Right Ventricular Function Following Sternotomy Versus a Less-Invasive Approach for Left Ventricular Assist Device Implant: Retrospective Cohort Study.

OBJECTIVES: Durable left ventricular assist device (LVAD) implantation is traditionally performed via median sternotomy (MS). Less-invasive implantation may lower the incidence of postimplant right ventricular failure (RVF). Our primary objective was to determine whether less-invasive implantation reduces the odds of severe RVF compared to MS. DESIGN: Retrospective cohort study. SETTING: St. Paul's Hospital, Vancouver, BC, Canada. PARTICIPANTS: One hundred ninety-eight adult patients between January 2008 and August 2021. INTERVENTIONS: Isolated LVAD implantation either via median sternotomy or via a less-invasive surgical approach. MEASUREMENTS AND MAIN RESULTS: Multivariable logistic regression was used to adjust for confounders. A sensitivity analysis using inverse probability of treatment weighting analysis based on propensity scores was conducted. One hundred seventy-two patients were analyzed; 54% (94/172) underwent LVAD implantation via MS, and 45% (78/172) via less-invasive approaches. Age, sex, and comorbidities were comparable, but the MS group tended to be more critically ill prior to surgery. After adjusting for confounders, less-invasive approaches did not show significant protection against severe postimplant RVF compared to MS (adjusted odds ratio 0.53; 95% confidence interval 0.20-1.44; p = 0.21). However, patients undergoing less-invasive techniques had reduced adjusted odds of 30-day mortality (odds ratio 0.29; 95% confidence interval 0.09-0.99); p = 0.049). There was no observed benefit of less-invasive approaches over MS for major bleeding, prevention of blood product transfusion, and listing for transplantation. CONCLUSIONS: There was no reduction in the odds of severe RVF following LVAD implantation using less-invasive approaches versus MS. However, we found improved odds of 30-day survival in the less-invasive group. The underlying mechanism requires further investigation.

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.

Towards equitable dental care in Canada: Lessons from the inception of Medicare.

Dental care in Canada is primarily financed through private insurance plans and out-of-pocket payments. While Canada is internationally recognized for Medicare, a publicly-funded health insurance system that covers hospital and physician-provided services at the point of care, it remains one of the least equitable Organization for Economic Co-operation and Development countries in terms of affordable access to dental care. Approximately one third of Canadians do not have access to dental insurance, including half of low-income individuals, and individuals with the greatest dental care needs are often unable to reliably access dental services. Select populations-such as children, Indigenous peoples, seniors, and persons living with disabilities-receive some level of publicly-funded dental services, amounting to approximately 6% of total dental spending nationwide. Despite the evolution of Medicare, dental care has been largely excluded from federal health legislation following World War II. However, in March 2022, the Liberal Party of Canada partnered with the federal New Democratic Party to advance common legislative goals, including a long-term nationwide dental program for low- and middle-income families. As an interim measure, Bill C-31 was signed into law on 17 November 2022, and created the Canada Dental Benefit, which provides a fixed transfer payment to individuals with an annual household income under $90,000. This commentary reviews the origins of Canadian Medicare, discusses the factors that led to the continued exclusion of dental care from federal health legislation, examines the newly-minted Canada Dental Benefit, and explores the potential for expanded public funding in Canadian dental care.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Ten year follow-up of high-risk patients treated during the early experience with transcatheter aortic valve replacement.

