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IMPORTANCE: Osteosarcopenia is an emerging geriatric syndrome characterized by age-related deterioration in muscle and bone. Despite the established relevance of frailty and sarcopenia among older adults undergoing transcatheter aortic valve replacement (TAVR), osteosarcopenia has yet to be investigated in this setting. OBJECTIVE: To determine the association between osteosarcopenia and adverse outcomes following TAVR. DESIGN, SETTING, AND PARTICIPANTS: This is a post hoc analysis of the Frailty in Aortic Valve Replacement (FRAILTY-AVR) prospective multicenter cohort study and McGill extension that enrolled patients aged 70 years or older undergoing TAVR from 2012 through 2022. FRAILTY-AVR was conducted at 14 centers in Canada, the United States, and France between 2012 and 2016, and patients at the McGill University–affiliated center in Montreal, Québec, Canada, were enrolled on an ongoing basis up to 2022. EXPOSURE: Osteosarcopenia as measured on computed tomography (CT) scans prior to TAVR. MAIN OUTCOMES AND MEASURES: Clinically indicated CT scans acquired prior to TAVR were analyzed to quantify psoas muscle area (PMA) and vertebral bone density (VBD). Osteosarcopenia was defined as a combination of low PMA and low VBD according to published cutoffs. The primary outcome was 1-year all-cause mortality. Secondary outcomes were 30-day mortality, hospital length of stay, disposition, and worsening disability. Multivariable logistic regression was used to adjust for potential confounders. RESULTS: Of the 605 patients (271 [45%] female) in this study, 437 (72%) were octogenarian; the mean (SD) age was 82.6 (6.2) years. Mean (SD) PMA was 22.1 (4.5) cm2 in men and 15.4 (3.5) cm2 in women. Mean (SD) VBD was 104.8 (35.5) Hounsfield units (HU) in men and 98.8 (34.1) HU in women. Ninety-one patients (15%) met the criteria for osteosarcopenia and had higher rates of frailty, fractures, and malnutrition at baseline. One-year mortality was highest in patients with osteosarcopenia (29 patients [32%]) followed by those with low PMA alone (18 patients [14%]), low VBD alone (16 patients [11%]), and normal bone and muscle status (21 patients [9%]) (P < .001). Osteosarcopenia, but not low VBD or PMA alone, was independently associated with 1-year mortality (odds ratio [OR], 3.18; 95% CI, 1.54-6.57) and 1-year worsening disability (OR, 2.11; 95% CI, 1.19-3.74). The association persisted in sensitivity analyses adjusting for the Essential Frailty Toolset, Clinical Frailty Scale, and geriatric conditions such as malnutrition and disability. CONCLUSIONS AND RELEVANCE: The findings suggest that osteosarcopenia detected using clinical CT scans could be used to identify frail patients with a 3-fold increase in 1-year mortality following TAVR. This opportunistic method for osteosarcopenia assessment could be used to improve risk prediction, support decision-making, and trigger rehabilitation interventions in older adults.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.jtcvs.2009.07.081 Byline: Daniel R. Wong, Jian Ye, Anson Cheung, John G. Webb, Ronald G. Carere, Samuel V. Lichtenstein Abbreviations: AVR, aortic valve replacement; LV, left ventricle (ventricular); TAVI, transapical aortic valve implantation; TEE, transesophageal echocardiography Abstract: 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. Author Affiliation: Divisions of Cardiac Surgery and Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada Article History: Received 30 March 2009; Revised 2 July 2009; Accepted 23 July 2009 Article Note: (footnote) Disclosures: Anson Cheung and John Webb report fees and grant support from Edwards.

ABSTRACTBackgroundTranscatheter aortic valve replacement (TAVR) with a standardized clinical pathway allows most patients to achieve safe next-day discharge. This approach has been successfully implemented across global centers as part of the Benchmark Program. Considering restricted hospital resources resulting from the COVID-19 pandemic, a modified same day discharge (SDD) clinical pathway was implemented for selected TAVR patients at a single Benchmark site.MethodsAll patients accepted for TAVR were assessed for the SDD clinical pathway. Eligibility criteria included adequate social support and accessibility to the TAVR program post-discharge. Patients with preexisting conduction disease were excluded. The clinical pathway comprised of mobilization, bloodwork and electrocardiogram 4 hours post-TAVR and discharge ≥8 hours following groin hemostasis.ResultsFrom June to December 2020, 142 patients underwent TAVR at a single community Benchmark site. Of those, 29 highly selected patients were successfully discharged the same day using the SDD clinical pathway. There were no vascular access complications, permanent pacemaker (PPM) implantation, or mortality in the SDD group during index admission or at 30-day follow-up. When compared to a standard therapy group, there was no statistically significant difference in 30-day cardiovascular readmission.ConclusionsThis study demonstrates the safety and feasibility of same day discharge post-TAVR in a highly selected cohort of patients, with no observable difference in safety outcomes when compared to patients who were discharged according to standard institutional practice.Abbreviations:AS: aortic stenosis; ACT: Activated clotting time; AV: atrioventricular; AVB: atrioventricular block; BBB: bundle branch block; CAIC: Canadian Society for Cardiovascular Angiography; CCL: cardiac catheterization laboratory; CT: Computed topography; CV: cardiovascular; IQR: Interquartile Range; IVCD: intraventricular conduction delay; LBBB: left bundle branch block; LOS: length of stay; NDD: next day discharge; PPM: permanent pacemaker; RBBB: right bundle branch block; SCAI: Society for Cardiovascular Angiography and Intervention; SD: standard deviation; SDD: same day discharge; ST: standard therapy; STS PROM: society of thoracic surgeons predicted risk of mortality; TAVR: transcatheter aortic valve replacement; TF: transfemoral; THV: transcatheter heart valve; TTE: transthoracic echocardiogram; VARC: Valve Academic Research Consortium

