Clinical outcomes of self-expandable vs. balloon-expandable TAVI for severe aortic stenosis.

Background: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). There is limited data exploring differences in outcomes post-TAVI SEV vs. BEV. This study compared procedural success and 30-d clinical outcomes self-expandable valves (SEV), vs. balloon-expandable valves (BEV) for patients with severe AS.Methods: Retrospective analysis was undertaken of patients receiving TAVI at St Vincent's Hospital, Melbourne between August 2009 and May 2018. The primary endpoints included procedural success, clinical outcomes and complication rates at 30-d.Results: Out of 151 patients undergoing TAVI, 70 received (46.3%) SEV (Medtronic CoreValve & Evolut-R) and 81 (53.6%) BEV (Edwards SAPIEN-XT & S3). The mean Society of Thoracic Surgery (STS) risk score did not differ between the groups, SEV (83.6 ± 4.9 years, STS 4.4 ± 3.8) compared to BEV (82.3 ± 5.8 years, STS 4.9 ± 4.9). Procedural success was similar SEV 67 (95.7%) vs. BEV 78 (96.3%). Rates of ≥ moderate paravalvular aortic regurgitation (PAR) at 30-d were significantly higher in SEV compared to BEV (6.7 vs. 0.0%; p = .02). SEV patients had higher rates of pacemaker insertion (36.4 vs. 9.5%; p = .001) and stroke rates (12.4 vs. 1.4%; p = .04) compared to BEV patients. The difference in 30-d mortality between the two groups was similar (SEV 4.6% vs. BEV 1.3%; p = .23).Conclusions: This real-world retrospective analysis demonstrates higher rates of ≥ moderate PAR, stroke and pacemaker insertion with SEV compared to BEV at 30 d post-TAVI for severe symptomatic AS.

Percutaneous coronary intervention in recurrent spontaneous coronary artery dissection: a case report.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an infrequent but potentially life-threatening condition in patients with acute myocardial infarction. Conservative medical therapy is recommended in patients with SCAD. However, very little evidence exists in the management of recurrent SCAD when conservative medical therapy fails. CASE SUMMARY: A 48-year-old woman presented with non-ST-elevation myocardial infarction (NSTEMI) on a background of cigarette smoking. Her coronary angiogram showed the first diagonal artery (D1) and right marginal branch (RM) occlusion with angiographic appearance that is consistent with SCAD. She was medically managed. She represented 2 months later with another NSTEMI, and her coronary angiogram showed healing SCAD in the D1 and RM, but a new SCAD in the first obtuse marginal artery (OM1). She was managed medically. She represented 4 months later complaining of angina every 2 days. This time her coronary angiogram showed healed SCAD in OM1 and RM, but the recurrence of SCAD in D1. Given that she had recurrent events despite medical therapy, we decided to proceed with percutaneous coronary intervention (PCI) to D1. She presented with an atypical chest pain 10 months later and her coronary angiogram showed complete healing of all coronary arteries and a patent stent in D1. She has remained symptom free. DISCUSSION: The management of SCAD is contentious given the lack of randomized clinical trials to assess optimal treatment strategy. In most patients with SCAD, conservative medical therapy is recommended after the diagnosis is secured. We believe that PCI may be beneficial in patients with recurrent SCAD.

Outcomes of incidental findings on multi-detector computed tomography for transcatheter aortic valve implantation assessment: A single-centre study and review of the literature.