BACKGROUND: The long-term clinical performance of transcatheter heart valves (THV) is unknown. AIMS: This study assessed the clinical outcomes, rate of structural valve deterioration (SVD) and bioprosthetic valve failure in patients after transcatheter aortic valve replacement (TAVR) to 10-year follow-up. METHODS: Consecutive patients undergoing TAVI for native aortic valve stenosis or failed aortic surgical bioprosthesis, between 2005 and 2009 at our institution were included. A total of 235 consecutive patients. RESULTS: At the time of TAVI mean age was 82.4 ± 7.9 years. All patients were judged to be high risk, with a STS score > 8 in 53.6%. THVs implanted were the Cribier-Edwards (20.9%), Edwards SAPIEN (77.4%) or CoreValve (1.7%). Mortality at 1, 5, and 10-year follow-up was 23.4%, 63%, and 91.6%, respectively. Of the total cohort, 15 patients had structural valve deterioration/bioprosthetic valve failure, with a cumulative incidence at 10-years of 6.5% (95% CI 3.3%, 9.6%). The rate of SVD/BVF at 4, 6, 8, and 10 years was 0.4%, 1.7%, 4.7%, and 6.5%, respectively. Nine patients had moderate SVD and six patients had severe SVD. Of the six patients with severe SVD, two patients had reintervention (one patient had redo TAVR, and the second had surgical aortic valve replacement). Survivors (n = 19) at 10-year follow-up, had a mean gradient of 14.0 ± 7.6 mmHg and aortic regurgitation ≥moderate in 5%. Quality of life measures in 10-year survivors demonstrated ADLs 6/6 in 43.8%, and ambulation without a mobility aid of 62.5%. CONCLUSION: Using early generation balloon expandable THVs in a high-risk population, there was a low rate of structural valve deterioration and valve failure at 10-year follow-up. This study provides insights into the long-term performance of transcatheter heart valves and patients self-reported derived benefits.

Building Environmentally Sustainable Health Systems in Canada: The Time Is Now for Emergent and Strategic Leadership.

Canada's healthcare sector produces the third highest healthcare-related emissions per capita globally. However, Canada has no national strategy toward environmentally sustainable healthcare. Transforming Canada's health systems to be environmentally sustainable requires leadership from many stakeholders and collaboration between trainees and health leaders. This article provides an overview of student and trainee leadership among health-related fields in response to the climate crisis and highlights the formation of a trainee-led organization focused on building capacity among emerging leaders in healthcare. We share key lessons learned by this group that are essential for all leaders seeking to leverage interdisciplinary action toward sustainable health systems in Canada.

Transcatheter aortic valve-in-valve implantation for failed surgical bioprosthetic valves. A minimalist approach without contrast aortography or echocardiographic guidance.

OBJECTIVES: To demonstrate safety, feasibility and short-term clinical outcomes after transcatheter aortic valve-in-valve (ViV) implantation under local anesthesia without contrast aortography or echocardiographic guidance. BACKGROUND: Transcatheter ViV implantation is an emerging treatment modality for patients with degenerative surgical bioprostheses. Given the radiopaque properties of the surgical aortic valve (SAV) frame, ViV procedures can often be performed with fluoroscopic guidance alone. METHODS: ViV implantation was performed in 37 patients with SAV failure under local anesthesia without contrast aortography. Clinical and echocardiographic data were obtained at baseline, discharge, and 30 days. RESULTS: Mean age was 74 ± 10 years and STS predicted risk of mortality was 5.6 ± 2.4%. Mean transaortic gradient decreased from 39.4 ± 15.5 mmHg to 13 ± 6.3 mmHg at discharge (p < .001), and 20 ± 7.5 mmHg at 30 days (p < .001 compared to baseline), aortic valve area increased from 0.9 ± 0.3 cm2 to 1.2 ± 0.4 cm2 at 30 days (p = .007). No patient had more than mild aortic regurgitation. Hospital discharge occurred at a median of 2.6 ± 4.4 days. At 30-day follow-up there were no deaths, myocardial infarctions, strokes, repeat hospital admissions for heart failure, or renal failure. One patient (2.7%) required a new pacemaker. 93% of the patients were in New York Heart Association functional class I or II. CONCLUSIONS: Transcatheter aortic ViV implantation for selected patients with degenerative surgical bioprostheses under local anesthesia without aortography or echocardiographic guidance is feasible and safe.

Performance of the TRUE dilatation balloon valvuloplasty catheter beyond rated burst pressure: A bench study.

