Impact of the first COVID-19 lockdown in Austria on laboratory and mental parameters in diabetic patients: a retrospective analysis highlighting the importance of regular medical consultations in a patient cohort.

BACKGROUND: Due to the COVID-19 pandemic, the first lockdown was implemented in Austria for almost 7 weeks. In contrast to many other countries, medical consultations were permitted, either by telemedicine or at doctors' offices. Nevertheless, restrictions related to this lockdown could possibly cause an increased risk of deterioration in health, especially in diabetes. This study aimed to assess the impact of Austria's first lockdown on laboratory and mental parameters in a type-2 diabetes mellitus cohort. METHODS: Overall 347 mainly elderly patients with type-2 diabetes (56% male; aged 63.7±10.1 years) were included in this retrospective practitioner-based analysis. Laboratory as well as mental parameters were compared from before and after the lockdown. RESULTS: The lockdown showed no significant effect on HbA1c levels. On the other hand, total cholesterol (P<0.001) and LDL cholesterol (P<0.001) levels improved significantly, whereas body weight (P<0.01) and mental well-being based on the EQ-5D-3L questionnaire (P<0.01) increased significantly in terms of worsening. CONCLUSIONS: Lack of movement and staying at home resulted in a significant weight gain and worsening of mental well-being in type-2 diabetes during the first lockdown in Austria. Thanks to regular medical consultations, laboratory parameters remained stable or even improved. Thus, routine health check-ups in mainly elderly type 2 diabetic patients are essential to minimize the deterioration of health conditions during lockdowns.

Two-dimensional speckle-tracking strain echocardiography in long-term heart transplant patients: a study comparing deformation parameters and ejection fraction derived from echocardiography and multislice computed tomography.

AIMS: Longitudinal strain determined by speckle tracking is a sensitive parameter to detect systolic left ventricular dysfunction. In this study, we assessed regional and global longitudinal strain values in long-term heart transplants and compared deformation indices with ejection fraction as determined by transthoracic echocardiography (TTE) and multislice computed tomographic coronary angiography (MSCTA). METHODS AND RESULTS: TTE and MSCTA were prospectively performed in 31 transplant patients (10.6 years post-transplantation) and in 42 control subjects. Grey-scale apical views were recorded for speckle tracking (EchoPAC 7.0, GE) of the 16 segments of the left ventricle. The presence of coronary artery disease (CAD) was assessed by MSCTA. Strain analysis was performed in 1168 segments [496 in transplant patients (42.5%), 672 in control subjects (57.7%)]. Global longitudinal peak systolic strain was significantly lower in the transplant recipients than in the healthy population (-13.9 ± 4.2 vs. -17.4 ± 5.8%, P< 0.01). This was still the case after exclusion of the nine transplant patients with CAD (-14.1 ± 4.4 vs. -17.4 ± 5.8%, P=0.03). Transplant patients exhibited significantly lower regional strain values in 9 of the 16 segments. Left ventricular ejection fraction (%) (MSCTA/Simpsons method) was 60.7 ± 10.1%/60.2 ± 6.7% in transplant recipients vs. 64.7 ± 6.4%/63.0 ± 6.2% in the healthy population, P=ns. CONCLUSION: Even though 'healthy' heart transplants without CAD exhibit normal ejection fraction, deformation indices are reduced in this population when compared with control subjects. Our findings suggests that strain analysis is more sensitive than assessment of ejection fraction for the detection of abnormalities of systolic function.

Amino-terminal pro-B-type brain natriuretic peptide: screening for cardiovascular disease in the setting of alcoholism.

AIMS: N-terminal pro-BNP (NtBNP) has attracted attention as a biomarker for heart failure. The aims of our study are (a) to characterize the role of NtBNP as a biological marker in the setting of alcoholism; (b) to describe potential gender differences with respect to NtBNP; (c) to correlate NtBNP with other clinical and haemodynamic variables. METHODS: We examined 83 alcohol-dependent patients according to International Classification of Disease 10th Revision (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV; 59 males and 24 females, age: 50 ± 10.5 years) referred to the department of psychiatry for alcohol withdrawal therapy. In these patients, we determined NtBNP, markers of alcohol abuse and transthoracic echocardiography to determine systolic left ventricular ejection fraction (EF). These measurements were repeated after alcohol withdrawal. RESULTS: At Day 1 of alcohol withdrawal, 43 patients (52%; 27 males and 16 females) had elevated NtBNP levels (394.4 ± 438.7 pg/ml) despite normal EF (64.7 ± 6.2%). After withdrawal therapy (16.6 ± 7.8 days), NtBNP decreased significantly (228.6 ± 251.2 pg/ml; P < 0.01), despite unchanged EF (65.0 ± 5.8%; P = ns). This was the case in both males and females (328.9 ± 235.5 to 216.7 ± 194.3 pg/ml; P < 0.05 vs. 492.7 ± 635.7 to 246.6 ± 327.7 pg/ml; P < 0.05). Elevated NtBNP levels were related significantly to the history of arterial hypertension (P < 0.05). CONCLUSION: This study highlights the fact that NtBNP can be elevated in the setting of alcoholism. The elevation in NtBNP is unrelated to EF and is reversible after alcohol withdrawal. We suggest a subclinical detrimental effect of alcohol abuse on cardiac function.

