Stent graft treatment for infra-inguinal arterial disease for either instent-restenosis and denovo lesions associated with very high rates of failure.

BACKGROUND: FDA approved the Gore Viabahn (WL Gore, Flagstaff, AZ, USA) stent for both femoro-popliteal arterial denovo and instent restenosis (ISRS) lesions. To date there is little data on Viabahn stent graft outcomes in ISRS arterial disease. METHODS: Between 2007 and 2014 we identified 734 patients who underwent 1573 endovascular interventions in our institution for infra-inguinal revascularization. Among these, 48 patients had 143 Viabahn stents placed. Of these, 26 patients had 94 stents placed for ISRS and 22 patients had 49 stents placed for denovo lesions. RESULTS: The patients in the ISRS group were younger and more likely to have hypertension, hyperlipidemia, coronary artery disease, compared to the patients in the denovo group. Stents were placed principally for femoro-popliteal lesions, with mean length of 21 ± 12.5 cm (19.2 ± 14, ISRS vs. 22.1 ± 11, denovo; P = 0.2). Both groups had low primary patency rates during one year follow up (54% vs. 33%, OR = 2.3 (0.9-2.2). Target lesion revascularization (TLR) (57% vs. 27%, P < 0.0001, OR = 3.7, CI = 1.8-8) and surgical revascularization (21% vs. 4%, OR = 6.3, CI = 1.4-28) occurred more frequently in the ISRS group than in the denovo group. Amputation rate (17% vs. 31%, OR 0.7, CI = 0.2-1), cumulative blockage (defined as ISRS and thrombosis) (62% vs. 47%, P = 0.09, OR = 1.8, CI = 0.9-3.6), and Restenosis (40% vs. 31%, OR 1.5, CI = 0.7-3.2) were not statistically different between the two groups. Mean duration of follow-up was 12.8 ± 13 months. CONCLUSION: Stent graft treatment using the Gore Viabahn for denovo and ISRS in femoro-popliteal arterial obstructive disease have high restenosis and failure rates, of both stent patency and limb outcomes, which is consistent with existed literature.

Transcatheter aortic valve replacement in unicuspid aortic valve stenosis.

Unicuspid aortic valve (UAV) offers unique challenges to transcatheter aortic valve replacement (TAVR), due to asymmetric expansion and apposition of the prosthesis during implantation. Although TAVR in bicuspid is now a well described experience, TAVR in unicuspid valve has not yet been described. A challenging case is described with TAVR in UAV using a Edwards Sapiens prosthesis via transapical approach. © 2016 Wiley Periodicals, Inc.

Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study).

OBJECTIVES: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES. BACKGROUND: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient. METHODS: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively. RESULTS: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26-0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42-0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes. CONCLUSIONS: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.

Major adverse noncardiac events after PCI as predictors of long-term mortality.

BACKGROUND: Studies of percutaneous coronary intervention (PCI) routinely report major adverse cardiovascular events (MACE), but not major adverse noncardiac events (MANE) after PCI. MANE, such as post-PCI bleeding and contrast nephropathy, adversely influence survival, but are not recognized as a standard composite of complications. We assessed the feasibility and prognostic utility of deriving a composite of MANE. METHODS: In 985 consecutive patients who underwent PCI, we estimated the incidence and prognostic impact of in-hospital MACE (myocardial infarction [MI] target vessel revascularization, or stroke) and MANE (defined as thrombolysis in myocardial infarction [TIMI], bleeding [major or minor], or contrast nephropathy) and their impact on long-term survival. RESULTS: The incidence of MANE was >6-fold greater than MACE (9.5% vs 1.5%). Independent correlates of MANE included age, female gender, peripheral vascular disease, lower left ventricular ejection fraction, and use of an intraaortic balloon pump (IABP) during PCI. Of 973 patients who survived the index hospitalization, death occurred in 169(17%) at a median follow-up of 4.0 years. MANE (but not MACE) showed a significant relation with survival; 34 of 85 patients with MANE compared to 135 of 888 patients without MANE died during follow-up (40% vs 15%, log-rank P < 0.0001). After adjustment for several baseline clinical features, the occurrence of MANE was independently associated with a significant increase in long-term mortality (adjusted hazards ratio [HR]= 1.72, CI = 1.05-2.83) and myocardial infarction (adjusted HR = 3.43, CI = 1.55-7.58). CONCLUSIONS: After PCI, MANE are common and carry grave long-term prognostic significance. Our findings emphasize the need to monitor and report MANE, in addition to MACE, in PCI-related trials.