IMPORTANCE: Transcatheter aortic valve replacement (TAVR) failure is often managed by an urgent implantation of a supplementary valve during the procedure (2-valve TAVR [2V-TAVR]). Little is known about the factors associated with or sequelae of 2V-TAVR. OBJECTIVE: To examine the incidence, causes, and outcomes of 2V-TAVR. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was performed using data from an international registry of 21 298 TAVR procedures performed from January 1, 2014, through February 28, 2019. Among the 21 298 patients undergoing TAVR, 223 patients (1.0%) undergoing 2V-TAVR were identified. Patient-level data were available for all the patients undergoing 2V-TAVR and for 12 052 patients (56.6%) undergoing 1V-TAVR. After excluding patients with missing 30-day follow-up or data inconsistencies, 213 2V-TAVR and 10 010 1V-TAVR patients were studied. The 2V-TAVR patients were compared against control TAVR patients undergoing a 1-valve TAVR (1V-TAVR) using 1:4 17 propensity score matching. Final analysis included 1065 (213:852) patients. EXPOSURES: Urgent implantation of a supplementary valve during TAVR. MAIN OUTCOMES AND MEASURES: Mortality at 30 days and 1 year. RESULTS: The 213 patients undergoing 2V-TAVR had similar age (mean [SD], 81.3 [0.5] years) and sex (110 [51.6%] female) as the 10 010 patients undergoing 1V-TAVR (mean [SD] age, 81.2 [0.5] years; 110 [51.6%] female). The 2V-TAVR incidence decreased from 2.9% in 2014 to 1.0% in 2018 and was similar between repositionable and nonrepositionable valves. Bicuspid aortic valve (odds ratio [OR], 2.20; 95% CI, 1.17-4.15; P = .02), aortic regurgitation of moderate or greater severity (OR, 2.02; 95% CI, 1.49-2.73; P < .001), atrial fibrillation (OR, 1.43; 95% CI, 1.07-1.93; P = .02), alternative access (OR, 2.59; 95% CI, 1.72-3.89; P < .001), early-generation valve (OR, 2.32; 95% CI, 1.69-3.19; P < .001), and self-expandable valve (OR, 1.69; 95% CI, 1.17-2.43; P = .004) were associated with higher 2V-TAVR risk. In 165 patients (80%), the supplementary valve was implanted because of residual aortic regurgitation after primary valve malposition (94 [46.4%] too high and 71 [34.2%] too low). In the matched 2V-TAVR vs 1V-TAVR cohorts, the rate of device success was 147 (70.4%) vs 783 (92.2%) (P < .001), the rate of coronary obstruction was 5 (2.3%) vs 3 (0.4%) (P = .10), stroke rate was 9 (4.6%) vs 13 (1.6%) (P = .09), major bleeding rates were 25 (11.8%) vs 46 (5.5%) (P = .03) and annular rupture rate was 7 (3.3%) vs 3 (0.4%) (P = .03). The hazard ratios for mortality were 2.58 (95% CI, 1.04-6.45; P = .04) at 30 days, 1.45 (95% CI, 0.84-2.51; P = .18) at 1 year, and 1.20 (95% CI, 0.77-1.88; P = .42) at 2 years. Nontransfemoral access and certain periprocedural complications were independently associated with higher risk of death 1 year after 2V-TAVR. CONCLUSIONS AND RELEVANCE: In this cohort study, valve malposition was the most common indication for 2V-TAVR. Incidence decreased over time and was low overall, although patients with a bicuspid or regurgitant aortic valve, nontransfemoral access, and early-generation or self-expandable valve were at higher risk. These findings suggest that compared with 1V-TAVR, 2V-TAVR is associated with high burden of complications and mortality at 30 days but not at 1 year.

