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.

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.

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.

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.

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.

Impact of coronary artery disease on outcomes after transcatheter aortic valve implantation.

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.

Transcatheter aortic valve implantation: impact on clinical and valve-related outcomes.

BACKGROUND: Transcatheter aortic valve implantation is an alternative to open heart surgery in patients with aortic stenosis. However, long-term data on a programmatic approach to aortic valve implantation remain sparse. METHODS AND RESULTS: Transcatheter aortic valve implantation was performed in 168 patients (median age, 84 years) in the setting of severe aortic stenosis and high surgical risk. Access was transarterial (n=113) or, in the presence of small iliofemoral artery diameter, transapical (n=55). The overall success rate was 94.1% in this early experience. Intraprocedural mortality was 1.2%. Operative (30-day) mortality was 11.3%, lower in the transarterial group than the transapical group (8.0% versus 18.2%; P=0.07). Overall mortality fell from 14.3% in the initial half to 8.3% in the second half of the experience, from 12.3% to 3.6% (P=0.16) in transarterial patients and from 25% to 11.1% (P=0.30) in transapical patients. Functional class improved over the 1-year postprocedure period (P<0.001). Survival at 1 year was 74%. The bulk of late readmission and mortality was not procedure or valve related but rather was due to comorbidities. Paravalvular regurgitation was common but generally mild and remained stable at late follow-up. At a maximum of >3 years and a median of 221 days, structural valve failure was not observed. CONCLUSIONS: Transcatheter aortic valve implantation can result in early and sustained functional improvement in high-risk aortic stenosis patients. Late outcome is determined primarily by comorbidities unrelated to aortic valve disease.

Transapical transcatheter aortic valve implantation: 1-year outcome in 26 patients.

BACKGROUND: We reported the first case of successful transapical transcatheter aortic valve implantation in a human subject in 2005 and have now completed a 12-month follow-up on our first 26 patients. This is, to date, the longest follow-up of patients undergoing transapical aortic valve implantation. METHODS: Between October 2005 and January 2007, 26 patients (13 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement because of unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-up was performed before discharge and at 1, 6, and 12 months. Data from the 17 patients who survived over 12 months were used for comparisons of the baseline and follow-up results. RESULTS: The mean age was 80 +/- 9 years, and the predicted operative mortality was 37% +/- 20% by using logistic EuroSCORE and 11% +/- 6% by using the Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Six patients died within 30 days (30-day mortality, 23%), and 3 patients died from noncardiovascular causes after 30 days (late mortality, 12%). Among patients who survived at least 30 days, 12-month survival was 85%. There were no late valve-related complications. New York Heart Association functional class improved significantly. The aortic valve area and mean gradient remained stable at 12 months (1.6 +/- 0.3 cm(2) and 9.6 +/- 4.8 mm Hg, respectively). CONCLUSION: Our 1-year clinical and echocardiographic outcomes suggest that transapical transcatheter aortic valve implantation is a viable alternative to conventional aortic valve replacement in selected high-risk patients.

Osteoporosis in primary biliary cirrhosis: a randomized trial of the efficacy and feasibility of estrogen/progestin.

The optimal therapy for the prevention and treatment of osteoporosis in primary biliary cirrhosis (PBC) is unknown. Hormone replacement therapy (HRT) prevents osteoporosis, but may promote cholestasis. We performed a double-blind, randomized, placebo-controlled trial of transdermal estrogen/progestin in postmenopausal women with PBC. The 24-month study enrolled 31 patients, but trial uptake was limited and treatment arm dropout was significant. Placebo-treated patients had a higher percentage loss in femoral neck bone mineral density than actively treated patients (-3.76 +/- 1.37% versus 0.21 +/- 1.01%, respectively, P = .058). New fractures occurred in 2 patients on placebo, and in no patients on treatment. The mean monthly increase in bilirubin was not significantly different between groups, but individual data suggest HRT may worsen cholestasis. In conclusion, women with PBC have strong feelings about HRT, and recruitment for this intervention is difficult. Transdermal estrogen/progestin likely provides protection against bone loss in PBC patients, but may worsen cholestasis.