implantation for unprotected left main stenosis. However, information on very long-term (>5-year) outcomes is limited. The aim of this study was to assess the very long-term outcomes (6-years) following drug-eluting stent implantation for left main disease. METHODS: All consecutive patients with unprotected left main stenosis electively treated with drug-eluting stent implantation, between March 2002 and May 2005, were analyzed according to the location of the left main lesion (distal bifurcation vs ostial/body). RESULTS: The study included 149 patients: 113 with distal bifurcation and 36 with ostial/body lesion. Triple-vessel disease was significantly higher in the distal than in the ostial/body group (52.2% vs 33.2%, P=.05). At 6-years of follow-up, the cumulative major adverse cardiovascular event rate was 41.6% (45.1% distal vs 30.6% ostial/body, P=0.1), including 18.8% any death (22.1% distal vs 8.3% ostial/body, P=.08), 3.4% myocardial infarction (3.5% distal vs 2.8% ostial/body, P=1), and 15.4% target lesion revascularization (18.6% distal vs 5.6% ostial/body, P=.06). The composite of cardiac death and myocardial infarction was 10.7% (13.3% distal vs 2.8% ostial/body, P=.1) while the definite/probable stent thrombosis rate was 1.4% (all in the distal group). CONCLUSIONS: At 6-year clinical follow-up, percutaneous coronary intervention with drug-eluting stent implantation for unprotected left main disease was associated with acceptable rates of cardiac death, myocardial infarction and stent thrombosis. Favorable long-term outcomes in ostial/body lesions compared to distal bifurcation lesions were confirmed at long-term clinical follow-up.

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.

Clinical and procedural predictors of suboptimal outcome after the treatment of drug-eluting stent restenosis in the unprotected distal left main stem: the Milan and New-Tokyo (MITO) registry.

BACKGROUND: Few data are available regarding the optimal revascularization strategy for unprotected distal left main coronary artery (UDLM) in-stent restenosis (ISR). METHODS AND RESULTS: Between April 2002 and December 2008, UDLM-ISR following drug-eluting stent (DES) implantation occurred in 92 of 474 patients (19.4%). Of these, 8 (8.7%) who underwent a coronary artery bypass graft (CABG) were excluded, and the remaining 84 (91.3%) who underwent percutaneous coronary intervention (PCI) (43 plain old balloon angioplasty [POBA] and 41 DES) were analyzed to assess the feasibility of PCI for UDLM-ISR. The overall cardiac death, myocardial infarction (MI), and major adverse cardiac events during the follow-up period (median, 24 months) occurred in 4, 2, and 31 patients, respectively. Repeat target lesion revascularization (TLR) occurred in 28 patients. The incidence of repeat TLR was higher following PCI with POBA than with DES (hazard ratio [HR], 2.79; 95% CI, 1.23-6.34; P=0.014). On Cox regression analysis, the independent predictors of repeat TLR were treatment with POBA (HR, 3.29; 95% CI, 1.41-7.69; P=0.006) and EuroSCORE (European System for Cardiac Operative Risk Evaluation) >6 (HR, 2.53; 95% CI, 1.02-6.28; P=0.045). More complex lesions requiring a 2-stent strategy were associated with a higher occurrence of TLR for restenosis of the left circumflex coronary artery ostium (LCX-ISR) (HR, 2.51; 95% CI, 1.59-3.97; P=0.001) as well as repeat TLR for recurrent LCX-ISR (HR, 4.32; 95% CI, 0.97-19.20; P=0.05) compared to a 1-stent strategy. No cardiac death at 2 years occurred in patients with LCX-ISR. CONCLUSIONS: UDLM restenosis is better treated with DES than with POBA. The rate of recurrent ISR following repeat PCI was high, whereas the rates of MI and death were relatively low. Complex lesions requiring a 2-stent strategy had a higher recurrence rate at the ostial LCX but without an associated increased risk of MI and death.

Incidence of overall bleeding in patients treated with intra-aortic balloon pump during percutaneous coronary intervention: 12-year Milan experience.

