Aortic Valve Intervention Research Articles

Early outcomes of mitral valve replacement with a mechanical prosthesis for rheumatic mitral valve disease.

Objectives: To study the early outcomes of mitral valve replacement with a mechanical prosthesis is patients with rheumatic mitral valvular disease. Study Design: Retrospective Observational study. Setting: Punjab Institute of Cardiology, Lahore and Rawalpindi Institute of Cardiology, Rawalpindi. Period: From August 2014 to August 2017. Material & Methods: Consecutive patients who underwent mitral valve replacement for a rheumatic pathology were included in the study. Patients undergoing a redo surgery, those with concomitant aortic valve intervention, coronary artery bypass grafting and emergency procedures were excluded from the study. Results: Of the 104 patients included in the study, 58 (56.2%) were female patients. The mean age of the patients was 35 ± 12.36 years (median 33 years). Sixty (58.5%) had hypertension and 22 (21.28%) had diabetes. Mitral valve stenosis was the main pathology in 84 (81.25%). Severe pulmonary hypertension was recorded in 15 (15%) patients. The mean preoperative Tricuspid Valve Pressure Gradient (TVPG) was 55.33 ± 18.35 mmHg. The mean cross clamp time was 45.33 ± 12.32 minutes. The postoperative tricuspid valve pressure gradient came down to 31.5 ± 12.21 mmHg. No patients had acute renal injury, pulmonary complications or re-exploration for bleeding. Perioperative mortality was 4 (3.75%). Conclusion: Rheumatic valvular disease is still prevalent in our part of the world. Most of the patients with rheumatic heart disease will end up with replacement of the valve. Replacement with a mechanical prosthesis has favorable early outcomes.

Bicuspid aortic valve: different clinical profiles for subjects with versus without repaired aortic coarctation

ObjectivesA small proportion of patients undergoing bicuspid aortic valve (BAV) intervention have had prior repair of aortic coarctation (CoA). We aimed to describe phenotypic differences between BAV patients, comparing those...

Ascending Aortoplasty in Pediatric Patients Undergoing Aortic Valve Procedures

The risks of ascending aortic dilation and indications for intervention in pediatric patients are unclear. Given the concern for aortic size mismatch with growth, larger ascending aortic diameters have been accepted in pediatric patients. The purpose of this study was to evaluate the effectiveness of ascending aortic reduction at the time of aortic valve surgery and its effect on recurrent aortic regurgitation. A retrospective 8-year observational review (2010-2018) was conducted in pediatric patients with dilated ascending aorta undergoing aortic valve surgery at a single institution. Forty-seven patients underwent ascending aortoplasty during aortic valve surgery, of which 39 patients with complete data points had preoperative mean ascending aortic Z-scores of 5.35 ± 1.52 reduced to 1.22 ± 1.63 (P < .001) postoperatively. Ascending aortic Z-scores remained similar at 1.37 ± 1.72 at latest follow-up (P= .306). In contrast our matched control group (n= 39) without ascending aortoplasty had preoperative mean ascending aortic Z-scores of 4.15 ± 1.65 reduced to 3.26 ± 2.0 at the midterm follow-up. This reduction was significantly larger in the aortoplasty group, with an average difference in these changes of 3.12 (95% confidence interval, 2.43-3.8; P < .001). Multivariable logistic regression (controlling for aortic valve intervention type and body surface area) showed a 6.84 odds of moderate to severe aortic regurgitation at follow-up in the control group compared with the aortoplasty group (95% confidence interval, 1.43-32.8; P= .016). There were no complications associated with ascending aortoplasty. Ascending aortoplasty is effective in reducing ascending aortic dimensions and recurrent aortic regurgitation in pediatric patients. Longer-term follow-up is necessary to determine continued rate of growth.

Shockwave lithotripsy facilitates large-bore vascular access through calcified arteries.

