Everolimus-eluting bioresorbable vascular scaffolds for treatment of complex chronic total occlusions.

AIMS: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO). METHODS AND RESULTS: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation. CONCLUSIONS: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Differential thrombotic prolapse burden in either bioresorbable vascular scaffolds or metallic stents implanted during acute myocardial infarction: The snowshoe effect: Insights from the maximal footprint analysis.

BACKGROUND: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated. METHODS: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed. RESULTS: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group. CONCLUSIONS: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material.

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study.

AIMS: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure. CONCLUSIONS: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes.

15-Year outcome after normal exercise 99mTc-sestamibi myocardial perfusion imaging: what is the duration of low risk after a normal scan?

OBJECTIVE: The goal of this study was to evaluate the very long-term outcome after normal exercise (99m)Tc-sestamibi myocardial perfusion single-photon emission computed tomography (SPECT). Exercise (99m)Tc-sestamibi SPECT is widely used for risk stratification, but data on very long-term outcome after a normal test are scarce. METHODS: A consecutive group of 233 patients (122 men, mean age 54 ± 12 years) with known or suspected coronary artery disease (CAD) underwent exercise (99m)Tc-sestamibi SPECT and had normal myocardial perfusion at exercise and at rest. Follow-up endpoints were all-cause mortality, cardiac mortality, nonfatal myocardial infarction, and coronary revascularization. Predictors of outcome were identified by Cox proportional hazard regression models using clinical and exercise testing variables. RESULTS: During a mean follow-up of 15.5 ± 4.9 years, 41 (18%) patients died, of which 13 were cardiac deaths. A total of 18 (8%) patients had a nonfatal myocardial infarction, and 47 (20%) had coronary revascularization. The annualized event rates for all-cause mortality, cardiac mortality, cardiac mortality/nonfatal infarction, and major adverse cardiac events were, respectively, 1.1%, 0.3%, 0.7%, and 1.8%. Multivariate analysis demonstrated that the variables age, male gender, diabetes, diastolic blood pressure at rest, rate pressure product at rest, peak exercise heart rate, and ST segment changes were independent predictors of major adverse cardiac events. CONCLUSION: Patients with suspected or known CAD and normal exercise (99m)Tc-sestamibi myocardial perfusion SPECT have a favorable 15-year prognosis. Follow-up should be closer in patients with known CAD, and/or having clinical and exercise parameters indicating higher risk status.

Prediction of 9-year cardiovascular outcomes by myocardial perfusion imaging in patients with normal exercise electrocardiographic testing.

AIMS: Exercise myocardial perfusion imaging (MPI) is widely used, but the long-term prognostic value of this test in patients with normal exercise electrocardiographic testing is not defined. METHODS AND RESULTS: A consecutive group of 650 patients (428 men, mean age: 56 ± 11 years) with known or suspected coronary artery disease underwent exercise electrocardiographic testing and MPI. Follow-up endpoints were mortality and major adverse cardiac events (MACE). Predictors of outcome were identified by multivariate logistic regression analysis using clinical, exercise electrocardiographic testing and single-photon emission computed tomography (SPECT) variables. A total of 324 (50%) patients had an abnormal SPECT, and 131 (20%) had completely or partially reversible perfusion defects. During a mean follow-up of 9.2 ± 2.0 years, 107 (23%) patients died, 69 (11%) had a non-fatal myocardial infarction, 90 (14%) underwent coronary artery bypass surgery, and 142 (22%) percutaneous coronary intervention. Multivariate analysis demonstrated that the summed rest score was an independent predictor of mortality [hazard ratio (HR): 1.15, 95% confidence interval (CI): (1.08-1.22], P < 0.001). The summed stress score was an independent predictor of MACE [HR: 1.09, 95% CI: (1.04-1.13), P < 0.001]. The addition of SPECT variables to clinical and exercise electrocardiographic testing data provided incremental prognostic information for the prediction of mortality and MACE (both P < 0.001). CONCLUSION: Approximately 20% of patients with known or suspected coronary artery disease and normal exercise electrocardiographic testing have completely or partially reversible myocardial perfusion defects. MPI provides additional information for the prediction of 9-year cardiovascular outcomes in these patients.

Long-term prognostic value of dobutamine stress echocardiography in diabetic patients with limited exercise capability: a 13-year follow-up study.

OBJECTIVE: To determine the incremental prognostic value of dobutamine stress echocardiography (DSE) at 13-year follow-up (SD 3.2 years) for predicting mortality and cardiac events in diabetic patients. RESEARCH DESIGN AND METHODS: A total of 396 diabetic patients (mean age 61 ± 11 years; 252 men [64%]) with limited exercise capacity who underwent DSE for evaluation of ischemia were studied. End points were all causes of mortality, cardiac death, and hard cardiac events (cardiac death and nonfatal myocardial infarction). RESULTS: During a mean follow-up of 13 years, 230 patients (58%) died (121 cardiac deaths), and 30 patients had nonfatal myocardial infarction. Cumulative survival in patients with an abnormal DSE at 5, 10, and 15 years was 68, 49, and 41%, respectively. In patients with a normal DSE, these respective numbers were 74, 57, and 44%. Multivariate analyses showed that DSE provided incremental value over clinical characteristics and stress test parameters for prediction of mortality and cardiac events. Survival analysis showed that DSE provided optimal risk stratification up to 7 years after initial testing; after that period, the risk of adverse outcome increased comparably in both normal and abnormal DSE patients. CONCLUSIONS: DSE provided restricted predictive value of adverse outcome in patients with diabetes who were unable to perform an adequate exercise stress test. DSE provided optimal risk stratification up to 7 years after initial testing. Repeated DSE at that time might add to its prognostic value.

Ultrasonographic assessment of long finger tendon excursion in zone v during passive and active tendon gliding exercises.

PURPOSE: Cadaver and in vivo studies report variable results for tendon excursion during active and passive hand movements. The purpose of this study was to measure long finger flexor digitorum profundus (FDP) tendon excursion during active and passive movement using high-resolution ultrasound images. METHODS: The FDP tendon excursion was measured at the wrist level in 10 healthy subjects during full tip-to-palm active and passive flexion of the fingers. Passive movement was performed 2 ways: (1) straight to full fist: passive flexion starting at the metacarpophalangeal joint, followed by proximal interphalangeal and distal interphalangeal joint flexion; and (2) hook to full fist: passive flexion starting at the distal interphalangeal joint, followed by proximal interphalangeal and metacarpophalangeal joint flexion. Tendon excursion was measured using an in-house-developed, frame-to-frame analysis of high-resolution ultrasound images. RESULTS: Median FDP excursion was 24.3 mm, 14.0 mm, and 13.6 mm for active fist, straight to full fist, and hook to full fist movements, respectively. Tendon excursions during active movements was significantly larger than excursions during passive movements (p = .005). The adjusted median tendon excursion was 12.7 mm/100 degrees , 7.5 mm/100 degrees , and 7.4 mm/100 degrees for active fist, straight to full fist, and hook to full fist movements, respectively. Adjusted tendon excursions during active movement were significantly larger than those achieved during passive straight to full fist movement). Adjusted tendon excursions during straight to full fist movements were significantly larger than those achieved during passive hook to full fist movement. CONCLUSIONS: Active motion produced 74% and 79% increases in excursions compared to both passive motions in healthy controls. The study results can serve as a reference for evaluating excursions in patients with tendon pathology, including those who have had tendon repair and reconstruction.