Low Surgical Risk Research Articles

Association Between Persistent Hypothermia After Cardiopulmonary Bypass in Neonates and Odds of Serious Complications.

Persistent hypothermia after cardiopulmonary bypass (CPB) in neonates with congenital heart defects (CHD) has been historically considered benign despite lack of evidence on its prognostic significance. Examine associations between the magnitude and pattern of unintentional postoperative hypothermia and odds of complications in neonates with CHD undergoing CPB. Retrospective cohort study. Single northeastern U.S., urban pediatric quaternary care center with an established cardiac surgery program. Population-based sample of neonates greater than or equal to 34 weeks gestation undergoing their first CPB between 2015 and 2019. None. Hourly temperature measurements for the first 48 postoperative hours were extracted from inpatient medical records, and clinical characteristics and outcomes were accessed through the local patient registry. Group-based trajectory modeling (GBTM) identified latent temporal temperature trajectories. Associations of trajectories with outcomes were assessed using multivariable binary logistic regression. Outcomes (postoperative complications) were manually adjudicated by experts or were predefined by the patient registry. Four hundred fifty neonates met inclusion criteria. Their mean (sd) gestational age was 38 weeks (1.3), mean (sd) birth weight was 3.19 kilograms (0.55), median (interquartile range) surgical age was 4.7 days (3.3-7.0), 284 of 450 (63%) were male, and 272 of 450 (60%) were White. GBTM identified three distinct curvilinear temperature trajectories: persistent hypothermia (n = 38, 9%), resolving hypothermia (n = 233, 52%), and normothermia (n = 179, 40%). Compared with the normothermic group, those with persistent hypothermia had significantly higher odds of cardiac arrest, actionable arrhythmia, delayed first successful extubation, prolonged cardiac ICU length of stay, very poor weight gain, and 30-day hospital mortality. The persistent hypothermia group was characterized by greater odds of having a lower gestational age, more prevalent neurologic abnormalities, more unplanned reoperations, and a low surgical mortality risk assessment. Persistent postoperative hypothermia in neonates after CPB is independently associated with having greater odds of complications. Recovery patterns from postoperative hypothermia may be a clinically useful marker to identify patient instability in neonates. Additional research is needed for causal modeling and prospective validation before clinical adoption.

The Promise and Perils of Transcatheter Aortic Valve Replacement (TAVR) in Low Surgical Risk Patients with Severe Aortic Stenosis in the Current Era.

Transcatheter Aortic Valve Replacement (TAVR) has become the preferred treatment approach for many patients with symptomatic severe aortic valve stenosis (SsAS), particularly those who are deemed at high surgical risk. However, in low-risk surgical patients (LSRP) with SsAS, the choice between TAVR and surgical aortic valve replacement (SAVR) is often a matter of debate and depends on several clinical and anatomical considerations. Midterm data show similar clinical outcomes and durability of TAVR and SAVR bioprosthetic valves in LRSP. Data on long term durability and outcomes of TAVR in LRSP remains scarce. Both TAVR and SAVR are reasonable options in LRSP with SsAS. Nevertheless, many of these LRSP are expected to outlive their bioprosthetic valves and planning for the second aortic valve replacement should begin at the time of the index procedure with special consideration for coronary re-access, risk for coronary obstruction, and prothesis patient mismatch.

Conduction Abnormalities after Transcatheter Aortic Valve Implantation: Incidence, Impact and Management Using CT Data Interpretation.

The demonstrated safety and effectiveness of transcatheter aortic valve implantation (TAVI) among low surgical risk patients opened the road to its application in younger low-risk patients. However, the occurrence of conduction abnormalities and need for permanent pacemaker implantation remains a frequent problem associated with adverse outcomes. The clinical implications may become greater when TAVI shifts towards younger populations, highlighting the need for comprehensive strategies to address this issue. Beyond currently available clinical and electrocardiographic predictors, patient-specific anatomical assessment of the aortic root using multi-sliced CT (MSCT) imaging can refine risk stratification. Moreover, leveraging MSCT data for computational 3D simulations to predict device-anatomy interactions may help guide procedural strategy to mitigate conduction abnormalities. The aims of this review are to summarise the incidence and clinical impact of new left bundle branch block and permanent pacemaker implantation post-TAVI using contemporary transcatheter heart valves; and highlight the value of MSCT data interpretation to improve the management of this complication.