BackgroundOur objective is to explore the Peripheral Intravascular Lithotripsy (IVL) System in the treatment of calcific access vessels during thoracic endovascular aortic repair (TEVAR), endovascular aortic repair (EVAR), and transcatheter aortic valve intervention.MethodsThis retrospective, single-center study evaluated the outcomes of patients undergoing TEVAR, EVAR, or transcatheter aortic valve intervention with severe calcific arterial disease between July 2018 and August 2019. Maximum circumferential calcification, length of calcification, and inner/outer diameter measurements were collected with curved planar reformation by medical imaging software (Aquarius APS, TeraRecon, Foster City, Calif). Effective luminal gain was calculated using the minimal inner diameter and the largest bore passed within the vessel lumen. End points included technical success, mortality, adverse events, and requirement for bail out maneuvers. Technical success was defined as successful delivery and deployment of device or endograft.ResultsNine patients were included (mean age, 79.3 ± 9.79 years; range, 59-97 years]). four transcatheter aortic valve replacement, one TEVAR, one EVAR, and three fenestrated EVAR. Six patients (66.7%) had more than one artery treated; the segments treated included common iliac artery (seven patients [77.8%]), the external iliac artery (seven patients [77.8%]), and the common femoral artery (one patient [11.1%]). The average inner iliac vessel diameter was 3.38 ± 0.99 mm (range, 1.87-4.72 mm). The average outside diameter of device introduced was 7.2 ± 0.94 (range, 6.3-8.8 mm) with 229% effective luminal gain. Technical success was achieved in 100% of cases with a 0% mortality. Adjunctive measures were needed in five cases (55.6%). One vessel perforation was controlled with covered stent (Viabahn; W. L. Gore & Associates, Flagstaff, Ariz) deployment. Dissection was identified in two cases requiring stent placement. Two cases required the use of the Terumo International Systems SOLOPATH Balloon Expandable TransFemoral System (Terumo Interventional Systems, Somerset, NJ). One case deployed a Viabahn stent applying the “crack and pave” technique.ConclusionsAs the population of the United States ages, calcified arterial disease will become an everyday clinical conundrum. Furthermore, the procedures for which the IVL system is geared toward facilitating will likely also increase in use. The IVL system is an additional tool in the vascular surgeon's armamentarium to obtain large-bore access in these calcified vessels. Further studies are needed to better assess the clinical effectiveness of the IVL system.

Impact of Appropriate Use Criteria for Transthoracic Echocardiography in Valvular Heart Disease on Clinical Outcomes

The association between appropriate use criteria for transthoracic echocardiography (TTE) and clinical outcomes is unknown for patients with valvular heart disease (VHD). The aim of this study was to identify the association of TTE appropriateness with downstream cardiac tests and clinical outcomes in patients with VHD over 365days. A subset of 2,297 patients with VHD across six Ontario academic hospitals was selected from the Echo WISELY (Will Inappropriate Scenarios for Echocardiography Lessen Significantly) trial and linked to administrative databases. Each patient's index TTE was classified as "rarely appropriate" (rA) versus "appropriate" (comprising "appropriate" and "may be appropriate" TTE according to the 2011 appropriate use criteria). Overall, 431 of 452 patients with rA TTE were matched 1:1 with patients with appropriate TTE using propensity scores to account for measured confounding. Matched patients with rA TTE were less likely to undergo repeat TTE (relative risk, 0.46; 95% CI, 0.33-0.66) or cardiac catheterization (relative risk, 0.27; 95% CI, 0.16-0.47) at 90days compared with patients with appropriate TTE. rA TTE was significantly associated with a decreased hazard of aortic valve intervention (hazard ratio, 0.40; 95% CI, 0.14-0.42), all-cause hospitalization (hazard ratio, 0.44; 95% CI, 0.34-0.57), and death (hazard ratio, 0.31; 95% CI, 0.15-0.66) over 365days of follow-up. Patients with appropriate TTE for VHD were more likely to undergo subsequent cardiac testing within 90days and valve intervention within 1year than those with a rA TTE. The 2011 appropriate use criteria for TTE have important clinical implications for outcomes in patient with VHD.

Role of echocardiographic scoring systems in predicting successful biventricular versus univentricular palliation in neonates with critical aortic stenosis.

