Patient preferences for heart valve disease intervention.

BACKGROUND: This study aimed to determine how patients trade-off the benefits and risks of two different types of procedures used to treat heart valve disease (HVD). It also aimed to determine patients' preferences for HVD treatments (predicted uptake) and the relative importance of each treatment attribute. METHODS: A discrete choice experiment (DCE) was conducted in Australia and Japan with patients who required a heart valve procedure. Patients were stratified into three categories: no prior procedure experience, minimally invasive procedure experience and invasive procedure experience. DCE attributes included risk of mortality; risk of stroke; needing dialysis; needing a new pacemaker; valve durability; independence 1 month after surgery; and out-of-pocket expenses. Participants chose between two hypothetical labelled approaches to therapy ('invasive procedure' and 'minimally invasive procedure'), with a separate opt-out included. A mixed multinomial logit model was used to analyse preferences. RESULTS: The DCE was completed by 143 Australian and 206 Japanese patients. Both populations demonstrated an overall preference for the minimally invasive procedure over the invasive procedure. All attributes tested significantly predicted choice and were important to patient decision-making. However, patients' choices were most influenced by the durability of the valve and the likelihood of independence postprocedure, irrespective of their prior procedure experience. Differences in preference were observed between Australian and Japanese patients; valve durability was the most important attribute among Australian patients, while Japanese patients emphasised regaining independence postsurgery. Risk of mortality was less important relative to other key attributes in Japan; however, it remained significant to the model. CONCLUSIONS: HVD patients prefer a minimally invasive procedure over an invasive procedure, irrespective of prior treatment experience. Key attributes contributing to treatment preferences are valve durability and faster recovery. These results can be used to help inform healthcare decision-makers about what features of heart valve procedures patients value most. PATIENT AND PUBLIC CONTRIBUTION: People with lived experience of HVD were included in multiple stages of the design phase of this research. First, patients and doctors were consulted by taking part in qualitative interviews. The qualitative interviews helped inform which treatment attributes to include in the DCE based on what was important to those with lived experience and those who help make treatment decisions on behalf of patients. Qualitative interview participants also assisted with the framing of questions in the online survey to ensure the terminology was patient-friendly and relevant to those with lived experience. Following qualitative interviews, the DCE attribute list was agreed on in expert consultation with a steering committee, which included patient representatives and treating physicians (interventional cardiologists, cardiothoracic surgeons). The survey was also pilot tested with a small sample of patients and minor adjustments were made to the wording to ensure it was appropriate and meaningful to those with lived experience of HVD.

First results from the ACURATE Prime XL human feasibility study.

BACKGROUND/PURPOSE: This prospective, open-label, single-arm study evaluated transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis with ACURATE Prime XL, an iteration of the ACURATE neo2 device designed with improved radial force and adaptations for compatibility with a larger annulus diameter (≥ 26.5 mm and ≤ 29 mm based on pre-procedure diagnostic imaging). METHODS: The composite primary device success endpoint was based on Valve Academic Research Consortium (VARC)-2 criteria. The primary safety endpoint was a composite of all-cause mortality and all stroke at 30 days. Aortic valve (AV) performance, including mean AV gradient, AV area, and grade of paravalvular leak (PVL), was assessed by an independent core laboratory. RESULTS: 13 male patients were enrolled at 3 Australian centers (mean age: 83.1 years; 10 of 13 were considered high/extreme operative risk). 61.5 % of patients met the primary device success endpoint. At 30 days, no patients experienced death or stroke; one patient received a permanent pacemaker. Mean AV gradient improved from baseline (42.7 ± 11.0 mmHg) to discharge (7.7 ± 2.5 mmHg) and through 30 days (7.2 ± 2.3 mmHg). Mean AV area was 0.8 ± 0.1 cm2 at baseline, 1.9 ± 0.3 cm2 at discharge, and 1.7 ± 0.3 cm2 at 30 days. Per core-laboratory adjudication, no patient had moderate or severe PVL at 30 days; 91.7 % had no/trace PVL and 8.3 % had mild PVL. CONCLUSIONS AND RELEVANCE: In this first-in-human feasibility study of the ACURATE Prime XL valve, there were no safety concerns, and no deaths or strokes within 30 days. Valve hemodynamics were favorable, and no patient had >mild PVL.

Prehospital Activation of the Cardiac Catheterization Laboratory in ST-Segment-Elevation Myocardial Infarction for Primary Percutaneous Coronary Intervention.