OBJECTIVES: We undertook an independent bench test assessing the performance of the TRUE dilatation (TD) balloon valvuloplasty catheter (Bard Vascular Inc., Tempe, AZ) beyond its rated burst pressure (RBP). BACKGROUND: The TD balloon has a RBP of six atmospheres (atm), and its performance beyond this RBP is poorly understood. Techniques such as bioprosthetic valve fracture require inflation pressures beyond manufacturer recommendations. METHODS: A 20, 22, 24, 26, and 28 mm TD balloon were inflated to increasing pressures in increments of 3 atm until balloon failure. Measurements were performed at the proximal, middle, and distal balloon segments with scientific digital calipers. Z-MED balloons (Braun Interventional Systems Inc., Bethlehem, PA) were used as a comparator. RESULTS: The mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon at nominal pressure (3 atm) was 20.02 ± 0.09, 21.77 ± 0.07, 23.9 ± 0.06, 25.82 ± 0.08, and 27.62 ± 0.08 mm, respectively. The maximal mean diameter at the middle of the 20, 22, 24, 26, and 28 mm TD balloon was 20.39 ± 0.03 mm (15 atm), 22.35 ± 0.03 mm (15 atm), 24.55 ± 0.02 mm (15 atm), 26.48 ± 0.02 mm (12 atm), and 28.39 ± 0.03 mm (12 atm), respectively. The 20/22/24 and 26/28 mm balloon failed when inflated beyond 15 atm and 12 atm, respectively. Failure was due to either leakage or longitudinal balloon rupture. TD balloons were more likely to maintain dimensions similar to their labeled size and less likely to fail at higher pressures as compared to Z-MED balloons. CONCLUSION: The TD balloon catheter maintains a similar diameter to its labeled size, when inflated beyond its RBP. When inflated beyond 12 atm, the TD balloon can fail due to either leakage or rupture. This has implications for percutaneous structural heart interventions.

Mitral regurgitation in patients undergoing transcatheter aortic valve implantation for degenerated surgical aortic bioprosthesis: Insights from PARTNER 2 Valve-in-Valve Registry.

BACKGROUND: Valve-in-valve (VIV) treatment with transcatheter aortic valve replacement (TAVR) is a viable option for patients with failing aortic bioprosthetic valves. Optimal management of those with concomitant mitral regurgitation (MR) remains undetermined. Therefore, we sought to assess the implications of concomitant MR in patients undergoing VIV-TAVR. METHODS AND RESULTS: The PARTNER 2 VIV registry enrolled patients with degenerated surgical aortic bioprosthesis at high risk for reoperation. Patients with core-laboratory echocardiographic assessment of MR were analyzed; severe MR was excluded. We compared patients with ≤mild MR versus moderate MR and assessed changes in MR severity and clinical outcomes. A total of 339 patients (89 initial registry, 250 continued access) underwent VIV procedures; mean age 79.0 ± 10.2 years, mean Society of Thoracic Surgeon score 8.9 ± 4.5%. At baseline, 228/339 (67.3%) had ≤mild MR and 111/339 (32.7%) had moderate MR. In paired analysis, there was significant improvement in ≥moderate MR from baseline to 30 days (32.6% vs. 14.5%, p < .0001 [n = 304]), and no significant change between 30 days and 1 year (13.4% vs. 12.1%, p = .56 [n = 224]) or 1 year and 2 years (11.0% vs. 10.4%, p = .81 [n = 182]). There was no difference in death or stroke between ≤mild MR and moderate MR at 30 days (4.0% vs. 7.2%, p = .20), 1 year (15.5% vs. 15.3%, p = .98) or 2 years (26.5% vs. 23.5%, p = .67). CONCLUSION: Moderate concomitant MR tends to improve with VIV-TAVR, and was not a predictor of long-term adverse outcomes in this cohort. In selected patients undergoing VIV-TAVR, it may be appropriate to conservatively manage concomitant MR. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT# 03225001.

Overexpansion of older generation balloon expandable transcatheter heart valves: An ex-vivo bench study.