There are several published echo-derived scores to help predict successful biventricular versus univentricular palliation in neonates with critical aortic stenosis. This study aims to determine whether any published scoring system accurately predicted outcomes in these neonates. Single centre, retrospective cohort study including neonates who underwent aortic valve intervention (surgical valvotomy or balloon valvuloplasty) with the intention of biventricular circulation. Primary outcome was survival with biventricular circulation at hospital discharge. Data from their initial neonatal echocardiogram were used to compute the following scores - Rhodes, CHSS 1, Discriminant, CHSS 2, and 2 V. Between 01/1999 and 12/2017, 68 neonates underwent aortic valve intervention at a median age of 4 days (range 1-29 days); 35 surgical valvotomy and 33 balloon valvuloplasty. Survival with biventricular circulation was maintained in 60/68 patients at hospital discharge. Of the remaining eight patients, three were converted to univentricular palliation, four died, and one underwent heart transplant prior to discharge. None of the binary score predictions of biventricular versus univentricular (using that score's proposed cut-offs) were significantly associated with the observed outcome in this cohort. A high percentage of those predicted to need univentricular palliation had successful biventricular repair: 89.4% by Rhodes, 79.3% by CHSS 1, 85.2% by Discriminant, and 66.7% by CHSS 2 score. The 2 V best predicted outcome and agreed with the local approach in most cases. This study highlights the limitations of and need for alternative scoring systems/cut-offs for consistently accurate echocardiographic prediction of early outcome in neonates with critical aortic stenosis.

Clinical outcomes following balloon aortic valvuloplasty

BackgroundBalloon aortic valvuloplasty (BAV) remains a treatment option for the selected patients with severe aortic stenosis. We examined clinical outcomes and predictors of prognosis in patients undergoing BAV for severe aortic stenosis.MethodsWe identified all patients undergoing BAV from January 2010 to March 2018 (n=167) at a single transcatheter aortic valve implantation (TAVI) centre. Patient demographics, investigations, subsequent interventions and clinical outcomes were obtained from electronic health records.ResultsPatients undergoing BAV were elderly (median age 80, IQR 73–86 years) and half (n=87, 52%) were male. All-cause mortality at 30 days and 12 months was 11% and 43%, respectively. Reduce ejection fraction (EF 30%–50%: HR 1.76, 95% CI 1.05 to 2.94; EF <30%: HR 1.90, 95% CI 1.12 to 3.20) was the only independent predictor at baseline of overall mortality. Median survival was 212 (IQR 54–490) days from the index procedure. Mortality at 1 year was lowest in patients who subsequently underwent TAVI or SAVR but high among those who had no further interventions or those who had a repeat BAV (14%, 19%, 60%, 89% respectively, log-rank p<0.001).ConclusionBAV as a bridge to definitive aortic valve intervention in carefully selected patients offers acceptable outcomes. These contemporary observational findings demonstrate the ongoing potential utility of BAV in the TAVI era.

Prevalence, predictors, and outcomes of patient prosthesis mismatch in women undergoing TAVI for severe aortic stenosis: Insights from the WIN-TAVI registry.

To evaluate the incidence, predictors and outcomes of female patients with patient-prosthesis mismatch (PPM) following transcatheter aortic valve intervention (TAVI) for severe aortic stenosis (AS). Female AS TAVI recipients have a significantly lower mortality than surgical aortic valve replacement (SAVR) recipients, which could be attributed to the potentially lower PPM rates. TAVI has been associated with lower rates of PPM compared to SAVR. PPM in females post TAVI has not been investigated to date. The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multicenter registry of women undergoing TAVR for severe symptomatic AS. Two hundred and fifty patients with detailed periprocedural and follow-up echocardiographic investigations were included in the WIN-TAVI echocardiographic sub-study. PPM was defined as per European guidelines stratified by the presence of obesity. The incidence of PPM in our population was 32.8%. Patients with PPM had significantly higher BMI (27.4 ± 6.1 vs. 25.2 ± 5.0, p = .002), smaller sized valves implanted (percentage of TAVI ≤23 mm 61% vs. 29.2%, PPM vs. no PPM, p < .001) and were more often treated with balloon expandable valves (48.3 vs. 32.5%, p < .001) rather than self expanding ones (26.3 vs. 52.8%, <.001). BMI (OR = 1.08; 95%CI 1.02-1.14, p = .011) and valve size ≤23 mm (OR = 3.00 95%CI 1.14-7.94, p = .027) were the only independent predictors of PPM. There was no significant interaction between valve size and valve type (p = .203). No significant differences were observed in 1-year mortality or major adverse cardiovascular events. PPM in females undergoing TAVI occurs in one third of patients. BMI and valve size ≤23 mm are independent predictors. Larger registries are required to determine the impact of PPM on future clinical outcomes.

