Impact of design characteristics among studies comparing coronary computed tomography angiography to noninvasive functional testing in chronic coronary syndromes.

BACKGROUND: Coronary computed tomography angiography (CCTA) is widely adopted to detect obstructive coronary artery disease (CAD) in patients with chronic coronary syndromes (CCS). However, it is unknown to which extent study-specific characteristics yield different conclusions. METHODS: We summarized non-randomized and randomized studies comparing CCTA and noninvasive functional testing for CCS with information on the outcome of myocardial infarction (MI). We evaluated the differential effect according to study characteristics using random-effect meta-analysis with Hartung-Knapp-Sidik-Jonkman adjustments. RESULTS: Fifteen studies (8 non-randomized, 7 randomized) were included. CCTA was associated with decrease in relative (odds ratio (OR) 0.54, 95%CI 0.47 to 0.62, P < .001) and absolute MI risk (risk difference (RD) -0.4%, 95%CI -0.6 to -0.1, P = .005). The results remained consistent among the non-randomized (RD -0.4%, 95%CI -0.7 to -0.1, P=.029), but not among the randomized trials where there was no difference in the observed risk (RD 0.2%, 95%CI -0.6 to 0.1, P = .158). CCTA was not associated with MI reduction in studies with clinical outcome definition (OR 0.77, 95%CI 0.41 to 1.44, P = .212), research driven follow-up (OR 0.54, 95%CI 0.24 to 1.21, P = .090), central event assessment (OR 0.63, 95%CI 0.21 to 1.86, P = .207), outcome adjudication (OR 0.74, 95%CI 0.24 to 2.23, P = .178), or at low-risk of bias (OR 0.74, 95%CI 0.24 to 2.23, P = .178). CONCLUSIONS: Among studies of any design, CCTA was associated with lower risk of MI in CCS compared to noninvasive functional testing. This benefit was diminished among studies with clinical outcome definition, central outcome assessment/adjudication or at low-risk of bias.

Clinical and procedural outcomes of percutaneous coronary intervention for de novo lesions involving the ostial left circumflex coronary artery.

BACKGROUND: Percutaneous treatment for ostial left circumflex artery (LCx) lesions is known to be associated with suboptimal results. AIMS: The present study aims to assess the procedural and long-term clinical outcomes of percutaneous coronary intervention (PCI) for de novo ostial LCx lesions overall and according to the coronary revascularization strategy. METHODS: Consecutive patients undergoing PCI with second generation drug eluting stents or drug coated balloons for de novo ostial LCx lesions in three high-volume Italian centers between 2012 and 2021 were retrospectively evaluated. The primary endpoint was target-vessel revascularization (TVR) at 2 years. Secondary endpoints included major adverse cardiovascular and cerebrovascular events (MACCE), target lesion revascularization, myocardial infarction, stroke, all-cause death, and repeat revascularization. RESULTS: A total of 366 patients were included in the analysis with a median follow-up of 901 (IQR: 450-1728) days. 79.5% of the patients were male, 33.6% were diabetic, 49.7% had a previous PCI, and 23.1% a prior surgical revascularization. Very ostial LCx stenting was performed in 34.1%, crossover from left main to LCx in 17.3%, and a two-stent strategy in 48.6% of cases, respectively. In the overall population, the incidence of TVR at 2 years was 19.0% while MACCE rate was 25.7%. No major differences in clinical outcomes were found according to the stenting strategy. Use of intracoronary imaging was associated with fewer MACCE (HR: 0.47, 95% CI: 0.25-1.13, p = 0.01), while the diameter of the stent implanted in the ostial LCx was associated with less TVR (HR: 0.43, 95% CI: 0.25-0.75, p = 0.002). CONCLUSIONS: Percutaneous revascularization of the ostial LCx is associated with a high rate of TVR, regardless of the stenting strategy. Intracoronary imaging and proper stent sizing may reduce the failure rates.

