Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Early leaflet thrombosis complicating transcatheter implantation of a Sapien 3 valve in a native right ventricular outflow tract.

A 59-year-old female with Tetralogy of Fallot had a previous complete repair with RVOT patch enlargement. She developed subsequent severe symptomatic (NYHA III) pulmonary regurgitation with severe RV dilatation. She had a concomitant interstitial lung disease secondary to hypersensitivity pneumonitis that precluded her from cardiac surgery. After preprocedural assessment using computed tomography, echocardiography and invasive angiography we decided to implant a 29 mm Edwards Sapien 3 valve without pre-stenting. The Sapien 3 valve was implanted in a satisfactory position using rapid RV pacing. The valve appeared well expanded with good circularity on fluoroscopy. A transthoracic echocardiography on the following day showed no pulmonary regurgitation with a peak gradient of 14 mmHg across the prosthesis. At 4 weeks follow-up, the patient felt a marked improvement (NYHA II) but a CT scan showed bileaflet valve thickening with preserved stent expansion. A concomitant echo-doppler showed a significant increase of peak pulmonary gradient to 26 mmHg. After a six weeks course of warfarin therapy, the transpulmonary valve peak gradient came down to 16 mmHg and leaflet thickening resolved on CT. The Sapien 3 system helped achieve a successful transfemoral percutaneous pulmonary valve implantation in a challenging native RVOT anatomy. This case was complicated by early valve thrombosis as documented by CT and was successfully treated with oral anticoagulation.

Quality of Care for Percutaneous Coronary Intervention: Development of Canadian Cardiovascular Society Quality Indicators.

Currently there are more than 40 centres in Canada that perform more than 65,000 percutaneous coronary interventions (PCIs) in a year. Considering the high volume of procedures and number of operators, the potential for variation in processes of care is high, and might lead to variation in the quality of care. As part of its quality initiative, the Canadian Cardiovascular Society convened a working group to develop a set of PCI Quality Indicators (QIs) that would be relevant, scientifically acceptable, and feasible to measure and report. The working group was comprised of clinical experts from across Canada and members of provincial and federal organizations involved in promoting the quality of health care. Using the Canadian Cardiovascular Society "Best Practices for Developing Cardiovascular Quality Indicators" methodology, a total of 23 QIs were proposed. Subsequent ranking and discussion led to the selection of 8 QIs. The selection and ranking of QIs were on the basis of clinical importance and relevance, scientific acceptability, and feasibility of their operationalization at a national level. The data definitions and technical notes of the QIs were refined after feasibility testing and Web consultation. Feasibility testing indicated that standardization and enhancements of knowledge infrastructure are essential to provide the comprehensive patient data necessary to evaluate the quality of PCI across Canada.

A Plaque Disruption Index Identifies Patients with Non-STE-Type 1 Myocardial Infarction within 24 Hours of Troponin Positivity.

BACKGROUND: Markers of plaque destabilization and disruption may have a role in identifying non-STE- type 1 Myocardial Infarction in patients presenting with troponin elevation. We hypothesized that a plaque disruption index (PDI) derived from multiple biomarkers and measured within 24 hours from the first detectable troponin in patients with acute non-STE- type 1 MI (NSTEMI-A) will confirm the diagnosis and identify these patients with higher specificity when compared to individual markers and coronary angiography. METHODS: We examined 4 biomarkers of plaque destabilization and disruption: myeloperoxidase (MPO), high-sensitivity interleukin-6, myeloid-related protein 8/14 (MRP8/14) and pregnancy-associated plasma protein-A (PAPP-A) in 83 consecutive patients in 4 groups: stable non-obstructive coronary artery disease (CAD), stable obstructive CAD, NSTEMI-A (enrolled within 24 hours of troponin positivity), and NSTEMI-L (Late presentation NSTEMI, enrolled beyond the 24 hour limit). The PDI was calculated and the patients' coronary angiograms were reviewed for evidence of plaque disruption. The diagnostic performance of the PDI and angiography were compared. RESULTS: Compared to other biomarkers, MPO had the highest specificity (83%) for NSTEMI-A diagnosis (P<0.05). The PDI computed from PAPP-A, MRP8/14 and MPO was higher in NSTEMI-A patients compared to the other three groups (p<0.001) and had the highest diagnostic specificity (87%) with 79% sensitivity and 86% accuracy, which were higher compared to those obtained with MPO, but did not reach statistical significance (P>0.05 for all comparisons). The PDI had higher specificity and accuracy for NSTEMI-A diagnosis compared to coronary angiography (P<0.05). CONCLUSIONS: A PDI measured within 24 hour of troponin positivity has potential to identify subjects with acute Non-ST-elevation type 1 MI. Additional evidence using other marker combinations and investigation in a sufficiently large non-selected cohort is warranted to establish the diagnostic accuracy of the PDI and its potential role in differentiating type 1 and type 2 MI in patients presenting with troponin elevation of uncertain etiology.

