Mortality in STEMI Patients With Cardiogenic Shock: Results From a Nationwide PCI Registry and Focus on Left Main PCI.

BACKGROUND: The study aims to assess real-life short- and long-term outcomes of patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) complicated with cardiogenic shock (CS). Outcome after left main (LM) PCI is of particular interest. METHODS: Procedural, 30-day, and >30-day mortality rates were assessed in 2744 CS-STEMI patients enrolled between 2012 and 2019 in a nationwide registry involving 49 centers. RESULTS: Procedural, 30-day, and >30-day mortality rates were 6.9%, 39.8%, and 12.6%, respectively. The mortality rates were significantly higher in the 348 patients (12.7%) who underwent LM-PCI (13.5%, 59.5%, and 18.4%, respectively). LM-PCI, a suboptimal PCI result, and transfemoral access were independent predictors of procedural and 30-day mortality. Operator experience was an independent predictor of procedural mortality, but not 30-day mortality. CONCLUSIONS: Mortality remains high in CS-STEMI patients, especially within the first month. Patients undergoing LM-PCI are particularly at risk. Operator experience is predictive of procedural mortality.

Practice and long-term outcome of unprotected left main PCI: real-world data from a nationwide registry.

BACKGROUND: Percutaneous coronary intervention (PCI) is increasingly performed in significant left main (LM) lesions. Left untreated, the prognosis is poor, but PCI and coronary bypass surgery (CABG) behold risks as well. Additional long-term outcome data might guide future treatment decisions. METHODS: Between 2012 and 2019, all 6783 patients who underwent LM PCI were prospectively enrolled in a national registry. Patients with prior CABG or prior LM PCI, and patients presenting in cardiogenic shock or after out-of-hospital cardiac arrest were excluded. From the remaining 5284 patients, baseline and procedural data as well as long-term survival were assessed. RESULTS: The annual rate of LM PCI increased from 422 (2.2% of PCIs) in 2012 to 868 in 2018 (3.0%). By 2018, 71% of the interventional cardiologists performed at least 1 LM PCI a year, though only 5 on average. Use of transradial access (TRA) in LM PCI increased from 20.4% in 2012 to 59.5% in 2019. All-cause mortality was 6.0% at 30 days and 18.5% at a mean follow-up of 33.5 months. Independent predictors of higher long-term mortality were older age, diabetes, multivessel disease, an urgent indication, a suboptimal angiographical result, and non-exclusive use of drug-eluting stents. TRAand higher operator and centre LM PCI experience were independent predictors of a lower long-term mortality. CONCLUSION: LM PCI is associated with high short- and long-term mortality. Use of TRA and higher expertise in LM PCI were associated with better survival.

Evaluation of a no-reference image quality metric for projection X-ray imaging using a 3D printed patient-specific phantom.

PURPOSE: Feasability of a no-reference image quality metric was assessed on patient-like images using a patient-specific phantom simulating a frame of a coronary angiogram. METHODS: One background and one contrast-filled frame of a coronary angiogram, acquired using a clinical imaging protocol, were selected from a Philips Integris Allura FD (Philips Healthcare, Best, The Netherlands). The background frame's pixels were extruded to a thickness proportional to their grey value. One phantom was 3D printed using composite 80% bronze filament (max. thickness of 5.1 mm), the other was a custom PMMA cast (max thickness of 8.5 cm). A vessel mold was created from the contrast-filled frame and injected with a solution of 320 mg I/ml contrast fluid (75%), water and gelatin. Still X-ray frames of the vessel mold + background phantom + 16 cm PMMA were acquired at manually selected different exposure settings using a Philips Azurion (Philips Healthcare, Best, The Netherlands) in User Quality Control Mode and were exported as RAW images. The signal-difference-to-noise-ratio-squared (SDNR2) and a spatial-domain-equivalent of the noise equivalent quanta (NEQSDE) were calculated. The Spearman's correlation of the latter parameters with a no-reference perceptual image quality metric (NIQE) was investigated. RESULTS: The bronze phantom showed better resemblance to the original patient frame selected from a coronary angiogram of an actual patient, with better contrast and less blur than the PMMA phantom. Both phantoms were imaged using a comparable imaging protocol to the one used to acquire the original frame. The bronze phantom was hence used together with the vessel mold for image quality measurements on the 165 still phantom frames. A strong correlation was noted between NEQSDE and NIQE (SROCC = -0.99, p < 0.0005) and between SDNR2 and NIQE (SROCC = -0.97, p < 0.0005). CONCLUSION: Using a cost-effective and easy to realize patient-specific phantom we were able to generate patient-like X-ray frames. NIQE as a no-reference image quality model has the potential to predict physical image quality from patient images.