Short- and intermediate-term outcomes of transcatheter aortic valve replacement in low-risk patients: A meta-analysis and systematic review

BackgroundTranscatheter aortic valve replacement (TAVR) being currently employed in low surgical risk patients with severe symptomatic aortic stenosis (AS). The durability and extended outcomes of TAVR as compared to surgical aortic valve replacement (SAVR) in low-risk patients remains uncertain. MethodsWe selected randomized controlled trials (RCT) comparing outcomes of TAVR vs. SAVR in low surgical risk patients having severe AS using online databases. The primary outcome was all-cause death. The secondary outcomes were composite of all-cause death & disabling stroke, cardiovascular (CV) death, stroke, myocardial infarction (MI), permanent pacemaker (PPM) placement, new onset atrial fibrillation (AF), valve re-intervention and valve thrombosis. The outcomes were stratified at short- (1-year) and intermediate-term (≤5 years) follow-up. We used a random effect model to report outcomes as relative risk (RR) with a 95 % confidence interval (CI). ResultsThe analysis consisted of six RCTs comprising 5,122 subjects with a mean age of 75.4 years. At short-term follow up, there was a significant reduction in all-cause death (RR: 0.62, 0.46–0.82, p = 0.001) and composite of all-cause death and disabling stroke (RR: 0.62, 0.45–0.83, p = 0.002) in patients undergoing TAVR. At intermediate-term follow-up, there was no significant difference in survival (RR:0.95, 0.73–1.24, p = 0.71) and composite outcome (RR: 0.95, 0.74–1.22, p = 0.71). TAVR patients had lower incidence of new onset AF, however, higher PPM placement. ConclusionIn patients with severe AS having low-surgical risk, patients undergoing TAVR had improved short-term survival as compared to SAVR. This survival advantage was absent at intermediate-term follow-up. The long-term outcomes remain uncertain.

Coronary Bypass Surgery Guided By Multislice Computed Tomography Angiography In A Low Surgical Risk Population

Coronary Bypass Surgery Guided By Multislice Computed Tomography Angiography In A Low Surgical Risk Population

Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) now represents the mainstay of treatment for severe aortic stenosis. Owing to its exceptional procedural efficacy and safety, TAVI has been extended to include patients at lower surgical risk, thus now encompassing a diverse patient population receiving this treatment. Yet, long-term outcomes also depend on optimal medical therapy for secondary vascular prevention, with antithrombotic therapy serving as the cornerstone. Leveraging data from multiple randomized controlled trials, the current guidelines generally recommend single antithrombotic therapy, with either single antiplatelet therapy (SAPT) or oral anticoagulation (OAC) alone in those patients without or with atrial fibrillation, respectively. Yet, individualization of this pattern, as well as specific case uses, may be needed based on individual patient characteristics and concurrent procedures. This review aims to discuss the evidence supporting antithrombotic treatments in patients treated with TAVI, indications for a standardized treatment, as well as specific considerations for an individualized approach to treatment.

Transcatheter Aortic Valve Replacement in Low-Risk Patients at Four or More Years