Background Prehospital activation of the cardiac catheter laboratory is associated with significant improvements in ST-segment-elevation myocardial infarction (STEMI) performance measures. However, there are equivocal data, particularly within Australia, regarding its influence on mortality. We assessed the association of prehospital activation on performance measures and mortality in patients with STEMI treated with primary percutaneous coronary intervention from the Queensland Cardiac Outcomes Registry (QCOR). Methods and Results Consecutive ambulance-transported patients with STEMI treated with primary percutaneous coronary intervention were analyzed from January 1, 2017 to December 31, 2020 from the QCOR. The total and direct effects of prehospital activation on the primary outcomes (30-day and 1-year cardiovascular mortality) were estimated using logistic regression analyses. Secondary outcomes were STEMI performance measures. Among 2498 patients (mean age: 62.2±12.4 years; 79.2% male), 73% underwent prehospital activation. Median door-to-balloon time (34 minutes [26-46] versus 86 minutes [68-113]; P<0.001), first-electrocardiograph-to-balloon time (83.5 minutes [72-98] versus 109 minutes [81-139]; P<0.001), and proportion of patients meeting STEMI targets (door-to-balloon <60 minutes 90% versus 16%; P<0.001), electrocardiograph-to-balloon time <90 minutes (62% versus 33%; P<0.001) were significantly improved with prehospital activation. Prehospital activation was associated with significantly lower 30-day (1.6% versus 6.6%; P<0.001) and 1-year cardiovascular mortality (2.9% versus 9.5%; P<0.001). After adjustment, no prehospital activation was strongly associated with increased 30-day (odds ratio [OR], 3.6 [95% CI, 2.2-6.0], P<0.001) and 1-year cardiovascular mortality (OR, 3.0 [95% CI, 2.0-4.6]; P<0.001). Conclusions Prehospital activation of cardiac catheterization laboratory for primary percutaneous coronary intervention was associated with significantly shorter time to reperfusion, achievement of STEMI performance measures, and lower 30-day and 1-year cardiovascular mortality.

The Prognostic Value of Echocardiographic Wall Motion Score Index in ST-Segment Elevation Myocardial Infarction.

Background: When compared to left ventricular ejection fraction (LVEF), previous studies have suggested the superiority of wall motion score index (WMSI) in predicting cardiac events in patients who have suffered acute myocardial infarction. However, there are limited studies assessing WMSI and mortality in ST-segment elevation myocardial infarction (STEMI). We aimed to compare the prognostic value of WMSI in a cohort of STEMI patients treated with primary percutaneous coronary intervention (PCI). Methods: A comparison of WMSI, LVEF, and all-cause mortality in STEMI patients treated with primary PCI between January 2008 and December 2020 was performed. The prognostic value of WMSI, LVEF, and traditional risk scores (TIMI, GRACE) were compared using multivariable logistic regression modelling. Results: Among 1181 patients, 27 died within 30-days (2.3%) and 49 died within 12 months (4.2%). WMSI ≥1.8 was associated with poorer survival at 12-months (9.2% vs 1.5%; p < 0.001). When used as the only classifier for predicting 12-month mortality, the discriminatory ability of WMSI (area under the curve (AUC): 0.77; 95% CI: 0.68-0.84) was significantly better than LVEF (AUC: 0.71; 95% CI: 0.61-0.79; p=0.034). After multivariable modelling, the AUC was comparable between models with either WMSI (AUC: 0.89; 95% CI: 0.85-0.94) or LVEF (AUC: 0.87; 95% CI: 0.83-0.92; p < 0.08) yet performed significantly better than TIMI (AUC: 0.71; 95% CI: 0.62-0.79; p < 0.001), or GRACE (AUC: 0.63; 95% CI: 0.54-0.71; p < 0.001) risk scores. Conclusions: When examined individually, WMSI is a superior predictor of 12-month mortality over LVEF in STEMI patients treated with primary PCI. When examined in multivariable predictive models, WMSI and LVEF perform very well at predicting 12-month mortality, especially when compared to existing STEMI risk scores.

Sex differences in time to primary percutaneous coronary intervention and outcomes in patients presenting with ST-segment elevation myocardial infarction.