Combining Optimized Image Processing With Dual Axis Rotational Angiography: Toward Low-Dose Invasive Coronary Angiography.

Background Dual axis rotational coronary angiography (DARCA) reduces radiation exposure during coronary angiography on older x-ray systems. The purpose of the current study is to quantify patient and staff radiation exposure using DARCA on a modality already equipped with dose-reducing technology. Additionally, we assessed applicability of 1 dose area product to effective dose conversion factor for both DARCA and conventional coronary angiography (CCA) procedures. Methods and Results Twenty patients were examined using DARCA and were compared with 20 age-, sex-, and body mass index-matched patients selected from a prior study using CCA on the same x-ray modality. All irradiation events are simulated using PCXMC (STUK, Finland) to determine organ and effective doses. Moreover, for DARCA each frame is simulated. Staff dose is measured using active personal dosimeters (DoseAware, Philips Healthcare, The Netherlands). With DARCA, median cumulative dose area product is reduced by 57% (ie, 7.41 versus 17.19 Gy·cm2). Effective dose conversion factors of CCA and DARCA are slightly different, yet this difference is not statistically significant. The occupational dose at physician's chest, leg, and collar level are reduced by 60%, 56%, and 16%, respectively, of which the first 2 reached statistical significance. Median effective dose is reduced from 4.75 mSv in CCA to 2.22 mSv in DARCA procedures, where the latter is further reduced to 1.79 mSv when excluding ventriculography. Conclusions During invasive coronary angiography, DARCA reduces radiation exposure even further toward low-dose values on a system already equipped with advanced image processing and noise reduction algorithms. For both DARCA and CCA procedures, using 1 effective dose conversion factor of 0.30 mSv·Gy-1·cm-2 is feasible.

Evaluation of patient and staff exposure with state of the art X-ray technology in cardiac catheterization: A randomized controlled trial.

INTRODUCTION: Cardiac catheterization procedures result in high patient radiation exposure and corresponding staff doses are reported to be among the highest for medical staff. The purpose of current randomized controlled study was to quantify the potential radiation dose reduction for both patient and staff, enabled by recent X-ray technology. This technology is equipped with advanced image processing algorithms, real-time dose monitoring, and an acquisition chain optimized for cardiac catheterization applications. METHODS: A total of 122 adult patients were randomly assigned to one of two cath labs, either the reference X-ray modality (Allura Xper FD10, Philips Healthcare, the Netherlands) or the new X-ray system (AlluraClarity FD20/10 Philips Healthcare, the Netherlands). Exposure parameters and staff dosimeter readings were recorded for each exposure. Technical measurements were performed to define the radiation scatter behavior. RESULTS: With the newer equipment, patient radiation dose is reduced (as total dose-area product) by 67% based on geometric means with 95%CI of 53%, 77% for diagnostic and interventional procedures. The C-arm and leg dosimeter readings were both reduced with 65% (P < 0.001), while for the collar and chest dosimeter readings no statistically significant reduction was noticed. CONCLUSION: The new x-ray and image processing technology, significantly reduces patient dose in coronary angiographies, and PCIs by 67%. In general, scatter dose was also reduced, yet for some dosimeters the reduction was limited and not statistically significant. This study clearly indicates that the scatter behavior is highly dependent on C-arm rotation, operator movement and height, dosimeter position, beam filtration, clinical procedure type and system geometry.