INTRODUCTION: Patients with severe aortic stenosis (AS) require multi-detector computed tomography (MDCT) when considered for transcatheter aortic valve implantation (TAVI). Incidental findings on MDCT are common given the age group and region imaged. Our aim was to evaluate the frequency and outcome of incidental findings (IF) identified on MDCT and the impact on survival. METHODS: This single-centre analysis retrospectively reviewed severe AS patients who underwent MDCT during TAVI workup. MDCT reports were reviewed for any IF and defined into three categories: IF of no relevant clinical significance (IF-NoCS), IF of non-immediate clinical significance (IF-NICS) and IF of immediate clinical significance (IF-ICS). Demographics, follow-up of IF and survival were calculated from MDCT date. RESULTS: Two hundred and sixty-five patients underwent MDCT for TAVI suitability (mean age 83 ± 6 years, 52% male). The majority proceeded to TAVI (65%). Renal lesions (25%) and lung nodules (18%) were the most common IF. Fifty-nine patients (22%) had IF-NICS; 39% (23/59) were benign, 59% were not further investigated and one patient had suspected lung cancer. Six patients (2.3%) had IF-ICS and all were diagnosed with lung cancer. During a median follow-up of 272 days, there was no survival difference between patients with IF-ICS or IF-NICS versus patients without IF or IF-NoCS in the overall cohort (P = 0.44) or in TAVI patients (P = 0.88). CONCLUSION: Incidental findings on MDCT are common with one-quarter having IF-ICS or IF-NCIS. Most patients with IF-NICS did not undergo further investigation. Standardized reporting of MDCT may assist in clarifying the need for further investigation which will in turn influence decision and timing to proceed with TAVI.

Contemporary review of severe aortic stenosis.

Severe aortic stenosis (AS) is the most common form of valvular heart disease in the developed world, with a rising prevalence due to an ageing Australian population. Transcatheter aortic valve implantation (TAVI) offers a less invasive option for the treatment of severe AS, with evidence supporting TAVI compared with medical therapy in inoperable patients and superior with surgical aortic valve replacement (SAVR) in high-risk patients. Equal outcomes have been observed in all-comer intermediate-risk populations. The Heart Team utilises a shared decision-making approach between physicians and surgeons in risk-stratifying patients and reduces the intrinsic bias that may occur if decisions are made in isolation. Geriatric assessment is useful for identifying preoperative frailty, a major risk factor for death post-aortic valve intervention. In severe AS, a decision can be made collaboratively to pursue TAVI, SAVR, a Ross Procedure or conservative management. The learning curve associated with TAVI has improved markedly, with overall complication rates decreasing around the world. Contemporary changes in practice, such as conscious sedation without general anaesthesia, expedited recovery and early discharge, will likely improve cost-effectiveness. In 2018, TAVI is a well-established procedure in Australia that has revolutionised the management of severe AS. In the future, with an expanding elderly population, the number of patients to benefit from transcatheter therapies for severe AS is hypothesised to increase 4-10-fold. Heart Team assessment is crucial in patients with severe AS to direct appropriate management.

High-Sensitivity C-Reactive Protein Is a Predictor of Coronary Microvascular Dysfunction in Patients with Ischemic Heart Disease.

BACKGROUND: Inflammation and microvascular dysfunction (MVD) are independently associated with adverse cardiovascular outcomes in patients with ischemic heart disease. This study aimed to assess the relationship between inflammation, MVD, and myocardial injury. METHODS: Coronary microvascular function was assessed in 74 patients undergoing percutaneous coronary intervention (PCI) using the index of microvascular resistance (IMR) by a pressure-temperature sensor-tipped wire. Serum high-sensitivity C-reactive protein (hsCRP) level was quantified by rate turbidimetry. Severe MVD was defined as IMR ≥ 30. Pearson correlation was computed to assess the relationships between hsCRP, troponin, and IMR of culprit vessel. Predictors of severe MVD were assessed by regression analysis. RESULTS: Acute coronary syndromes (ACSs) represented 49% of the total cohort. Study cohort was divided into low C-reactive protein (CRP) (hsCRP < 3 mg/L) and high CRP (hsCRP ≥ 3 mg/L) groups. There was higher representation of smokers (78 vs. 52%), diabetics (39 vs. 18%), and ACS (61 vs. 33%), as well as higher body mass index (29.4 ± 4.6 vs. 27.2 ± 4.1) in the high CRP group. Pre-PCI and post-PCI IMR were significantly elevated in the high CRP group compared to the low CRP group (pre-PCI IMR: 29.0 ± 13.9 vs. 17.4 ± 11.1, p < 0.0001; post-PCI IMR: 23.0 ± 16.8 vs. 15.5 ± 8.4, p = 0.02). Peak troponin levels were significantly raised in the high CRP group (9.96 ± 17.19 vs. 1.17 ± 3.00 µg/L, p = 0.002). There was a strong positive correlation between hsCRP and pre-PCI IMR (r = 0.85, p < 0.0001). Pre- and post-PCI IMR levels were correlated with peak troponin level (r = 0.45, p < 0.0001; r = 0.33, p = 0.005, respectively). Predictors of severe MVD include male gender (OR 3.0), diabetes (OR 3.7), smoking history (OR 4.0), ACS presentation (OR 8.5), and hsCRP ≥ 3 mg/L (OR 5.6). CONCLUSION: hsCRP is a significant predictor of MVD while MVD is associated with myocardial injury, supporting the central role of inflammation and MVD in the pathophysiology and complications of coronary artery disease. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN): 12617000648325. Universal Trial Number (UTN): U1111-1196-2246.