Speckle Tracking-Derived Longitudinal Strain: Validation and Influence of Scanner Settings.

Speckle tracking-based strain analysis is an evolving technique for the assessment of left ventricular function. We evaluated the influence of machine settings on global longitudinal peak systolic strain (GLPSS) values in an everyday patient population (n = 35). In each patient, the four-chamber view was recorded multiple times with different machine parameters. Ejection fraction ranged between 10% and 76% and correlated well with GLPSS (r = -0.778). GLPSS was not altered systematically by modifications of gain and frame rate. Conversely, higher transducer frequencies (mean effect: 1.102%/MHz, p < 0.001, and 0.662%/MHz, p = 0.033, for harmonic and fundamental imaging frequencies, respectively) and lower sector depth (mean effect: -0.156%/cm, p < 0.001) were associated with a slight-but statistically significant-reduction in absolute GLPSS values. Intra- and inter-observer variability exhibited satisfactory repeatability. GLPSS analysis proved to be reproducible and robust in our patient cohort if common settings for adult echocardiography were applied.

Multimarker Approach to Identify Patients with Coronary Artery Disease at High Risk for Subsequent Cardiac Adverse Events: The Multi-Biomarker Study.

In our prospective non-randomized, single-center cohort study (n = 161), we have evaluated a multimarker approach including S100 calcium binding protein A12 (S100A1), interleukin 1 like-receptor-4 (IL1R4), adrenomedullin, copeptin, neutrophil gelatinase-associated lipocalin (NGAL), soluble urokinase plasminogen activator receptor (suPAR), and ischemia modified albumin (IMA) in prediction of subsequent cardiac adverse events (AE) during 1-year follow-up in patients with coronary artery disease. The primary endpoint was to assess the combined discriminatory predictive value of the selected 7 biomarkers in prediction of AE (myocardial infarction, coronary revascularization, death, stroke, and hospitalization) by canonical discriminant function analysis. The main secondary endpoints were the levels of the 7 biomarkers in the groups with/without AE; comparison of the calculated discriminant score of the biomarkers with traditional logistic regression and C-statistics. The canonical correlation coefficient was 0.642, with a Wilk's lambda value of 0.78 and p < 0.001. By using the calculated discriminant equation with the weighted mean discriminant score (centroid), the sensitivity and specificity of our model were 79.4% and 74.3% in prediction of AE. These values were higher than that of the calculated C-statistics if traditional risk factors with/without biomarkers were used for AE prediction. In conclusion, canonical discriminant analysis of the multimarker approach is able to define the risk threshold at the individual patient level for personalized medicine.

Time course of prothrombotic and proinflammatory substance release after intracoronary stent implantation.

We hypothesized that restenosis after coronary stenting is predicted by elevated levels of markers of thrombus formation and inflammation. Plasma levels of representative markers of inflammation, the thrombin and plasmin activation systems and adhesion molecules were measured in 59 patients with stable angina pectoris before, immediately after and 6 hours (h), 12 h, 24 h, one month and six months after elective stent implantation (radioactive phosphorus-32 stents/RSs/ n = 16, bare-metal stents/BMSs/ n = 43). All patients underwent clinical and angiographic follow-up (FUP) six months after stenting. RSs had significantly higher angiographic severity of restenosis than BMSs (47.1 +/- 20.1% vs. 27.6 +/- 22.0%, p = 0.003). Repeated measures ANOVA revealed significant differences between the BMS and RS groups as regards the increases in plasma levels of vascular cell adhesion molecule-1 (VCAM-1, p = 0.022), plasminogen activator inhibitor-1 (PAI-1, p = 0.047), tissue-type plasminogen activator (tPA, p = 0.047) and CD40 ligand (CD40L, p = 0.038). tPA levels tended to increase immediately after stenting in both groups, whereas the PAI-1 level one month after stenting was elevated significantly only in the RS group. In the RS group, the plasma levels of CD40L were increased at 24 h and six months after stenting, and the VCAM-1 level rose immediately after stenting and remained high during the FUP. Multivariate analysis on pooled laboratory data of both groups revealed elevated levels of VCAM-1 at 12 h and at six months as significant predictors of the severity of stent restenosis. In conclusion, the process of inflammation and thrombosis occurring after coronary interventions seems to be prolonged and enhanced in patients with high-grade restenosis at the follow up.