Low target-INR anticoagulation is safe in selected aortic valve patients with the Medtronic Open Pivot mechanical prosthesis: long-term results of a propensity-matched comparison with standard anticoagulation.

OBJECTIVES: To investigate the long-term results of a low international normalized ratio (INR)-anticoagulation program in selected patients after aortic valve replacement (AVR) with the Medtronic Open Pivot mechanical heart valve (OPMHV). METHODS: From January 1993 to December 2012, 909 OPMHV valves were used for single AVR. Patients with preserved sinus rhythm and left ventricular function (Low-INR, n = 552), were managed to an INR of 1.5-2.5 and compared to patients (Standard-INR, n = 357) treated with standard anticoagulation (INR 2.5-3.5). Long-term outcome was analysed for survival and valve-related events, on propensity score matched pairs of 169 patients/group. RESULTS: Within a follow-up cumulating 3096 patient-years, 10- and 15-year survival was significantly better for Low-INR patients: 79% and 63% vs 63% and 34% ( P < 0.001). Multivariate analysis of late mortality identified older age [odds ratio (OR) = 1.05], chronic pulmonary disease (OR = 1.90) and coronary artery disease (OR = 1.57) as patient-related risk factors, and erratic INR (OR = 2.57) as anticoagulation-related factor. The linearized thromboembolic rate was 0.72%/patient-year in Low-INR patients, vs 0.87%/patient-year in Standard-INR patients ( P = 0.59), revealing INR variability as sole predictor (OR 3.54, 95% confidence interval (CI) 1.20-10.51, P = 0.022). The linearized bleeding incidence was respectively 0.61%/patient-year and 1.21%/patient-year for Low-INR and Standard-INR patients ( P = 0.04), retaining older age (OR 1.06, 95% CI 1.02-1.12, P = 0.009), hypertension (OR 2.06, 95% CI 1.00-4.25, P = 0.05) and erratic INR (OR 9.83, 95% CI 5.21-18.56, P < 0.001) as independent risk factors. CONCLUSIONS: This study demonstrated that application of an anticoagulation regimen, aiming a low INR, individualized to selected aortic OPMHV patients, is safe and effective over more than 20 years, without increasing the thromboembolic complication rate while lowering the haemorrhagic events. However, INR variability remains worrisome because of its deleterious effect on outcome.

Proximal aortic stiffening in Turner patients may be present before dilation can be detected: a segmental functional MRI study.

BACKGROUND: To study segmental structural and functional aortic properties in Turner syndrome (TS) patients. Aortic abnormalities contribute to increased morbidity and mortality of women with Turner syndrome. Cardiovascular magnetic resonance (CMR) allows segmental study of aortic elastic properties. METHOD: We performed Pulse Wave Velocity (PWV) and distensibility measurements using CMR of the thoracic and abdominal aorta in 55 TS-patients, aged 13-59y, and in a control population (n = 38;12-58y). We investigated the contribution of TS on aortic stiffness in our entire cohort, in bicuspid (BAV) versus tricuspid (TAV) aortic valve-morphology subgroups, and in the younger and older subgroups. RESULTS: Differences in aortic properties were only seen at the most proximal aortic level. BAV Turner patients had significantly higher PWV, compared to TAV Turner (p = 0.014), who in turn had significantly higher PWV compared to controls (p = 0.010). BAV Turner patients had significantly larger ascending aortic (AA) luminal area and lower AA distensibility compared to both controls (all p < 0.01) and TAV Turner patients. TAV Turner had similar AA luminal areas and AA distensibility compared to Controls. Functional changes are present in younger and older Turner subjects, whereas ascending aortic dilation is prominent in older Turner patients. Clinically relevant dilatation (TAV and BAV) was associated with reduced distensibility. CONCLUSION: Aortic stiffening and dilation in TS affects the proximal aorta, and is more pronounced, although not exclusively, in BAV TS patients. Functional abnormalities are present at an early age, suggesting an aortic wall disease inherent to the TS. Whether this increased stiffness at young age can predict later dilatation needs to be studied longitudinally.