Aortic Valve Intervention During Aortic Root Surgery in Children: A Systematic Review.

Pediatric aortic root dilatation is a life-threatening condition that lacks guidelines for surgical management. We aimed to analyze the data on aortic valve interventions during root surgery to guide decision-making. A search was performed of MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, and WHO ICTRP. Citations were screened in duplicate and independently to identify randomized controlled trials, cohorts, and case series involving populations aged 0 to 18 years, who received valve-sparing and valve-replacing aortic root surgeries between 1999 and 2019. Outcomes considered included mortality (perioperative, one year, five year), reintervention rates. After duplicate removal, 689 citations were screened through abstract and full text review, identifying five eligible studies. All five were observational studies evaluating valve-sparing procedures. There were 81 patients with a mean study age range of 9.9 to 13.9 years. Both reimplantation (74%) and remodeling (26%) subtypes were done. Range of mean duration of follow-up was 1.2 to 4.4 years. There was no mortality reported until the one-year follow-up period. The long-term mortality rate was calculated as 0.02 per patient-year (95% CI: 0.01-0.05). The long-term reintervention rate was 0.08 per patient-year (95% CI: 0.05-0.13). There is limited experience on aortic valve intervention during aortic root surgery in children. Single-arm studies on valve-sparing surgeries show excellent survival up to one year. Mortality and reintervention rates increase in the longer term. The small sample size and lack of controlled studies do not allow for direct comparisons between procedure types.

Early Valve Replacement for Severe Aortic Valve Disease: Effect on Mortality and Clinical Ramifications.

Timing of aortic valve intervention for chronic aortic regurgitation (AR) and/or aortic stenosis (AS) potentially affects long-term survival. The 2014 American Heart Association/American College of Cardiology (AHA/ACC) guidelines provide recommendations for the timing of intervention. Subsequent to the guidelines’ release, several studies have been published that suggest a survival benefit from earlier timing of surgery for severe AR and/or AS. The aim of this review was to determine whether patients who have chronic aortic regurgitation (AR) and/or aortic stenosis (AS) have a survival benefit from earlier timing of aortic valve surgery. Medical databases were systematically searched from January 2015 to April 2020 for randomized controlled trials (RCTs) and observational studies that examined the timing of aortic valve replacement surgery for chronic AR and/or AS. For chronic AR, four observational studies and no RCTs were identified. For chronic AS, five observational studies, one RCT and one meta-analysis were identified. One observational study examining mixed aortic valve disease (MAVD) was identified. All of these studies, for AR, AS, and MAVD, found long-term survival benefit from timing of aortic valve surgery earlier than the current guidelines. Larger prospective RCTs are required to evaluate the benefit of earlier surgical intervention.

Outcomes of tissue versus mechanical aortic valve replacement in patients 50 to 70 years of age.

Societal guidelines suggest that aortic valve replacement (AVR) in patients age 50 to 70 years can be performed with either bioprosthetic or mechanical valves. This study reviewed outcomes between these valve types among patients aged 50 to 70 years undergoing AVR. We examined adult patients 50 to 70 years undergoing isolated AVR with a mechanical or bioprosthetic valve at a single institution between 2010 and 2018. Kaplan-Meier analysis was used to evaluate longitudinal survival and multivariable Cox regression analysis was used for risk adjustment. A propensity-matched analysis was performed as well. A total of 723 patients underwent isolated AVR with 467 (64.6%) receiving a bioprosthetic valve. At baseline, patients undergoing bioprosthetic AVR were older (median 65 vs 60 years; P < .001). One-year survival was comparable, however, survival at 5 years was significantly higher among patients undergoing mechanical AVR (95.5% vs 82.6%; P = .010). Among the 196 matched pairs, bioprosthetic AVR was associated with an increased adjusted hazard for death (hazards ratio, 3.29; P < .001). Additionally, 5-year freedom from stroke and bleeding were similar following matching, though mechanical AVR was associated with a greater freedom from repeat valve intervention (97.5% vs 92.9%; P = .020). In patients age 50 to 70, mechanical AVR is associated with improved long-term survival and freedom from repeat aortic valve intervention. Further large cohort studies should be performed to explore the potential benefits of mechanical valve replacement in this age range.