Randomized comparison between intracoronary beta-radiation brachytherapy and implantation of paclitaxel-eluting stents for the treatment of diffuse in-stent restenosis.

BACKGROUND AND PURPOSE: Intracoronary brachytherapy was the primary therapeutic option for the treatment of in-stent restenosis (ISR) during the last years. Especially for the treatment of diffuse ISR (lesions >10mm), beta-source brachytherapy was significantly superior to singular balloon angioplasty. Despite lacking clinical database, the implantation of drug eluting stents recently became a common procedure for the treatment of ISR. This randomized trial aimed to compare the efficacy of beta-brachytherapy with beta-radioisotopes (90)Sr/(90)Y and paclitaxel-eluting stent implantation for the treatment of diffuse ISR. MATERIAL AND METHODS: Thirty-seven patients with diffuse ISR were randomly assigned to beta-brachytherapy after balloon angioplasty (Beta-Cath in 17 patients) or paclitaxel-eluting stent implantation (Taxus-Express2 in 20 patients). Six-month clinical follow-up was obtained for all patients, while angiographic follow-up was available for 30 patients. RESULTS: Binary ISR (restenosis >50%) within target segment was observed in three patients treated with Beta-Cath, of which one needed target segment revascularisation for recurrent ISR, whereas no significant restenosis occurred in the patients treated with Taxus-Express2 (P=0.037). No further major adverse cardiac (target segment revascularisation, myocardial infarction, death) was found in either group (P=NS). Stent implantation was the more time-saving (31+/-11 min versus 60+/-23 min, P<0.001) procedure. CONCLUSIONS: Although this trial revealed a significant reduction of binary restenosis in the Taxus-Express2 arm, we found no difference in clinical outcome after implantation of paclitaxel-eluting stents for the treatment of diffuse ISR when compared to beta-brachytherapy.

Volumetric intravascular ultrasound imaging to illustrate the extent of coronary plaque burden in type 2 diabetic patients.

BACKGROUND: Although angiography is the gold standard for coronary imaging, its efficacy in outlining diffuse coronary atherosclerosis in diabetic patients remains questionable. We aimed to compare quantitative cineangiographic analysis (QCA) with three-dimensional intravascular ultrasound (IVUS) imaging in type 2 diabetic patients with coronary artery disease. METHODS: IVUS runs of 104 significant coronary lesions in 88 diabetic patients were performed. Arterial remodeling index was calculated as vessel area at minimal lumen area divided by mean reference vessel area. RESULTS: No difference between the two analysis modes was shown for lesion length and minimal lumen diameter, whereas a significant discrepancy between QCA and IVUS was found for diameter stenosis (10 +/- 9% vs. 41 +/- 8%; P<.001) and vessel diameter (3.01 +/- 0.66 vs. 4.53 +/- 0.70 mm; P<.001). A significant difference on arterial remodeling at lesion site was found between insulin-treated diabetic patients and non-insulin-treated diabetic patients (remodeling index: 0.98 +/- 0.16 vs. 1.07 +/- 0.21; P=.04). CONCLUSIONS: Coronary angiographic diagnosis in diabetic patients may be distorted due to a large plaque burden over longer vessel segments and the resulting absence of plaque-free reference segments. This distortion was found to be more pronounced in QCA analysis requiring a reference diameter, whereas volumetric IVUS imaging illustrated coronary artery dimensions more accurately according to anatomic structures. Constrictive arterial remodeling was observed more frequently in type 2 diabetic patients treated with insulin.

Duration of development of symptomatic in-stent restenosis correlates with the stent-to-vessel-diameter ratio: an intravascular ultrasound study.