Diagnostic accuracy of a novel method for detection of acute transmural myocardial ischemia based upon a self-applicable 3-lead configuration.

BACKGROUND: Delayed medical attendance is a leading cause of death in patients with ST elevation myocardial infarction (STEMI). METHODS: We aimed to introduce, develop, and validate a novel method (RELF method) for detection of transmural ischemia based on a new and easy-to-use 3-lead configuration and orthonormalization of ST reference vectors (STDVN). The study included 60 patients undergoing coronary artery occlusion (CAO) during balloon inflation and 30 healthy subjects. RESULTS: STDVN was significantly different and an optimal discriminator between CAO patients and healthy subjects (respectively 8.00±4.50 vs. 1.90±0.86 normalized units, p<0.001). Compared to the 12-lead ECG, the RELF method was sensitive (90 vs. 73%, p=0.13) and more specific (91 vs. 75%, p<0.001). CONCLUSIONS: The RELF method is highly accurate for early detection of acute occlusion related ischemia and it outperforms the conventional 12-lead ECG criteria for STEMI. This method provides a platform for self-detection of CAO with handheld devices or smart phones.

Impact of gender difference in hospital outcomes following percutaneous coronary intervention. Results of the Belgian Working Group on Interventional Cardiology (BWGIC) registry.

AIMS: To determine whether there are gender-based differences in in-hospital outcomes among patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: We studied a large cohort using clinical data from a registry of 130,985 PCI procedures in Belgium, from January 2006 to February 2011. Compared to males, females were significantly older (70.3 vs. 64.8 years), and were more frequently diabetic or hypertensive. Men smoked more and more frequently had previous myocardial infarction (MI), previous PCI or previous coronary artery bypass graft (CABG) surgery. Coronary artery disease (CAD) was less severe in women, and PCI to the left anterior descending artery was more common in female patients. Unadjusted in-hospital mortality rates were higher in females versus males (2.5% for women and 1.6% for men, p<0.0001). After multivariable analysis, female gender remained an independent predictor of mortality (odds ratio 1.35, 95% CI: 1.22-1.49, p<0.0001). CONCLUSIONS: Gender-based differences in hospital mortality rates after PCI were observed in this large registry. Female sex remained an independent predictor of mortality after multivariable adjustment.

Novel X-ray imaging technology enables significant patient dose reduction in interventional cardiology while maintaining diagnostic image quality.

OBJECTIVES: The purpose of this study was to quantify the reduction in patient radiation dose during coronary angiography (CA) by a new X-ray technology, and to assess its impact on diagnostic image quality. BACKGROUND: Recently, a novel X-ray imaging technology has become available for interventional cardiology, using advanced image processing and an optimized acquisition chain for radiation dose reduction. METHODS: 70 adult patients were randomly assigned to a reference X-ray system or the novel X-ray system. Patient demographics were registered and exposure parameters were recorded for each radiation event. Clinical image quality was assessed for both patient groups. RESULTS: With the same angiographic technique and a comparable patient population, the new imaging technology was associated with a 75% reduction in total kerma-area product (KAP) value (decrease from 47 Gycm2 to 12 Gycm2, P<0.001). Clinical image quality showed an equivalent detail and contrast for both imaging systems. On the other hand, the subjective appreciation of noise was more apparent in images of the new image processing system, acquired at lower doses, compared to the reference system. However, the higher noise content did not affect the overall image quality score, which was adequate for diagnosis in both systems. CONCLUSIONS: For the first time, we present a new X-ray imaging technology, combining advanced noise reduction algorithms and an optimized acquisition chain, which reduces patient radiation dose in CA drastically (75%), while maintaining diagnostic image quality. Use of this technology may further improve the radiation safety of cardiac angiography and interventions.