ABSTRACTFrailty is a multi-system clinical syndrome characterized by reduced physiological reserve and increased vulnerability to stressors. There is now established evidence recognizing its incremental value as a predictor of suboptimal outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) beyond conventional surgical risk scores and objective frailty assessment is integrated in major guidelines. Several frailty assessment tools have been developed and validated for use in patients undergoing TAVR with varying complexity, clinical pragmatism and outcomes assessed. In contemporary TAVR practice, frailty assessment guides patient selection, informs care requirements, and identifies those who may require supplemental treatment. Further opportunities to improve patient care in this area include identification of interventions that can mitigate the deleterious impact of frailty, evaluation of the role of frailty assessment in low surgical risk patients, and development of frailty management models that can be delivered virtually. In this review, we aim to provide an overview of the concept of frailty, the available assessment tools, peri-procedural considerations in frail patients undergoing TAVR and future directions.

ABSTRACTDegeneration of surgical bioprosthetic heart valves (BPVs) occurs in up to one third of surviving patients within a decade of implantation and is a common cause of cardiovascular morbidity. Valve-in-valve transcatheter aortic valve replacement (VIV TAVR) is a safe and effective treatment for patients with failed BPVs who are unsuitable for reoperation. However, there may be patient-prosthesis mismatch (PPM) following VIV TAVR, particularly in patients with small BPVs. This may influence both morbidity and mortality. Bioprosthetic valve fracture (BVF) has emerged as a novel technique to prevent PPM. It involves high-pressure inflation of a non-compliant balloon to fracture the ring of the BPV, allowing for further expansion of the implanted transcatheter heart valve (THV) and thereby reducing residual transvalvular gradients. Early experience with this technique has been promising. This review will describe the procedural technique of BVF, explore the lessons learned from bench testing and early clinical experience, and discuss the limitations of the current literature as well as future directions.Abbreviations:ACn: ACURATE neo; BPV: Bioprosthetic heart valve; BVF: Bioprosthetic valve fracture; BVR: Bioprosthetic valve remodeling; EOA: Effective orifice area; NYHA: New York Heart Association; PPM: Patient-prosthesis mismatch; PWI: Pin-wheeling index; S3: Sapien 3; SAVR: Surgical aortic valve replacement; TAVR: Transcatheter aortic valve replacement; TPVR: Transcatheter pulmonary valve replacement; THV: Transcatheter heart valve; VIV: Valve-in-valve

Supplemental Digital Content is available in the text.

There has been an exponential increase in the demand for transcatheter aortic valve replacement (TAVR). Our goal was to examine trends in TAVR capacity and wait-times across Canada.

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ABSTRACTBackgroundThis study sought to investigate the impact of extensive over-expansion of transcatheter heart valves (THVs) on leaflet structure. THVs may be over-expanded beyond recommended labeling in certain clinical scenarios. However, it is unknown whether over-expansion damages pericardial leaflets. Therefore, we assessed the effect of over-expansion on THV leaflets.MethodsSAPIEN 3 THVs (one of each a 23 mm, 26 mm, and 29 mm valve) were expanded to nominal dimensions and then over-expanded to larger than the recommended diameters. Leaflets from a nominally expanded THV were used as control. Structural changes to the leaflets were assessed by histology, scanning electron microscopy (SEM), and second-harmonic generation (SHG) microscopy.ResultsAnalysis of leaflets by SHG microscopy using texture analysis demonstrated that over-expansion of 23 mm, 26 mm, and 29 mm THVs resulted in significant disorganization of the fibrilar collagen on both aortic and ventricular surfaces (p< 0.05 for all). Histological analysis demonstrated significant thinning of leaflets in over-expanded THVs compared to control (p< 0.05 for over-expanded THVs) as well as a significant increase in pericardial tissue density within the leaflet (p< 0.05 for all over-expanded THVs) compared to control conditions. SEM analysis demonstrated breaks, stretching, and disorganization of collagen fibers within over-expanded THVs.ConclusionsSequential over-expansion by 1 mm increments up to 3 mm, which is not typically used in clinical practice, of SAPIEN 3 valves on the bench results in damage to the aortic and ventricular surfaces of pericardial leaflets. Whether a lesser degree of over-expansion or degree of over-expansion used clinically will cause similar leaflet injury will require further investigation.AbbreviationsAS: Aortic stenosis; A.U.: Arbitrary units; CT: Computed tomography; ECM: Extracellular matrix; GLCM: Gray level co-occurrence matrix (GLCM); H&E: Hematoxylin and eosin; ROI: Region of interest; S3: SAPIEN 3 transcatheter valve; SEM: Scanning electron microscopy; SHG: Second-harmonic generation; TAVR: Transcatheter aortic valve replacement; THV: Transcatheter heart valve

The globe is currently in the midst of a COVID-19 pandemic, resulting in significant morbidity and mortality. This pandemic has placed considerable stress on health care resources and providers. This document from the Canadian Association of Interventional Cardiology- Association Canadienne de Cardiologie d'intervention, specifically addresses the implications for the care of patients in the cardiac catheterization laboratory (CCL) in Canada during the COVID-19 pandemic. The key principles of this document are to maintain essential interventional cardiovascular care while minimizing risks of COVID-19 to patients and staff and maintaining the overall health care resources. As the COVID-19 pandemic evolves, procedures will be increased or reduced based on the current level of restriction to health care services. Although some consistency across the country is desirable, provincial and regional considerations will influence how these recommendations are implemented. We believe the framework and recommendations in this document will provide crucial guidance for clinicians and policy makers on the management of coronary and structural procedures in the CCL as the COVID-19 pandemic escalates and eventually abates.