OBJECTIVE: Several predictors for in-stent restenosis (ISR) have been defined by intravascular ultrasound (IVUS) assessment; however, there is a lack of data correlating IVUS parameters with the speed of development of ISR. This study aims to investigate the relation between the duration of development of symptomatic ISR and the relative stent diameter. METHODS: A total of 46 lesions in 43 consecutive patients with symptomatic ISR were investigated by IVUS with the Endosonics system (Volcano Therapeutics Inc., Rancho Cardova, California, USA). Duration of development of symptomatic ISR was determined by the period of angiographic evidence for ISR. Early ISR was defined in case of occurrence before 6 months. Reference vessel diameter was assessed as mean diameter limited by the external elastic membrane. Relative stent diameter was defined by the stent-to-vessel-diameter ratio (SVDR). RESULTS: Mean duration of symptomatic ISR was 10.3+/-11.5 months for all 46 lesions. Early ISR was observed in 25 lesions (54%). Multivariate analysis revealed SVDR as the only independent predictor for early ISR (P=0.0242). Significant correlation was observed between the duration of development of symptomatic ISR and SVDR (r=0.634, P<0.001). On the basis of the receiver operating curve analysis, relative stent diameter was defined as small when SVDR< or =0.90. Symptomatic ISR within stents of small relative diameter occurred significantly earlier (5.3+/-3.0 versus 16.7+/-15.0 months, P<0.001) and more frequently before 6 months (73 versus 30%, P=0.003) than in stents with SVDR>0.90. CONCLUSIONS: This IVUS study revealed significant correlation between the duration of development of symptomatic ISR and SVDR, which was an independent predictor for early ISR. IVUS-guided stenting may avoid early ISR by adapting the stent diameter to the vessel diameter.

Randomized blinded clinical trial of intracoronary brachytherapy with 90Sr/Y beta-radiation for the prevention of restenosis after stent implantation in native coronary arteries in diabetic patients.

BACKGROUND: We report a double-blind, randomized clinical trial of intracoronary beta-radiation for prevention of restenosis after stent implantation in native coronary de novo lesions in diabetic patients. METHODS: After successful stent implantation in native coronary de novo lesions, 106 lesions in 89 diabetic patients were randomly allocated to treatment with beta-radiation with 18 Gy at 1 mm vessel depth (n = 53) or placebo treatment (n = 53). RESULTS: Angiographic analysis at 9 month follow-up revealed a late lumen loss of 0.7+/-0.9 mm in the radiotherapy group versus 1.2+/-0.8 mm in the control group at the injured segment (P = 0.006), 0.9+/-1.0 versus 1.3+/-0.7 mm at the radiated segment (P = 0.02), and 0.9+/-1.0 versus 1.3+/-0.7 mm at the target segment (P = 0.04) (defined as active source length plus 5mm on proximal and distal sites). Binary restenosis rates were significantly lower in the radiation group in all subsegments (injured segment: 10.9 versus 37.3%, P = 0.003; radiated segment: 21.7 versus 49.0%, P = 0.005; target segment: 23.9 versus 49.0%, P = 0.01). Target lesion revascularization for restenosis was required in nine lesions (17.6%) in the radiotherapy group versus 18 (34.0%) in the placebo group (P = 0.05). Late thrombosis occurred in four radiated patients (after premature discontinuation of antiplatelet therapy in all), resulting in a major adverse clinical event rate of 37.2% in the brachytherapy group versus 38.6% in the placebo group (P = ns). CONCLUSIONS: In diabetic patients with de novo coronary lesions, intracoronary radiation after stent implantation significantly reduced restenosis. However, this clinical benefit was reduced by the frequent occurrence of late thrombosis.

Long-Term Outcome of Combined (Percutaneous Intramyocardial and Intracoronary) Application of Autologous Bone Marrow Mononuclear Cells Post Myocardial Infarction: The 5-Year MYSTAR Study.

OBJECTIVE: The long-term (5-year) outcome of early (3-6 weeks after acute myocardial infarction [AMI], BM-MNC Early group) and late (3-4 months after AMI, BM-MNC Late group) combined (percutaneous intramyocardial and intracoronary) delivery of autologous bone marrow mononuclear cells (BM-MNCs) was evaluated in patients with ejection fractions (EF) between 30-45% post-AMI. METHODS: Major adverse cardiac and cerebrovascular events (MACCE) and hospitalization were recorded. Left (LV) and right (RV) ventricular function were measured by transthoracic echocardiography. Cardiac magnetic resonance imaging (MRI) and myocardial single photon emission computed tomography was performed in a subgroup of patients. Pre-cell therapy myocardial voltage values of treated areas (assessed by NOGA mapping) were correlated with clinical outcome. RESULTS: Five-year MACCE incidences (7.4%. vs 24.1%) and the composite of all adverse events (11.1% vs 27.6%) were not different between the Early and Late treatment groups. The significant LV-EF increase at 1-year follow-up was preserved at the 5-year control (from baseline to 5-year: 5.3%, 95% CI:0.5-10.1, and 5.7%, 95% CI:1.7-9.6, p<0.05 in the Early and Late groups, respectively), with no significant changes between 1- and 5-year follow-ups. Similarly, RVEF increased significantly from baseline to the 5-year follow-up (Early group: 5.4%, 95% CI:1.0-9.6; and Late group: 8.4%, 95% CI:4.5-12.3). Lower baseline levels of myocardial viability of the treated cardiac area (6.3±2.4 vs 8.2±3.0 mV, p<0.05) were associated with incidence of MACCE. CONCLUSIONS: Percutaneous combined delivery of autologous BM-MNCs is feasible and safe after 5 years, and may result in sustained improvement of cardiac function at 5 years in patients with low EF post-AMI (Clinicaltrials.gov NCT01395212).