OBJECTIVES: This study aims to report a "real-world" experience of in hospital complications and clinical outcome of a large cohort of consecutive patients who underwent percutaneous coronary intervention (PCI) with intra-aortic balloon pump counterpulsation (IABP) support, from a tertiary care center over a 12-year period. BACKGROUND: The incidence of vascular complications in patients treated with PCI and IABP is expected to be higher due to simultaneous puncture of femoral arteries, larger IABP sheath size, and longer duration of IABP therapy. METHODS: A total of 360 consecutive patients (mean age of 65.9 ± 11.2 years; 80.6% male) who required an IABP support during percutaneous PCI were classified into 3 groups: Urgent: 133 patients (36.9%) admitted with acute coronary syndrome in whom IABP therapy was started before urgent PCI; Emergent: 56 patients (15.6%) in whom emergent IABP insertion was required to manage hypotension during PCI; and Elective: 171 patients (47.5%) with stable angina pectoris in whom IABP was inserted before elective PCI. Overall bleeding was defined according to the newest the Bleeding Academic Research Consortium (BARC) definition criteria. RESULTS: BARC bleeding occurred in 68 patients (19%), with the highest incidence noted in the Urgent group (31.1%), in comparison with the Emergent (26.8%) and Elective (7%) groups, p < 0.0001. Bleeding related to the IABP access site was 7.5%, which accounted for 82% of any access site-related bleeding. It was significantly higher in the Urgent group (12.8%) compared with the Elective (4.1%) and Emergent (5.4%) groups. At multivariate analysis, IABP treatment duration and renal impairment were the only independent predictors of BARC bleeding. CONCLUSIONS: Bleeding related to the IABP access site was significantly higher in the Urgent group and accounted for more than two-thirds of overall access site-related bleeding. IABP treatment duration and renal impairment were independent predictors of overall bleeding.

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.

Recognition and management of complications during transcatheter aortic valve implantation.

In the field of interventional cardiology, transcatheter aortic valve implantation is the newest and most exciting development of recent years. With a growing evidence base for both prognostic and symptomatic benefit, more and more interventionalists are keen to learn the procedure. However, the concomitant risk associated with a technically challenging procedure in a high-risk patient population is significant, and complications can arise suddenly and often unexpectedly. It is essential that new, and even established, operators are meticulously aware of the potential for complications, are able to identify them at an early stage, and manage them quickly and effectively. We have significant experience with transcatheter aortic valve implantation, through the implantation of 260 devices, which brings first-hand experience of most major complications. This article provides insight into the potential for complications, offering advice on effective treatment, recognition, and ultimately, prevention. It also suggests a number of procedural and technical modifications, which might improve outcomes in the future.

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.

A high dose of adenosine to induce transient asystole for valvuloplasty in patients undergoing transcatheter aortic valve implantation (TAVI): is it a valid alternative to rapid pacing? A prospective pilot study.

BACKGROUND: Rapid right ventricular pacing (RRVP) at rates above 200 beats/minute is used to suppress cardiac output during balloon aortic valvuloplasty (BAV) in transcatheter aortic valve replacement (TAVI) patients. A risk of inducing myocardial ischemia with RRVP remains, especially in patients with left ventricular dysfunction. Alternatively, a transient cardiac arrest can be achieved with administration of adenosine. METHODS: The primary endpoint was successful valvuloplasty defined by complete balloon inflation and deflation across aortic valve during the transient asystole induced by adenosine. Secondary endpoints were defined as the failure of adenosine to induce asystole, the incidence of ventricular ectopic beats (VEB) during balloon inflation or deflation, and balloon displacement. RESULTS: From November 2010 to January 2011, twenty consecutive patients who underwent TAVI were included. A balloon for valvuloplasty was positioned across the aortic valve. A low-dose (24 mg, n = 10) or high-dose (36 mg, n = 10) bolus of adenosine was administrated. A single bolus of adenosine-induced atrioventricular (AV) block (mean duration, 18.6 ± 6.6 seconds) followed by cardiac asystole in 16 patients (80%) (low-dose, n = 9). A successful BAV was achieved in 12 patients (60%) (low-dose, n = 8). Adenosine induced only bradycardia in 4 patients (20%) (low-dose, n = 1). A burst of VEB during BAV occurred in all patients. Balloon displacement occurred in 6 patients (37.5%). CONCLUSION: BAV after administration of adenosine is feasible, safe, and may represent an option for high-risk TAVI patients in whom RRVP might not be well tolerated. The occurrence of ventricular ectopic contractions triggered by balloon inflation and deflations accounts for balloon displacement and crossover to RRVP.