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Percutaneous Transluminal Coronary Angioplasty: Part 2 Because of the increased level of local thrombogenicity, unstable ischemia is not an optimal environment for mechanical intervention. Nevertheless, in certain clinical situations (as [...]

Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision.

ABSTRACTBackground:Index hospital costs for transcatheter aortic valve replacement (TAVR) remain high. Next-day discharge (NDD) is a safe and feasible strategy in select patients. We sought to explore cost savings associated with NDD TAVR.Methods:We conducted a retrospective observation cohort study of all fee-for-service Medicare beneficiaries who underwent elective, uncomplicated, transfemoral TAVR in 2016. We employed a cross-sectional regression analysis to estimate risk-adjusted hospital costs savings of NDD relative to longer length of stay (LOS), and logistic regression to determine differences in direct home discharge and readmission.Results:Among 14,765 patients (59.2% of all TAVR), 2,169 (14.7%) were identified as NDD. They were younger (81.3 vs. 82.2, p< 0.01), more likely to be male (63% vs. 52%, p< 0.01), and had lower Charlson Comorbidity Index scores (2.73 vs. 2.98, p< 0.01). The adjusted cost for NDD was $7,499 lower compared to non-NDD (p< 0.001), and $5,188 when controlling for hospital fixed effects (p< 0.001); estimated total cost savings ranged from $6,522,183 to $16,265,331. NDD was associated with higher rates of discharged home (83% vs. 59%, p< 0.0001) without home health (16% vs. 28%, p< 0.0001), and lower incidence of readmission at 30 days [OR 0.72 (0.61–0.86), p= 0.0003], 60 days [0.71 (0.61–0.82), p< 0.0001] and 90 days [0.74 (0.65–0.85), p< 0.0001] than non-NDD.Conclusions:There is significant heterogeneity in LOS after TAVR. Cost savings could be achieved with the implementation of clinical pathways and other strategies. Future research is needed to fully capture the multiple effects associated with LOS.

The coexistence of chronic kidney disease (CKD) and severe aortic stenosis (AS) is common, and the prevalence of both is rising. The 2 conditions are inherently linked in that significant CKD may accelerate the development of AS and severe AS may result in deteriorating kidney function. The volume of and indications for transcatheter aortic valve implantation (TAVI) procedures are ever-increasing, and there are many challenges that need to be considered in patients with concomitant severe AS and CKD being assessed for TAVI. Throughout the process of working these patients up for definitive management of their valvular heart disease, the presence of CKD impacts on diagnostic investigations, treatment decisions, and therapeutic interventions. Herein we review the current literature regarding TAVI in patients with CKD focusing on the decision-making process and specific risks involved in TAVI and CKD. We also provide specific practical strategies to best manage this challenging patient cohort.

Chronic kidney disease (CKD) has a negative impact on outcomes after transcatheter aortic valve replacement (TAVR). Data on outcomes in renal transplant recipients (RTRs) undergoing TAVR are scarce. We compared the outcomes in RTRs undergoing TAVR with matched patients who have native kidneys and similar kidney function.

ABSTRACTBackground:Valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) for failing bioprosthetic valves has been shown to be safe and effective in high-risk (HR) patients. Outcomes in intermediate-risk (IR) patients have not been reported.Methods:IR and HR patients that underwent VIV-TAVR between June 2015 and March 2018 were included. IR patients had a Society of Thoracic Surgeons’ (STS) score <8% without high-risk features. HR patients had STS ≥8% and/or high-risk features. IR and HR groups were compared with respect to baseline and procedural variables, and 30-day outcomes.Results:A total of 63 patients underwent VIV-TAVR: 39 IR and 24 HR (STS 3.74% [2.80] vs. 10.9% [6.71], p < 0.0001). Baseline and procedural variables were similar. Length of stay was shorter in the IR group (1.0 [2.0] vs. 3.0 [4.5] days, p = 0.0273). Post-procedure mean transaortic gradient was similar (12.0 [6.5] vs. 11.0 [7] mmHg, p = 0.53; aortic regurgitation ≤mild in all patients). New York Heart Association (NYHA) class improved between baseline and 30 days (IR 3.0 [1.0] vs. 1.0 [1.0], p < 0.0001, HR 4.0 [1.0] vs. 2.0 [1.0], p < 0.0001) and was better in the IR group at 30 days (1.0 vs. 2.0, p = 0.024). Rehospitalization occurred in 8.6% IR and 16.7% HR patients (p = 0.32). At 30-days, there were two deaths in the HR group and zero in the IR group (p = 0.14).Conclusion:VIV-TAVR in IR and HR patients show similar outcomes in terms of hemodynamics, rehospitalization and 30-day mortality. Length of stay and NYHA functional class at 30-days are superior in IR patients. VIV-TAVR is likely to continue to expand into intermediate-risk patients as experience and evidence accumulates.

