Differences between sexes in STEMI treatment and outcomes with contemporary primary PCI.

BACKGROUND: Historically, differences in timely reperfusion and outcomes have been described in females who suffer ST-segment elevation myocardial infarction (STEMI). However, there have been improvements in the treatment of STEMI patients with contemporary Percutaneous Coronary Intervention (PCI) strategies. METHODS: Comparisons between sexes were performed on STEMI patients treated with primary PCI over a 4-year period (January 1, 2017-December 31, 2020) from the Queensland Cardiac Outcomes Registry. Primary outcomes were 30-day and 1-year cardiovascular mortality. Secondary outcomes were STEMI performance measures. The total and direct effects of gender on mortality outcomes were estimated using logistic and multinomial logistic regression models. RESULTS: Overall, 2747 (76% male) were included. Females were on average older (65.9 vs. 61.9 years; p < 0.001), had longer total ischemic time (69 min vs. 52 min; p < 0.001) and less achievement of STEMI performance targets (<90 min) (50% vs. 58%; p < 0.001). There was no evidence for a total (odds ratio [OR] 1.3 (95% confidence interval [CI]: 0.8-2.2; p = 0.35) or direct (adjusted OR 1.2 (95% CI: 0.7-2.1; p = 0.58) effect of female sex on 30-day mortality. One-year mortality was higher in females (6.9% vs. 4.4%; p = 0.014) with total effect estimates consistent with increased risk of cardiovascular mortality (Incidence rate ratio [IRR]: 1.5; 95% CI: 1.0-2.3; p = 0.059) and noncardiovascular mortality (IRR: 2.1; 95% CI: 0.9-4.7; p = 0.077) in females. However, direct (adjusted) effect estimates of cardiovascular mortality (IRR: 1.0; 95% CI: 0.6-1.6; p = 0.94) indicated sex differences were explained by confounders and mediators. CONCLUSION: Small sex differences in STEMI performance measures still exist; however, with contemporary primary PCI strategies, sex is not associated with cardiovascular mortality at 30 days or 1 year.

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.

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.

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.

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification.

Aims: We sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)]. Methods and results: From the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0 ± 7.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; P < 0.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; P < 0.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; P < 0.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; P < 0.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; P = 0.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30 days (34.5% vs. 9.9% vs. 6.2%; log-rank P < 0.001) and 1 year (62.8% vs. 30.6% vs. 14.0%; log-rank P < 0.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; P = 0.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; P < 0.001]. Conclusion: The TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

A repeat alcohol septal ablation procedure for hypertrophic obstructive cardiomyopathy where the first septal branch arose from the intermediate (ramus) artery.

Septal reduction therapy (via alcohol septal ablation or surgical myomectomy) is indicated in patients with hypertrophic obstructive cardiomyopathy (HOCM) who have NYHA class III/IV symptoms despite maximal medical therapy. In 90% of patients with HOCM the target septal artery arises from the LAD or diagonal artery. In the remaining 10% of cases it may arise from the ramus, proximal circumflex, or posterolateral or posterior descending branches of the RCA. We present a case where alcohol septal ablation was initially performed on the first septal branch arising from the left anterior descending artery. Left ventricular outflow tract (LVOT) obstruction with symptoms recurred. Upon repeat angiography, a large septal branch in fact arose from the proximal intermediate (ramus) artery. Alcohol ablation of this branch achieved a sustained response. This case highlights that correctly identifying the most suitable septal perforating artery, in addition to myocardial contrast echocardiography, may improve response rates and overall outcomes for patients with hypertrophic obstructive cardiomyopathy.

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.

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.

Impact of implant depth on hydrodynamic function with the ACURATE neo transcatheter heart valve following valve-in-valve transcatheter aortic valve replacement in Mitroflow bioprosthetic valves: an ex vivo bench study.

AIMS: We aimed to assess the impact of implant depth on hydrodynamic function following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) using the ACURATE neo transcatheter heart valve (THV) through an ex vivo bench study. METHODS AND RESULTS: Multiple implantation depths were tested at incremental depths of 2 mm using a small size ACURATE neo valve for VIV TAVR in 19 mm, 21 mm, 23 mm, and 25 mm Mitroflow bioprosthetic valves. Multimodality imaging and hydrodynamic evaluation was performed at each implantation depth. A low implantation was associated with higher transvalvular gradients. The highest transvalvular gradient was observed at -10 mm depth for 19 mm (40.0±0.5 mmHg), -8 mm for 21 mm (15.3±0.2 mmHg), -6 mm for 23 mm (14.7±0.3 mmHg) and -8 mm for 25 mm (8.4±0.2 mmHg) surgical valves. The lowest transvalvular gradient was observed at 0 mm depth for the 19 mm (14.9±0.2 mmHg)/21 mm (7.2±0.1 mmHg), and +2 mm depth for the 23 mm (5.7±0.1 mmHg)/25 mm (5.8±0.1 mmHg) surgical valves. At low implantation depth, there was worse leaflet pin-wheeling and also evidence of interaction of THV leaflets with those of the surgical valve that impaired leaflet coaptation, resulting in a high regurgitant fraction (42.5% in the 21 mm and 83.3% in the 23 mm surgical valve at -10 mm depths). CONCLUSIONS: A high implant is desirable to facilitate favourable hydrodynamic function when performing VIV TAVR using the ACURATE neo THV for Mitroflow aortic bioprostheses sized ±25 mm. In a 19 mm Mitroflow valve, positioning the upper crown of the ACURATE neo THV above the posts of the surgical valve is desirable to facilitate favourable transvalvular gradients. Low implantation results in higher transvalvular gradients and worse pin-wheeling, and THV leaflet dysfunction can be severe due to interaction with the surgical valve.