BackgroundTranscatheter aortic valve replacement (TAVR) is accepted as an alternative to surgical aortic valve replacement (SAVR) in patients with severe symptomatic aortic valve stenosis. Prior studies have shown that TAVR has comparable or superior outcomes to SAVR in intermediate and high-risk patients. However, there is paucity of data about outcome of TAVR vs SAVR in low-surgical-risk patients evaluated at 4 or more years post-procedure. MethodsA systematic review of all published randomized controlled trials comparing TAVR and SAVR in low-risk patients was completed. A random-effects model meta-analysis was performed to study major outcomes, including all-cause mortality, stroke, myocardial infarction, and aortic valve reintervention. ResultsThree randomized trials comprising 2644 patients (1371 TAVR and 1273 SAVR) with a mean age of 74.3 ± 5.8 years were included in this analysis. There was no significant difference in all-cause and cardiovascular mortality, stroke, myocardial infarction, or aortic valve reintervention between the TAVR and SAVR groups at long-term follow-up. Transcatheter aortic valve replacement was associated with higher rate of pacemaker implantation, whereas SAVR was associated with more atrial fibrillation. ConclusionsAt 4 or more years of follow-up, TAVR is safe and has comparable outcomes to SAVR in low-surgical-risk patients. Possibility of TAVR and its risks and benefits should be discussed with low-surgical-risk patients.

The Use of Pressure Recording Analytical Method in Patients Undergoing Endovascular Repair for Abdominal Aortic Aneurysm: The Impact on Clinical Decisions for the Appropriate Postoperative Setting and Cost-effective Analysis.

To analyze the use of the Pressure Recording Analytical Method (PRAM), an hemodynamic monitoring system, in evaluating intraoperative and postoperative hemodynamic instability in patients undergoing endovascular repair for abdominal aortic aneurysm, and to evaluate if the decision to refer patients to a ordinary ward or to a Cardiac Step-Down Unit (CSDU) after the intervention on the basis of intraoperative hemodynamic monitoring could be more cost-effective. After preoperative clinical evaluation, 44 patients were divided in this non-randomised study into two groups according to their postoperative destination: Group 1-ward (N=22) and Group 2-CSDU (N=22). All patients underwent monitoring with PRAM during the intervention and in the 24 postoperative hours, measuring several indices of myocardial contractility and other hemodynamic variables. According to the variability of two parameters, Stroke Volume Variation and Pulse Pressure Variation, patients were classified as stable or unstable. Unstable patients showed a significant alteration in several hemodynamic indices, in comparison to stable ones. According to the intraoperative monitoring, eight high risk patients could have been sent to an ordinary ward due to their stability, with a reduction in the improper use of CSDU and, consequently, in costs. Hemodynamic monitoring with PRAM can be useful in these patients, both for intraoperative management and for the choice of the more appropriate postoperative setting, possibly reducing the improper use of CSDU for hemodynamically stable patients who are judged to be at high risk preoperatively, and re-evaluating low surgical risk patients with an unstable intraoperative pattern, with a possible reduction in costs.

Echocardiographic and clinical features of patients developing prosthesis‐patient mismatch after transcatheter aortic valve replacement: Insights from the Recovery-TAVR registry