ABSTRACTBackground:We assessed the safety and efficacy of a clinical pathway with transfemoral transcatheter aortic valve replacement (TAVR) performed in the catheterization laboratory, accelerated recovery on a general cardiology ward and early discharge.Methods:The Vancouver accelerated recovery clinical pathway is an initiative with aims to implement (1) multidisciplinary team selection of patients with lower TAVR procedural risk; (2) peri-procedural minimalist approach with minimal procedural sedation; (3) pre-specified criteria for accelerated transfer to a general cardiology ward; (4) rapid reconditioning post-procedural care; and (5) identification of patients suitable for early (<48 hours) discharge home.Results:A total of 100 prospective patients underwent TAVR with the Vancouver accelerated recovery pathway between September 2016 and August 2018 with a mean age of 79.4 ± 7.4 years and Society of Thoracic Surgeons (STS) score of 3.5 ± 1.7 (55% had STS≥3). Only one (1%) patient needed conversion to general anesthesia, two (2%) patients needed urgent pacemaker implantation for conduction disorder, one (1%) patient had a stroke and five (5%) patients had minor vascular complications. All patients were transferred to the ward but one (1%) patient subsequently needed escalation of care to the coronary care unit. Mean time to first mobilization was 267 ± 60 minutes. Overall, 87 (87%) patients achieved next day discharge and 97 (97%) patients were discharged ≤48 hours. The 30-day mortality was 1% and all-cause readmission rate was 5%.Conclusion:Use of the Vancouver accelerated recovery pathway in highly-selected patients allows TAVR to be performed in the catheterization laboratory followed by accelerated recovery to the ward, with minimal mortality, morbidity, and a high proportion of early discharge. As TAVR continues to expand, this has important implications for health care delivery.

Transcatheter aortic valve implantation (TAVI) has become an important treatment option for aortic stenosis, even among younger patients, with similar rates of efficacy as compared with surgical valve replacement. However, complications including device failure persist; these can be addressed by surgical explantation and repeat TAVI. Ongoing research emphasizes the long-term potential of TAVI as an alternative to surgical intervention for aortic stenosis.

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ABSTRACTBackground:Patients with severe aortic stenosis (AS) at intermediate surgical risk, treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) have similar 2-year survival. Significant obesity (SigOb), defined as body mass index (BMI) ≥ 35 kg/m2, has been associated with increased surgical risk and post-operative complications. There are no data comparing clinical outcomes after SAVR versus TAVR in patients with SigOb.Methods:In the PARTNER 2A trial, 2032 patients with severe AS and intermediate surgical risk were randomized to TAVR with the SAPIEN XT valve or SAVR. After excluding 32 patients who had very low BMI < 18.5 kg/m2, the remaining 2000 patients were categorized based on BMI at baseline to SigOb or not SigOb, and compared in regards to 2-year risk of adverse cardiovascular events.Results:A total of 250 patients (12.5%) were SigOb and were younger, more often female, and more frequently diabetic. The 30-day and 2-year rates of the primary composite endpoint death and disabling stroke as well as the risks of its components, were similar for patients with versus without SigOb. However, the 2-year relative risk of cardiovascular death was lower with TAVR versus SAVR for SigOb patients (5.7% vs 15.4%, p = 0.02; HR 0.36, 95% CI 0.15–0.88) but not for not SigOb patients (10.6% vs 10.7%, p = 0.91; HR 0.98, 95% CI 0.73–1.32; pinteraction = 0.03). These results remained consistent after multivariable adjustment.Conclusions:In the PARTNER 2A Trial, intermediate-risk patients with severe AS and BMI ≥ 35 kg/m2undergoing TAVR experienced significantly lower cardiovascular mortality than similar patients undergoing SAVR.

Minimalist transcatheter aortic valve replacement (TAVR) can be implemented with no apparent compromise in patient outcomes. Although this approach is applicable for many patients undergoing TAVR, patient selection by the heart team is critical; one must be cognizant of factors whereby a minimalist approach is unsuitable. In the current era of TAVR, a minimalist approach should encompass the entire process of care and not just the procedure. Streamlining and homogenizing preprocedural workup has potential benefits for patients and health services. Minimalist TAVR is likely the right pathway forward for most patients, but the focus should be patient centered with no compromise to safety.

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.