Prediction of type 4a myocardial infarction with the angiography-derived hemodynamic (ADDED) index.

Percutaneous coronary intervention (PCI) is frequently complicated by type 4a myocardial infarction (MI), which is associated with an increased risk of mortality. We assessed the usefulness of the angiography-derived hemodynamic index (ADDED), which is based on the extent of myocardium at risk and on the anatomical lesion severity, in predicting type 4a MI in patients with chronic coronary syndrome (CCS) undergoing PCI. We enrolled 442 patients treated with single-vessel PCI. The ADDED index was calculated as the ratio of the Duke Jeopardy Score to the minimum lumen diameter assessed with quantitative angiography analysis. Type 4a MI was defined according to the 4th Universal Definition of MI. The overall population was divided into tertiles of ADDED index. Type 4a MI occurred in 5 patients (3.3%) in the ADDED-low tertile, 8 (5.5%) in the ADDED-mid tertile, and 26 (17.7%) in the ADDED-high tertile (p < 0.0001). At ROC curve analysis, the ADDED index could significantly discriminate between patients with and without type 4a MI (area under the curve 0.745). At multivariate analysis, an ADDED index value > 5.25 was the strongest independent predictor type 4a MI. Our results support the role of the ADDED index as a predictor of type 4a MI in patients with CCS treated with elective PCI of a single vessel. Whether a selective use of additional preventive measures in patients considered at high risk based on ADDED index values may improve peri-procedural and long-term outcomes remains to be tested in dedicated investigations.

Iatrogenic aorta-coronary dissection: Case report and systematic review.

OBJECTIVES AND BACKGROUND: Iatrogenic aorto-coronary dissection (ICD) is one of the most feared complications of interventional cardiology. Although rare, it is characterized by anterograde coronary ischemia and a concomitant aortic dissection, with potentially fatal consequences. METHODS: We present an example case of IACD and an accurate case-series review of the literature including 125 published cases. RESULTS: There were no significant predisposing factors and the IACD occurred equally in elective and urgent procedures. A significant number of IACDs were associated with CTO procedures. The factors associated with a worse outcome were hemodynamic instability, the presence of anterograde ischemia, and the extent of dissection according to the Dunning classification. Bail-out stenting was the most used strategy and its failure was associated with mortality. CONCLUSION: The main features of IACD are anterograde ischemia, retrograde dissection, and hemodynamic instability, each of them should be addressed with no time delay, possibly with bailout stenting, the most employed exit-strategy. According to our proposed algorithm, a shock team approach is required to coordinate the interdisciplinary skills and enabled patients to receive the best treatment.

Computed tomography analysis of coronary ostia location following valve-in-valve transcatheter aortic valve replacement with the ACURATE neo valve: Implications for coronary access.

BACKGROUND: Valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is an emerging alternative to re-do surgery. However, the challenge of coronary access (CA) following ViV-TAVR is a potential limitation as TAVR expands to younger lower-risk populations. OBJECTIVES: Using post-implantation computed tomography (CT) scans to evaluate the geometrical relationship between coronary ostia and valve frame in patients undergoing ViV-TAVR with the ACURATE neo valve. METHODS: Post-implant CT scans of 18 out of 20 consecutive patients treated with the ACURATE neo valve were analyzed. Coronary ostia location in relation to the highest plane (HP) (highest point of the ACURATE neo or surgical valve) was determined. Ostia located below the highest plan were further subclassified according to the gap available between the transcatheter heart valve frame and ostium (transcatheter-to-coronary [TTC] distance). The impact implantation depth has on these geometrical relationships was evaluated. RESULTS: A total of 21 out of 36 coronary ostia (58%) were located below the level of the HP with the left coronary artery (36%) more likely to be affected than the right (22%). Further sub-classification of these ostia revealed a large (>6 mm), moderate (4-6 mm), and small (<4 mm) TTC distance in 57% (12/21), 38% (8/21), and in 6% (1/18) of cases, respectively. At an implantation depth <4 mm compared to >4 mm, all ostia were located below the HP with no difference in post-procedural mean gradients (14.5 mmHg ± 4.7 vs. 12.6 mmHg ± 5.8; p = .5, 95%CI 3.8-7.5). CONCLUSIONS: CA following ACURATE neo implantation for ViV-TAVR could potentially be challenging in a significant proportion of patients and specific consideration should be given to the implantation depth.