BACKGROUND: The SAPIEN 3 (S3) transcatheter heart valve (THV) can be over-expanded beyond its labeled diameter. Overexpansion can be achieved with use of either a compliant or non-compliant balloon. Objective data regarding the ability to over-expand older generation balloon expandable valves are limited. We sought to assess the effects of over-expanding the SAPIEN and SAPIEN XT (Edwards Lifesciences, Irvine, CA) valve beyond labeled size (diameter) through an ex-vivo bench study. METHODS AND RESULTS: We assessed SAPIEN and SAPIEN XT THVs, sized 23/26 mm and 23/26/29 mm, respectively. The SAPIEN THVs were explanted samples. Valves were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. When an appropriate sized non-compliant balloon was not available, a compliant balloon was utilized. Valves underwent visual and radiographic assessment of overexpansion. SAPIEN THVs with labeled size of 23 and 26 mm could be incrementally overexpanded to midvalve (MV) diameters of 26.7 and 27.4 mm, respectively. SAPIENT XT THVs with labeled size of 23, 26, and 29 mm could be incrementally overexpanded to MV diameters of 26.8, 28.3, and 28.8 mm, respectively. The desired degree of overexpansion was only achieved with use of non-compliant balloons and not with compliant balloons. The outflow of the SAPIEN and SAPIEN XT had larger diameters than the MV and inflow of the THV. CONCLUSION: Overexpansion of older generation SAPIEN and SAPIEN XT THVs is possible. Achieving the desired degree of overexpansion was only achieved with use of non-compliant balloons. This has potential implications for the treatment of failed THVs.

Patterns of somatic distress among internally displaced persons in Ukraine: analysis of a cross-sectional survey.

PURPOSE: There are often high rates of mental disorders in low- and middle-income countries during humanitarian crises, but the prevalence of somatic distress (SD) is underreported in the existing health service research. We aim to examine the patterns of SD among internally displaced persons (IDPs) in Ukraine, who were forcibly displaced due to the ongoing conflict in the country's eastern region. METHODS: The study design was a cross-sectional survey of 2203 adult IDPs throughout Ukraine. The survey collected data on sociodemographic characteristics, traumatic life events (Life Events Checklist), utilisation of mental health care services, and self-reported outcomes of SD (Patient Health Questionnaire 15), anxiety (Generalised Anxiety Disorder 7), depression (Patient Health Questionnaire 9), and post-traumatic stress (PTSD Checklist). Descriptive and multivariate regression analyses were used. RESULTS: Over half of respondents (n = 1142, 55%) were identified as being at risk of SD (PHQ-15 score ≥ 6), and the prevalence of moderate (n = 377, 18%) and high severity SD risk (n = 275, 13%) was substantial. There were significant associations (p < 0.05) between SD and age, female gender, economic status, self-reported depression and post-traumatic stress, and multiple trauma exposures. Being at risk of SD was also significantly associated with increased functional disability. Use of mental health care services was low across this population and only high SD risk seemed to be a reliable predictor of care-seeking behaviour. CONCLUSIONS: There is a significant risk of SD among IDPs in Ukraine. Our results illustrate the need for targeted health service research and regional programs to ensure that mental health needs are appropriately met.

The prognostic importance of the diastolic pulmonary gradient, transpulmonary gradient, and pulmonary vascular resistance in patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the association between markers of precapillary pulmonary hypertension (PH) and survival in transcatheter aortic valve replacement (TAVR). BACKGROUND: The importance of precapillary PH has been sparsely investigated in patients undergoing TAVR. It may prove an important risk factor for poor outcomes. METHODS: We identified patients at our institution undergoing TAVR with a baseline right heart catheterization (RHC) demonstrating PH. We evaluated the association between markers of precapillary PH and survival including the diastolic pulmonary gradient (DPG), transpulmonary gradient (TPG), and pulmonary vascular resistance (PVR). A multivariable analysis was performed using Cox Proportional Hazards Models, adjusting for age, gender, body mass index, and pulmonary artery systolic pressure (PASP) on echocardiography. RESULTS: We identified 133 patients with PH on RHC. Of these 111 had low DPG and 22 had high DPG. All 3 markers of precapillary PH were associated with worse survival post TAVR, with OR of 2.1 (95% CI 1.1-3.9, P = 0.02), 3.4 (95% CI 1.8-6.4, P < 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003) for high DPG, TPG, and PVR, respectively. On multivariable analysis, both TPG and PVR remained predictors of worse survival, with OR of 3.4 (95% CI 1.7-6.9, P = 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003). Echocardiographic PASP and DPG were not predictive of survival. CONCLUSIONS: In patients undergoing TAVR, parameters of precapillary PH are associated with lower survival, and provide incremental prognostication over echocardiographic PASP. RHC should continue to play an important role in risk stratification prior to TAVR. © 2017 Wiley Periodicals, Inc.

