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Background: Ticagrelor was shown to reduce mortality in patients who underwent coronary artery bypass grafting (CABG), but its effect on graft patency is unknown.Methods: We performed a prospective, randomised, double-blind, placebo-controlled trial, comparing ticagrelor 90 mg twice daily versus placebo for 3 months added to aspirin 81 mg/day, following isolated CABG. Aspirin was started within 12 h, and study medication within 72 h after CABG. Primary outcome was graft occlusion on CT angiography (CTA) performed 3 months post CABG. Patients were followed to 12 months for death, myocardial infarction, stroke, repeat revascularisation and bleeding.Results: The study was terminated prematurely after randomising 70 patients between September 2011 and August 2014 because of slow recruitment. CTA was performed in 56 patients who completed >1 month of study drug. Graft occlusion occurred in 7/25 (28.0%) patients on ticagrelor and 17/31 (48.3%) on placebo, p=0.044. Of 207 analysable grafts, graft occlusion occurred in 9/87 (10.3%) with ticagrelor and 22/120 (18.3%) with placebo, p=0.112. Graft occlusion or stenosis ≥50% occurred in 10/87 (11.5%) ticagrelor vs 32/120 (26.7%) placebo, p=0.007. There was no major bleeding, but minor bleeding was higher with ticagrelor (31.4% vs 2.9%, p=0.003). In univariate analysis, ticagrelor use reduced graft occlusion (OR 0.32, 95% CI 0.10 to 0.97, p=0.047), which remained significant on multivariable analysis (OR 0.25, 95% CI 0.073 to 0.873, p=0.03).Conclusions: Ticagrelor added to aspirin after CABG reduced the proportion of patients with graft occlusion, and was a significant univariate and multivariable predictor of graft occlusion. These results are hypothesis-generating and should be confirmed in larger studies.Trial Registration Number: NCT01373411: Results. [ABSTRACT FROM AUTHOR]

Transcatheter aortic valve replacement (TAVR) is increasingly accepted as a feasible and safe therapeutic alternative to open heart surgery in select patients. Procedural success and technological advances combined with favorable clinical outcomes and demonstrated prolonged survival are establishing TAVR as the standard of care in symptomatic patients who are at higher risk or not candidates for conventional surgery.The growing number of referrals and complexities of care of TAVR candidates warrants a program that ensures appropriate patient assessment and triage, establishes appropriate processes, and promotes continuity of care.To address these needs and prepare for the anticipated growth of transcatheter heart valve (THV) therapeutic options, the TAVR program at St. Paul’s Hospital, Vancouver, Canada, implemented an electronic centralized and clinically managed referral and triage program, and a THV Nurse Coordinator position to support the program and patients, conduct a global functioning assessment, and provide clinical triage coordination, waitlist management, patient and family education and communication with clinicians. Interdisciplinary rounds assist in the selection of candidates, while a clinical data management system facilitates standardized documentation and quality assurance from referral to follow-up.The unique needs of TAVR patients and programs require the implementation of unique processes of care and tailored assessment. [ABSTRACT FROM AUTHOR]

Background: Patients who have had transcatheter aortic valve replacement (TAVR) are at risk of hospitalization during the first year postprocedure. Few studies have examined the incidence of heart- failure hospitalizations (HFH) post-TAVR and the impact this has on subsequent hospitalizations and mortality. Our aim was to determine the incidence, predictors, and mortality associated with HFH post-TAVR., Methods: We used prospectively collected data for all patients who underwent TAVR between August 1, 2010, and March 31, 2015; 742 consecutive patients who underwent TAVR during the study period were included. Patients were followed for a minimum of 1 year post-TAVR., Results: Mean age was 80.9 ± 8.1, and 58.2% were men. Hospitalizations post-TAVR occurred in 20% of patients at 30 days and 59.7% at 1 year. Of patients hospitalized, HFH was the primary cause of hospitalization in 25.8% and 21.4% of patients at 30 days and 1 year post-TAVR, respectively. Patients with HFH at either 30 days or 1 year had higher subsequent rates of rehospitalization compared with patients who had non-HFH. Patients with HFH or non-HFH at 30 