Subclinical atrial fibrillation: when to give NAO?

Atrial fibrillation is defined as subclinical (SAF) when occurs without symptoms and is discovered only during the interrogation of permanent or temporary cardiac implantable devices. The significant interest in this condition derives from the fact that could easily be otherwise undiagnosed, portending to a potential serious neurological and cardiovascular consequences. The diagnosis of SAF is important for both the primary form and for patients after a stroke, and an appropriate management of antithrombotic treatment becomes a central instrument of prevention. Atrial fibrillation carries a five times increase in the thromboembolic risk. The subclinical asymptomatic forms of atrial tachyarrhythmias and fibrillation, diagnosed by interrogation of implantable cardiac devices, foretell a non-irrelevant risk of stroke, significantly higher than the one for patients without rhythm disturbances. Regardless the cause, the long-lasting asymptomatic arrhythmias, in patients with a significant risk profile, predict more important consequences and can justify anticoagulant treatment, also in primary prevention settings.

The co-predictive value of a cardiovascular score for CV outcomes in diabetic patients with no atrial fibrillation.

BACKGROUND: Risk factors included in the cardiovascular (CHA2 DS2 -VASc) score, currently used for atrial fibrillation (AF), may predispose to cardiovascular events whether or not AF is present. The aim was to explore the predictive role of CHA2 DS2 -VASc score on cardiovascular outcomes in diabetic patients without AF. METHODS: We accessed individual data from 610 diabetic patients without AF at baseline included in the prospective cohort of the Malmö Diet and Cancer study. Main outcome measure was the occurrence of cardiovascular events (stroke, coronary events) and death. Mean follow-up was 14.5 ± 5 years (8845 person/years). RESULTS: The CHA2 DS2 -VASc score significantly predicted the risk of all outcome measures. There was a significant increase in stroke, coronary events, and death risk by each point of CHA2 DS2 -VASc score elevation [stroke: adjusted hazard ratio (aHR) 1.43, 95% CI 1.14-1.79, P = 0.001; coronary events: aHR 1.55, 95% CI 1.34-1.80, P < 0.0001; death: aHR 1.94, 95% CI 1.71-2.21, P < 0.0001]. A CHA2 DS2 -VASc score ≥4 was associated with higher incidence of ischemic stroke (aHR 1.47, 95% CI 1.18-1.82; P = 0.001), coronary events (aHR 1.32; 95% CI 1.11-1.58; P = 0.002), and death (aHR 1.36; 95% CI 1.20-1.54; P < 0.001). CONCLUSIONS: In this population-based study on diabetic patients without AF, the CHA2 DS2 -VASc score was an independent predictor of ischemic stroke, coronary events, and overall mortality. Regardless of the AF status, the CHA2 DS2 -VASc score might represent a rapid and user-friendly tool for clinical assessment of diabetic patients at higher cardiovascular risk.

Transradial versus transfemoral ancillary approach in complex structural, coronary, and peripheral interventions. Results from the multicenter ancillary registry: A study of the Italian Radial Club.

OBJECTIVES: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. BACKGROUND: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. METHODS: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings. RESULTS: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients. CONCLUSIONS: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.

Expansion in calcific lesions and overall clinical outcomes following bioresorbable scaffold implantation optimized with intravascular ultrasound.