Prevalence and impact of preoperative moderate/severe tricuspid regurgitation on patients undergoing transcatheter aortic valve replacement.

OBJECTIVES: Significant tricuspid regurgitation (TR) is a marker for late-stage myocardial and valvular heart disease. Whether preoperative TR affects clinical outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) has never been investigated. This study sought to identify the impact of moderate and severe TR on outcomes after TAVR. METHODS: All patients undergoing TAVR from January 2007 to August 2012 at St. Paul's Hospital, Vancouver, Canada, (n = 518) were dichotomized according to the severity of preoperative TR (moderate/severe vs. none/mild). All clinical outcomes were defined according to the valve academic research consortium-2 definitions. RESULTS: At baseline, moderate or severe TR was reported in 79 patients (15.2%). At 30 days, moderate/severe TR had improved in 12 patients (15.2%), was unchanged in 46 patients (58.3%), and worsened in 7 patients (8.9%). Of those with none/mild TR at baseline, 35 (7.9%) patients had moderate TR at 30-day follow-up. Two-year all-cause (38.4% vs. 20.0%, Log-rank test, P = 0.001) and cardiac mortality (12.9% vs. 4.6%, Log-rank test, P = 0.004) as estimated by Kaplan-Meier analysis were considerably higher in patients with significant TR. However, significant TR did not emerge as independent risk factor for 2-year all-cause mortality (adjusted OR: 1.55, 95% confidence interval (CI): 0.91-2.64, P = 0.105). Pre-specified subgroups showed an interaction between TR and left ventricular systolic function (Pinteraction = 0.047). Indeed, moderate/severe TR was significantly related to mortality only in patients with left ventricular ejection fraction (LVEF) > 40% (adjusted OR: 2.01, CI: 1.05-3.84, P = 0.036). In patients with LVEF ≤ 40%, TR had no significant impact on all-cause mortality (adjusted OR: 1.04, CI: 0.34-3.16, P = 0.946). No significant interactions were identified regarding patients with perioperative moderate/severe mitral regurgitation (Pinteraction = 0.829) and patients with baseline systolic pulmonary artery pressure ≥ 60 mm Hg (Pinteraction = 0.669). CONCLUSIONS: In patients undergoing TAVR, significant preoperative TR was present in 15% of patients and associated with more comorbidities. Despite being associated with a doubling of mortality rate, after a robust adjustment, significant TR was not an independent predictor of 2-year mortality. However, a significant interaction between TR and left ventricular systolic function was found. The response of TR to TAVR was extremely variable.

Blood loss and transfusion rates associated with transcatheter aortic valve replacement: recommendations for patients who refuse blood transfusion.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is less invasive than surgical aortic valve replacement and may be preferred for patients who refuse blood transfusions. OBJECTIVES: Our study sought to define transfusion rates in TAVR, identify predictors and develop recommendations for patients who refuse transfusions. METHODS: A large cohort of consecutive patients undergoing TAVR was prospectively studied. Blood loss and transfusion rates were observed in patients undergoing transfemoral (TF-TAVR) and transapical TAVR (TA-TAVR). Predictors for transfusion were investigated in a multivariate model. RESULTS: Of 373 consecutive patients, 270 underwent TF-TAVR and 103 TA-TAVR. Transfusion rates were significantly lower in TF-TAVR than TA-TAVR (11.1 vs 41.7%; P < 0.001). In patients who did not receive transfusions, blood loss was significantly lower in TF-TAVR than TA-TAVR (23.6 ± 12.2 g/l vs 28.9 ± 13.7 g/l; P = 0.004), but did not differ in transfused patients (36.9 ± 12.9 g/l vs 33.4 ± 21.2 g/l; P = 0.428). Predictors for transfusions were low baseline hemoglobin, female sex, low body weight and decreased renal function. In seven Jehovah's Witness patients, who refused transfusions, no vascular complications occurred and clinical outcome was excellent. CONCLUSION: In patients, who refuse transfusions, TAVR may be performed with good clinical outcomes provided a high baseline hemoglobin level, careful management of the access site and strict measurements to reduce blood loss. TF-TAVR is associated with less blood loss and a lower rate of transfusions than TA-TAVR, and may be the preferred option for patients, who refuse transfusions.