OBJECTIVES: We assessed sex differences in treatment and outcomes in ST-segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PCI). BACKGROUND: Historically, delays to timely reperfusion and poorer outcomes have been described in women who suffer STEMI. However, whether these sex discrepancies still exist with contemporary STEMI treatment remains to be evaluated. METHODS: Consecutive STEMI patients treated with primary PCI patients over a 10-year period (January 1, 2010 to December 31, 2019) from a tertiary referral center were assessed. Comparisons were performed between patient's sex. Primary outcomes were 30-day and 1-year mortality. Secondary outcomes were STEMI performance measures. RESULTS: Most patients (n = 950; 76%) were male. Females were on average older (66.8 vs. 61.4 years males; p < 0.001). Prehospital treatment delays did not differ between sexes (54 min [IQR: 44-65] females vs. 52 min [IQR: 43-62] males; p = 0.061). STEMI performance measures (door-to-balloon, first medical contact-to-balloon [FMCTB]) differed significantly with longer median durations in females and fewer females achieving FMCTB < 90 min (28% females vs. 39% males; p < 0.001). Women also experienced greater rates of initial radial arterial access failure (11.3% vs. 3.1%; p < 0.001). However, there were no significant sex differences in crude or adjusted mortality between sexes at 30-days (3.6% male vs. 5.1% female; p = 0.241, adjusted OR: 1.1, 95% CI: 0.5-2.2, p = 0.82) or at 1-year (4.8% male vs. 6.8% female; p = 0.190, adjusted OR: 1.0, (95% CI: 0.5-1.8; p = 0.96). CONCLUSION: Small discrepancies between sexes in measures of timely reperfusion for STEMI still exist. No significant sex differences were observed in either 30-day or 1-year mortality.

Clinical Outcomes in Pre-Hospital Activation and Direct Cardiac Catheterisation Laboratory Transfer of STEMI for Primary PCI.

INTRODUCTION: Pre-hospital activation and direct cardiac catheterisation laboratory (CCL) transfer of ST segment elevation myocardial infarction (STEMI) has previously been shown to improve door-to-balloon (DTB) times yet there is limited outcome data in the Australian context. We aimed to assess the impact of pre-hospital activation on STEMI performance measures and mortality. METHODS: Prospective cohort study of consecutive ambulance transported STEMI patients treated with primary percutaneous coronary intervention (PCI) patients over a 10-year period (1 January 2008-31 December 2017) at The Prince Charles Hospital, a large quaternary referral centre in Brisbane, Queensland Australia. Comparisons were performed between patients who underwent pre-hospital CCL activation and patients who did not. STEMI performance measures, 30-day and 1-year mortality were examined. RESULTS: Amongst 1,009 patients included (mean age: 62.8 yrs±12.6), pre-hospital activation increased over time (26.6% in 2008 to 75.0% in 2017, p<0.001). Median DTB time (35 mins vs 76 mins p<0.001) and percentage meeting targets (DTB<60 mins 92% vs 27%, p<0.001) improved significantly with pre-hospital activation. Pre-hospital activation was associated with significantly lower 30-day (1.0% vs 3.5%, p=0.007) and 1-year (1.2% vs 7.7%, p<0.001) mortality. After adjusting for confounders and mediators, we observed a strong total effect of pre-hospital activation on 1-year mortality (OR 5.3, 95%CI 2.2-12.4, p<0.001) compared to patients who did not have pre-hospital activation. False positive rates were 3.7% with pre-hospital activation. CONCLUSION: In patients who underwent primary PCI for STEMI, pre-hospital activation and direct CCL transfer is associated with low false positive rates, significantly reduced time to reperfusion and lower 30-day and 1-year mortality.

Impact of Patient BMI on Patient and Operator Radiation Dose During Percutaneous Coronary Intervention.

AIMS: This study sought to investigate patient and operator radiation dose in patients undergoing percutaneous coronary intervention (PCI) and the impact of body mass index (BMI) on patient and operator dose. METHODS: In patients undergoing PCI, radiation dose parameters, baseline characteristics and procedural data were collected in a tertiary centre for 3.5 years. Operators wore real time dosimeters. Patients were grouped by BMI. Dose area product (DAP) and operator radiation dose were compared across patient BMI categories. Multivariable analysis was performed to investigate the impact of patient BMI and other procedural variables on patient and operator dose. RESULTS: 2,043 patients underwent 2,197 PCI procedures. Each five-unit increase in BMI increased patient dose (expressed as DAP) by an average 31% (95% CI: 29-33%) and operator dose by 27% (95% CI: 20-33%). Patient dose was 2.3 times higher and operator dose was 2.4 times higher in patients with a BMI>40 than for normal BMI patients. Multivariable analysis indicated that there were many procedural factors that were predictors for increasing operator dose and patient dose but that patient BMI was a major contributor for both operator dose and patient dose. CONCLUSION: Increasing BMI increases the DAP and operator dose for PCI procedures and BMI is demonstrated to be a major factor that contributes to both patient and operator radiation dose.