Customized covered stent graft for percutaneous closure of Fontan baffle leak.

We report the innovation of both a partly-covered and completely-covered, variable-diameter, balloon-expandable stent that was custom-designed by NuMed, Inc for percutaneous closure of a baffle leak after total caval pulmonary connection (TCPC). A 50-year-old patient, born with tricuspid atresia, who had undergone TCPC, developed severe persistent cyanosis due to a right-to-left shunt through a TCPC baffle leak. Re-operation was deemed too high risk. Therefore, considering his complex anatomy, a custom-made, partly-covered, tapered, balloon-expandable stent was designed and successfully deployed. Months later, the shunt recurred at the junction of the covered to uncovered stent cells; subsequently, a second fully-covered, custom-made, tapered stent was implanted with an excellent outcome. The use of covered or partly-covered customized variable-diameter stents for closure of baffle leak after TCPC is feasible and resulted in marked clinical improvement. Customized balloon-expandable stents may be superior to traditional cylindrical stents because of better anchoring and apposition.

Pathology of transcatheter valve therapy.

OBJECTIVES: This study sought to report on the pathology of transcatheter aortic valves explanted at early and late time points after transcatheter aortic valve implantation. BACKGROUND: Information on pathological findings following transcatheter aortic valve implantation is scarce, particularly late after transcatheter aortic valve implantation. METHODS: This study included 20 patients (13 men, median age 80 years [interquartile range: 72 to 84] years) with previous transcatheter aortic valve implantation with a valve explanted at autopsy (n = 17) or surgery (n = 3) up to 30 months after implantation (10 transapical and 10 transfemoral procedures). RESULTS: Structural valve degeneration was not seen, although fibrous tissue ingrowth was observed at later time points with minimal effects on cusp mobility in 1 case. Minor alterations in valve configuration or placement were observed in up to 50% of cases, but they were not accompanied by substantial changes in valve function or reliably associated with chest compressions. Vascular or myocardial injury was common, especially within 30 days of transcatheter aortic valve implantation (about 69%), with the latter associated with left coronary ostial occlusion by calcified native aortic valve tissue in 2 cases. Mild to severe myocardial amyloidosis was present in nearly 33% of cases and likely played a role in the poor outcome of 3 patients. Endocarditis, migration of the valve, and embolization during the procedure led to surgical valve removal. CONCLUSIONS: Structural degeneration was not seen and minor alterations of valve configuration or placement did not affect valve function and were not reliably caused by chest compressions. Vascular or myocardial injury is very common early after transcatheter aortic valve implantation and myocardial amyloidosis represents a relatively frequent potentially significant comorbid condition.

Non-red blood cell transfusion as a risk factor for mortality following percutaneous coronary intervention.