days had 1-year mortality rates of 23.1% and 21.4%, respectively, whereas those with HFH by 1 year had a higher 1-year rate of mortality compared with patients who had non-HFHs (25% vs 10.9%, P < 0.001)., Conclusions: HF accounts for a quarter of all hospitalizations post-TAVR and is associated with higher rates of subsequent rehospitalization and death compared with those who had non-HFH. Understanding predictors of readmissions post-TAVR will allow for better risk stratification and improve outcomes in patients receiving TAVR., (Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) can cause injury to the atrioventricular conduction system. We evaluated the effect of transcatheter heart valve (THV) type on the rate of new pacemaker implantation and length of hospital stay., Methods: Patients across all hospitals performing transfemoral TAVR in the province of British Columbia between 2012 and 2016 participated in a mandated registry with linkages to provincial health databases. We evaluated 1141 patients undergoing successful transfemoral TAVR for native aortic valve stenosis with 5 commonly used valves., Results: Valves implanted were balloon-expandable (BEV) (n = 728), self-expandable (SEV) (n = 341), and mechanically-expandable (MEV) (n = 72). Baseline clinical characteristics were similar between groups: mean age 82.5 years with multiple comorbidities. The mean Society of Thoracic Surgeons predicted risk of mortality was 6.0%. Indwelling temporary pacemakers after TAVR varied by THV type: (BEV) 4.0%, (SEV) 69.3%, and (MEV) 63.0% (P < 0.002). The need for a new permanent pacemaker varied by THV type: (BEV) 6.6%, (SEV) 24.0%, and (MEV) 32.8% at 30 days (P < 0.001). At 1 year, permanent pacemaker rates continued to rise, and remained divergent: (BEV) 8.9%, (SEV) 26.9%, and (MEV) 35.9% (P < 0.001). Median length of stay varied according to THV type: (BEV) 1, (SEV) 3, and (MEV) 4 days (P < 0.001 across groups). Crude mortality rates were not statistically different by THV type, either at 30 days (BEV 3.0%, SEV 2.9%, and MEV 0.0%; P = 0.33), or at 1 year (BEV 10.3%, SEV 15.0%, and MEV 8.3%; P = 0.11)., Conclusions: The choice of a THV device was associated with significant differences in the need for post-TAVR temporary pacemakers, hospital length of stay, and both early and late pacemaker implantation rates. These differences may have an impact on patient morbidity and resource utilization., (Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

We describe the development, implementation, and evaluation of a standardized clinical pathway to facilitate safe discharge home at the earliest time after transfemoral transcatheter aortic valve replacement. Between May 2012 and October 2014, the Heart Team developed a clinical pathway suited to the unique requirements of transfemoral transcatheter aortic valve replacement in contemporary practice. The components included risk-stratified minimalist periprocedure approach, standardized postprocedure care with early mobilization and reconditioning, and criteria-driven discharge home. Our aim was to reduce variation in care, identify a subgroup of patients suitable for early discharge (≤48 hours), and decrease length of stay for all patients. We addressed barriers related to historical practices, complex multidisciplinary stakeholder engagement, and adoption of length of stay as a quality indicator. We retrospectively reviewed the experiences of 393 consecutive patients; 150 (38.2%) were discharged early. At baseline, early discharge patients had experienced less previous balloon aortic valvuloplasty, had higher left ventricular ejection fraction, better cognitive function, and were less frail than the standard discharge group (>48 hours). Early discharge was associated with the use of local anesthesia, implantation of balloon expandable device, avoidance of urinary catheter, and early removal of temporary pacemaker. Median length of stay was 1 day for early discharge and 3 days for other patients; 97.7% were discharged home. There were no differences in 30-day mortality (1.3%), disabling stroke (0.8%), or readmission (10.7%). The implementation of a transcatheter aortic valve replacement clinical pathway shifted the program's approach to combine standardized processes and individual risk stratification. The Vancouver transcatheter aortic valve replacement clinical pathway requires a rigorous assessment to determine its efficacy, safety, and reproducibility., (© 2016 American Heart Association, Inc.)