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.

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).

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.

Transcatheter valve-in-valve implantation for degenerated surgical bioprostheses.

Transcatheter valve-in-valve (VIV) procedures are less invasive than re-do open heart surgery, and have proven relatively safe and effective. In large multicentre registries morbidity and mortality risks are generally lower than with surgery, and improvement in quality of life can be profound. Outcomes continue to improve with advances in transcatheter heart valve (THV) technology, techniques, and expertise. However specific concerns remain; including residual stenosis, coronary obstruction, left ventricular outflow tract obstruction, and thrombosis. The unknown durability is a concern in patients with the potential for longevity. Transcatheter VIV procedures will likely increasingly be favoured over reoperation when bioprosthetic heart valves fail, particularly when surgical risks are high.

Combined Transapical Valve-in-Valve/Valve-in-Ring Transcatheter Mitral Valve Implantation and Paravalvular Leak Closure for Failed Mitral Valve Surgery.

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

Overexpansion of the SAPIEN 3 Transcatheter Heart Valve: An Ex Vivo Bench Study.

OBJECTIVES: This study assessed the effect of overexpansion beyond labeled size (diameter) of transcatheter heart valves through an ex vivo bench study. BACKGROUND: Transcatheter heart valves function optimally when expanded to specific dimensions. However, clinicians may sometimes wish to overexpand balloon-expandable valves to address specific clinical challenges. The implications of overexpansion have assumed considerable importance, and objective information to guide practice is limited. METHODS: We evaluated SAPIEN 3 transcatheter heart valves (Edwards Lifesciences, Irvine, California). Valves (diameters of 23, 26, and 29 mm) were expanded to nominal dimensions, and then incrementally overexpanded with balloons sized 1-, 2-, and 3-mm larger than the recommended diameter. Valves underwent visual, microcomputed tomography, and hydrodynamic evaluation at various degrees of overexpansion. RESULTS: SAPIEN 3 valves with labeled diameters of 23, 26, and 29 mm could be incrementally overexpanded to midvalve diameters of 26.4, 28.4, and 31.2 mm, respectively. With overexpansion, there was visible restriction of the valve leaflets, which was particularly evident with the smaller valves. After maximal overexpansion of a 26-mm valve a leaflet tear was observed. High-speed video demonstrated impaired leaflet motion of both the 23- and 26-mm valves and hydrodynamic testing documented a regurgitant fraction for the 23- and 26-mm valves above accepted international standards. The maximally overexpanded 29-mm SAPIEN 3 still had relatively normal leaflet motion and excellent hydrodynamic function. Durability was not specifically evaluated. CONCLUSIONS: Overexpansion of balloon-expandable valves is possible. However, excessive overexpansion may be associated with impaired hydrodynamic function, acute leaflet failure, and reduced durability. Smaller valves may be at greater risk with overexpansion than larger valves. Overexpansion is best avoided unless clinical circumstances are compelling.

Implications of Concomitant Tricuspid Regurgitation in Patients Undergoing Transcatheter Aortic Valve Replacement for Degenerated Surgical Aortic Bioprosthesis: Insights From the PARTNER 2 Aortic Valve-in-Valve Registry.

OBJECTIVES: The aim of this study was to assess the implications of concomitant tricuspid regurgitation (TR) in patients undergoing valve-in-valve (VIV) transcatheter aortic valve replacement. BACKGROUND: Patients undergoing VIV transcatheter aortic valve replacement with concomitant TR may have worse outcomes, and optimal management remains undetermined. METHODS: The multicenter PARTNER 2 (Placement of Aortic Transcatheter Valves) VIV trial enrolled patients with symptomatic degenerated surgical aortic bioprostheses who were at high risk for reoperation. Outcomes were assessed between patients with mild or no TR versus moderate or severe TR. RESULTS: A total of 237 patients underwent VIV procedures (mean age 78.7 ± 10.8 years, mean Society of Thoracic Surgeons score 9.1 ± 4.8%). In this cohort, 162 patients (68.4%) had mild or no TR, and 75 patients (31.6%) had moderate or severe TR. Although there was no difference in New York Heart Association functional class III or IV symptomatic status (89.3% vs. 91.4%; p = 0.62) or moderate or severe right ventricular dysfunction (9.4% vs. 16.9%; p = 0.11), patients with moderate or severe TR were more likely to be at high surgical risk, with a Society of Thoracic Surgeons score of >8 (62.7% vs 46.9%; p = 0.02). There was no difference in a composite endpoint of death and rehospitalization between moderate or severe TR and mild or no TR, either at 30 days (10.7% vs. 9.9%; p = 0.85) or at 1-year follow-up (24.1% vs. 23.2%; p = 0.80). There was a significant reduction in overall moderate or severe TR from baseline at 30 days (31.1% vs. 21.1%; p = 0.002), which was sustained at 1-year follow-up (38.0% vs. 22.8%; p = 0.004). CONCLUSIONS: Despite higher predicted surgical risk, the presence of TR was not a predictor of long-term outcomes. Importantly, there was significant reduction in TR severity at both short- and long-term follow-up. In selected patients undergoing VIV transcatheter aortic valve replacement, it may be appropriate to conservatively manage concomitant TR.