Natural History of Asymptomatic Severe Aortic Stenosis and the Association of Early Intervention With Outcomes

Whether intervention should be performed in patients with asymptomatic severe aortic stenosis (AS) remains debated. To meta-analyze the natural history of asymptomatic severe AS and examine the association of early intervention with survival. PubMed, Embase, and Cochrane databases were searched from inception to February 1, 2020. Observational studies of adult patients with asymptomatic severe AS. Two investigators independently extracted study and patient characteristics, follow-up time, events, and prognostic indicators of events. Random-effects models were used to derive pooled estimates. The meta-analysis on natural history was performed on the primary end point of all-cause death occurring during a conservative treatment period, with secondary end points consisting of cardiac death, death due to heart failure, sudden death, development of symptoms, development of an indication for aortic valve intervention, and aortic valve intervention. The primary end point for the meta-analysis of early intervention vs a conservative strategy was all-cause death during long-term follow-up. Finally, meta-analysis was performed on the association of prognostic indicators with the composite of death or aortic valve intervention found in multivariable models. A total of 29 studies with 4075 patients with 11 901 years of follow-up were included. Pooled rates per 100 patients per year were 4.8 (95% CI, 3.6-6.4) for all-cause death, 3.0 (95% CI, 2.2-4.1) for cardiac death, 2.0 (95% CI, 1.3-3.1) for death due to heart failure, 1.1 (95% CI, 0.6-2.1) for sudden death, 18.1 (95% CI, 12.8-25.4) for an indication for aortic valve intervention, 18.5 (95% CI, 13.4-25.5) for development of symptoms, and 19.2 (95% CI, 15.5-23.8) for aortic valve intervention. Early intervention was associated with a significant reduction in long-term mortality (hazard ratio, 0.38; 95% CI, 0.25-0.58). Factors associated with worse prognosis were severity of AS, low-flow AS, left ventricular damage, and atherosclerotic risk factors. Data from observational studies and a recent randomized clinical trial suggest that many patients with asymptomatic severe AS develop an indication for aortic valve intervention, and their deaths are mostly cardiac but not only sudden. Other end points besides sudden death should be considered during the decision to perform early intervention that are associated with improved survival.

Pacing Over the Guidewire in Cardiac Structural Intervention: A Practical Guide

Left ventricular access for aortic valve intervention provides the opportunity to deliver rapid pacing over the guidewire for device positioning and deployment. Temporary pacing delivered via the left ventricle can obviate the need for venous access and has been shown to be a safe alternative to temporary right ventricular pacing. The technique requires some basic knowledge and experience in temporary cardiac pacing. We outline safe practical steps and common pitfalls in using this technique.

Long-term outcomes of sutureless and rapid-deployment aortic valve replacement: a systematic review and meta-analysis.

Sutureless and rapid-deployment aortic valve replacement (SURD-AVR) has become a prominent area of research as the medical community evaluate its place amongst other aortic valve interventions. The main advantages of SURD-AVR established to date are the reduced cross-clamp and cardiopulmonary bypass (CPB) times, as well as facilitating minimally invasive surgery in high-risk surgical patients. This current systematic review and meta-analysis, to our knowledge, is the first focusing on long-term outcomes regarding safety, efficacy and durability of SURD-AVR from available current literature. A literature search via six electronic databases was performed from their inception to November 2019. Inclusion criteria for this systematic review included survival and postoperative echocardiographic outcomes greater than five years in patients who underwent SURD-AVR with either Perceval or Intuity valves. Studies were identified and data extracted by two independent reviewers. Long-term survival outcomes were aggregated using digitized Kaplan-Meier curves where available. After applying predefined inclusion and exclusion criteria, four studies were identified for review. All four studies were observational and in total reported data for 1,998 patients. Almost half (42.4%) of patients underwent SURD-AVR via full sternotomy, with almost one third (30.1%) also undergoing concomitant cardiac procedures. Aggregate overall survival rates at 1-, 2-, 3-, and 5-year follow-up were 94.9%, 91.2%, 89.0%, and 84.2%, respectively. Incidence of strokes (4.8%), severe paravalvular leaks (PVLs) (1.5%) and permanent pacemaker (PPM) insertion (8.2%) at up to 5-year follow-up were acceptable. At 5-year follow-up hemodynamic outcomes were also acceptable for mean pressure gradient (MPG) (range, 8.8-13.6 mmHg), peak pressure gradient (PPG) (range, 18.9-21.1 mmHg) and effective orifice area (EOA) (range, 1.5-1.8 cm2). Evaluation of the evidence reporting long-term outcomes of SURD-AVR suggests that it is a safe procedure for AVR with low rates of complications. Long-term outcomes presented in this review show that not only does SURD-AVR have acceptable survival rates, but also good hemodynamic performance at 5-year follow-up.