Objectives: This study sought to describe the development of a multicenter, transcatheter aortic valve replacement program and regional systems of care intended to optimize coordinated, efficient, and appropriate delivery of this new therapy., Background: Transcatheter aortic valve replacement (TAVR) has become an accepted treatment option for patients with severe aortic stenosis who are at high surgical risk. Regional systems of care have led to improvements in outcomes for patients undergoing intervention for myocardial infarction, cardiac arrest, and stroke. We implemented a regional system of care for patients undergoing TAVR in British Columbia, Canada., Methods: We describe a prospective observational cohort of 583 patients who underwent TAVR in British Columbia between 2012 and 2014. Regionalization of TAVR care in British Columbia refers to a centrally coordinated, funded, and evaluated program led by a medical director and a multidisciplinary advisory group that oversees planning, access to care, and quality of outcomes at the 4 provincial sites. Risk-stratified case selection for transfemoral TAVR is performed by heart teams at each site on the basis of consensus provincial indications. Referrals for lower volume and more complicated TAVR, including nontransfemoral access and valve-in-valve procedures, are concentrated at a single site. In-hospital and 30-day outcomes are reported., Results: The median age was 83 years (interquartile range [IQR]: 78 to 87 years) and median STS score was 6% (IQR: 4% to 8%). Transfemoral access was performed in 499 (85.6%) cases and nontransfemoral in 84 (14.4%). Transcatheter valve-in-valve procedures in for failed bioprosthetic valves were performed in 43 patients (7.4%). A balloon-expandable valve was inserted in 386 (66.2%) and a self-expanding valve in 189 (32.4%). All-cause 30-day mortality was 3.5%. All-cause in-hospital mortality and disabling stroke occurred in 3.1% and 1.9%, respectively. Median length of stay was 3 days (IQR: 3 to 6 days), with 92.8% of patients discharged directly home., Conclusions: This experience demonstrates the potential benefits of a regional system of care for TAVR. Excellent outcomes were demonstrated: most patients had short in-hospital stays and were discharged directly home., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We report our 8-year experience in transcatheter aortic and mitral valve-in-valve (VinV) implantation., Background: Feasibility and good early outcomes associated with transcatheter aortic and mitral VinV implantation into failed surgical bioprostheses have been confirmed, but the mid-term and long-term outcomes of transcatheter aortic and mitral VinV is unknown., Methods: A total of 73 patients with aortic (n = 42) and mitral (n = 31) bioprosthetic valve dysfunction underwent transcatheter VinV implantation between April 2007 and December 2013. Edwards balloon-expandable transcatheter valves (Edwards Lifesciences Inc., Irvine, California) were used. Median follow-up was 2.52 years with a maximum of 8 years., Results: Seventy-two patients (mean age 79.7 ± 9.4 years, 32 women) underwent successful VinV implantation (success rate 98.6%). At 30 days, all-cause mortality was 1.4%, disabling stroke 1.4%, life-threatening bleeding 4.1%, acute kidney injury requiring hemodialysis 2.7%, and coronary artery obstruction requiring intervention 1.4%. No patient had greater than mild paravalvular leak. Estimated survival rates were 88.9%, 79.5%, 69.8%, 61.9%, and 40.5% at 1, 2, 3, 4, and 5 years, respectively. The small surgical valve size (19 and 21 mm) was an independent risk factor for reduced survival in aortic VinV patients. At 2-year follow-up, 82.8% of aortic and 100% of mitral VinV patients were in New York Heart Association functional class I or II., Conclusions: Transcatheter VinV for failed surgical bioprostheses can be performed safely with a high success rate and minimal early mortality and morbidity. Transcatheter VinV provides encouraging mid-term clinical outcomes in this high-risk elderly cohort of patients. Transcatheter VinV is an acceptable alternative therapy for failed aortic or mitral bioprostheses in selected high-risk patients., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve replacement (TAVR) program experience and advances present opportunities to introduce minimalist clinical pathways. The purpose of this study was to determine the safety and feasibility of preprocedural individualized risk stratification for general anaesthesia and transesophageal echocardiography (GA/TEE) or awake TAVR and the postprocedural standard or rapid discharge TAVR clinical pathways., Methods: Standardized screening and multidisciplinary heart team consensus was used to evaluate individual periprocedural risk and requirements. Postprocedural clinical status and criteria guided the timing of discharge. We evaluated standardized TAVR outcomes and length of stay according to periprocedural practice and postprocedural trajectory., Results: In 144 consecutive patients who underwent TAVR in 2013 (mean age, 82.0 ± 7.1 years; 38.2% women; mean Society of Thoracic Surgeons score, 6.5% ± 4.1%), 101 (69.1%) were assigned to the GA/TEE protocol, whereas 43 (29.9%) were assigned to the minimalist awake TAVR protocol. Irrespective of mode of anaesthesia, 