Update on Transcatheter Treatment of Mitral and Tricuspid Valve Regurgitation.

PURPOSE OF REVIEW: Mitral and tricuspid regurgitation represents a clinical challenge. They are associated with a poor prognosis, and many patients are not eligible for conventional surgery. Transcatheter therapies have been the focus of numerous studies and devices over the past decade. Here, we provide a summary of current options for transcatheter treatment of these 2 entities. RECENT FINDINGS: Recent studies have demonstrated the benefits of edge-to-edge repair for increasing numbers of patients. Encouraging early results with transcatheter valve replacement are also becoming available. To date, transcatheter edge-to-edge repair is currently the first-line transcatheter treatment for both mitral and tricuspid regurgitation for many patients who are not candidates for surgery. A number of transcatheter replacement devices are under development and clinical investigation but, for the most part, their current use is limited to compassionate cases or clinical trials.

Complete Revascularization Versus Culprit-Lesion-Only PCI in STEMI Patients With Diabetes and Multivessel Coronary Artery Disease: Results From the COMPLETE Trial.

BACKGROUND: In the COMPLETE trial (Complete Versus Culprit-Only Revascularization to Treat Multivessel Disease After Early PCI for STEMI), a strategy of complete revascularization reduced the risk of major cardiovascular events compared with culprit-lesion-only percutaneous coronary intervention in patients presenting with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease. Patients with diabetes have a worse prognosis following STEMI. We evaluated the consistency of the effects of complete revascularization in patients with and without diabetes. METHODS: The COMPLETE trial randomized a strategy of complete revascularization, consisting of angiography-guided percutaneous coronary intervention of all suitable nonculprit lesions, versus a strategy of culprit-lesion-only percutaneous coronary intervention (guideline-directed medical therapy alone). In prespecified analyses, treatment effects were determined in patients with and without diabetes on the first coprimary outcome of cardiovascular death or new myocardial infarction and the second coprimary outcome of cardiovascular death, new myocardial infarction, or ischemia-driven revascularization. Interaction P values were calculated to evaluate whether there was a differential treatment effect in patients with and without diabetes. RESULTS: Of the 4041 patients enrolled in the COMPLETE trial, 787 patients (19.5%) had diabetes. The median HbA1c (glycated hemoglobin) was 7.7% in the diabetes group and 5.7% in the nondiabetes group. Complete revascularization consistently reduced the first coprimary outcome in patients with diabetes (hazard ratio, 0.87 [95% CI, 0.59-1.29]) and without diabetes (hazard ratio, 0.70 [95% CI, 0.55-0.90]), with no evidence of a differential treatment effect (interaction P=0.36). Similarly, for the second coprimary outcome, no differential treatment effect (interaction P=0.27) of complete revascularization was found in patients with diabetes (hazard ratio, 0.61 [95% CI, 0.43-0.87]) and without diabetes (hazard ratio, 0.48 [95% CI, 0.39-0.60]). CONCLUSIONS: Among patients presenting with STEMI and multivessel disease, the benefit of complete revascularization over a culprit-lesion-only percutaneous coronary intervention strategy was consistent regardless of the presence or absence of diabetes.

[Tricuspid regurgitation in 2023 : Where are we with the treatment of the forgotten valve?] / Insuffisance tricuspide en 2023 : modalités de traitement pour la valve oubliée.

The negative impact of tricuspid regurgitation on prognosis in now well established. It also appears clear that surgical and possibly percutaneous treatment should be performed before reaching a point of no return with advanced heart failure and deterioration of right ventricle function. Percutaneous treatment has been divided into coaptation restoration devices, annuloplasty devices, and ortho- or heterotopic valve replacement. The present article offers a brief review of diagnostic modalities beyond echocardiography, surgical treatment as well as of the multiple recent development in the percutaneous treatment of this frequent condition.