Transcatheter versus Surgical Aortic Valve Replacement in High-risk Patients: A propensity-score matched analysis.

BACKGROUND: There is limited data from Australia and New Zealand comparing transcatheter aortic valve implantation (TAVI) with conventional surgical aortic valve replacement (sAVR). METHODS: Between 2009 and 2015, 64 patients underwent TAVI and 669 underwent sAVR at a single centre. Patients' peri-operative details were analysed and compared between groups. Propensity-score matching was performed for risk adjustment. RESULTS: Patients receiving TAVI were older (mean age in years TAVI: 83.9±4.6 vs. sAVR: 71±9.9, P<0.001), and were more likely to be female (TAVI: 67%, 43/64, vs. sAVR: 32%, 217/669, P <0.001). Unadjusted 30-day mortality was comparable between groups (2/64, 3% vs. 22/669, 3%, P >0.99). The matched analysis revealed comparable 30-day mortality (TAVI: 2/44, 5% vs. sAVR: 2/44, 5%, P > 0.99). New atrial arrhythmia occurred more frequently within the sAVR cohort (TAVI: 1/44, 2% vs. sAVR 18/44, 41%, P <0.001). Complete heart block requiring permanent pacemaker was more frequent amongst the TAVI cohort (TAVI: 10/44, 23% vs. sAVR 2/44, 5%, P=0.039). At two years, survival was comparable between groups (TAVI: 74±1.7 vs. sAVR: 80±0.1%, P=0.65). CONCLUSION: This single centre experience suggests that TAVI is a valuable treatment option for high-risk surgical patients with comparable survival.

1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.

OBJECTIVES: This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study. BACKGROUND: The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement. METHODS: The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team. RESULTS: The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm(2), and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm(2). A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year. CONCLUSIONS: At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691).

Symplicity multi-electrode radiofrequency renal denervation system feasibility study.

AIMS: The aim of this study was to test the safety and performance of the Symplicity™ multi-electrode radio-frequency renal denervation system which was designed to reduce procedure time during renal denervation. METHODS AND RESULTS: The multi-electrode radiofrequency renal denervation system feasibility study is a prospective, non-randomised, open label, feasibility study that enrolled 50 subjects with hypertension. The study utilises a new renal denervation catheter which contains an array of four electrodes mounted in a helical configuration at 90 degrees from each other to deliver radiofrequency energy simultaneously to all four renal artery quadrants for 60 seconds. The protocol specified one renal denervation treatment towards the distal end of each main renal artery with radiofrequency energy delivered for 60 seconds per treatment. Total treatment time for both renal arteries was two minutes. The 12-month change in office systolic blood pressure (SBP) and 24-hour SBP was -19.2±25.2 mmHg, p<0.001, and -7.6±20.0 mmHg, p=0.020, respectively. There were three patients with access-site complications, none of which was related to energy delivery; all were treated successfully. No new renal artery stenosis or hypertensive emergencies occurred. CONCLUSIONS: The Symplicity multi-electrode radiofrequency renal denervation system was associated with a significant reduction in SBP at 12 months and minimal complications whilst it also reduced procedure time. TRIAL REGISTRATION: NCT01699529.