94 (65.3%) patients were discharged within the standard time, whereas 50 (34.7%) patients were suitable for rapid discharge. Overall outcomes at 30 days were 2.1% mortality, 1.4% stroke, and 2.1% life-threatening bleeding. Median length of stay was shortest in the awake TAVR group (2 days; interquartile range [IQR], 1-3 days) and rapid discharge group (2 days; IQR, 1-2 days) and longer in the GA/TEE and standard discharge (3 days, IQR, 3-4 days) groups., Conclusions: Excellent outcomes and decreased length of stay can be achieved with individualized risk stratification to select the optimal periprocedural practice and determine the timing of discharge. These findings should be further evaluated in a large long-term clinical study., (Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background and Aim of the Study: Increased life expectancy has resulted in the elderly frequently presenting with severe aortic stenosis. It has therefore become important to define indications for conventional aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) in this patient population. Thus, patients aged > or = 70 years undergoing conventional isolated AVR were evaluated for predictors of early and late mortality., Methods: A retrospective analysis was conducted of prospectively collected data available from 1,061 consecutive patients (age range: 70-94 years) who underwent isolated AVR between 1982 and 2002. The patient age groups were 70-74 years (n = 466), 75-79 years (n = 367), and > or = 80 years (n = 228). The mean follow up was 6.0 +/- 4.4 years, and the total follow up 6,390 patient-years. Twenty-two variables were considered as potential risk factors for early and late mortality., Results: Early mortality was higher in patients aged > or = 80 years than in those aged 70-79 years. Early mortality in patients aged > or = 80 years was lower between 1998 and 2002 than between 1982 and 1997. Multivariate predictors of early mortality were age > or = 80 years, operative status, previous intervention, renal failure, and mitral regurgitation. The early nonfatal complication rate was similar for patients aged 70-79 years and > or = 80 years, but late mortality was lower between 1998 and 2002 than between 1982 and 1997 in patients aged 70-79 years, and in those aged > or = 80 years. The 10-year actuarial survivals after AVR in patients aged 70-74, 75-79, and > or = 80 years were 54 +/- 3.0%, 43 +/- 3.8% and 17 +/- 3.9%, respectively. Multivariate predictors of late mortality were age 75-79 years, age > or = 80 years, peripheral vascular disease (PVD) and chronic obstructive pulmonary disease (COPD). Female gender was shown to be protective., Conclusion: Early mortality was higher in patients aged > or = 80 years undergoing AVR, though this has declined recently and is currently at an acceptable level. Other important predictors of mortality in elderly patients undergoing AVR are operative status, previous interventions, renal failure, mitral regurgitation, male gender, PVD, and COPD. Thus, conventional AVR remains a safe treatment option for the elderly patient.

Objectives: This study assesses if there exists a high-risk period for cerebrovascular events (CeV) after transcatheter aortic valve implantation (TAVI)., Background: Even though acute strokes after TAVI have been described, it is uncertain if stroke rates continue to remain high in the early months after TAVI. Furthermore, the optimal dose and duration of thromboprophylaxis is unclear., Methods: Patients who underwent TAVI were evaluated at baseline, at discharge, at 1 and 6 months, and yearly. Risk factors for CeV events, procedural details, and antithrombotic therapy were recorded. Outcomes assessed were CeV events and death. The timing of such events, predictors, and impact on survival were analyzed., Results: A total of 253 patients were assessed. Median age was 85 years. The median Society of Thoracic Surgeons score was 8.1% (interquartile range [IQR]: 5.5% to 12.0%). Risk factors included smoking (47%), hypertension (70%), dyslipidemia (66%), and diabetes mellitus (25%). Twenty-three percent had known cerebrovascular disease and 39% had atrial fibrillation. Median follow-up was 455 days (IQR: 160 to 912 days) at which time 23 patients experienced a CeV event. The incidence was highest in the first 24 h but remained high for 2 months. In-hospital mortality rate after a CeV event was 21%. A prior history of CeV disease was an independent predictor of an event (hazard ratio: 4.23, 95% CI: 1.60 to 11.11, p = 0.004)., Conclusions: The incidence of CeV events is highest within 24 h of TAVI, but this risk may remain elevated for up to 2 months. A prior history of cerebrovascular disease is an independent predictor. This may have implications for patient selection and antithrombotic strategies., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study aims to assess the mid- to long-term follow-up of patients after valve embolization at the time of transcatheter aortic valve implantation (TAVI)., Background: Transcatheter heart valve (THV) embolization is a rare but serious complication during TAVI. Although various techniques have been developed to manage acute complications and reduce periprocedural morbidity/mortality, long-term clinical and hemodynamic consequences after these events