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.

Mid-term outcome in patients with bicuspid aortic valve stenosis following transcatheter aortic valve replacement with a current generation device: A multicenter study.

OBJECTIVES: To perform clinical and echocardiographic follow-up beyond 1 year in consecutive patients with severe bicuspid aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with a current generation balloon-expandable valve. BACKGROUND: Treatment of bicuspid aortic valve disease with TAVR remains controversial and late follow-up data is still scarce. METHODS: We collected baseline characteristics, procedural data, 30-day and mid-term clinical follow-up findings from six centers in Europe and Canada from patients with bicuspid AS treated with TAVR using the SAPIEN 3 valve. RESULTS: Seventy-nine patients underwent TAVR. Mean age was 76 ± 9 years; median STS risk score for mortality was 3.8% (interquartile range 2.3-5.5%). Median follow-up was 390 days (interquartile range 138-739 days). Device success was achieved in 95% of patients. Postimplantation mean aortic gradient decreased from 50.2 ± 16.2 to 8.8 ± 4.4 mmHg and no patient had more than mild aortic regurgitation. At last follow-up, there was persistent good valve performance. At 30 days and 1 year, the rates of all-cause mortality were 3.8 and 7.7%, stroke 1.2 and 1.2%, and the rate of new pacemakers 18 and 18%. CONCLUSIONS: Our data confirm that treating patients with stenotic bicuspid aortic valves is safe, effective, and has favorable valve performance over time.

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.

3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for degenerated surgical bioprosthetic aortic valves is associated with favorable early outcomes. However, little is known about the durability and longer-term outcomes associated with this therapy. OBJECTIVES: The aim of this study was to examine late outcomes after valve-in-valve TAVR. METHODS: Patients with symptomatic degeneration of surgical aortic bioprostheses at high risk (≥50% major morbidity or mortality) for reoperative surgery were prospectively enrolled in the multicenter PARTNER (Placement of Aortic Transcatheter Valves) 2 valve-in-valve and continued access registries. Three-year clinical and echocardiographic follow-up was obtained. RESULTS: Valve-in-valve procedures were performed in 365 patients. The mean age was 78.9 ± 10.2 years, and the mean Society of Thoracic Surgeons score was 9.1 ± 4.7%. At 3 years, the overall Kaplan-Meier estimate of all-cause mortality was 32.7%. Aortic valve re-replacement was required in 1.9%. Mean transaortic gradient was 35.0 mm Hg at baseline, decreasing to 17.8 mm Hg at 30-day follow-up and 16.6 mm Hg at 3-year follow-up. Baseline effective orifice area was 0.93 cm2, increasing to 1.13 and 1.15 cm2 at 30 days and 3 years, respectively. Moderate to severe aortic regurgitation was reduced from 45.1% at pre-TAVR baseline to 2.5% at 3 years. Importantly, moderate or severe mitral and tricuspid regurgitation also decreased (33.7% vs. 8.6% [p < 0.0001] and 29.7% vs. 18.8% [p = 0.002], respectively). Baseline left ventricular ejection fraction was 50.7%, increasing to 54.7% at 3 years (p < 0.0001), while left ventricular mass index was 136.4 g/m2, decreasing to 109.1 g/m2 at 3 years (p < 0.0001). New York Heart Association functional class improved, with 90.4% in class III or IV at baseline and 14.1% at 3 years (p < 0.0001), and Kansas City Cardiomyopathy Questionnaire overall score increased (43.1 to 73.1; p < 0.0001). CONCLUSIONS: At 3-year follow-up, TAVR for bioprosthetic aortic valve failure was associated with favorable survival, sustained improved hemodynamic status, and excellent functional and quality-of-life outcomes. (The PARTNER II Trial: Placement of Aortic Transcatheter Valves II - PARTNER II - Nested Registry 3/Valve-in-Valve [PII NR3/ViV]; NCT03225001).

Impact of Chronic Kidney Disease on Decision Making and Management in Transcatheter Aortic Valve Interventions.

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.