OBJECTIVES: This study aimed to investigate clinical outcomes following bioresorbable scaffold (BRS) optimized with intravascular ultrasound (IVUS), and furthermore expansion of BRS in calcific lesions. BACKGROUND: Although IVUS use has contributed to improved clinical outcomes with metallic stent implantation, it is unclear if this is also true with regards to BRS, especially in calcified lesions. METHODS: Between May 2012 and April 2015, 291 lesions in 198 patients were treated with BRS with IVUS use. We evaluated overall clinical outcomes at 1-year and investigated the expansion and eccentricity index of BRS amongst quadrants categorized by calcium arc (CA) every 90-degrees. RESULTS: The rates of major adverse cardiac events were 5.4% (at 6 months) and 10.7% (at 12 months). TLR was observed in 3.1% at 6-month and 7.5% at 12-month follow up. Although there was a significant difference among quadrants regarding to eccentricity of calcium (0°â‰¦CA < 90°: 0.82 ± 0.09, 90°â‰¦CA < 180°: 0.75 ± 0.12, 180°â‰¦CA < 270°: 0.78 ± 0.11, and 270°â‰¦CA≦360°: 0.79 ± 0.09, ANOVA P = 0.002), the BRS expansion index [minimal scaffold area (MSA) divided by BRS area expanded at a nominal pressure] was comparable between quadrants. CONCLUSIONS: The use of IVUS to optimize BRS implantation results in favorable clinical outcomes even for complex lesions. Although eccentric calcium distribution resulted in asymmetric expansion of BRS, the final MSA was comparable irrespective of calcium distribution. © 2016 Wiley Periodicals, Inc.

Treatment of drug-eluting stent restenosis: Comparison between drug-eluting balloon versus second-generation drug-eluting stents from a retrospective observational study.

OBJECTIVES: To compare drug-eluting balloons (DEBs) versus second-generation DES in the treatment of drug-eluting stent restenosis (DES-ISR). BACKGROUND: The optimal treatment of DES-ISR remains unclear. Several modes of treatment ranging from plain-old balloon angioplasty to repeated use of DES have yielded disappointing results. DEBs are increasingly been used in restenotic lesions; however, their use in DES-ISR is less established. METHODS: We evaluated all procedures between 2009 and 2011, involving DES-ISR that were treated either with DEB or second-generation DES. The measured end-points during the follow-up period were cardiac-death, target-vessel MI, TLR, TVR, and MACE defined as composite of cardiac-death, TV-MI, and TVR. RESULTS: Two hundred and forty-seven patients (302 lesions) with DES-ISR were treated with either DEB (81 patients; 104 lesions) or second-generation DES (166 patients; 198 lesions). The mean age of patients was 66.1 ± 9.4 years. There were higher numbers of patients with diabetes in the DEB group (DEB 47% vs DES 33%; p = 0.03). The mean length of DEB was significantly longer than the DES (35.4 vs 19.8 mm; p < 0.001). During the 12-month follow-up, there were no significant differences in the MACE rates (12.3% vs 8.4%; p = 0.3) and TLR rates (9.9% vs 7.8%; p = 0.6) between DEB and DES, respectively. On the multivariate analysis, use of DEB or DES was not the predictor of MACE (hazard ratio: 0.84, 95% CI: 0.46-1.85; p = 0.6). There were no cases of definite or probable stent thrombosis in either group. CONCLUSION: There were no significant differences in the clinical outcomes between DEB and second-generation DES in the treatment of DES-ISR. These results should encourage operators to consider DEB in the treatment of DES-ISR, which offers certain advantages over DES. © 2015 Wiley Periodicals, Inc.

Clinical outcomes following target lesion revascularization for bioresorbable scaffold failure.