Transjugular Transcatheter Tricuspid Valve Replacement: Early Compassionate Use Outcomes.

BACKGROUND: Data on procedural and early outcomes after transjugular transcatheter tricuspid valve replacement (TTVR) are limited. OBJECTIVES: This study sought to evaluate first-in-man procedural and clinical outcomes after transjugular TTVR with a special focus on patients who received large device sizes in whom TTVR outcomes have been questioned. METHODS: The retrospective registry included patients who underwent TTVR using the LuX-Valve Plus system (Jenscare Biotechnology Co Ltd) for symptomatic tricuspid regurgitation (TR) from January 2022 until February 2024 at 15 international centers in a compassionate use setting. The endpoints were procedural TR reduction, in-hospital death, adverse events, and 1-month survival. We further stratified results according to the size of the implanted device (<55 vs ≥55 mm). RESULTS: The registry included a total of 76 patients at a median age of 78 years (Q1-Q3: 72-83 years, 47.4% women). TR was reduced to ≤2+ and ≤1+ in 94.7% and 90.8% of patients (75.0% of patients received TTVR devices ≥55 mm) with well-sustained results at 1-month follow-up (TR ≤2+ in 95.0% and ≤1+ 86.8%). Residual TR was paravalvular in all cases. In-hospital death occurred in 4 patients (5.3%). Four patients (5.3%) underwent cardiac surgery during index hospitalization. Major in-hospital bleeding events occurred in 5 patients (6.6%). New in-hospital pacemaker implantation was required in 3.9% of patients in the overall cohort (5.7% in "pacemaker-naive" individuals). No cases of valve thrombosis, stroke, myocardial infarction, or pulmonary embolism were observed. At 1-month follow-up, survival was 94.4%, and NYHA functional class significantly improved. One further patient received a pacemaker, 1 further bleeding event occurred, and 2 patients underwent reintervention or surgery within the first 30 days after TTVR. No differences in procedural outcomes or adverse events were observed after stratification for valve size. CONCLUSIONS: Transjugular TTVR appears to be a safe and effective treatment option for patients with severe TR with comparable outcomes in very large tricuspid anatomies.

Timing, predictive factors, and prognostic value of cerebrovascular events in a large cohort of patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The objective of this study was to evaluate the timing, predictive factors, and prognostic value of cerebrovascular events (CVEs) after transcatheter aortic valve implantation. METHODS AND RESULTS: The study included 1061 consecutive patients who underwent transcatheter aortic valve implantation with a balloon-expandable (64%) or self-expandable (36%) valve. CVEs were classified as acute (≤24 hours), subacute (1-30 days), or late (>30 days). CVEs occurred in 54 patients (5.1%; stroke, 4.2%) within 30 days after transcatheter aortic valve implantation (acute in 54% of cases). The predictors of acute CVEs were balloon postdilation of the valve prosthesis (odds ratio, 2.46; 95% confidence interval,1.07-5.67) and valve dislodgment/embolization (odds ratio, 4.36; 95% CI, 1.21-15.69); new-onset atrial fibrillation (odds ratio, 2.76; 95% CI, 1.11-6.83) was a predictor of subacute CVEs. Late CVEs occurred in 35 patients (3.3%; stroke, 2.1%) at a median follow-up of 12 months (3-23 months). The predictors of late CVEs were chronic atrial fibrillation (2.84; 95% CI, 1.46-5.53), peripheral vascular disease (hazard ratio, 2.02; 95% CI, 1.02-3.97), and prior cerebrovascular disease (hazard ratio, 2.04; 95% CI, 1.01-4.15). Major stroke was associated with 30-day (odds ratio, 7.43; 95% CI, 2.45-22.53) and late (hazard ratio, 1.75; 95% CI, 1.01-3.04) mortality. CONCLUSIONS: In a large cohort of patients undergoing transcatheter aortic valve implantation, the rates of acute and subacute CVEs were 2.7% and 2.4%, respectively. While balloon postdilation and valve dislodgment/embolization were the predictors of acute CVEs, new-onset atrial fibrillation determined a higher risk for subacute events. Late events were determined mainly by a history of chronic atrial fibrillation and peripheral and cerebrovascular disease. The occurrence of major stroke was associated with increased early and late mortality. These results provide important insights for the implementation of preventive measures for CVEs after transcatheter aortic valve implantation.