Twenty-year single-center experience with the medtronic open pivot mechanical heart valve.

BACKGROUND: Since May 1992 the Medtronic Open Pivot mechanical heart valve has been implanted routinely at the authors' institution. The study aim was to analyze, retrospectively, the 20-year clinical results of the valve. METHODS: Between May 1992 and December 2011 a total of 1,520 valves was inserted into 1,382 consecutive patients (1,012 aortic, 473 mitral, 26 tricuspid, 9 pulmonary). The mean age of the patients was 61±13.2 years. Preoperatively, 65% of the patients were in New York Heart Association (NYHA) class III or greater. Frequent comorbidities included atrial fibrillation (n=419), coronary disease (n=357), and diabetes (n=255). The 99% complete follow-up totaled 10,527 patient-years (range 12 to 244 months). RESULTS: Ninety-day mortality was 5.2% (n=73, 8 valve related). Of the 550 total deaths, 240 were cardiac and 56 valve related. Multivariate analysis selected age, NYHA III or greater, concomitant coronary revascularization, and respiratory insufficiency as risk factors for death. Renal failure was considered a risk factor in the aortic and atrial fibrillation in the mitral subgroup. Erratic international normalized ratio (INR), NYHA class III or greater, and non-sinus rhythm were risk factors for thromboembolism; likewise redo operations in the aortic subgroup. Erratic INR and age were risk factors for bleeding as were over-coagulation and coronary revascularization in the aortic subgroup and redo operations and renal failure in mitral patients. CONCLUSIONS: This 20-year experience demonstrated excellent clinical outcomes with no structural valve failure. Odds ratio defined aortic patients as the lowest risk for adverse events. By contrast atrial fibrillation and elderly age, in combination with instable anticoagulation, yielded the worst long-term results.

Three-dimensional rotational X-ray acquisition technique is reducing patients' cancer risk in coronary angiography.

OBJECTIVES: The purpose of this study was to assess patient-specific organ doses and cancer risk with 3D-rotational acquisitions versus the current standard of multiple single-plane coronary angiography (CA). BACKGROUND: Catheter-based CA remains one of the most commonly performed diagnostic invasive procedures delivering a relatively high radiation dose to the patient. With the introduction of flat-panel technology, three-dimensional rotational angiography became an alternative for the conventional two-dimensional angiography. However, limited information is available on the difference in patient radiation exposure with both acquisition techniques. METHODS: Eighty adult patients (45 males, age 38-93 years) were randomly assigned to the rotational or standard angiography group. Exposure parameters were registered and skin dose distribution was measured during the procedure. Patient-specific organ doses and related cancer risks were assessed with dedicated software. RESULTS: Rotational angiograms were associated with 33% lower KAP-values (decrease from 49.99 Gycm(2) to 33.37 Gycm(2), P < 0.001). A significant (P < 0.001) lower peak skin dose was measured with rotational acquisitions (80 mGy, median) versus planar imaging (172 mGy, median). Moreover, the skin dose was smoothed over the whole chest of the patient. Contrast medium consumption decreased from 104 mL to 73 mL (P < 0.001) with the use of 3D-imaging. The reduction in radiation exposure resulted in a corresponding decrease of organ doses. The latter contributed to an overall cancer risk reduction of 21% for males and 50% for females. CONCLUSIONS: The current study demonstrates that in CA radiation risk reduction is feasible by using a rotational acquisition technique.

Twenty years' single-center experience with mechanical heart valves: a critical review of anticoagulation policy.