L'impact pronostique défavorable de l'insuffisance tricuspide (IT) est maintenant bien établi, ainsi que la nécessité d'intervenir chirurgicalement ou de manière percutanée lorsque le traitement médicamenteux est insuffisant. Des données récentes suggèrent par ailleurs qu'il est probablement judicieux d'intervenir avant qu'un stade trop avancé d'insuffisance cardiaque et d'atteinte du ventricule droit ne soit atteint. Le traitement percutané est divisé en dispositifs de restauration de la coaptation valvulaire, d'annuloplastie et de remplacement de valve ortho ou hétérotopique. Cet article propose une brève revue des modalités diagnostiques au-delà de l'échocardiographie, du traitement chirurgical ainsi que des multiples développements récents dans le traitement percutané de cette pathologie fréquente.

Precautions and Procedures for Coronary and Structural Cardiac Interventions During the COVID-19 Pandemic: Guidance from Canadian Association of Interventional Cardiology.

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.

The Relationship Between Heart-Failure Hospitalization and Mortality in Patients Receiving Transcatheter Aortic Valve Replacement.

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.

Percutaneous Transcatheter Mitral Valve Replacement: First-in-Human Experience With a New Transseptal System.

BACKGROUND: Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option. OBJECTIVES: The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system. METHODS: This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction <30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6 mm Hg, left ventricular outflow tract gradient >20 mm Hg) at 30 days. RESULTS: Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to ≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4 mm Hg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5 days. At 30 days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had ≤1+ MR. No patients died. CONCLUSIONS: Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted.

Outcomes following percutaneous coronary revascularization among South Asian and Chinese Canadians.

BACKGROUND: Previous data suggest significant ethnic differences in outcomes following percutaneous coronary revascularization (PCI), though previous studies have focused on subgroups of PCI patients or used administrative data only. We sought to compare outcomes in a population-based cohort of men and women of South Asian (SA), Chinese and "Other" ethnicity. METHODS: Using a population-based registry, we identified 41,792 patients who underwent first revascularization via PCI in British Columbia, Canada, between 2001 and 2010. We defined three ethnic groups (SA, 3904 [9.3%]; Chinese, 1345 [3.2%]; and all "Others" 36,543 [87.4%]). Differences in mortality, repeat revascularization (RRV) and target vessel revascularization (TVR), at 30 days and from 31 days to 2 years were examined. RESULTS: Adjusted mortality from 31 days to 2 years was lower in Chinese patients than in "Others" (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.53-0.97), but not different between SAs and "Others". SA patients had higher RRV at 30 days (adjusted odds ratio [OR] 1.30; 95% CI: 1.12-1.51) and from 31 days to 2 years (adjusted hazard ratio [HR] 1.17; 95% CI: 1.06-1.30) compared to "Others". In contrast, Chinese patients had a lower rate of RRV from 31 days to 2 years (adjusted HR 0.79; 95% CI: 0.64-0.96) versus "Others". SA patients also had higher rates of TVR at 30 days (adjusted OR 1.35; 95% CI: 1.10-1.66) and from 31 days to 2 years (adjusted HR 1.19; 95% CI: 1.06-1.34) compared to "Others". Chinese patients had a lower rate of TVR from 31 days to 2 years (adjusted HR 0.76; 95% CI: 0.60-0.96). CONCLUSIONS: SA had higher RRV and TVR rates while Chinese Canadians had lower rates of long-term RRV, compared to those of "Other" ethnicity. Further research to elucidate the reasons for these differences could inform targeted strategies to improve outcomes.

Vancouver Transcatheter Aortic Valve Replacement Clinical Pathway: Minimalist Approach, Standardized Care, and Discharge Criteria to Reduce Length of Stay.

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.

Potential Candidates for a Structured Canadian ECPR Program for Out-of-Hospital Cardiac Arrest.