OBJECTIVES: To investigate clinical outcomes following target lesion revascularization (TLR) for bioresorbable scaffold (BRS) failure in a real world population. BACKGROUND: BRS has become a new option in percutaneous coronary intervention, and may be potentially advantages because of the absence of a permanent metallic cage and the possibility for restoration of vasomotion and endothelial function. However, the requirement for TLR following BRS has been reported, but data on outcomes following reintervention are currently lacking. METHODS: Eighteen patients (20 lesions) who underwent TLR for BRS failure were identified at two high-volume centers in Milan, Italy. Clinical outcomes including all cause death, myocardial infarction, and repeat TLR after TLR for BRS failure were examined. RESULTS: The type of scaffold failure at TLR was classified into focal pattern in 15 lesions, diffuse pattern in two lesions, restenosis at side branch ostium in one lesion and scaffold thrombosis in two lesions. TLR was treated with plain old balloon angioplasty (POBA) in two lesions, with drug-coating balloon in three lesions, drug eluting stent implantation in 11 lesions, further BRS implantation in four lesions. During the followup (median: 345 days after TLR), one sudden death and three repeat TLRs were observed. CONCLUSION: In our series, we observed an adverse event rate of 20% of during the followup period following TLR for BRS failure. The optimal treatment option for these patients remains to be determined.

Trans-subclavian versus transapical access for transcatheter aortic valve implantation: A multicenter study.

OBJECTIVES: To compare the outcomes of trans-subclavian (TS) and transapical (TA) access for transcatheter aortic valve implantation (TAVI). BACKGROUND: A considerable proportion of patients undergoing TAVI are not eligible for transfemoral approach. To date, there are few data to guide the choice between alternative vascular access routes. METHODS: Among 874 consecutive patients who underwent TAVI, 202 procedures were performed through TA (n = 142, 70.3%) or TS (n = 60, 29.7%) access. Medtronic Corevalve (CV, Medtronic, Minneapolis, MN) was implanted in 17.3% of the patients, the Edwards-Sapien (ES, Edwards Lifesciences Inc., Irvine, CA) in 81.2% and other prostheses in 0.1%. In-hospital and long-term outcome were assessed using the Valve Academic Research Consortium (VARC)-2 definitions. RESULTS: Mean age was 82 ± 6 years, STS score 9.3 ± 7.9%. The 2 groups showed a relevant imbalance in baseline characteristics. In hospital mortality was 6.4% (1.7% TS vs. 8.4% TA, P = 0.06), stroke 2.0%, acute myocardial infarction 1.0%, acute kidney injury 39.4%, sepsis 4.0% with no significant differences between groups, while bleeding was more frequent in TA patients (53.5% vs. 11.7% TS, P < 0.001). One- and 2-year survival was 85.2% and 73.2% in TS patients, and 83.9% and 74.9% in TA patients (P = ns for both). Access site was not an independent predictor of mortality at multivariable analysis. CONCLUSION: Transapical compared with trans-subclavian access for TAVI was associated with a nonsignificant trend to increased periprocedural events. However, 1- and 2-year survival appears similar.

Clinical outcomes following bioresorbable scaffold implantation for bifurcation lesions: Overall outcomes and comparison between provisional and planned double stenting strategy.

The aim of this study was to investigate clinical outcomes of patients treated with a provisional stenting (PS) versus a double stenting (DS) strategy for coronary bifurcation lesions with bioresorbable scaffolds (BRS). There are limited data available with regards to outcomes following BRS implantation for bifurcation lesions. A total of 132 bifurcation lesions treated with BRS between 2012 and 2014 were analyzed. Of the total of 132 bifurcation lesions, 10 lesions were treated without crossover stenting. 99 lesions (81%) were treated with a PS strategy and 23 lesions (19%) with a DS strategy. The DS group consisted of patients with a greater number of true bifurcation lesions (PS 52.0% vs. DS 91.3%: P < 0.001). In the PS group, seven lesions (7.1%) were crossed-over to T-stenting. In the DS group, 13 lesions (57%) were treated with BRS to the side branch (SB). A hybrid stenting technique [BRS to the main branch, and metallic drug-eluting stent (DES) to the SB] was utilized in 10 (43%) lesions. Target lesion revascularization (TLR) rates were 5.5% for PS and 11.2% for DS (P = 0.49) at 1-year follow-up. Definite scaffold thrombosis did not occur at the site of any bifurcation lesion. These findings suggest that BRS implantation for bifurcation lesions is technically feasible. The rates of TLR tended to be higher in the DS group compared to when a PS strategy was employed. Larger studies are eagerly awaited to determine longer-term follow-up of this treatment strategy.