Intracoronary thrombectomy with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution in patients with acute coronary syndrome: a prospective, randomized, controlled study.

BACKGROUND: In patients with acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) may cause thrombus dislodgment followed by reduced flow and impaired microcirculatory function. We prospectively compared conventional PCI to a strategy of additional pretreatment using the X-sizer thrombectomy system. METHODS AND RESULTS: Sixty-six patients (51 [77%] men; 54.9+/-9.9 years) with ACS (49 with ST-elevation infarction [STEMI]) and suspected intracoronary thrombus were randomized 1:1 to pretreatment with X-sizer and conventional PCI alone. Various aspects of epicardial flow and microvascular function were studied. Baseline data were similar in both groups. Postprocedural TIMI 3 flow was obtained in 90% of X-sizer-treated patients and in 84% of controls (NS); however, corrected TIMI frame count was lower in X-sizer- treated patients (18.3+/-10.2 versus 24.7+/-14.1; P<0.05). No significant group differences were observed in final coronary flow reserve, myocardial blush grade, and myocardial dye intensity. In STEMI, the sum of ST elevation was significantly lower in X-sizer-treated patients immediately after (2.78+/-3.05 versus 6.15+/-6.32 mm; P<0.03) and 6 hours after (2.17+/-2.31 versus 4.14+/-3.7 mm; P<0.05) intervention. ST-segment resolution >50% was observed in 83% of X-sizer-treated patients and in 52% of controls (P<0.03). Multivariate analysis identified X-sizer treatment as the single independent predictor of ST-segment resolution >50% (OR 4.35; 95% CI, 1.13 to 16.9; P<0.04). Major adverse cardiac events after 30 days occurred in 2 patients in each group. CONCLUSIONS: In ACS with suspected thrombus, pretreatment with the X-sizer catheter system improves epicardial flow and accelerates ST-segment resolution compared with conventional PCI alone.

Geographical miss during intracoronary irradiation: impact on restenosis and determination of required safety margin length.

OBJECTIVE: The goal of this study was to evaluate the incidence and effects of underdosage of injured segments during intracoronary irradiation and to define the minimal length of safety margin required to avoid mismatched source placement. BACKGROUND: Underdosage of injured segments due to misplacement of active source has been suggested as the underlying mechanism for the occurrence of edge restenosis. METHODS: Baseline angiograms of 112 vessels in 109 patients with in-stent restenosis undergoing coronary reintervention followed by intracoronary irradiation ((192)Ir: Checkmate, Cordis, Miami, Florida; (32)P: Gallileo, Guidant, Houston, Texas; (90)Sr/Y: Beta-Cath, Novoste, Norcross, Georgia) were analyzed. The distances between the outermost injury and outermost end of "reference isodose length" (RIL), defined as a segment with >/=90% of reference dose at 1 mm vessel wall depth, were measured. "Safety margin" was defined as the distance between the outermost injury and outermost end of the RIL, "geographical miss" (GM) as a complete injured segment not being covered by the RIL, and "restenosis" as the percent diameter stenosis >50%. RESULTS: Baseline angiographic analysis was performed for 224 edges in 112 vessels. Geographical miss was found in 46 (20.6%) edges. The incidence of target lesion restenosis within the 78 vessels with available follow-up was 43.3% for patients with GM versus 14.9% for patients with no GM (p = 0.005). Analysis of various injured segments exposed highest restenosis rates in injured segments with negligible irradiation (27.8%) in comparison with injured segments with dose fall-off (16.7%) or injured segments with full-dose irradiation (7.7%) (p = 0.006). Receiver operating curve analysis revealed a safety margin of 10 mm required per vessel (i.e., 5-mm safety margin/edge) to achieve 95% specificity of GM. CONCLUSIONS: Geographical miss is associated with a higher incidence of restenosis at the corresponding edges. Restenosis was more pronounced in injured segments with negligible irradiation than in injured segments at the dose fall-off zones. We recommend a safety margin of 10 mm per vessel to minimize GM.