Transcatheter mitral valve-in-valve implantation: current experience and review of literature.

PURPOSE OF REVIEW: Transcatheter mitral valve-in-valve (MVIV) implantation is an emerging technique for reoperative mitral valve replacement in high-risk patients. Clear guidelines on the use of transcatheter MVIV implantation are yet to be determined. In this review, we report our own experience as well as the recent available literature on this procedure. RECENT FINDINGS: Since 2010, four case series of three or more patients have been reported with a total number of 23 patients. We also include unpublished data of 13 additional patients, who recently had MVIV implantation at our institution. Mean age was 78.45 ± 9.2 years with a median follow-up ranging from 70 to 357 days. Mean The Society of Thoracic Surgeons (STS) score was 14.1   ±â€Š7.1%. All patients were in New York Heart Association (NYHA) class III or IV. Thirty days mortality was 7.5% (n = 3) and late mortality was 10% (n = 4). All patients had improvement in postoperative NYHA class to I/II following MVIV implantation. The mitral regurgitation grade was reduced from 3+ or 4+ preoperatively to a grade of 0 or 1 postoperatively. There was no structural valve deterioration reported in the follow-up period in any of the studies. SUMMARY: The available literature supports the use of transcatheter MVIV implantation in selected high-risk patients with favorable results. Although there are no available long-term data on the procedure, the early and mid-term outcomes are excellent with no evidence of structural valve deterioration in the available follow-up period.

First-in-human valve-in-valve implantation of a 20 mm balloon expandable transcatheter heart valve.

An 86-year-old lady with recurrent admissions for heart failure due to a severely regurgitant aortic bioprosthesis (SJM Epic 19 mm) was not a candidate for re-operation due to age and frailty. Her small ilio-femoral arteries precluded a transfemoral transcatheter valve-in-valve (VIV) approach. The small internal diameter of her bioprosthesis (16 mm) forbids the implantation of the smallest available transapical transcatheter heart valve (THV). We, therefore, decided to perform a first-in-human transapical aortic VIV implantation using a 20 mm balloon expandable THV and a transfemoral delivery system. The procedure was successfully performed under general anesthesia, without any contrast dye and under fluoroscopy as well as transesophageal echocardiography guidance. The post-procedural transvalvular gradient was 15 mm Hg (pre-procedural 14 mm Hg). At 30-day follow-up, the lady was living independently at home without shortness of breath during her daily activities. If redo-surgery for prosthetic regurgitation is not an option, VIV implantation in very small surgical bioprosthesis is feasible and leads to acceptable hemodynamics and clinical improvement.

Case Report: Stretching the limits-late valvuloplasty for THV dysfunction following redo mitral valve-in-valve implantation.

Late balloon valvuloplasty can be used to treat under-expansion-related transcatheter heart valve (THV) dysfunction. Whether this can be performed following redo-THV implantation is unknown. Herein, we report a case of a 72-year-old male presenting with symptomatic gradient elevation following redo mitral valve-in-valve implantation. The patient was successfully treated with late balloon valvuloplasty with gradient improvement. In conclusion, late valvuloplasty is effective even with several layers of valves. However, larger studies are required to clarify the role of this approach further.