OBJECTIVE: Extracorporeal cardiopulmonary resuscitation (ECPR), while resource-intensive, may improve outcomes in selected patients with refractory out-of-hospital cardiac arrest (OHCA). We sought to identify patients who fulfilled a set of ECPR criteria in order to estimate: (1) the proportion of patients with refractory cardiac arrest who may have benefited from ECPR; and (2) the outcomes achieved with conventional resuscitation. METHODS: We performed a secondary analysis from a 52-month prospective registry of consecutive adult non-traumatic OHCA cases from a single urban Canadian health region serving one million patients. We developed a hypothetical ECPR-eligible cohort including adult patients <60 years of age with a witnessed OHCA, and either bystander CPR or EMS arrival within five minutes. The primary outcome was the proportion of ECPR-eligible patients who had refractory cardiac arrest, defined as termination of resuscitation pre-hospital or in the ED. The secondary outcome was the proportion of EPCR-eligible patients who survived to hospital discharge. RESULTS: Of 1,644 EMS-treated OHCA, 168 (10.2%) fulfilled our ECPR criteria. Overall, 54/1644 (3.3%; 95% CI 2.4%-4.1%) who were ECPR-eligible had refractory cardiac arrest. Of ECPR-eligible patients, 114/168 (68%, 95% CI 61%-75%) survived to hospital admission, and 70/168 (42%; 95% CI 34-49%) survived to hospital discharge. CONCLUSION: In our region, approximately 10% of EMS-treated cases of OHCA fulfilled our ECPR criteria, and approximately one-third of these (an average of 12 patients per year) were refractory to conventional resuscitation. The integration of an ECPR program into an existing high-performing system of care may have a small but clinically important effect on patient outcomes.

Transition to palliative care when transcatheter aortic valve implantation is not an option: opportunities and recommendations.

PURPOSE OF REVIEW: Transcatheter aortic valve implantation (TAVI) is the recommended treatment for most patients with symptomatic aortic stenosis at high surgical risk. However, TAVI may be clinically futile for patients who have multiple comorbidities and excessive frailty. This group benefits from transition to palliative care to maximize quality of life, improve symptoms, and ensure continuity of health services. We discuss the clinical determination of utility and futility, explore the current evidence guiding the integration of palliative care in procedure-focused cardiac programs, and outline recommendations for TAVI programs. RECENT FINDINGS: The determination of futility of treatment in elderly patients with aortic stenosis is challenging. There is a paucity of research available to guide best practices when TAVI is not an option. Opportunities exist to build on the evidence gained in the management of end of life and heart failure. TAVI programs and primary care providers can facilitate improved communication and processes of care to provide decision support and transition to palliative care. SUMMARY: The increased availability of transcatheter options for the management of valvular heart disease will increase the assessment of people with life-limiting conditions for whom treatment may not be an option. It is pivotal to bridge cardiac innovation and palliation to optimize patient outcomes.

Prediction of fluoroscopic angulation and coronary sinus location by CT in the context of transcatheter mitral valve implantation.

BACKGROUND: We sought to determine if preprocedural CT can predict appropriate fluoroscopic angulations to achieve a coplanar view during transcatheter mitral valve implantation (TMVI) and to assess the relationship of the mitral annulus and the coronary sinus to determine the feasibility of using this as an additional landmark on fluoroscopy. METHODS: With CT, the mitral annulus was segmented in 25 patients with functional mitral regurgitation. After this, optimal projection curves were plotted and the necessary angulations for specific views parallel to the trigone-to-trigone line (TT view) and septal-to-lateral distance (SL view) were noted. The outer contour of the coronary sinus and great cardiac vein were segmented to simulate a guide wire, and its relation to the annular plane was assessed. Employed angulations and coplanarity of device depiction were investigated in 4 patients who underwent TMVI. RESULTS: The mitral annulus is oriented in an anterior superior fashion with tilting to the right. SL and TT views were found at 29.4 ± 9.0° right anterior oblique (RAO), 20.1 ± 8.7° cranial (CAU) and 81.6 ± 18.9° RAO, 56.7 ± 8.0° caudal (CAU). The optimal projection curve and the relationship of coronary sinus to the mitral annular plane showed a wide intersubject variability. Commonly, the coronary sinus passed along the atrial wall with a mean distance of 13.2 ± 3.7 mm toward the mitral annular plane at P2 and 1.4 ± 3.1 mm anteriorly in alignment with the TT line. Coplanar depiction of the TMVI prosthesis was achieved in all 4 patients, with a compromise view chosen on the optimal projection curve between the TT view and SL view. CONCLUSION: CT allows for prediction of optimal fluoroscopic angulations to achieve a coplanar view of the mitral annulus. The relationship of the coronary sinus to the mitral annulus is variable and preprocedural CT segmentation may allow for a more patient-specific approach to the use of a coronary sinus guide wire as a fluoroscopic landmark.