Recurrent mitral regurgitation (MR) after mitral valve repair or replacement is associated with adverse outcomes. MR may be transvalvular, paravalvular/para-ring, or both, and careful evaluation with transesophageal echocardiography is required. Often patients have high risk of morbidity or mortality, and transcatheter therapies are emerging as an alternative to reoperation. We present 2 cases of complex recurrent MR treated by a transapical transcatheter approach and discuss important clinical and technical considerations.

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ABSTRACTBackground: Preoperative mitral regurgitation (MR) in patients undergoing transcatheter (TAVR) and surgical aortic valve replacement (SAVR) has been studied in high-risk cohorts. This study examines the outcomes of preoperative MR (≥ moderate) in a larger, intermediate-risk cohort.Methods: The Placement of Aortic Transcatheter Valves (PARTNER) 2A Trial randomized 2032 intermediate-risk patients with severe, symptomatic aortic stenosis to TAVR or SAVR. An ad-hoc analysis was performed on 1738 patients with baseline MR echocardiographic data. Patients were analyzed according to the degree of preoperative MR (≥ moderate versus ≤ mild).Results: At baseline, ≥ moderate MR was reported in 300 patients (17%). At 30 days, ≥ moderate MR had improved in 47% to ≤ mild. Thirty-day mortality was higher in SAVR patients with ≥ moderate MR (8.0 versus 3.5%; p = 0.01), but this difference was not seen in TAVR (2.7 vs. 3.1%; p = 0.78). At 2-years, the combined outcome of death (20.5 vs. 16.3%; p = 0.07), stroke (12.9 vs. 9.0%; p = 0.06), and rehospitalization (22.0 versus 17.4%; p = 0.06) was higher in the ≥ moderate MR (40.4 vs. 32.6%; p = 0.009), and similar between SAVR and TAVR (39.8 vs. 41.0%; p = 0.89).Conclusions: Significant MR is prevalent in patients with severe AS and affects clinical outcomes after both TAVR and SAVR. SAVR patients with MR have high early risk, but the increased risk of death/stroke/rehospitalization becomes similar in both groups over time. Improvement in MR is common, especially in patients with lower ejection fraction and larger left-ventricular dimensions.

Objective Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary occlusion, patient prosthesis mismatch, and valve malposition. The incidence of coronary occlusion is higher in aortic valve-in-valve than de novo aortic stenosis cases. Multiple factors can contribute to this complication, and the type of bioprosthesis has been implicated.Methods We examined our experience of 80 aortic valve-in-valve cases with internally and externally mounted leaflet valves.Results Procedural success was achieved in 95% of cases with an overall 30-day mortality of 1.3%. Clinical and procedural outcomes were similar in the both cohorts.Conclusions Our data suggest that aortic valve-in-valve implantation can be safely performed in carefully selected patient with internally and externally mounted leaflet bioprosthesis.

IMPORTANCE: Depression is increasingly recognized as a risk factor for adverse outcomes in cardiovascular disease. However, little is known about depression in older adults undergoing transcatheter (TAVR) or surgical (SAVR) aortic valve replacement. OBJECTIVE: To determine the prevalence of depression and its association with all-cause mortality in older adults undergoing TAVR or SAVR. DESIGN, SETTING, AND PARTICIPANTS: This preplanned analysis of the Frailty Aortic Valve Replacement (FRAILTY-AVR) prospective cohort study included 14 centers in 3 countries from November 15, 2011, through April 7, 2016. Individuals 70 years or older who underwent TAVR or SAVR were enrolled. Depressive symptoms were evaluated using the Geriatric Depression Scale Short Form at baseline and follow-up. MAIN OUTCOMES AND MEASURES: All-cause mortality at 1 and 12 months after TAVR or SAVR. Logistic regression was used to determine the association of depression with mortality after adjusting for confounders such as frailty and cognitive impairment. RESULTS: Among 1035 older adults (427 men [41.3%] and 608 women [58.7%]) with a mean (SD) age of 81.4 (6.1) years, 326 (31.5%) had a positive result of screening for depression, whereas only 89 (8.6%) had depression documented in their clinical record. After adjusting for clinical and geriatric confounders, baseline depression was found to be associated with mortality at 1 month (odds ratio [OR], 2.20; 95% CI, 1.18-4.10) and at 12 months (OR, 1.532; 95% CI, 1.03-2.24). Persistent depression, defined as baseline depression that was still present 6 months after the procedure, was associated with a 3-fold increase in mortality at 12 months (OR, 2.98; 95% CI, 1.08-8.20). CONCLUSIONS AND RELEVANCE: One in 3 older adults undergoing TAVR or SAVR had depressive symptoms at baseline and a higher risk of short-term and midterm mortality. Patients with persistent depressive symptoms at follow-up had the highest risk of mortality.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