BACKGROUND AND AIM OF THE STUDY: Since January 1990, a variety of mechanical valves (St. Jude Medical, CarboMedics, ATS Medical) have been implanted routinely at the authors' institution. The study aim was to analyze, retrospectively, the 20-year clinical results of those mechanical valves, and to challenge the anticoagulation policy employed over the years. METHODS: Between January 1990 and December 2008, a total of 2,108 mechanical valves was inserted into 1,887 consecutive patients (1,346 aortic, 725 mitral, 27 tricuspid, 10 pulmonary). The mean age of the patients was 63 +/- 13.2 years, and the majority (61%) were males. Preoperatively, 71% the patients were in NYHA class > or = III (average 3.01). The most frequent comorbidities included: atrial fibrillation (n = 594), coronary disease (n = 567) and diabetes (n = 398). The follow up (99% complete) totaled 13,721 patient-years (pt-yr), and ranged from 12 to 241 months (average 84 months). RESULTS: In-hospital mortality was 5.2% (n = 98, 14 valve-related). Of the 629 late deaths, the majority were cardiac (n = 276). Survival (Kaplan-Meier estimation) was significantly better for aortic valve patients compared to mitral or multiple valve replacement (Mantel-Cox, p < 0.0001). The overall linearized incidences (as %/pt-yr) were: valve thrombosis 0.31, thromboembolism 1.08, and bleeding 0.91. However, as repeated events occurred in several patients, the hazard function was not constant. Multivariate analysis (Cox regression model) showed age > 70 years (p < 0.0001), NYHA class > or = III (p < 0.0001), non-sinus rhythm (p = 0.001), concomitant coronary artery bypass grafting (p = 0.008) and higher International Normalized Ratio (INR) values (p = 0.013) as significant risk factors for death, with a trend for redo operations (p = 0.052). Multivariate analysis found variable INR, non-sinus rhythm and NYHA class > II as significant risk factors for thromboembolism, while long-acting coumadin and NYHA class > II were significant risk factors for bleeding. CONCLUSION: This 20-year experience demonstrated excellent clinical outcomes for patients with mechanical prostheses, with no valve structural failure and an acceptable incidence of adverse events. INR values between 2-2.5 for aortic valve patients, and 3-3.5 for mitral valve patients, yielded the fewest major adverse events.

Bypass versus drug-eluting stents at three years in SYNTAX patients with diabetes mellitus or metabolic syndrome.

BACKGROUND: Diabetes mellitus increases adverse outcomes after coronary revascularization; however, the impact of metabolic syndrome is unclear. We examined the impact of diabetes and metabolic syndrome on coronary artery bypass graft surgery (CABG) and stenting outcomes to determine the optimal revascularization option for the treatment of complex coronary artery disease. METHODS: Patients (n = 1,800) with left main or three-vessel disease or both were randomly allocated to treatment with a TAXUS Express(2) paclitaxel-eluting stent (PES) or CABG, and were included in predefined nondiabetic (n = 1,348) or diabetic subgroups (n = 452); 258 patients with diabetes also had metabolic syndrome. RESULTS: Among diabetic patients, the 3-year major adverse cardiac and cerebrovascular event (MACCE) rate (22.9% CABG, 37.0% PES; p = 0.002) and revascularization rate (12.9% CABG, 28.0% PES; p < 0.001) were higher after PES treatment. Diabetes increased MACCE rates among PES-treated patients, but had little impact on results after CABG. Compared with CABG, PES treatment yielded comparable MACCE in diabetic patients (30.5% versus 29.8%, p =0.98) and nondiabetic patients (20.2% versus 20.3%, p =0.99) with low Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) study scores of 22 or less. For patients with SYNTAX Scores of 33 or greater, MACCE rates were lower with CABG (18.5% versus 45.9%, p < 0.001 diabetic; 19.8% versus 30.0%, p = 0.01 nondiabetic). Metabolic syndrome did not significantly predict MACCE or repeat revascularization. CONCLUSIONS: These exploratory analyses suggest that among diabetic patients with complex left main or three-vessel disease, or both, 3-year MACCE is higher after PES compared with CABG. Although PES is a potential treatment option in patients with less complex lesions, CABG should be the revascularization option of choice for patients with more complex anatomic disease, especially with concurrent diabetes. Metabolic syndrome had little impact on 3-year outcomes.