The impact of prosthesis-patient mismatch (PPM) on major endpoints after transcatheter aortic valve replacement (TAVR) is controversial and the effects on progression of heart damage are poorly investigated. Therefore, our study aims to evaluate the prevalence and predictors of PPM in a "real world" cohort of patients at intermediate and low surgical risk, its impact on mortality and the clinical-echocardiographic progression of heart damage. 963 patients who underwent TAVR procedure between 2017 and 2021, from the RECOVERY-TAVR international multicenter observational registry, were included in this analysis. Multiparametric echocardiographic data of these patients were analyzed at 1-year follow-up (FU). Clinical and echocardiographic features were stratified by presence of PPM and PPM severity, as per the most current international recommendations, using VARC-3 criteria. 18% of patients developed post-TAVR. PPM, and 7.7% of the whole cohort had severe PPM. At baseline, 50.3% of patients with PPM were male (vs 46.2% in the cohort without PPM, P = .33), aged 82 (IQR 79-85y) years vs 82 (IQR 78-86 P = .46), and 55.6% had Balloon-Expandable valves implanted (vs 46.8% of patients without PPM, P = .04); they had smaller left ventricular outflow tract (LVOT) diameter (20 mm, IQR 19-21 vs 20 mm, IQR 20-22, P = .02), reduced SVi (34.2 vs 38 mL/m2, P < .01) and transaortic flow rate (190.6 vs 211 mL/s, P < .01). At predischarge FU patients with PPM had more paravalvular aortic regurgitation (moderate-severe AR 15.8% vs 9.2%, P < .01). At 1-year FU, maladaptive alterations of left ventricular parameters were found in patients with PPM, with a significant increase in end-systolic diameter (33 mm vs 28 mm, P = .03) and a significant increase in left ventricle end systolic indexed volume in those with moderate and severe PPM (52 IQR 42-64 and 52, IQR 41-64 vs 44 IQR 35-59 in those without, P = .02)). No evidence of a significant impact of PPM on overall (P = .71) and CV (P = .70) mortality was observed. Patients with moderate/severe PPM had worse NYHA functional class at 1 year (NYHA III-IV 13% vs 7.8%, P = .03). Prosthesis size≤23 mm (OR 11.6, 1.68-80.1) was an independent predictor of PPM, while SVi (OR 0.87, 0.83-0.91, P < .001) and LVOT diameter (OR 0.79, 0.65-0.95, P = .01) had protective effect. PPM was observed in 18% of patients undergoing TAVR. Echocardiographic evaluations demonstrated a PPM-related pattern of early ventricular maladaptive alterations, possibly precursor to a reduction in cardiac function, associated with a significant deterioration in NYHA class at 1 year. These findings emphasize the importance of prevention of PPM of any grade in patients undergoing TAVR procedure, especially in populations at risk.

TAVI transcarotídeo: la técnica paso a paso

Introduction and objectivesTranscatheter aortic valve implantation as a treatment for aortic stenosis is positioned as the therapy of choice for a specific population of patients, which is steadily increasing and is no longer limited to patients with prohibitively high surgical risk. This stems from the advancement and refinement of devices, as well as the development of different access routes. Our goal is to share and standardize the transcarotid access technique, which we have implemented and developed since 2019 with very good results. Method and resultsBetween 01/01/2019 and 31/12/2023, 79 transcatheter valves were implanted via the carotid route (21.43% of the total implants in our center), with no intraoperative mortality and less than 1% mortality during the first month of intervention. The incidence of established strokes in these patients is 0%. ConclusionsWe have adopted the transcarotid route as an equally valid alternative to the transaxillary access. Due to recent changes in patient selection criteria, we believe that the cardiovascular surgeon should have an active role in decision-making and implantation of this type of prosthesis, since many patients have low surgical risk and are consequently susceptible to intervention in case of procedure complications.

Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients: An Updated Metanalysis of Extended Follow-Up Randomized Controlled Trials

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm2/m2, 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

E-29 | Analysis of Procedure Volume and Outcomes of Surgical and Transcatheter Aortic Valve Replacement following Regulatory Approval of low-surgical risk patients

E-29 | Analysis of Procedure Volume and Outcomes of Surgical and Transcatheter Aortic Valve Replacement following Regulatory Approval of low-surgical risk patients

Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan

Objective To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective. Methods A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9–1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health. Results In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses. Conclusions TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.

Catheter-based and surgical treatment for aortic valve diseases

The pathophysiology of aortic valve diseases is of predominantly degenerative nature, characterized by calcific aortic valve stenosis, which is associated with areduction in prognosis. The prevalence of aortic valve insufficiency also increases with advancing age. Timely causal treatment is crucial in the management of aortic valve diseases. Following the indication for intervention, the heart team plays acentral role in evaluating the results and making therapeutic decisions that consider the patient's preferences. In the assessment of treatment options, considerations regarding the long-term perspective are particularly crucial, especially in younger patients. The most common therapeutic approach for aortic valve diseases is the introduction of anew valve prosthesis. In the majority of cases, this is now achieved through catheter-based implantation of abioprosthetic heart valve, known as transcatheter aortic valve implantation (TAVI). Open surgical aortic valve replacement (AVR) is favored in younger patients with low surgical risk or in the case that TAVI is not feasible. In AVR, both biological and the longest-lasting mechanical prosthesis types are used. Surgical repair techniques are primarily applied in cases of aortic valve regurgitation. Notably, TAVI, as well as surgical procedures for the treatment of aortic valve diseases, have undergone significant advancements in recent years, including expanded indications for TAVI and, on the surgical side, in particular the development of minimally invasive surgical techniques.