BACKGROUND: Bleeding following percutaneous coronary intervention (PCI) is common and may lead to transfusion and death. Although previous work has examined the effect of red blood cell (RBC) transfusion in patients with coronary disease, no study had investigated whether transfusion of non-RBC components was associated with mortality following PCI. METHODS: All subjects transfused in the 10 days following PCI were identified using the British Columbia Cardiac and Central Transfusion Registries. Patients undergoing cardiac surgery following PCI were excluded as transfusion was assumed to be due to surgical related bleeding. Transfusion products were categorised as RBC and non-RBC comprising platelets, plasma and cryoprecipitate. Blood product use was compared according to thirty day mortality using multivariate regression and propensity adjustment for confounding variables. RESULTS: From a total of 32,580 patients who underwent PCI, 952 patients received at least 1 blood product within 10 days of PCI. Non-RBC transfusion occurred more commonly in the cohort of transfused patients dying within 30 days (p<0.001). After adjustment for baseline risk, transfusion of plasma/cryoprecipitate (HR 5.17; 95% C.I. 2.87-9.32, p<0.001) and platelets (HR 2.13; 95% C.I. 1.10-4.13, p=0.03) was associated with increased 30 day mortality. In a propensity risk adjusted model, transfusion of plasma/cryoprecipitate and RBC transfusion volume remained as significant predictors of 30-day mortality (p<0.001). CONCLUSIONS: Transfusion following PCI appears to be associated with an increased risk of death within 30 days. We now report that transfusion with plasma rich non-RBC products may confer an additional mortality risk to patients undergoing PCI.

Transatrial transcatheter tricuspid valve-in-valve implantation of balloon expandable bioprosthesis.

Transcatheter valve-in-valve implantation into failing mitral and aortic bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. Tricuspid valve-in-valve implantation has not been described. We report a case of failing bioprosthetic tricuspid valve in a 48-year-old woman with carcinoid syndrome. We attempted a transatrial transcatheter approach and we successfully deployed a 26-mm Edwards Sapien balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) into a severely stenotic tricuspid bioprosthesis. This case demonstrates the technical feasibility and safety of this approach. Therefore, tricuspid valve-in-valve implantation may be a viable treatment alternative in carefully selected patients.

A proposed clinical model for efficient utilization of invasive coronary angiography.

More than 1/4 of patients who undergo invasive coronary angiography are found to have no visible or nonobstructive (<50% stenosis) coronary artery disease (CAD). With the rapid evolution of noninvasive imaging for CAD diagnosis, avoiding invasive coronary angiography in patients unlikely to require coronary revascularization is desirable. We undertook to develop a clinical prediction tool to identify patients with a low likelihood of obstructive (> or =50% stenosis) CAD. The derivation cohort included 24,637 patients with a diagnosis of "stable angina" or "acute coronary syndrome" referred for first cardiac catheterization in the province of British Columbia, Canada. The model was validated using an external dataset from the province of Alberta and comprised 18,606 patients. Seven variables (female gender, age <50 years, atypical Canadian Cardiovascular Society angina class, absence of ST-segment change on electrocardiogram, lifelong nonsmoking, and absence of diabetes and hyperlipidemia) were associated with the angiographic finding of "no or nonobstructive CAD." The c-statistics for the derivation model were 0.76 and 0.74 using the validation dataset. In conclusion, this simple clinical prediction tool, applied to patients for whom determination of coronary anatomy was clinically indicated, identifies patients who have a low likelihood of obstructive CAD. The patient population identified by this tool may represent a population best suited to a noninvasive diagnostic strategy.

Red blood cell storage duration and mortality in patients undergoing percutaneous coronary intervention.

BACKGROUND: Blood transfusion has been associated with an increased mortality in patients undergoing percutaneous coronary intervention (PCI). Although the reasons for this remain unclear, it may be related to the structural and functional changes occurring within red blood cells (RBCs) during storage. We investigated whether RBC storage duration was associated with mortality in patients requiring transfusion after PCI. METHODS: We collected data on all RBC transfusions occurring within 10 days of PCI (excluding those related to cardiac surgery) using the British Columbia Cardiac Registry and Central Transfusion Registry. Transfusion details were analyzed according to 30-day survival. RESULTS: From a total of 32,580 patients undergoing PCI, 909 (2.8%) patients received RBCs with a mean storage duration of 25 +/- 10 days. In these 909 patients, mean transfusion volumes were lower in survivors (2.8 +/- 2.1 vs 3.8 +/- 2.9 U, P = .002) than those who died within 30 days. In a multivariate analysis to adjust for baseline risk, mean RBC storage age (HR 1.02 [95% CI 1.01-1.04], P = .002) and transfusion volume (HR 1.26 [95% CI 1.18-1.34], P < .001) both predicted 30-day mortality. Transfused patients who received only older blood (RBC min age >28 days) appeared to be at greater risk of death (HR 2.49 [95% CI 1.45-4.25], P = .001). CONCLUSION: Red blood cell transfusion is associated with increased 30-day mortality in patients undergoing PCI. Although current transfusion practice permits RBC storage for up to 42 days, the use of older red cells may pose an additional hazard to this patient group.