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

OBJECTIVES: 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. BACKGROUND: BVS represents the most interesting development in the drug-eluting stent field over recent years with promising results emerging from clinical trials. Available data however on the use of the ABSORB in real-world patients is limited. METHODS: All patients (n = 92) treated with BVS and 1296 patients treated with EES were included in this study. Propensity score matching was performed to adjust for differences in baseline clinical characteristics, yielding 92 patient pairs (BVS = 92 patients with 137 lesions and EES = 92 patients with 124 lesions). Clinical outcomes were examined between the 2 groups at 6-months. RESULTS: In both groups, most lesions were classified as either B2 or C (83.9% vs. 77.4%, P = 0.19). Predilatation (97.8% vs. 75.8%, P < 0.01) as well as postdilation (99.3% vs. 77.4%, P < 0.01) was more common in the BVS group. Clinical outcomes at 6-months were similar between the two groups with respect to both target lesion revascularization (3.3% vs. 5.4%, P = 0.41) and major adverse cardiac events (defined as the composite of target vessel revascularization, follow-up myocardial infraction and all-cause death) (3.3% vs. 7.6%, P = 0.19). CONCLUSIONS: ABSORB BVS for the treatment of complex lesions appears to be associated with good procedural and early clinical outcomes similar to those observed with conventional drug-eluting stents. Larger studies with long-term follow-up are required in order to fully assess the role of BVS in the treatment of such lesions and how this compares with that of conventional stents. © 2014 Wiley Periodicals, Inc.

First generation versus new generation drug-eluting stents for the treatment of ostial/midshaft lesions in unprotected left main coronary artery: the Milan and New-Tokyo (MITO) registry.

OBJECTIVES: To compare the clinical outcomes following unprotected left main coronary artery (ULMCA) percutaneous coronary intervention (PCI) of ostial/midshaft lesions between first and new generation drug-eluting stents (DES). BACKGROUND: Clinical outcomes after treatment of ostial/midshaft lesions in ULMCA with first generation DES were favorable. However, to date, data regarding treatment for those lesion subsets with new generation DES have not been reported. METHODS: A total of 219 patients with ostial/midshaft lesions in ULMCA treated with first (n = 139) or new generation DES (n = 80) were analyzed. RESULTS: There was a higher prevalence of IVUS use (35.2% vs. 50.0%, P = 0.032) and postdilation (70.5% vs. 93.8%, P < 0.001) with larger maximum balloon diameter (3.81 ± 0.45 vs. 4.08 ± 0.44, P < 0.001) in the new generation DES group. At a median follow-up period of 730 days, there were no significant differences in the propensity-score adjusted analyses, for major adverse cardiac events (MACE) defined as composite endpoint of all-cause death, myocardial infarction, and target vessel revascularization (hazard ratio (HR) [new vs. first generation DES]: 1.22; 95% confidence interval (CI): 0.64-2.31; P = 0.549). Of note, target lesion revascularization rates at 2-years were only 0.9% and 2.7%, for first and new generation DES groups, respectively (P = 0.339). On multivariable analysis, SYNTAX score (HR: 1.06; 95% CI: 1.02-1.11, P = 0.006) and European System for Cardiac Operative Risk Evaluation (HR: 1.14; 95% CI: 1.00-1.31, P = 0.051) were independent predictors for MACE. CONCLUSIONS: This study suggests that new generation DES for ostial/midshaft lesions in ULMCA are associated with favorable clinical outcomes, similar to those observed with first generation DES.