Circumferential distribution of the neointima at six-month and two-year follow-up after a bioresorbable vascular scaffold implantation: a substudy of the ABSORB Cohort B Clinical Trial.

AIMS: To investigate the extent and the circumferential distribution of the neointima tissue developed following an Absorb bioresorbable vascular scaffold (BVS) implantation. METHODS AND RESULTS: Twenty-three patients who were treated with the Absorb BVS and had optical coherence tomographic examination after scaffold implantation, at six-month and at two-year follow-up, were included in the current analysis. The lumen and the scaffold borders were detected and the circumferential thickness of the neointima was measured at one degree intervals. The symmetry of the neointima was defined as: minimum/maximum thickness. The lumen area was decreased at six months compared to baseline but it did not change between six-month and two-year follow-up (baseline: 7.49 [6.13-8.00] mm², six months: 6.31 (4.75-7.06) mm², two years: 6.01 [4.67-7.11] mm², p=0.373). However, the mean neointima thickness (six months: 189 [173-229] m, two years: 258 [222-283] m, p<0.0001) and the symmetry index of the neointima (six months: 0.06 [0.02-0.09], two years: 0.27 [0.24-0.36], p<0.0001) were increased at two years. Full circumferential coverage of the vessel wall by neointima tissue was seen in 91% of the studied frames at two years. CONCLUSIONS: This study demonstrates that after an Absorb BVS implantation neointima tissue develops that covers almost the whole circumference of the vessel wall. In contrast to the metallic stents, the neointima tissue does not compromise the luminal dimensions. Further research is required to evaluate the neointimal characteristics and assess the potential value of the device in passivating high-risk plaques.

The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled.

AIMS: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population. METHODS AND RESULTS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year. CONCLUSIONS: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Diabetes and poor glycaemic control in rural patients with coronary artery disease.

BACKGROUND: The burden of cardiovascular disease is higher in rural populations. Existing data on rural cardiovascular health is mainly based on community surveys. Regional differences are not well addressed. This study aims to identify regional inequalities in cardiovascular risk factors (CVRFs) in Australian patients with suspected coronary artery disease. METHODS AND RESULTS: 538 subjects (72% male; mean age 63years) were recruited from a single cardiac catheter laboratory over a 24-month period. Subjects were stratified into Remoteness Areas (RAs) according to the Australian Standard Geographical Classification (RA1 corresponds to Major Cities, RA2 to Inner Regional Areas, RA3 to Outer Regional Areas). Body-mass index, blood pressure, hypertension, dyslipidaemia, diabetes and smoking history were recorded. A blood sample taken before the angiogram was analysed for lipids and fasting blood glucose (FBG). Distribution of the study population across RA1, RA2 and RA3 was 34.8%, 46.1% and 19.1%. Only FBG (p=0.019) and diagnosed diabetes (p=0.009) were significantly different i.e. higher in RA1. Of those without known diabetes, RA3 had the highest prevalence of dysglycaemia (p=0.023) with two-thirds having either pre-diabetes or undiagnosed diabetes. Logistic regression showed that age and RA3 were the only statistically significant predictors of elevated FBG. CONCLUSION: CAD patients from remote Australia had higher rates of pre-diabetes, undiagnosed diabetes and poorer glycaemic control. Analysis of the main CVRFs revealed a regional inequality in the recognition and management of diabetes alone. Attention to this gap in rural and urban healthcare is crucial to future cardiovascular health outcomes in Australia.

Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.