Effect of precision nursing model on aortic valve disease in elderly patients at high risk after transapical interventional aortic valve implantation.

article: Effect of precision nursing model on aortic valve disease in elderly patients at high risk after transapical interventional aortic valve implantation - Minerva Medica 2022 October;113(5):901-2 - Minerva Medica - Journals

Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial)

Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. clinicaltrials.gov: NCT04160130.

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

BackgroundThere is limited information on the longer-term outcome after transcatheter aortic valve replacement (TAVR) with new-generation prostheses compared to surgical aortic valve replacement (SAVR). The aim of this study was to compare the mid-term outcomes after TAVR with Sapien 3 and SAVR with Perimount Magna Ease bioprostheses for severe aortic stenosis.MethodsIn a retrospective study, we included patients who underwent transfemoral TAVR with Sapien 3 or SAVR with Perimount Magna Ease bioprosthesis between January 2008 and October 2017 from the nationwide FinnValve registry. Propensity score matching was performed to adjust for differences in the baseline characteristics. The Kaplan-Meir method was used to estimate late mortality.ResultsA total of 2000 patients were included (689 in the TAVR cohort and 1311 in the SAVR cohort). Propensity score matching resulted in 308 pairs (STS score, TAVR 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, p = 0.918). In-hospital mortality was 3.6% after SAVR and 1.3% after TAVR (p = 0.092). Stroke, acute kidney injury, bleeding and atrial fibrillation were significantly more frequent after SAVR, but higher rate of vascular complications was observed after TAVR. The cumulative incidence of permanent pacemaker implantation at 4 years was 13.9% in the TAVR group and 6.9% in the SAVR group (p = 0.0004). At 4-years, all-cause mortality was 20.6% for SAVR and 25.9% for TAVR (p = 0.910). Four-year rates of coronary revascularization, prosthetic valve endocarditis and repeat aortic valve intervention were similar between matched cohorts.ConclusionsThe Sapien 3 bioprosthesis achieves comparable midterm outcomes to a surgical bioprosthesis with proven durability such as the Perimount Magna Ease. However, the Sapien 3 bioprosthesis was associated with better early outcome.Trial registrationClinicalTrials.gov Identifier: NCT03385915.

Impacto de los inhibidores del sistema renina-angiotensina en el pronóstico tras recambio valvular aórtico quirúrgico o percutáneo. Metanálisis

Introduction and objectivesTo determine whether renin-angiotensin system inhibitor (RASi) prescription is associated with better outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). MethodsAll comparative studies of RASi vs no RASi prescription in patients undergoing TAVI/SAVR were gathered from PubMed, Web of Science, and Google Scholar through August, 2019. We extracted hazard ratios (HRs) with their confidence intervals (CIs) for mortality from each study and combined study-specific estimates using inverse variance-weighted averages of logarithmic HRs in the random effects model. ResultsWe identified 6 eligible studies with a total of 21 390 patients (TAVI: 17 846; SAVR: 3544) and included them in the present meta-analysis. The 6 studies were observational comparative studies (including 3 propensity score matched and 3 cohort studies) of RASi vs no RASi prescription. The analysis demonstrated that RASi prescription was associated with significantly lower mortality in the whole group of patients undergoing aortic valve intervention (HR, 0.64; 95%CI, 0.47-0.88; P <.001). However, subgroup analysis suggested differences according to the selected therapy, with TAVI showing better mortality rates in the RASi group (HR, 0.67; 95%CI, 0.49-0.93) but not in the SAVR group (HR, 0.61; 95%CI, 0.29-1.30). No funnel plot asymmetry was identified, suggesting minimum publication bias. Sensitivity analyses sequentially eliminating dissimilar studies did not substantially alter the primary result favoring RASI prescription. ConclusionsThese findings suggest a mortality benefit of RASi in patients with AS treated with aortic valve replacement that might be particularly relevant following TAVI. Future randomized studies are warranted to confirm this relevant finding.