Transplant coronary artery disease: Incidence, progression and interventional revascularization.

BACKGROUND: Allograft coronary artery disease (CAD) remains the main factor responsible for late graft loss. This analysis describes data on incidence and progression of allograft CAD at our institute, as well as our experience with coronary interventions in heart transplant recipients. METHODS: Angiographic results of cardiac transplant patients undergoing coronary angiography were prospectively selected and analyzed. Angiographic outcome at follow-up were assessed for all coronary revascularizations in denovo lesions. RESULTS: Four hundred thirty-two coronary angiographies were performed in a total of 246 patients. Seventy-six patients (30.9%) showed angiographic evidence of CAD with %DS>50%, of which 48 patients revealed significant stenosis with %DS>70% (19.5%). Within the first 5 years after the transplantation, 10.1% show angiographic signs of a CAD; at the time of 10.1 years, 50% of all heart transplant patients have developed a CAD. Once a CAD with %DS between 50% and 60% has evolved, the disease shows fast progression. Coronary intervention was performed in 28 vessels at an average time of 9.5 years after heart transplantation. Follow-up angiography was available for 27 vessels (1 death before re-angiography) within a mean follow-up period of 19.3 months. Binary restenosis was found in 7 out of 27 vessels (25.9%). Comparison of the occurrence of total occlusion in vessels with %DS>70% which were not revascularized to the occurrence of MACE after successful revascularization revealed better long term results in the group of patients with coronary intervention (p=0.04). CONCLUSION: Whereas coronary artery disease is found in rare cases within the first 5 years after heart transplantation, the incidence grows in exponential manner after this period. Mid-term follow-up after coronary intervention exhibit restenosis-rates which are similar to the ones of other high risk patients. Comparison of coronary intervention versus conservative treatment in vessels with %DS>70% show significant better mid-term outcome in the interventional group.

Preclinical randomised safety, efficacy and physiologic study of the silicon dioxide inert-coated Axetis and bare metal stent: short-, mid- and long-term outcome.

AIMS: To evaluate the short-, mid- and long-term safety, efficacy and vascular physiology of Axetis silicon dioxide (SiO2, abrading the micropores) inert-coated stent implantation in a randomised preclinical setting. METHODS AND RESULTS: Coronary arteries of domestic pigs were randomised to receive either Axetis or BMS (same design) stents with one-, three- and six-month follow-up (FUP), controlled by coronary angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS) and histology (n=32). The time-dependent vasomotor reaction of coronary arteries to stenting was measured using modified myography (n=12). Complete endothelialisation of the Axetis stent was confirmed by OCT, IVUS and histology at one-month FUP. Histopathology revealed continuous healing of the vessel wall with a gradual reduction of inflammation and fibrin score during the six-month FUP in both stent types. Significantly smaller neointimal area and %area stenosis were measured in Axetis stents compared with BMS at each FUP time point. Vascular reactivity measurements showed significantly better endothelium-dependent vasodilation of stented arteries with Axetis implantation. CONCLUSIONS: Implantation of the Axetis SiO2-coated stent resulted in a significantly better safety, efficacy and vessel physiology profile compared with BMS of the same design with a continuous decrease in vessel inflammation during the six-month FUP.

Quality assurance in intracoronary brachytherapy. Recommendations for determining the planning target length to avoid geographic miss.

BACKGROUND AND PURPOSE: A new method of assessing geographic miss (GM) in endovascular brachytherapy (EVBT) is applied to evaluate the quality of intracoronary brachytherapy treatments, retrospectively. Based on the Vienna experience, recommendations for adequate safety margins are derived to avoid GM. PATIENTS AND METHODS: Evaluation is done on 136 vessels of 128 consecutive patients treated between October 1999 and July 2001. The quality of EVBT is assessed using the concept and terminology of the EVA GEC ESTRO task group. Evaluation of GM and/or safety margin is performed by comparing the outermost interventions with the reference isodose length (RIL) of the applied delivering devices on recorded compact disk (CD) angiograms. The RIL is defined as the length of the vessel segment, which receives at least 90% of the reference dose at the reference depth (=1 mm within the vessel). GM is defined as injured vessel segments, which receive a dose lower than 90% of reference dose. Measurements of intervention length (IL) and active source length (ASL) are performed with respect to anatomical landmarks within the vessel in the region of interest (e.g. stent edges), and by using the nominal length of the devices (balloons, sources) as a reference scale. The edges of RIL are determined by subtracting the length of the dose-fall-off zone (specific to the applied delivery devices: (192)Ir 4.5 mm, (90)Sr 2.5 mm, (32)P 2.0 mm) from the edges of ASL. RESULTS: The described method to assess GM is applicable to 128 vessels (94%). GM is found in 23% of proximal edges and 20% of distal edges. 95% of all GM are observed if the total margin (proximal+distal margin) between RIL and IL is shorter than 10.5 mm. CONCLUSIONS: GM in intracoronary brachytherapy can be widely avoided by adding an appropriate safety margin to the IL (5-6 mm each edge in this study) in order to determine the necessary RIL for a treatment.