BACKGROUND: Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). OBJECTIVES: The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis. METHODS: Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria. RESULTS: Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm(2). The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR. CONCLUSIONS: REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691).

Development of the Heart Failure Screening Tool (Heart-FaST) to measure barriers that impede engagement in self-care.

BACKGROUND: Screening for self-care capacity is advocated before applying educational strategies. No screening tool has been specifically developed to assess barriers that impede engagement in self-care in people with heart failure. Earlier conceptual work (InCOGNITO) identified NYHA class, mild cognitive impairment and depressive symptoms as barriers that impede engagement in HF self-care. AIMS: Study aims were: 1) to develop the Heart Failure Screening Tool (Heart-FaST) as a means of assessing three critical barriers to self-care; 2) to assess the content validity of the Heart-FaST; and 3) to test the feasibility of implementing the Heart-FaST in clinical practice. METHODS: The Heart-FaST was developed from barriers identified in previous research (InCOGNITO) and from expert panel consensus. Content validity was assessed by examining the proportion of experts who scored each item as relevant. RESULTS: The InCOGNITO study indicated that four cognitive tasks, seven emotional questions and NYHA functional class were significantly correlated with the self-care scales: maintenance, management and confidence. These factors were used to create the Heart-FaST items. Consensus on wording and items to be included in the Heart-FaST was reached after two rounds of panel discussion. All items had an item-level content validity index ≥ 0.78. High scores on each barrier (physical, cognitive and emotional functioning) suggest poor self-care and the need for more intensive disease management efforts. CONCLUSION: The Heart-FaST measures three critical barriers that impede engagement in self-care. In clinical practice this tool may assist in individually tailoring educational and support strategies to promote effective heart failure self-care.

Comparison between the first and second generation bioresorbable vascular scaffolds: a six month virtual histology study.

AIMS: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). METHODS AND RESULTS: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10 ± 0.46 mm2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57 ± 1.3 mm2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external elastic membrane area (y=0.68x-0.1; r=0.58, p=0.03). CONCLUSIONS: Based on 6-months IVUS-VH analysis, the BVS 1.1 appears to have a different backscattering signal compared to the BVS 1.0, which may reflect differences in the speed of chemical and structural alteration.

Dual visualization: a technique to simplify native vessel intervention in patients with bypass grafts.

We describe a case of stenting to a distal left anterior descending artery stenosis via the native vessel aided by contrast injection via a left internal mammary artery graft. This dual visualization technique allows good distal vessel opacification whilst minimising instrumentation of the internal mammary artery and its associated risks.

Long-term clinical outcomes with the next-generation Resolute Stent System: a report of the two-year follow-up from the RESOLUTE clinical trial.

AIMS: The 12-month results of RESOLUTE were favourable for the new Resolute stent. Two-year safety and efficacy results from RESOLUTE have been evaluated and are now reported. METHODS AND RESULTS: RESOLUTE was a prospective, multicentre, non-randomised, single-arm, controlled trial of the Resolute stent in 139 participants with symptomatic ischaemic heart disease due to single de novo lesions in a native coronary artery. The 2-year rates of MACE (all-cause death, myocardial infarction, emergent cardiac bypass surgery, and target lesion revascularisation [TLR]), death, late stent thrombosis, target vessel revascularisation (TVR), and target vessel failure (TVF) were assessed. Clinical events included two MACE (one TLR; one non-cardiac death) occurring between year one and two resulting in cumulative 2-year TLR, TVR, and TVF rates of 1.4%, 1.4%, and 7.9%, respectively. One possible stent thrombosis event occurred in the first year after stent implantation however no late or very late ARC-defined definite and probable stent thromboses occurred through two years. CONCLUSIONS: The 2-year data from RESOLUTE demonstrated no safety concerns including no late stent thrombosis or loss of effectiveness with the Resolute stent. The finding that few events occurred in year two is encouraging, yet requires verification in a larger population.