Prognostic value of myocardial fibrosis in severe aortic stenosis: study protocol for a prospective observational multi-center study (FIB-AS)

BackgroundAdverse cardiac remodeling with a myocardial fibrosis as a key pathophysiologic component may be associated to worse survival in aortic stenosis (AS) patients. Therefore, with the application of advanced cardiac imaging we aim to investigate left ventricular myocardial fibrosis in severe AS patients undergoing aortic valve replacement (AVR) and determine its impact with post-intervention clinical outcomes.MethodsIn a prospective, observational, cohort study patients with severe AS scheduled either for surgical or transcatheter AVR will be recruited from two tertiary heart centers in Denmark and Lithuania. All patients will receive standard of care in accordance with the current guidelines and will undergo additional imaging testing before and after AVR: echocardiography with deformation analysis and cardiovascular magnetic resonance (CMR) with T1 parametric mapping. Those undergoing surgical AVR will also have a myocardial biopsy sampled at the time of a surgery for histological validation. Patients will be recruited over a 2-year period and followed up to 2 years to ascertain clinical outcomes. Follow-up CMR will be performed 12 months following AVR, and echocardiography with deformation analysis will be performed 3, 12, and 24 months following AVR. The study primary outcome is a composite of all-cause mortality and major adverse cardiovascular events.DiscussionDespite continuous effort of research community there is still a lack of early predictors of left ventricular decompensation in AS, which could improve patient risk stratification and guide the optimal timing for aortic valve intervention, before irreversible left ventricular damage occurs. Advanced cardiac imaging and CMR derived markers of diffuse myocardial fibrosis could be utilized for this purpose. FIB-AS study is intended to invasively and non-invasively assess diffuse myocardial fibrosis in AS patients and investigate its prognostic significance in post-interventional outcomes. The results of the study will expand the current knowledge of cardiac remodeling in AS and will bring additional data on myocardial fibrosis and its clinical implications following AVR.Ethics/disseminationThe study has full ethical approval and is actively recruiting patients. The results will be disseminated through scientific journals and conference presentations.Trial registrationClinicalTrials.govNCT03585933. Registered on 02 July 2018.

Impact of a nurse-led same day admission pathway on hospital length of stay for transcatheter aortic valve implantation

Background/Aims Patients undergoing transcatheter aortic valve intervention are commonly admitted the day before their procedure. Same-day admission offers a potential approach to reduce length of stay and procedural costs but there are little data on the feasibility and safety of this approach. This study aimed to explore the feasibility and safety of a same-day admission programme facilitated by a specialist nurse for patients undergoing elective transfemoral transcatheter aortic valve implantation. Methods Consecutive patients undergoing transcatheter aortic valve implantation through a standard care pathway (admission to hospital before the day of procedure) from July 2015 to July 2016 were retrospectively compared to those going through a same-day admission pathway from April 2017 to December 2018 at the James Cook University Hospital. Baseline and procedural characteristics, length of stay and clinical outcomes were analysed using chi square, Student's t-test and Mann–Whitney U tests. Results Overall, 121 of 135 (90%) patients were eligible for same-day admission and all underwent successful same-day transcatheter aortic valve implantation. There were 77 patients in the standard care group. Average length of stay in the same-day group was lower than the standard care group (1.5 vs 3.9 days; P&lt;0.01) with no differences in mortality, procedural complications or readmission within 30 days between the two groups. Conclusions Routine same-day admission for transfemoral transcatheter aortic valve implantation facilitated by a specialist nurse can be safely implemented, leading to a shorter length of stay with no detrimental effect on clinical outcomes. This represents a highly effective method of reducing the procedural cost of transcatheter aortic valve implantation.