Ten years single-centre experience with intra-aortic balloon pump.

OBJECTIVES: The objective of this study was to investigate the patient characteristics and outcomes in 1406 patients undergoing intra-aortic balloon pump (IABP) counterpulsation. METHODS: Between 1998 and 2008, 1406 consecutive patients were recorded in a prospective database. Based on the main clinical indication for IABP use, we defined 3 groups: group A, 630 cases of coronary ischaemia or infarction without serious left ventricular (LV) dysfunction; group B, 466 patients with left ventricular failure or cardiogenic shock; group C, 310 patients where IABP was used for miscellaneous procedures such as weaning from cardiopulmonary bypass or during high-risk angioplasty or surgery. RESULTS: Global mortality was 28% (n = 390), with a significant difference between group A (15%, n = 95) and group B (41%, n = 191) (P < 0.001). Mortality in group C was 34% (n = 104). Most insertions were done in the catheterization laboratory (n = 943) with subsequent mortality of 23% whereas 199 balloons were inserted in the operation room with 34% mortality. 170 balloons inserted in the intensive care unit resulted in 46% mortality (P < 0.001). Major IABP-induced complications were 6.8% with no statistical differences between the three groups. Advanced age, left ventricular failure and low BMI were identified as prognostic risk factors for early mortality. CONCLUSIONS: IABP deployed at an early clinical stage yields the best results, especially for acute coronary patients with preserved LV function whereas LV failure and late insertion result in worse outcome.

Sutureless replacement of aortic valves with St Jude Medical mechanical valve prostheses and Nitinol attachment rings: feasibility in long-term (90-day) pig experiments.

OBJECTIVE: Nitinol attachment rings (devices) used to attach mechanical aortic valve prostheses suturelessly were studied in long-term (90 days) pig experiments. METHODS: The aortic valve was removed and replaced by a device around a St Jude Medical mechanical valve prosthesis in 10 surviving pigs. Supravalvular angiography was done at the end of the operation. No coumarin derivates were given. RESULTS: No or minimal aortic regurgitation was confirmed in all surviving pigs at the end of the operation. Total follow-up was 846 days. In 4 pigs, follow-up was shorter than 90 days (28-75 days); the other 6 pigs did reach 90 days' survival or more. Repeat angiography in 4 pigs at the end of follow-up confirmed the unchanged position of the device at the aortic annulus, without aortic regurgitation. At autopsy, in all pigs the devices proved to be well grown in at the annulus, covered with endothelium, and sometimes tissue overgrowth related to not using coumarin derivates. There was no case of para-device leakage, migration, or embolization. No damage to surrounding anatomic structures or prosthetic valves was found. CONCLUSIONS: Nitinol attachment rings can be used to replace the aortic valve suturelessly with St Jude Medical mechanical aortic valve prostheses, without para-device leakage, migration, or damage to the surrounding tissues, in long-term pig experiments during a follow-up of 90 days or more. Refraining from anticoagulation in pigs with mechanical valve prostheses can lead to tissue overgrowth of the valve prosthesis. Further studies are needed to determine long-term feasibility of this method in human beings.

A novel simulation strategy for stent insertion and deployment in curved coronary bifurcations: comparison of three drug-eluting stents.

The introduction of drug-eluting stents (DES) has reduced the occurrence of restenosis in coronary arteries. However, restenosis remains a problem in stented coronary bifurcations. This study investigates and compares three different second generation DESs when being implanted in the curved main branch of a coronary bifurcation with the aim of providing better insights into the related changes of the mechanical environment. The 3D bifurcation model is based on patient-specific angiographic data that accurately reproduce the in vivo curvatures of the vessel segments. The layered structure of the arterial wall and its anisotropic mechanical behavior are taken into account by applying a novel algorithm to define the fiber orientations. An innovative simulation strategy considering the insertion of a folded balloon catheter over a guide wire is proposed in order to position the stents within the curved vessel. Straightening occurs after implantation of all stents investigated. The resulting distributions of the wall stresses are strongly dependent on the stent design. Using a parametric modeling approach, two design modifications, which reduce the predicted maximum values of the wall stress, are proposed and analyzed.