Comparison of long-term clinical and angiographic outcomes following implantation of bare metal stents and drug-eluting stents in aorto-ostial lesions.

Percutaneous coronary intervention (PCI) to aorto-ostial (AO) lesions is technically demanding and associated with high revascularization rates. The aim of this study was to assess outcomes after bare metal stent (BMS) compared to drug-eluting stent (DES) implantation after PCI to AO lesions. A retrospective cohort analysis was conducted of all consecutive patients who underwent PCI to AO lesions at 2 centers. Angiographic and clinical outcomes in 230 patients with DES from September 2000 to December 2009 were compared to a historical control group of 116 patients with BMS. Comparison of the baseline demographics showed more diabetics (32% vs 16%, p = 0.001), lower ejection fractions (52.3 ± 9.7% vs 55.0 ± 11.5%, p = 0.022), longer stents (17.55 ± 7.76 vs 14.37 ± 5.60 mm, p <0.001), and smaller final stent minimum luminal diameters (3.43 ± 0.53 vs 3.66 ± 0.63 mm, p = 0.001) in the DES versus BMS group. Angiographic follow-up (DES 68%, BMS 66%) showed lower restenosis rates with DES (20% vs 47%, p <0.001). At clinical follow-up, target lesion revascularization rates were lowest with DES (12% vs 27%, p = 0.001). Cox regression analysis with propensity score adjustment for baseline differences suggested that DES were associated with a reduction in target lesion revascularization (hazard ratios 0.28, 95% confidence interval 0.15 to 0.52, p <0.001) and major adverse cardiac events (hazard ratio 0.50, 95% confidence interval 0.32 to 0.79, p = 0.003). There was a nonsignificantly higher incidence of Academic Research Consortium definite and probable stent thrombosis with DES (n = 9 [4%] vs n = 1 [1%], p = 0.131). In conclusion, despite differences in baseline characteristics favoring the BMS group, PCI with DES in AO lesions was associated with improved outcomes, with lower restenosis, revascularization, and major adverse cardiac event rates.

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.

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.

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.

[Treatment of chronic total coronary occlusions by the subintimal tracking and reentry modified technique. The contrast-guided STAR technique]. / Trattamento delle occlusioni croniche totali delle coronarie mediante la tecnica subintimal tracking and reentry (STAR) modificata. La tecnica STAR guidata dal contrasto.

BACKGROUND: Previous data showed that recanalization of chronic total occlusions (CTO) with the subintimal tracking and reentry (STAR) technique is feasible. However, this technique is challenging and requires skilled operators to be performed. The aim of this study was to evaluate procedural and clinical outcomes of patients undergoing a contrast-guided STAR procedure. METHODS: All consecutive patients (n=121) with coronary CTO treated with the contrast-guided STAR technique in three Italian centers were included in this study, after failure of conventional CTO approaches. RESULTS: The right coronary artery was involved in 76.8%, with blunt morphology in 62.8%. Angiographic and procedural success rates were 82.6% and 64.4%, respectively, with a 69.4% rate of complete recanalization. Stent implantation was performed in 81.8% of cases, using drug-eluting stents in 94.4%. Procedural complications occurred in 7.4% of cases. During follow-up no episodes of myocardial infarction were observed, but one cardiac death (0.8%). No definite or probable stent thrombosis was reported. The overall rate of target lesion revascularization was 21.4%. CONCLUSIONS: This study demonstrated that the contrast-guided STAR technique appears to be a feasible and relatively safe procedure when performed as rescue technique after failure of conventional CTO approaches. However, this procedure is limited by a high rate of target lesion revascularization and a second procedure may be necessary to obtain a definitive result.

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.