are unknown., Methods: Patients who developed THV embolization after TAVI were prospectively assessed. Clinical and echocardiographic characteristics were recorded at baseline and after successful TAVI/surgical aortic valve replacement. The THV migration and strut fractures/degeneration were assessed by computed tomography., Results: A total of 7 patients had THV embolization, all of which occurred immediately after valve deployment. The embolized THV was repositioned in the aortic arch proximal to the left subclavian artery (n = 2), immediately distal to the left subclavian artery (n = 2), and in the abdominal aorta (n = 3). A second THV was implanted successfully at the same sitting in 4 patients and at the time of a second procedure in 2 patients. Elective conventional aortic valve replacement was performed in 1 patient. Median follow-up was 1,085 days. One patient died during follow-up from an unrelated cause. The remaining 6 survivors were in New York Heart Association functional class I or II at final follow-up. Mid-term computed tomography follow-up (n = 4,591 to 1,548 days) showed that the leaflets of the embolized THV remain open in all phases of the cardiac cycle. There was also no strut fracture or migration of these valves., Conclusions: Clinical outcomes remain good when THV embolization is managed effectively. There are no apparent hemodynamic consequences of a second valve placed in the series. These embolized valves remain in a stable position with no evidence of strut fractures at mid-term follow-up., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery disease (CAD) negatively impacts prognosis of patients undergoing surgical aortic valve replacement and revascularization is generally recommended at the time of surgery. Implications of CAD and preprocedural revascularization in the setting of transcatheter aortic valve implantation (TAVI) are not known., Method: Patients who underwent successful TAVI from January 2005 to December 2007 were retrospectively divided into five groups according to the extent of CAD assessed with the Duke Myocardial Jeopardy Score: no CAD, CAD with DMJS 0, 2, 4, and > or =6. Study endpoints included 30-day and 1-year survival, evolution of symptoms, left ventricular ejection fraction (LVEF), and mitral regurgitation (MR) and need of revascularization during follow-up., Results: One hundred and thirty-six patients were included, among which 104 (76.5%) had coexisting CAD. Thirty-day mortality in the five study groups was respectively 6.3, 14.6, 7.1, 5.6, and 17.7% with no statistically significant difference between groups (P = 0.56). Overall survival rate at one year was 77.9% (95% CL: 70.9, 84.9) with no difference between groups (P = 0.63). Symptoms, LVEF, and MR all significantly improved in the first month after TAVI, but the extent of improvement did not differ between groups (P > 0.08). Revascularization after TAVI was uncommon., Conclusion: The presence of CAD or nonrevascularized myocardium was not associated with an increased risk of adverse events in this initial cohort. On the basis of these early results, complete revascularization may not constitute a prerequisite of TAVI. This conclusion will require re-assessment as experience accrues in patients with extensive CAD., ((c) 2010 Wiley-Liss, Inc.)

Background: The effect of prosthesis-patient mismatch on long-term survival after aortic valve replacement has received considerable attention but there remains controversy. This study was performed to determine the predictors of mortality after aortic valve replacement and influence of prosthesis-patient mismatch on survival., Methods: Contemporary mechanical prostheses and bioprostheses were implanted in 3,343 patients with aortic valve replacement between 1982 and 2003. The mean age was 68.06 +/- 11.20 years (median 70.06; range, 19 to 94), and the mean follow-up was 6.18 +/- 4.96 years, for a total of 20,666 years of follow-up. Prosthesis-patient mismatch was classified by effective orifice area index categories: normal (> 0.85 cm(2)/m(2)), 1,547 (46.3%); mild-to-moderate (> 0.65 cm(2)/m(2) to < or = 0.85 cm(2)/m(2)), 1,584 (47.4%); and severe (< 0.65 cm(2)/m(2)), 212 (6.3%)., Results: The predictors of overall mortality were age, age categorization, New York Heart Association functional class III/IV, concomitant coronary artery bypass graft surgery, prosthesis type, preoperative congestive heart failure, diabetes mellitus, renal failure, and chronic obstructive pulmonary disease. All categories of effective orifice area indexes were not predictive of overall mortality, late mortality, or early mortality. The 15-year overall survival was differentiated by effective orifice area index categories: 38.1% +/- 2.1%, 37.0% +/- 2.2%, and 22.1% +/- 6.5%, respectively, for the three categories. Survival adjusted for the covariates (effective orifice area index, age, basal mass index, and ejection fraction) determined no effect except severe effective orifice area index when adjusted for ejection fraction more than 50% (p = 0.049)., Conclusions: Prosthesis-patient mismatch is not a predictor of overall standard unadjusted mortality to 15 years after aortic valve replacement, regardless of the category of effective orifice area index., (2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)