Fifteen years' single-center experience with the ATS bileaflet valve.

BACKGROUND AND AIM OF THE STUDY: Since its introduction in May 1992, the bileaflet ATS Open Pivot valve has been implanted routinely at the authors' institution. The study aim was to analyze, retrospectively, the 15-year clinical results of these implanted ATS valves. METHODS: Between May 1992 and December 2005, a total of 1,160 ATS valves (749 aortic, 381 mitral, 21 tricuspid, nine pulmonary) was implanted in 1,047 consecutive patients (655 males, 392 females; mean age 62.1 +/- 12.4 years). Preoperatively, 75% of the patients were in NYHA class III or higher (mean 3.1). The most frequent comorbidities included atrial fibrillation (n = 381), coronary disease (n = 288) and diabetes (n = 172). RESULTS: The mean follow up was 78 months (range: 24-183 months); the total follow up was 6,887 patient-years (pt-yr) and was 99.8% complete. In-hospital mortality was 4% (n = 43; three valve-related). Survival (Kaplan-Meier) at five and 10 years was significantly better for aortic than for mitral valve patients (84% and 65% versus 75% and 41%, respectively) (Mantel-Cox, p < 0.001). A log rank analysis detected no statistical difference in the incidence of thromboembolism (p = 0.182) or bleeding (p = 0.375) between both groups. The overall linearized incidences were: thromboembolism 1.08%/pt-yr; bleeding 0.91%/pt-yr; endocarditis 0.22%/pt-yr; paravalvular leakage 0.33%/pt-yr; and valve thrombosis 0.21%/pt-yr. Multivariate analysis (Cox regression) indicated age > 70 years (p < 0.0001), NYHA class > or = III (p < 0.0001), non-sinus rhythm (p = 0.001), concomitant CABG (p = 0.008) and higher INR values (p = 0.013) to be significant risk factors for death. CONCLUSION: This 15-year experience with the ATS bileaflet prosthesis showed excellent clinical outcomes for patients, with no structural failure and an acceptable incidence of adverse events.

Drug-eluting stents: a study of international practice.

OBJECTIVE: We aimed to analyze trends in drug-eluting stents (DES) use in four international health care and regulatory settings. BACKGROUND: Accounts suggest a differential approach to DES internationally and recent reductions in use following reports of late stent thrombosis. Current studies of clinical practice are limited in their scope. METHODS: Data were pooled from angioplasty registries in Alberta (Canada), Belgium, Mayo Clinic (Rochester, MN), and Scotland (UK) that have routinely recorded consecutive patients treated since 2003. Trend analysis was performed to examine variations in DES use over time and by clinical subgroup. RESULTS: A total of 178,504 lesions treated between January 2003 and September 2007 were included. In the Mayo Clinic Registry, rapid adoption to a peak of 91% DES use for all lesions by late 2004 was observed. In contrast, Alberta and Scotland showed delayed adoption with lower peak DES use, respectively, 56% and 58% of lesions by early 2006. Adoption of DES in Belgium was more gradual and peak use of 35% lower than other registries. Reductions in DES use were seen in all data sets during 2006, although this varied in absolute and relative terms and by clinical subgroup. CONCLUSION: Adoption and use of DES showed wide variation in four countries. The determinants of use are complex, and it is likely that nonclinical factors predominate. Recent reductions in use may be as a consequence of publicity and concerns regarding late stent thrombosis. The optimum application of DES in clinical practice is unclear and is reflected in the degree of international variation demonstrated.