Risk stratification and clinical pathways to optimize length of stay after transcatheter aortic valve replacement.

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.

Transcatheter mitral valve implantation with Tiara bioprosthesis.

Mitral valve surgery is the gold standard therapy for severe mitral regurgitation, but can be associated with significant morbidity and mortality. Percutaneous mitral leaflet repair has recently been established as a viable alternative to surgery, but many patients are ineligible and repair may not be optimal. Transcatheter mitral valve implantation may be an alternate therapeutic option, particularly for high-risk patients. We outline the initial preclinical and first-in-human experience with the Tiara transapical mitral valve implantation system, highlighting the ease of implantation, proven feasibility and excellent haemodynamic performance.

Left main dissection conservatively managed with optical coherence tomography guidance.

Left main dissection (LMD) is a rare but feared complication of cardiac catheterization. It is usually managed by bailout stent implantation or coronary artery bypass surgery. We describe a case of iatrogenic, retrograde LMD during percutaneous coronary intervention. After covering the retrograde entry of the dissection in the ostial left anterior descending artery (LAD), optical coherence tomography (OCT) showed, that there was no antegrade entry in the left main and that the minimal true lumen area in the left main was 7.2 mm(2) . It was therefore decided to treat the LMD conservatively and reassess the results by angiography 6 months later. At follow-up angiography, no stenosis or residual dissection in the left main were noted. The patient was doing fine at 1-year follow-up. OCT is a valuable tool for assessing coronary artery dissections and may guide the decision, whether to stent or not to stent a dissection. In selected cases LMD may be managed conservatively.

Impact of preoperative moderate/severe mitral regurgitation on 2-year outcome after transcatheter and surgical aortic valve replacement: insight from the Placement of Aortic Transcatheter Valve (PARTNER) Trial Cohort A.

BACKGROUND: The effect of preoperative mitral regurgitation (MR) on clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) is controversial. This study sought to examine the impact of moderate and severe MR on outcomes after TAVR and surgical aortic valve replacement (SAVR). METHODS AND RESULTS: Data were drawn from the randomized Placement of Aortic Transcatheter Valve (PARTNER) Trial cohort A patients with severe, symptomatic aortic stenosis undergoing either TAVR (n=331) or SAVR (n=299). Both TAVR and SAVR patients were dichotomized according to the degree of preoperative MR (moderate/severe versus none/mild). At baseline, moderate or severe MR was reported in 65 TAVR patients (19.6%) and 63 SAVR patients (21.2%). At 30 days, among survivors who had isolated SAVR/TAVR, moderate/severe MR had improved in 25 SAVR patients (69.4%) and 30 TAVR patients (57.7%), was unchanged in 10 SAVR patients (27.8%) and 19 TAVR patients (36.5%), and worsened in 1 SAVR patient (2.8%) and 4 TAVR patients (5.8%; all P=NS). Mortality at 2 years was higher in SAVR patients with moderate or severe MR than in those with mild or less MR (49.8% versus 28.1%; adjusted hazard ratio, 1.73; 95% confidence interval, 1.01-2.96; P=0.04). In contrast, MR severity at baseline did not affect mortality in TAVR patients (37.0% versus 32.7%, moderate/severe versus none/mild; hazard ratio, 1.14; 95% confidence interval, 0.72-1.78; P=0.58; P for interaction=0.05). CONCLUSIONS: Both TAVR and SAVR were associated with a significant early improvement in MR in survivors. However, moderate or severe MR at baseline was associated with increased 2-year mortality after SAVR but not after TAVR. TAVR may be a reasonable option in selected patients with combined aortic and mitral valve disease. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Structural heart diseases interventional training in Canada.