Causes and timing of death during long-term follow-up after transcatheter aortic valve replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an effective therapeutic option for patients with severe aortic stenosis at high risk for surgery. Identification of causes of death after TAVR may help improve patient selection and outcome. METHODS: We enrolled 874 consecutive patients who underwent TAVR at 3 centers using all approved bioprostheses and different access routes. Clinical outcomes during follow-up were defined according to the Valve Academic Research Consortium 2 definitions. Causes of deaths were carefully investigated. RESULTS: Mean logistic European System for Cardiac Operative Risk Evaluation was 23.5% ± 15.3%; Society of Thoracic Surgery score, 9.0% ± 8.2%. The Corevalve (Medtronic, Minneapolis, MN) was used in 41.3%; the Edwards Sapien (Edwards Lifesciences Inc., Irvine, CA) in 57.3%. Vascular access was transfemoral in 75.7%. In-hospital mortality was 5.0%. Cumulative mortality rates at 1 to 3 years were 12.4%, 23.4%, and 31.5%, respectively. Landmark analysis showed a significantly higher incidence of cardiovascular (CV) death in the first 6 months of follow-up and a significantly higher incidence of non-CV death thereafter. At Cox regression analysis, the independent predictors of in-hospital mortality were acute kidney injury grades 2 to 3 (hazard ratio [HR] 3.41) life-threatening bleeding (HR 4.26), major bleeding (HR 4.61), and myocardial infarction (HR 3.89). The independent predictors of postdischarge mortality were chronic obstructive pulmonary disease (HR 1.48), left ventricular ejection fraction at discharge (HR 0.98), and glomerular filtration rate <30 mL/min per 1.73 m(2) (HR 1.64). CONCLUSIONS: Around a third of patients treated with TAVR in daily practice die within the first 3 years of follow-up. Early mortality is predominantly CV, whereas late mortality is mainly non-CV, and it is often due to preexisting comorbidity.

Extended follow-up following "full-metal jacket" percutaneous coronary interventions with drug-eluting stents.

OBJECTIVES: To report very long-term follow-up of "Full-Metal Jacket" (FMJ) percutaneous coronary interventions (PCI) in long-diffuse coronary lesions with drug-eluting stents (DES). BACKGROUND: PCI for long-diffuse lesions may result in FMJ, which is not preferred by some operators due to long-term risk of restenosis and stent thrombosis. The data on long-term follow-up of patients with FMJ are limited and would be useful in understanding the safety and feasibility of such a strategy. METHODS: Between April 2002 and March 2007, 274 patients (297 lesions in native coronary arteries) underwent PCI utilizing DES. FMJ was described as lesions requiring ≥ 60 mm of continuous stent. The measured endpoints were cardiac death, target-vessel myocardial infarction (MI), target lesion revascularization (TLR), target-vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as composite of cardiac death, target-vessel MI, and TVR. RESULTS: The mean age of patients was 62.1 ± 11 years. The mean length of total stents used was 75.1 ± 16.4 mm (60-150). During the median follow-up of 74.7 months (interquartile range: 58-96), the rates of cardiac death, MI, TLR, and TVR were: 5.8% (n = 16), 6.2% (n = 17), 27.3% (n = 81), and 30% (n = 89), respectively. The MACE rate was 34%. Definite and probable stent thrombosis occurred in 10 patients (3.6%). CONCLUSION: The long-term follow-up of patients with FMJ is acceptable especially in regards to hard endpoints (death and MI) given the complexity of lesions treated. The high MACE rate was driven mainly by TVR. The availability of newer-generation DES and bioabsorbable scaffolds may improve these results. © 2014 Wiley Periodicals, Inc.

Comparison of abluminal biodegradable polymer biolimus-eluting stents and durable polymer everolimus-eluting stents in the treatment of coronary bifurcations.