Five-year clinical follow-up after implantation of the Endeavor zotarolimus-eluting stent: ENDEAVOR I, first-in-human study.

OBJECTIVE: To evaluate the 5-year clinical outcomes of patients treated with the Endeavor zotarolimus-eluting stent (ZES) in the ENDEAVOR I first-in-human study. BACKGROUND: ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. METHODS: Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have > or = 50% stenosis, be < or = 15 mm in length, and located in a vessel with a reference diameter of 3.0-3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. RESULTS: The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non-Q-wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. CONCLUSIONS: Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis.

Extremely late drug-eluting stent thrombosis: 2037 days after deployment.

Thrombosis of drug eluting stents has been documented up to four years after stent implantation, often in the setting of cessation of antiplatelet therapy. We present a case of drug-eluting stent thrombosis, 2037 days after initial implantation, which we believe is the latest reported case. Late stent thrombosis remains a rare but catastrophic complication of coronary intervention. We hypothesize that the procoagulant milieu of surgery, coupled with cessation of one or both antiplatelet agents preoperatively, compounds the risk of perioperative stent thrombosis.

Stents auto-expansíveis versus balão-expansível para tratamento de lesões em vasos de fino calibre: estudo com ultra-som intracoronário tridimensional / Self-expanding versus balloon-expandable stents for the treatment of small coronary vessels: a three-dimensional intracoronary ultrasound study

Introdução: Intervenção coronária pecutânea em vasos de fino calibre (VF) está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose. Estudos prévios têm sugerido que stents auto-expansíveis causam menos injúria vascular no momento do implante, com expansão de seus volumes com o tempo, gerando maiores áreas luminais que stents balão-expansíveis. A influência desses fenômenos em VF ainda é desconhecida. Objetivos: Avaliar as propriedades mecânicas e a eficácia do novo stent CardioMind no tratamento de lesões em VF em comparação ao stent balão-expansível Multi-link Pixel (Pixel). Método: Treze pacientes portadores de lesões únicas primárias < 14 mm de extensão, em artérias coronárias nativas < 2,5 mm de diâmetro, foram tratados com o stent CardioMind e comparados a uma corte histórica de 25 pacientes, com os mesmos critérios de inclusão, tratados com o stent Pixel. Ultrasom intracoronário (USIC) seriado foi realizado pós-procedimento e aos 7,3 +/- 1,0 meses. Resultados: A média das idades foi de 58,1 +/- 9,9 anos, com 60,5 por cento do sexo masculino e 39,4 por cento diabéticos. Ambos os stents produziram volumes de hiperplasia neo-intimal (HNI) smelhantes...

Background: Percutaneous coronary intervention in small vessels (SV) is associated with poor short- and long-term outcomes, with high rates of restenosis. Previous studies have suggested that self-expanding stents can cause less vessel injury at implantation, expanding their volumes over time, and leading to larger luminal areas than those of balloon-expandable stents. The influence of these phenomena on SV remains unknown. Objectives: To assess the mechanical properties and efficacy of the novel CardioMind™ stent in comparison with the balloon-expandable Multi-Link Pixel™ (Pixel) stent in the treatment of SV. Methods: Thirteen patients with single, de novo, < 14 mm length lesions in native coronary arteries < 2.5 mm in diameter were treated with the CardioMind™ stent and compared with a historical cohort of 25 patients, with the same inclusion criteria, treated with the Pixel™ stent. Intravascular ultrasound (IVUS) was performed serially after the procedure and at 7.3 ± 1.0 months of follow-up. Results: Mean age was 58.1 ± 9.9 years; 60.5% were male and 39.4% were diabetic. Both stents produced similar neointimal hyperplasia (NIH) volumes (indexed NIH volume: 1.45 ± 0.46 mm³/mm for CardioMind™ versus 1.66 ± 1.02 mm³/mm for Pixel™; p = 0.48). However, the CardioMind™ stentpresented a 12% expansion of its volume, leading to a...