Structural heart disease interventions have evolved into an important component of interventional cardiology fellowship programs worldwide. Given the complexity of such interventions, the breadth of knowledge needed for optimal patient selection and postprocedural management, and the skills to perform them efficiently, advanced training has become mandatory. Postgraduate medical training in Canada has always been on the cutting edge of new technology, and excellent care is provided to the increasing population of adult patients with congenital heart disease. The current survey sought to collect relevant information and assess the opinion of interventional cardiology program directors in Canada regarding training in structural interventions. Our study reports the approximate number of structural procedures performed by interventional cardiology fellows in Canadian interventional cardiology fellowship programs, the form of the structural training, and the suggestions of program directors who are actively trying to integrate structural training into interventional cardiology fellowship programs.

Implementation of processes of care to support transcatheter aortic valve replacement programs.

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.

Permission to contact (PTC)--a strategy to enhance patient engagement in translational research.

UNLABELLED: Improving patient recruitment and consent to participate in clinical studies is an important issue. The process of consent involves three steps: patient referral for contact, the preliminary interview to determine patient interest, and the informed consent discussion. We hypothesized that putting the first step of the consent process into a 'Permission to Contact' (PTC) platform would improve patient engagement, would improve the efficiency of the other steps of the process, and would be acceptable to diverse patient groups. METHODS: To test this hypothesis, four PTC platforms were established in three types of outpatient health clinics (cancer, cardiac, maternal health) in different British Columbia health centers. Each began as a research project where clinic personnel were engaged, clinic flow processes were mapped, and a design for each PTC was derived by consensus. All patients at these clinics were asked for 'permission to be contacted for future research purposes.' Patient approach and permission response rates were assessed and operational costs were estimated. RESULTS: Overall permission rates were high for all projects, but ranged from 94% of 'cancer' patients to 80% of 'congenital heart' patients who were approached (p<0.0001). Sustainability was demonstrated by stable enrollment levels after several years, and ongoing costs averaged $25 (range $12-$39) for each 'permission' across all four platforms. CONCLUSIONS: A PTC platform is a feasible mechanism to engage patients in research programs such as biobanking. It is well supported by clinic staff and receives high engagement and acceptance from patients. Patient-approach rates vary in different clinics, likely due to both clinic and PTC process factors, but this strategy provides an efficient means of engaging patients in research and sets the stage for enhanced enrollment into translational research programs.

Transcatheter aortic valve replacement: outcomes of patients with moderate or severe mitral regurgitation.

OBJECTIVES: The aim of this study was to evaluate the impact of mitral regurgitation (MR) on outcomes after transcatheter aortic valve replacement (TAVR) and the impact of TAVR on MR. BACKGROUND: Little is known of the influence of MR on outcomes after TAVR. METHODS: The outcomes of patients with mild or less (n = 319), moderate (n = 89), and severe (n = 43) MR were evaluated after TAVR at 2 Canadian centers. RESULTS: Patients with moderate or severe MR had a higher mortality rate than those with mild or less MR during the 30 days after TAVR (adjusted hazard ratio: 2.10; 95% confidence interval: 1.12 to 3.94; p = 0.02). However, the mortality rates after 30 days were similar (adjusted hazard ratio: 0.82; 95% confidence interval: 0.50 to 1.34; p = 0.42). One year after TAVR, moderate MR had improved in 58%, remained moderate in 17%, and worsened to severe in 1%, and 24% of patients had died. Severe MR had improved in 49% and remained severe in 16%, and 35% of patients had died. Multivariate predictors of improved MR at 1 year (vs. unchanged MR, worse MR, or death) were a mean transaortic gradient ≥ 40 mm Hg, functional (as opposed to structural) MR, the absence of pulmonary hypertension, and the absence of atrial fibrillation. CONCLUSIONS: Moderate or severe MR in patients undergoing TAVR is associated with a higher early, but not late, mortality rate. At 1-year follow-up, MR was improved in 55% of patients with moderate or severe MR at baseline. Improvement was more likely in patients with high transaortic gradients, with functional MR, without pulmonary hypertension and without atrial fibrillation.