OBJECTIVES: To compare biodegradable polymer biolimus-eluting (BES) with abluminal drug elution and durable polymer everolimus-eluting (EES) stents in the treatment of bifurcation lesions. BACKGROUND: The persistence of a polymer in drug-eluting stents (DES) following drug elution has been viewed as a possible culprit for restenosis. DES with biodegradable polymer may thus be associated with improved clinical outcomes, especially in high-risk lesions such as those at bifurcation sites. METHODS: We performed a retrospective study of consecutive de novo bifurcation lesions treated with EES between October 2006 and October 2011 and BES between February 2008 and March 2012. Study endpoints included major adverse cardiac events (MACE) defined as all-cause death, myocardial infarction (MI), including peri-procedural MI, and target vessel revascularization (TVR) as well as target lesion revascularization (TLR) separately. RESULTS: We analyzed 236 bifurcation lesions treated with either BES (79 lesions in 69 patients) or EES (157 lesions in 154 patients). Patient and procedural characteristics were broadly similar between the two groups. Estimated MACE and TVR rates at 2-year follow-up were similar between the BES and EES groups (MACE = 13.6 ± 4.6% vs. 14.6 ± 3.2% (P = 0.871); TVR = 6.9 ± 3.5% vs. 8.0 ± 2.7% (P = 0.889). No significant differences were noted between the two groups following propensity-score matched analysis. There was no probable or definite stent thrombosis. CONCLUSION: BES use in the treatment of bifurcation lesions appears to be associated with good clinical outcomes, comparable to those seen with EES, at long-term follow-up. These results are hypothesis-generating and need to be validated with larger studies.

Drug-eluting balloon in the treatment of in-stent restenosis and diffuse coronary artery disease: real-world experience from our registry.

OBJECTIVES: To report a single-center experience of drug-eluting balloons (DEB) in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease. BACKGROUND: DEB are emerging as an alternative treatment for coronary stenosis especially when metal scaffolding is undesirable (in-stent restenosis and small-vessel de novo disease). Although there are various randomized trials and registry studies, the data from real-world cohorts are lacking. METHODS: Consecutive patients treated with the In.Pact Falcon™ (Medtronic Inc., Minneapolis, MN, USA) paclitaxel-eluting balloon between January 2009 and December 2011 were retrospectively studied. The measured end-points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TVR. RESULTS: A total of 275 lesions were successfully treated in 184 patients. The mean age was 66.2 ± 9.6 years, and 87% were males. The predominant indication for DEB use was ISR (62%), with de novo lesions accounting for the remainder (38%). A mean of 1.48 ± 0.9 DEB were used per patient. Bailout stenting was required in 24% of lesions. The median clinical follow-up was 14.6 months (IQR 12-23). The overall rates of cardiac death, MI, TLR, TVR, and MACE were 3.8%, 1.6%, 16.8%, 17.9%, and 21.7%, respectively. The overall rate of stent thrombosis was 0.5% (n = 1). CONCLUSION: Our results suggests that DEB can be considered in lesions where the use of stents is not desirable, especially restenotic lesions. Further long-term follow-up of these patients will provide us more insights on the long-term outcomes.

Transcatheter Aortic Valve Implantation to Treat Degenerated Aortic, Mitral and Tricuspid Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) is now well established as the treatment of choice for patients with native aortic valve stenosis who are high or intermediate risk for surgical aortic valve replacement. Recent data has also supported the use of TAVI in patients at low surgical risk and also in anatomical subsets that were previously felt to be contra-indicated including bicuspid aortic valves and aortic regurgitation. With advancements and refinements in procedural techniques, the application of this technology has now been further expanded to include the management of degenerated bioprosthesis. After the demonstration of feasibility and safety in the management of degenerated aortic bioprosthetic valves, mitral and tricuspid bioprosthetic valve treatment is now also well-established and provides an attractive alternative to performing redo surgery. In this review, we appraise the latest clinical evidence and highlight procedural considerations when utilising TAVI technology in the management of degenerated aortic, mitral or tricuspid prosthesis.