First-in-man use of a tapered endovascular stent graft for treatment of aneurysm after coarctation repair.

OBJECTIVES: Endovascular stenting of aneurysms late after surgical repair of coarctation may have to deal with marked changes in aortic diameter proximal and distal to the aneurysm. We report our first-in-man successful use of a custom-made tapered (variable diameter) covered stent. METHODS: The aneurysm was 42 mm in diameter with a length of 40 mm. On MRI, the aorta measured 19.6 mm proximal and 13.3 mm distal to the aneurysm. The aim was to oversize the stent by 10-20%. A covered Cheatham-platinum stent was designed so that cranial portion of the stent would expand to 22 mm and the caudal portion to 15 mm with a length of 8.5 cm when fully inflated. The stent was mounted on a balloon-in-balloon delivery system and was delivered through an 18 F femoral arterial sheath. Rapid-pacing technique was used for deployment. RESULTS: The stent was successfully deployed without complications. After deployment, the stent diameter measured 21.2 mm cranially and 15.6 mm caudally. A mild distal endoleak due to inadequate fixation of the stent graft was resolved by post dilation expanding the stent diameter to 22.1 mm and 15.9 mm, respectively. The femoral access site was closed using two percutaneous closure devices and the patient discharged the day after the procedure. Follow-up CT-angiography showed continued successful exclusion of the aneurysm. CONCLUSIONS: A new custom-made balloon expandable covered stent-design enabled successful treatment of an aortic aneurysm. This design may offer greater potential for more favorable initial angiographic results and potentially long-term outcomes due to superior apposition to the aortic wall.

Transapical transcatheter aortic valve implantation: follow-up to 3 years.

BACKGROUND: We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. METHODS: Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 +/- 11.5 months with a total of 917.3 months of follow-up. RESULTS: Mean age was 80.0 +/- 8.1 years and predicted operative mortality was 34.5% +/- 20.4% by logistic EuroSCORE and 12.1% +/- 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% +/- 6.4% and 58.0% +/- 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% +/- 6.4% and 69.8% +/- 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 +/- 0.8 to 1.8 +/- 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 +/- 0.3 cm(2) and 10.3 +/- 5.9 mm Hg, respectively). CONCLUSION: Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.

Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves.

BACKGROUND: The majority of prosthetic heart valves currently implanted are tissue valves that can be expected to degenerate with time and eventually fail. Repeat cardiac surgery to replace these valves is associated with significant morbidity and mortality. Transcatheter heart valve implantation within a failed bioprosthesis, a "valve-in-valve" procedure, may offer a less invasive alternative. METHODS AND RESULTS: Valve-in-valve implantations were performed in 24 high-risk patients. Failed valves were aortic (n=10), mitral (n=7), pulmonary (n=6), or tricuspid (n=1) bioprostheses. Implantation was successful with immediate restoration of satisfactory valve function in all but 1 patient. No patient had more than mild regurgitation after implantation. No patients died during the procedure. Thirty-day mortality was 4.2%. Mortality was related primarily to learning-curve issues early in this high-risk experience. At baseline, 88% of patients were in New York Heart Association functional class III or IV; at the last follow-up, 88% of patients were in class I or II. At a median follow-up of 135 days (interquartile range, 46 to 254 days) and a maximum follow-up of 1045 days, 91.7% of patients remained alive with satisfactory valve function. CONCLUSIONS: Transcatheter valve-in-valve implantation is a reproducible option for the management of bioprosthetic valve failure. Aortic, pulmonary, mitral, and tricuspid tissue valves were amenable to this approach. This finding may have important implications with regard to valve replacement in high-risk patients.

Technical considerations to avoid pitfalls during transapical aortic valve implantation.