The salvage potential of coronary sinus interventions: meta-analysis and pathophysiologic consequences.

OBJECTIVES: Intermittent coronary sinus occlusion has been described to be effective in salvaging ischemic myocardium. This meta-analysis aims to review the efficacy of intermittent coronary sinus occlusion and intermittent coronary sinus occlusion in combination with retroperfusion of arterial blood as methods of myocardial salvage. METHODS: A Medline search was performed to review the published literature on intermittent coronary sinus occlusion. The study inclusion criterion was a randomized, placebo-controlled trial with area of infarction (expressed as a percentage of the area at risk) as the primary end point. RESULTS: Seven experimental trials comprising 125 test animals were found that analyzed the effects of intermittent coronary sinus occlusion on ischemic damage during coronary occlusion. A further 5 studies comprising 88 animals were designed to evaluate the effect of intermittent coronary sinus occlusion in combination with retroperfusion of arterial blood on the infarct size. A meta-analysis of the 7 studies analyzing the effect of intermittent coronary sinus occlusion revealed a significant reduction in infarct size of 29.3% in the treatment group compared with that in the placebo group (P <.001; 95% confidence interval, -40.9 to -17.7). A meta-analysis of the 5 trials analyzing the effect of intermittent coronary sinus occlusion in combination with retroperfusion revealed a reduction in infarct size of 39.4% in the treatment group compared with that in the placebo group (P <.001; 95% confidence interval, -48.9 to -29.9). Comparison between intermittent coronary sinus occlusion and intermittent coronary sinus occlusion in combination with retroperfusion of arterial blood showed no statistical difference (P =.19). An inverse relationship between achieved coronary sinus pressure increase per minute and infarct size could be found in the intermittent coronary sinus occlusion group (r = -0.92; P <.007), whereas in combination with retroperfusion, there was a negative correlation both between achieved coronary sinus pressure and the amount of the retroperfusate and myocardial salvage (r = -0.97; P <.004). CONCLUSIONS: The use of intermittent coronary sinus occlusion and intermittent coronary sinus occlusion in combination with retroperfusion of arterial blood significantly decreases ischemic damage during coronary occlusions. Intermittent coronary sinus occlusion in combination with retroperfusion exhibits no significant profit in salvaging the ischemic myocardium in comparison with that provided by intermittent coronary sinus occlusion alone.

Arterial compliance: a diagnostic marker for atherosclerotic plaque burden?

BACKGROUND: Previous studies have shown atherogenesis to be related with increased vessel stiffness. Measures of the arterial compliance can be performed noninvasively from pressure pulse contour analysis of arterial waveforms. In this prospective study we aimed to analyze to what extent vessel compliance can reflect the angiographic coronary artery status. METHODS: Large and small arterial elasticity indices (LAEI in milliliters per mm Hg x 10 and SAEI in milliliters per mm Hg x 100) were measured in 151 patients on the radial artery with the PulseWave Sensor HDI device. All patients were classified into diffuse-coronary artery disease (CAD) (defined as stenosis length >15 mm), focal-CAD (defined as stenosis length between 1 and 15 mm), or no-CAD. RESULTS: We found both LAEI and SAEI to be reduced in the diabetic group (LAEI: 11.2 +/- 2.9 v 13.4 +/- 4.5, P =.006; SAEI: 3.7 +/- 1.6 v 4.7 +/- 2.4, P =.01). Inverse association was seen between age and LAEI (r = -0.41; P <.001) and SAEI (r = -0.38; P <.001). No-CAD was found in 31 patients, focal-CAD in 64 patients, and diffuse-CAD in 56 patients. Mean LAEI were 13.8 +/- 3.5, 13.7 +/- 4.7, and 11.3 +/- 3.5 in the groups no-CAD, focal-CAD, and diffuse-CAD, respectively (P =.004), (no-CAD versus diffuse-CAD: P =.04; focal-CAD versus diffuse-CAD: P =.009). Respective SAEI values were 5.6 +/- 2.5, 5.0 +/- 2.1, and 3.1 +/- 1.6 (P <.001), (no-CAD versus diffuse-CAD: P <.001; focal-CAD versus diffuse-CAD: P <.001). Multivariate analysis revealed SAEI (P <.001), hypercholesterolemia (P =.005), systolic blood pressure (BP) (P <.001), mean arterial BP (P <.001), pulse pressure (P =.003), and male gender (P =.001) to be diagnostic markers of the type of vessel disease. CONCLUSIONS: Compliance measurements may be used for identification of patients with diffuse atherosclerotic processes of the coronary arteries.