IMPORTANCE: Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined. OBJECTIVE: To determine the midterm hemodynamic performance of balloon-expandable transcatheter heart valves. DESIGN, SETTING, AND PARTICIPANTS: In this study, we analyzed core laboratory–generated data from echocardiograms of all patients enrolled in the Placement of Aortic Transcatheter Valves (PARTNER) 1 Trial with successful TAVR or surgical AVR (SAVR) obtained preimplantation and at 7 days, 1 and 6 months, and 1, 2, 3, 4, and 5 years postimplantation. Patients from continued access observational studies were included for comparison. INTERVENTIONS: Successful implantation after randomization to TAVR vs SAVR (PARTNER 1A; TAVR, n = 321; SAVR, n = 313), TAVR vs medical treatment (PARTNER 1B; TAVR, n = 165), and continued access (TAVR, n = 1996). Five-year echocardiogram data were available for 424 patients after TAVR and 49 after SAVR. MAIN OUTCOMES AND MEASURES: Death or reintervention for aortic valve structural indications, measured using aortic valve mean gradient, effective orifice area, Doppler velocity index, and evidence of hemodynamic deterioration by reintervention, adverse hemodynamics, or transvalvular regurgitation. RESULTS: Of 2795 included patients, the mean (SD) age was 84.5 (7.1) years, and 1313 (47.0%) were female. Population hemodynamic trends derived from nonlinear mixed-effects models showed small early favorable changes in the first few months post-TAVR, with a decrease of −2.9 mm Hg in aortic valve mean gradient, an increase of 0.028 in Doppler velocity index, and an increase of 0.09 cm2 in effective orifice area. There was relative stability at a median follow-up of 3.1 (maximum, 5) years. Moderate/severe transvalvular regurgitation was noted in 89 patients (3.7%) after TAVR and increased over time. Patients with SAVR showed no significant changes. In TAVR, death/reintervention was associated with lower ejection fraction, stroke volume index, and aortic valve mean gradient up to 3 years, with no association with Doppler velocity index or valve area. Reintervention occurred in 20 patients (0.8%) after TAVR and in 1 (0.3%) after SAVR and became less frequent over time. Reintervention was caused by structural deterioration of transcatheter heart valves in only 5 patients. Severely abnormal hemodynamics on echocardiograms were also infrequent and not associated with excess death or reintervention for either TAVR or SAVR. CONCLUSIONS AND RELEVANCE: This large, core laboratory–based study of transcatheter heart valves revealed excellent durability of the transcatheter heart valves and SAVR. Abnormal findings in individual patients, suggestive of valve thrombosis or structural deterioration, were rare in this protocol-driven database and require further investigation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00530894

ABSTRACTBackground:There has been a renewed interest in balloon aortic valvuloplasty (BAV) since the inception of transcatheter aortic valve replacement (TAVR) in treating aortic stenosis (AS). This study aimed to demonstrate the safety and feasibility of a novel aortic valvuloplasty balloon catheter for the treatment of symptomatic severe aortic valve stenosis.Methods:Data from 25 patients who underwent BAV with the AngioSculpt Valvuloplasty Scoring Balloon Catheter at two Canadian centers with clinical follow-up and echocardiographic assessment at 30 days, 6 months, and 12 months were analyzed.Results:Mean age of the patients was 83.6 ± 5.8 years with 68% females. Mean gradient across the aortic valve was 44.0 ± 15.1 mmHg pre- and 33.6 ± 13.8 mmHg post-valvuloplasty (average reduction of 24% post-BAV, p < 0.05). 38% of patients showed ≥ 30% aortic gradient reduction. There were no major adverse cardiovascular events. Stroke and major vascular complication rates were zero. Two patients had moderate aortic regurgitation post-valvuloplasty.Conclusion:Preliminary results with a novel valvuloplasty scoring balloon for aortic stenosis demonstrate no safety concerns with a favorable gradient reduction. Additional studies will be required to demonstrate clinical utility in selected patients.

Once considered a childhood disease, the number of adults living with congenital heart disease (CHD) has now exceeded the number of pediatric patients. The landscape of percutaneous intervention for adult congenital heart disease (ACHD) has evolved over the past decade and has yet to be characterized in Canada. The aim of this study was to begin to understand the current infrastructure underlying ACHD interventions in Canada and to characterize the type and number of interventions being carried out across the country. A cross-sectional national survey was distributed by e-mail to all cardiac catheterization laboratory directors in 2015. All Canadian laboratories involved in ACHD interventions responded, encompassing 19 institutions spanning 69 cardiac catheterization laboratories. A total of 1451 percutaneous interventions were recorded. Nationwide, the most common simple ACHD interventions were for atrial septal defect and patent foramen ovale closures. The most common ACHD interventions of increased complexity were for coarctation stenting and transcatheter pulmonary valve implantation. There was a marked clustering of procedures in Ontario, Québec, British Columbia, and Alberta in keeping with Canada's population-density distribution. A total of 23 ACHD operators were identified, half of whom had ACHD-specific fellowship training. These data can be used as a starting point to inform the present state of affairs in the area and lay the groundwork for further work to assess resource allocation and human resource planning for the care of patients with ACHD in Canada.