OBJECTIVE: Transapical aortic valve implantation is a recent therapeutic advance for aortic valvular disease. We sought to identify complications--and the relevant technical and management considerations--from our learning curve with this procedure. METHODS: We retrospectively reviewed perioperative complications during the first 60 transapical aortic valve implantations at a single institution, performed under compassionate release for patients who were candidates neither for conventional aortic valve replacement nor for transfemoral aortic valve implantation. Access was through a small left anterolateral thoracotomy. Particular attention was paid to securing the apical access site. Rapid ventricular pacing to reduce cardiac forward flow was used during balloon valvuloplasty and valve deployment. Careful positioning was guided by echocardiography and fluoroscopy. RESULTS: This was a select, high-risk (mean Society of Thoracic Surgeons score, 12.3% +/- 7.8% mortality) cohort. Mean age was 81.1 +/- 7.8 years. Technical success was achieved in 59 (98.3%) cases. One valve was malpositioned too far toward the ventricle, necessitating that a second device be implanted within it. In-hospital, 30-day mortality was 18.3% (11 deaths) overall, decreasing from 33.3% in the first 15 patients to 13.3% in the subsequent 45 patients. The only intraoperative death probably resulted from left main ostial obstruction by extensively calcified aortic cusps. Significant left ventricular apical bleeding occurred in 3 (5.0%) patients. Other complications included stroke in 2 (3.3%) patients and permanent atrioventricular block in 3 (5.0%). There were 4 (6.6%) cases of late pseudoaneurysm of the left ventricular apical access site. CONCLUSIONS: Important lessons have been learned from our early experience with transapical aortic valve implantation, and these may guide others as this technology is adopted more broadly.

Current balloon-expandable transcatheter heart valve and delivery systems.

OBJECTIVES: Transcatheter valve and valve delivery systems are undergoing rapid evolution. We describe the current generation balloon-expandable valve and delivery systems. BACKGROUND AND METHODS: The SAPIEN XT valve represents the newest generation balloon-expandable aortic bioprosthesis. A cobalt-chromium alloy frame and additional design modifications facilitate a reduction in delivery profile while maintaining structural integrity, hemodynamics, and durability. The RetroFlex 3 delivery system represents the latest clinically available delivery system. It incorporates a fixed, tapered, and deflecting crossing tip to facilitate atraumatic introduction and a rapid inflation lumen to reduce valve motion during deployment. The NovaFlex delivery system represents the next generation delivery catheter. When used in conjunction with the SAPIEN XT valve and a specially constructed introducer sheath the inner and the outer diameters are 18 and 21 F, respectively. RESULTS: The RetroFlex 3 delivery system was utilized in nine patients and the NovaFlex delivery system in four. The valve implanted was the SAPIEN in six and the SAPIEN XT valve in seven. Implantation was successful in all patients. A reduction in device movement during balloon deployment was apparent as compared with earlier delivery systems. Aortic mean gradient fell from 45.6 (+/-15.1) mm Hg to 13.2 (+/-5.1) mm Hg, valve area rose from 0.68 (+/-0.19) to 1.5 (+/-0.28) cm(2). No patient had more than mild paravalvular regurgitation. CONCLUSION: Transcatheter valves and delivery systems continue to improve in terms of profile and ease of use.

Transcatheter valve-in-valve aortic valve implantation: 16-month follow-up.

Off-pump transcatheter, transapical valve-in-valve aortic valve implantation into a failed surgically implanted aortic valve was successfully performed in an 85-year-old man. He was discharged on postoperative day 5, and remained well at his 16-month follow-up. Echocardiography at 12 months showed normal prosthetic valve function without displacement, recoil, or regurgitation. Transcatheter transapical valve-in-valve aortic valve implantation is feasible and could be a viable approach for selected patients.

Effect of operator and institutional volume on clinical outcomes after percutaneous coronary interventions performed in Canada and the United States: a brief report from the Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) study.