Have we given up on intra-aortic balloon counterpulsation in post-myocardial infarction cardiogenic shock?

The recently published Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial concluded that intra-aortic counterpulsation (IACP) does not reduce 30-day mortality in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI) for whom early revascularization strategy was planned. The study resulted in downgrading IACP in post-AMI CS patients by certain professional organizations like the European Society of Cardiology. Although this is the largest and most important CS study of this decade, it suffers from considerable shortcomings: (1) time intervals from chest-pain onset or AMI recognition to revascularization, enrollment, and IACP initiation are not disclosed; (2) 86.6% of the treatment arm initiated IACP only post-percutaneous coronary intervention (PCI), and 4.3 % did not receive IACP at all; (3) 17.4% of the control arm crossed over to IACP or other mechanical support, mostly due to protocol violations; (4) there is no adjudication of the mortality events; (5) follow-up is limited to 30 days; and (5) both methodology (especially IACP device size) and quality of IACP are not evaluated and documented. Because the study assessed mostly the efficacy and safety of IACP initiated post-PCI, the study conclusions should not be extrapolated to IACP pre-PCI or during PCI in CS. Moreover, IACP had a favorable effect on the mortality of younger patients. Intra-aortic counterpulsation should remain the first line of mechanical circulatory support for the hemodynamically compromised AMI patients with or without CS who are undergoing primary PCI. Early upgrade to more advanced mechanical circulatory support should be considered for selective suitable candidates who remain in refractory CS despite revascularization and IACP.

Use of antiplatelet agents in patients with atherosclerotic disease.

Platelets play a key role in the initiation of hemostatic mechanisms during vascular injury. When contemplating prescription of antiplatelet agents (APAs) for patients as primary prevention for cardiovascular events, the physician should carefully weigh the potential benefits of cardiovascular risk reduction with the likelihood of harm, related mostly to hemorrhagic complications. The role of APAs in secondary prevention of atherosclerosis and coronary artery disease is well established, however, optimal duration of therapy and intensity of patient treatment are not settled and probably need to be individualized per patient. We describe the data emerging from contemporary trials on the efficacy and safety of the use of oral APAs in various patient subpopulations. We also discuss the advantages and potential roles of new APAs during and following acute coronary syndromes, percutaneous coronary interventions, and symptomatic atherosclerosis. We propose certain strategies and directions for future research to enhance the safety and efficacy prevention by optimizing the beneficial effects of APAs along with other contemporary treatment modalities of primary and secondary prevention.

Prognostic significance of elevated baseline troponin in patients with acute coronary syndromes and chronic kidney disease treated with different antithrombotic regimens: a substudy from the ACUITY trial.

BACKGROUND: Elevation of baseline cardiac troponin in patients presenting with acute coronary syndromes (ACS) confers an adverse prognosis. The prognostic value of troponin elevation in patients with chronic kidney disease (CKD) and ACS is less certain. METHODS AND RESULTS: In the ACUITY (Acute Catheterization and Urgent Intervention Triage strategy) trial, 13 819 patients with moderate and high-risk ACS were assigned randomly to receive heparin plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin monotherapy. Among 2179 patients with CKD (creatinine clearance <60 mL/min), baseline troponin elevation was present in 1291 patients (59.2%). Major bleeding and major adverse cardiac events (MACE), including death, myocardial infarction (MI), or unplanned revascularization, were examined according to baseline troponin status and randomization arm. Patients with CKD in whom the baseline troponin level was elevated had significantly higher rates of death, MI, and MACE at 30 days and 1 year compared with CKD patients without elevated baseline troponin. By multivariable analysis, baseline troponin elevation in patients with CKD was an independent predictor of composite death or MI at 30 days (hazard ratio [95% CI]=2.05 [1.48, 2.83], P<0.0001) and 1 year (1.72 [1.36, 2.17], P<0.0001). In CKD patients with baseline troponin elevation, bivalirudin monotherapy compared with heparin plus a GPI significantly reduced the 30-day rates of major bleeding with nonsignificantly different rates of MACE at 30 days and 1 year. CONCLUSIONS: In patients with ACS and CKD, baseline troponin elevation is associated with significantly worse short- and long-term clinical outcomes. Bivalirudin monotherapy safely reduces major bleeding in ACS patients with CKD and baseline troponin elevation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158.