Transcatheter or Surgical Aortic Valve Replacement in Women With Small Annuli at Low or Intermediate Surgical Risk

There are limited data from randomized controlled trials assessing the impact of transcatheter aortic valve replacement (TAVR) or surgery in women with aortic stenosis and small aortic annuli. We evaluated 2-year clinical and hemodynamic outcomes after aortic valve replacement to understand acute valve performance and early and midterm clinical outcomes. This post hoc analysis pooled women enrolled in the randomized, prospective, multicenter Evolut Low Risk and Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) intermediate risk trials. Women with severe aortic stenosis at low or intermediate surgical risk who had a computed tomography-measured annular perimeter of ≤72.3 mm were included and underwent self-expanding, supra-annular TAVR or surgery. The primary end point was 2-year all-cause mortality or disabling stroke rate. The study included 620 women (323 TAVR, 297 surgery) with a mean age of 78 years. At 2 years, the all-cause mortality or disabling stroke was 6.5% for TAVR and 8.0% for surgery, p = 0.47. Pacemaker rates were 20.0% for TAVR and 8.3% for surgery, p <0.001. The mean effective orifice area at 2 years was 1.9 ± 0.5 cm2 for TAVR and 1.6 ± 0.5 cm2 for surgery and the mean gradient was 8.0 ± 4.1 versus 12.7 ± 6.0 mm Hg, respectively (both p <0.001). Moderate or severe patient-prothesis mismatch at discharge occurred in 10.9% of patients who underwent TAVR and 33.2% of patients who underwent surgery, p <0.001. In conclusion, in women with small annuli, the clinical outcomes to 2 years were similar between self-expanding, supra-annular TAVR and surgery, with better hemodynamics in the TAVR group and fewer pacemakers in the surgical group.

One-stage or two-stage elective coronary artery bypass graft surgery and abdominal aortic aneurysm open repair in low and moderate cardiac surgical risk patients.

One-stage or two-stage elective coronary artery bypass graft surgery and abdominal aortic aneurysm open repair in low and moderate cardiac surgical risk patients.

Transcatheter Heart Valves—An Update on Types of Valves Available, Hardware Characteristics, and Patient Selection: An Indian Perspective

Transcatheter aortic valve implantation has taken the world by storm. The past decade saw expanding indications of Transcatheter aortic valve implantation to include patients at low surgical risk for surgical aortic valve replacement, patients with degenerated aortic bioprosthesis, and repurposing existing transcatheter aortic valves to treat pathology involving other valves. Also around the same time, various iterations of existing transcatheter heart valves and newly launched valves were made available for human use in India. This article highlights salient features of all the commercially available transcatheter heart valves in India. The article also provides a narrative to help a cardiologist choose a particular valve that would best suit the patient taking into account the valve design characteristics and features.