BACKGROUND: The Enhanced Suppression of the Platelet glycoprotein IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial compared the use of eptifibatide with placebo in 2064 coronary intervention patients. It was previously reported that Canadian patients had reduced rates of 30-day and one-year death, myocardial infarction (MI) or target vessel revascularization (TVR) compared with patients in the United States (US). OBJECTIVE: To examine whether operator or institutional volume differences explain the regional variation in clinical outcome. METHODS AND RESULTS: Each site received an operator and institutional volume survey. Fifty-seven sites (62%) returned complete data on 1338 patients. In this smaller cohort, Canadian patients had reduced rates of 30-day and one-year death, MI or TVR compared with US patients (6.3% versus 10.3% and 14.9% versus 20.1%, respectively; P<0.05 for both comparisons). Among 176 physicians with a median of 13 years experience, the median operator volume was 200 cases per year. Operators with fewer than 100 cases per year had higher rates of 30-day death, MI or TVR (13.2% versus 8.7%; P=0.18) and large MI (7.7% versus 3.3%; P=0.06) than those with 100 or more cases per year. The median institutional volume was 1064 cases per year. Canadian and US centres had similar operator and institutional volumes. By multivariate modelling, operator volume was not predictive of adverse clinical events. However, the rates of 30-day and one-year death, MI or TVR fell by 3% for every 100 patients treated by the institution (OR 0.97; P=0.058 and P=0.002, respectively). Enrollment in Canada was associated with improved outcomes at 30 days (OR 0.50; P=0.001) and one year (OR 0.66; P=0.001) despite inclusion of volume variables in the models. CONCLUSIONS: In the ESPRIT study, institutional volume was associated with a modest reduction in risk of death, MI or TVR over short- and long-term follow-up periods. The Canadian and US investigators and institutions selected in ESPRIT had similar annual procedural volumes. Therefore, volume variables did not explain the differential risk of clinical events observed for patients enrolled in the two countries.

CT of the ilio-femoral arteries using direct aortic contrast injection: proof of feasibility in patients screened towards percutaneous aortic valve replacement.

PRINCIPLES: Transfemoral aortic valve implantation (TAVI) is a promising treatment modality for selected patients with severe symptomatic aortic stenosis. Peripheral access via the femoral and iliac artery is an important issue, limiting this technique's applicability in patients suffering from peripheral arterial disease. Multislice computed tomography (MSCT) reliably identifies patients with suitable peripheral access. However, MSCT involves an additional contrast dye burden in patients often suffering from renal failure. In this study, the feasibility of direct-aortic-contrast-injection for MSCT was investigated, aiming to reduce total contrast load. METHODS: Patients undergoing evaluation for TAVI underwent an aortogram including iliac and femoral arteries. In 7 selected patients with questionable peripheral access, MSCT was performed by advancing a pigtail catheter to the level of L2, followed by direct injection of 15-20 ml of contrast mixed with an equal volume of saline. This injection was followed by an injection of 40 ml of saline. Scanning was initiated 4 seconds after starting the contrast injection. All MSCT scans were obtained using a 64 slice scanner. RESULTS: In all 7 patients, except one, the distal aorta, iliac and femoral arteries where adequately imaged to allow reliable assessment of peripheral access for TAVI. Of the 7 patients evaluated, 2 were rejected for TAVI based on the information of the MSCT using direct-aortic-contrast-injection. Limitations of the technique may be an underestimation of the arterial diameter due to spasms at the puncture site. CONCLUSION: MSCT using direct-aortic-contrast-injection for assessment of peripheral access for TAVI is feasible and may provide good diagnostic images with a reduced volume of contrast.

Percutaneous coronary intervention in the Occluded Artery Trial: procedural success, hazard, and outcomes over 5 years.

BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI failure, procedural hazard, and crossover on trial results has not been reported. METHODS: Study angiograms were analyzed and adjudicated centrally. Factors associated with PCI failure were examined. Time-to-event analysis using the OAT primary outcome was performed by PCI success status. Landmark analysis (up to and beyond 30 days) partitioned early hazard versus late outcome according to treatment received. RESULTS: Percutaneous coronary intervention was adjudicated successful in >87%. Percutaneous coronary intervention failure rates were similar in US and non-US sites, and did not significantly influence outcome at 60 months (hazard ratio for success vs fail 0.79, 99% CI 0.45-1.40, P = .29). Partitioning of early procedural hazard revealed no late benefit for PCI (hazard ratio for PCI success vs medical therapy alone 1.06, 99% CI 0.75-1.50, P = .66). CONCLUSIONS: Percutaneous coronary intervention failure and complication rates in the OAT were low. Neither PCI failure nor early procedural hazard substantively influenced the primary trial results.