Mechanism of lumen gain during coronary stent deployment in diabetic patients compared with non-diabetic patients.

BACKGROUND: Diabetic patients show an increased incidence of restenosis after coronary angioplasty than non-diabetic patients. This may be because of differences in the mechanism of lumen gain during coronary revascularization in this population cohort. DESIGN: This study analyses the mechanism of lumen gain during coronary stent deployment in diabetic patients compared with non-diabetic patients with intravascular ultrasound (IVUS). METHODS: IVUS images were obtained prior to and after revascularization in 26 diabetic and 97 non-diabetic patients. The external elastic membrane cross-sectional area (EEM) and lumen cross-sectional area (LA) were measured. Plaque area (PA) was calculated as EEM minus LA. Differences between pre- and post-LA (deltaLA), EEM (deltaEEM) and PA (deltaPA) were calculated. RESULTS: Pre-interventional PA (diabetic patients: 12.4 +/- 4.4 mm2 compared with non-diabetic patients: 10.7 +/- 3.6 mm2, = 0.04) and pre-interventional EEM (15.5 +/- 4.4 mm2 compared with 13.6 +/- 3.7 mm2 respectively, P = 0.02) were larger in the diabetic group. Postinterventional PA (10.2 +/- 3.2 mm2 compared with 8.0 +/- 3.4 mm2, P = 0.004) was also larger and postinterventional LA (6.3 +/- 2.2 mm2 compared with 7.4 +/- 2.4 mm2 = 0.04), deltaEEM (0.9 +/- 1.8 mm2 compared with 1.8 +/- 1.8 mm2 P = 0.04) and deltaLA (3.1 +/- 1.6 mm2 compared with 4.2 +/- 2.2 mm2, P = 0.03) were smaller in the diabetic group. The diabetic group exhibited longer lesion lengths (P = 0.04) and a higher inflation pressure was used during revascularization in this patient cohort (P = 0.02). CONCLUSION: Diabetic patients have less reduction of PA during revascularization and because the vessel wall cannot be stretched outwards despite higher inflation pressure, postinterventional LA remains smaller than in the non-diabetic population cohort. This might be a rudiment for consideration of different treatment strategies such as cutting balloon or atherectomy prior to stenting in this population group in order to achieve better procedural outcome.

Intracoronary brachytherapy with beta-radiation for the treatment of long diffuse in-stent restenosis.

OBJECTIVE: To assess the efficacy of intracoronary brachytherapy with beta-radiation (Sr/Y) for the treatment of long diffuse in-stent restenosis (ISR). METHODS: As recurrent ISR depends on intimal injury after coronary angioplasty, long in-stent restenotic lesions were defined as lesions with a treatment length >26 mm (lesion length >20 mm plus a treatment margin of 3 mm at each end). Seventy-eight patients with long ISR were treated at our institution with beta-brachytherapy after coronary angioplasty. Patients were irradiated with either an approximate dose of 12 Gy at 1 mm vessel wall depth or with 18 Gy at 1 mm vessel wall depth. Clinical follow-up was available for 69 patients and angiographic follow-up for 65 patients. Late lumen loss (LLL), binary restenosis (stenosis >50%), target lesion revascularization (TLR) and major adverse cardiac events (MACE) were assessed for a follow-up time of 6.6+/-2.2 months. RESULTS: Mean interventional treatment length was 46+/-18 mm. TLR was performed in all 23 patients with binary restenosis (33%). Death of cardiac cause was reported for two patients, one of whom did not undergo TLR. Thus, overall MACE rate was 35%. Recurrent ISR was significantly more frequent in patients with geographic miss. Comparison of the different radiation dose regimens revealed significantly lower LLL in patients irradiated with the higher dose (0.20+/-0.68 mm compared with 0.65+/-0.96 mm, P=0.03). CONCLUSION: Intracoronary brachytherapy with beta-radiation (Sr/Y) is a safe and effective therapeutic option for the reduction of recurrent ISR in long diffuse lesions. We recommend a high-dose irradiation with 18 Gy at 1 mm vessel wall depth.