Current status of surgical treatment for angular kyphosis in spinal tuberculosis

To review current status of surgical treatment for angular kyphosis in spinal tuberculosis and provide reference for clinical treatment. The literature on the surgical treatment for angular kyphosis of spinal tuberculosis in recent years was extensively reviewed and summarized from the aspects of surgical indications, surgical contraindications, surgical approach, selection of osteotomy, and perioperative management. Angular kyphosis of spine is a common complication in patients with spinal tuberculosis. If kyphosis progresses gradually, it is easy to cause neurological damage, deterioration, and delayed paralysis, which requires surgical intervention. At present, surgical approaches for angular kyphosis of the spine include anterior approach, posterior approach, and combined anterior and posterior approaches. Anterior approach can be performed for patients with severe spinal cord compression and small kyphotic Cobb angle. Posterior approach can be used for patients with large kyphotic Cobb angle but not serious neurological impairment. A combined anterior and posterior approaches is an option for spinal canal decompression and orthosis. Osteotomy for kyphotic deformity include Smith-Peterson osteotomy (SPO), pedicle subtraction osteotomy (PSO), vertebral column resection(VCR), vertebral column decancellation (VCD), posterior vertebral column resection (PVCR), deformed complex vertebral osteotomy (DCVO), and Y-shaped osteotomy. SPO and PSO are osteotomy methods with relatively low surgical difficulty and low surgical risks, and can provide 15°-30° angular kyphosis correction effect. VCR or PVCR is a representative method of osteotomy and correction. The kyphosis correction can reach 50° and is suitable for patients with severe angular kyphosis. VCD, DCVO, and Y-shaped osteotomy are emerging surgical techniques in recent years. Compared with VCR, the surgical risks are lower and the treatment effects also improve to varying degrees. Postoperative recovery is also a very important part of the perioperative period and should be taken seriously. There is no consensus on the choice of surgical treatment for angular kyphosis in spinal tuberculosis. Osteotomy surgery are invasive, which is a problem that colleagues have always been concerned about. It is best to choose a surgical method with less trauma while ensuring the effectiveness.

Long-term prognostic value of the H2FPEF score in patients undergoing transcatheter aortic valve implantation.

A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H2FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI. Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF≥50% (median age: 85years, 72% female) were selected for calculation of the H2FPEF score and were dichotomized into two groups: the low H2FPEF score [0-5 points; n=1399 (83.6%)] group and the high H2FPEF score [6-9 points; n=275 (16.4%)] group. Patients with high H2FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P<0.001), diabetes (24.4% vs. 18.5%, P=0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P<0.001). These patients showed worse prognoses than those with low H2FPEF scores regarding the cumulative 2year all-cause mortality (26.3% vs. 15.5%, log-rank P<0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P<0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P<0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P<0.001). After adjustment for several confounders, the high H2FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P=0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P<0.001). Subgroup analysis confirmed the excess risk of high H2FPEF scores relative to low H2FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P<0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P=0.28; Pinteraction=0.030). The H2FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H2FPEF scores, particularly in those with a lower surgical risk.

Transcatheter or Surgical Treatment of Aortic-Valve Stenosis

BackgroundAmong low-risk patients with severe, symptomatic aortic stenosis who are eligible for both transcatheter aortic-valve implantation (TAVI) and surgical aortic-valve replacement (SAVR), data are lacking on the appropriate treatment strategy in routine clinical practice.MethodsIn this randomized noninferiority trial conducted at 38 sites in Germany, we assigned patients with severe aortic stenosis who were at low or intermediate surgical risk to undergo either TAVI or SAVR. Percutaneous- and surgical-valve prostheses were selected according to operator discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at 1 year.ResultsA total of 1414 patients underwent randomization (701 to the TAVI group and 713 to the SAVR group). The mean (±SD) age of the patients was 74±4 years; 57% were men, and the median Society of Thoracic Surgeons risk score was 1.8% (low surgical risk). The Kaplan–Meier estimate of the primary outcome at 1 year was 5.4% in the TAVI group and 10.0% in the SAVR group (hazard ratio for death or stroke, 0.53; 95% confidence interval [CI], 0.35 to 0.79; P<0.001 for noninferiority). The incidence of death from any cause was 2.6% in the TAVI group and 6.2% in the SAVR group (hazard ratio, 0.43; 95% CI, 0.24 to 0.73); the incidence of stroke was 2.9% and 4.7%, respectively (hazard ratio, 0.61; 95% CI, 0.35 to 1.06). Procedural complications occurred in 1.5% and 1.0% of patients in the TAVI and SAVR groups, respectively.ConclusionsAmong patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year. (Funded by the German Center for Cardiovascular Research and the German Heart Foundation; DEDICATE-DZHK6 ClinicalTrials.gov number, NCT03112980.)