Cardiovascular disease encompasses coronary artery disease and valvular heart disease, and the prevalence of both increases with age. Over the past decade, the landscape of interventional cardiology has evolved to encompass a new set of percutaneous procedures outside the coronary tree, including transcatheter aortic valve implantation, transcatheter mitral valve repair, and left atrial appendage occlusion. These interventions have sparked a new discipline within interventional cardiology referred to as structural heart disease (SHD) intervention. The access to and numbers of such procedures performed in Canada is currently unknown. This “first of its kind” survey of structural interventions provides insight into the landscape of SHD intervention in Canada and the challenges faced by cardiologists to deliver this important care.

Supplemental Digital Content is available in the text.Severe mitral regurgitation is a common and complex disease that is associated with an adverse prognosis. For decades, surgical treatment has been the standard of care. Recently, multiple technologies for transcatheter mitral therapy have emerged, with the potential for both repair and replacement in patients with native mitral regurgitation. Transcatheter mitral technologies have potential as solutions for unmet clinical needs. Further rigorous clinical studies are needed to determine their efficacy and safety, as well as the appropriate patient candidates. These evaluations will help to define the role of transcatheter mitral therapy as a potentially exciting new strategy to improve the lives of patients with mitral regurgitation.

ABSTRACTBackground:Residual stenosis is a major limitation of transcatheter aortic valve replacement inside failed surgical bioprostheses (valve-in-valve). Our aim was to evaluate whether pre-procedure CT assessment could identify cases at risk for having residual stenosis after the procedure.Methods:Patients with failed surgical aortic bioprostheses were prospectively enrolled in the multicenter PARTNER II valve-in-valve registry. Core-lab assessment of echocardiographic and CT findings were utilized.Results:A total of 84 patients that underwent pre-procedural CT were included in the current analysis with a median age of 79.9 ± 9.6 years with 65.5% being male. CT average annulus internal area was 331.64 ± 73.52mm2. Post SAPIEN XT implantation mean gradient was 17.95 ± 7.59 mmHg and average aortic valve area was 1.06 ± 0.35 cm2. Small internal annular area per CT was significantly associated with increased gradients in intermediate/large surgical valves (true ID > 20 mm, p= 0.01). ROC curve for the evaluation of predictability of CT measured area on post-procedural gradients in intermediate/large surgical valves was high (AUC 0.81). Cutoff of 329 mm2had negative predictive value of 95%.Conclusions:CT-derived annulus area in cases with intermediate and large surgical valves can identify cases at risk for poor hemodynamics after valve-in-valve and influence clinical decision making.

Favourable early outcomes have been reported following valve-in-valve transcatheter mitral valve replacement (TMVR). However, reports of long-term outcomes are lacking. We aimed to evaluate early and late outcomes in a large first-in-human valve-in-valve TMVR 13-year experience.

Transcatheter aortic valve implantation (TAVI) is a relatively new procedure to treat aortic stenosis in patients at high surgical risk, and it is becoming increasingly available in Canada. Variation exists in the clinical care, program coordination, evaluation, and funding across provinces and centres. As a part of the Canadian Cardiovascular Society (CCS) quality initiative, the TAVI Quality Indicator (QI) Working Group was established in 2014 to develop a set of indicators to measure quality of care for Canadians undergoing TAVI for aortic stenosis. The TAVI QI Working Group is composed of expert clinical and government agency representatives. The group developed consensus agreements for the selection of the first iteration of measurable structure, process, and outcome indicators reflective of the quality of care for patients undergoing TAVI. The objectives of the project are to develop quality indicators with the eventual goal of standardizing TAVI quality reports across Canada and to support local and national quality assurance, as well as engage multiple stakeholders to build a national strategy for the evaluation of quality of care.

Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.

Transcatheter Aortic Valve Implantation (TAVI) is an innovative and resource-intensive treatment of valvular heart disease. Growing evidence and excellent outcomes are contributing to increased patient demand. The Heart Team is foundational to TAVI programs to manage the complexities of case selection and other aspects of care. The competencies and expertise of nurses are well suited to provide administrative and clinical leadership within the TAVI Heart Team to promote efficient, effective, and sustainable program development. The contributions of nursing administrative and clinical leaders exemplify the leadership roles that nurses can assume in healthcare innovation.

La válvula autoexpandible Portico es una nueva válvula de implante transcatéter que ha mostrado resultados prometedores en estudios preliminares; sin embargo, no existen estudios que comparen este dispositivo con sistemas previos de válvula aórtica transcatéter. El objetivo de este estudio es comparar los resultados hemodinámicos de la válvula autoexpandible Portico con los de la válvula expandible mediante balón SAPIEN XT en un estudio de casos apareados con análisis en un laboratorio central de ecocardiografía

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.