The Vancouver 3M (Multidisciplinary, Multimodality, But Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers: The 3M TAVR Study.

OBJECTIVES: The authors sought to prospectively determine the safety and efficacy of next-day discharge using the Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway. BACKGROUND: Transfemoral transcatheter aortic valve replacement (TAVR) is an alternative to surgery in high- and intermediate-risk patients; however, hospital stays average at least 6 days in most trials. The Vancouver 3M Clinical Pathway is focused on next-day discharge, made possible by the use of objective screening criteria as well as streamlined peri- and post-procedural management guidelines. METHODS: Patients were enrolled from 6 low-volume (<100 TAVR/year), 4 medium-volume, and 3 high-volume (>200 TAVR/year) centers in Canada and the United States. The primary outcomes were a composite of all-cause death or stroke by 30 days and the proportion of patients successfully discharged home the day following TAVR. RESULTS: Of 1,400 screened patients, 411 were enrolled at 13 centers and received a SAPIEN XT (58.2%) or SAPIEN 3 (41.8%) valve (Edwards Lifesciences, Irvine, California). In centers enrolling exclusively in the study, 55% of screened patients were enrolled. The median age was 84 years (interquartile range: 78 to 87 years) with a median STS score of 4.9% (interquartile range: 3.3% to 6.8%). Next-day discharge home was achieved in 80.1% of patients, and within 48 h in 89.5%. The composite of all-cause mortality or stroke by 30 days occurred in 2.9% (95% confidence interval: 1.7% to 5.1%), with neither component of the primary outcome affected by hospital TAVR volume (p = 0.51). Secondary outcomes at 30 days included major vascular complication 2.4% (n = 10), readmission 9.2% (n = 36), cardiac readmission 5.7% (n = 22), new permanent pacemaker 5.7% (n = 23), and >mild paravalvular regurgitation 3.8% (n = 15). CONCLUSIONS: Adherence to the Vancouver 3M Clinical Pathway at low-, medium-, and high-volume TAVR centers allows next-day discharge home with excellent safety and efficacy outcomes.

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.

Valve-in-Valve Transcatheter Aortic Valve Replacement and Bioprosthetic Valve Fracture Comparing Different Transcatheter Heart Valve Designs: An Ex Vivo Bench Study.

OBJECTIVES: The authors assessed the effect of valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) followed by bioprosthetic valve fracture (BVF), testing different transcatheter heart valve (THV) designs in an ex vivo bench study. BACKGROUND: Bioprosthetic valve fracture can be performed to improve residual transvalvular gradients following VIV TAVR. METHODS: The authors evaluated VIV TAVR and BVF with the SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) and ACURATE neo (Boston Scientific Corporation, Natick, Massachusetts) THVs. A 20-mm and 23-mm S3 were deployed in a 19-mm and 21-mm Mitroflow (Sorin Group USA, Arvada, Colorado), respectively. A small ACURATE neo was deployed in both sizes of Mitroflow tested. VIV TAVR samples underwent multimodality imaging, and hydrodynamic evaluation before and after BVF. RESULTS: A high implantation was required to enable full expansion of the upper crown of the ACURATE neo and allow optimal leaflet function. Marked underexpansion of the lower crown of the THV within the surgical valve was also observed. Before BVF, VIV TAVR in the 19-mm Mitroflow had high transvalvular gradients using either THV design (22.0 mm Hg S3, and 19.1 mm Hg ACURATE neo). After BVF, gradients improved and were similar for both THVs (14.2 mm Hg S3, and 13.8 mm Hg ACURATE neo). The effective orifice area increased with BVF from 1.2 to 1.6 cm2 with the S3 and from 1.4 to 1.6 cm2 with the ACURATE neo. Before BVF, VIV TAVR with the ACURATE neo in the 21-mm Mitroflow had lower gradients compared with S3 (11.3 mm Hg vs. 16 mm Hg). However, after BVF valve gradients were similar for both THVs (8.4 mm Hg ACURATE neo vs. 7.8 mm Hg S3). The effective orifice area increased from 1.5 to 2.1 cm2 with the S3 and from 1.8 to 2.2 cm2 with the ACURATE neo. CONCLUSIONS: BVF performed after VIV TAVR results in improved residual gradients. Following BVF, residual gradients were similar irrespective of THV design. Use of a small ACURATE neo for VIV TAVR in small (≤21 mm) surgical valves may be associated with challenges in achieving optimum THV position and expansion. BVF could be considered in selected clinical cases.