Low Surgical Risk Research Articles

Mechanical Thrombectomy for Transcatheter Aortic Valve Insertion (TAVI)-Related Periprocedural Stroke: Current Literature and Future Directions

Transcatheter aortic valve implantation (TAVI) has dramatically altered the treatment of high-risk patients with symptomatic, severe aortic stenosis. Its utilisation has also begun to extend into intermediate- and low-surgical risk patients. Despite major advancements in the field of TAVI, stroke remains a significant complication because of its high mortality and morbidity rate . This article reviews the role of mechanical thrombectomy (MT) in the management of TAVI-related periprocedural stroke. A comprehensive literature search was performed for studies to include in this systematic review of MT in periprocedural and post-TAVI stroke patients. The search identified 11 case reports in which MT was utilised to treat periprocedural stroke successfully. MT without thrombolysis has several potential benefits for TAVI-related periprocedural stroke because a large proportion of strokes are secondary to nonthrombotic emboli and there is a high bleeding risk associated with patients undergoing TAVI. The authors propose that centres undertaking TAVI procedures have dedicated thrombolysis and thrombectomy pathways for patients who experience a TAVI-related periprocedural stroke.

Early de-tethering: analysis of urological and clinical consequences in a series of 40 children.

Early de-tethering procedures are performed on spinal dysraphisms to prevent neuro-urological deterioration caused by growth. Partial lipoma removal may cause delayed deterioration by re-tethering, while complete removal may increase the risk of postoperative worsening. The present study evaluates the risk of postoperative deterioration and the protective potential of intraoperative neurophysiological monitoring (IOM), with a special reference to the conus lipomas treated with the radical approach. Forty toddlers (< 24months) underwent complete perioperative neurological and urological assessment, including urodynamic study (UDS). The dysraphisms were subgrouped according to Pang's classification. IOM was applied in all patients: transcranial motor evoked potentials (tMep) combined with mapping were recorded in all cases while bulbocavernosus reflex (BCR) was evaluable just in 7 cases. At preoperative evaluation, 11 children already had UDS impairment and 2 had motor disturbances before neurosurgery. At 1-month follow-up, preoperative motor disturbances were stable, 7/11 UDS alterations normalized, and the remaining 4 were stable. At 6-month follow-up, all motor deficits and 8/11 preoperative UDS alterations had improved. Unfortunately, 7 children with previously normal UDS experienced a new impairment after surgery: 2/7 normalized while 5/7 did not recover. This postoperative permanent urodynamic impairment occurred in 4 chaotic lipoma (CLchaos) and in one terminal myelocystocele (TMC) that means a surgical deterioration rate of 22% for the high risk cases. This small highly selected series confirms that early de-tethering may stop or revert the spontaneous neuro-urological deterioration: in fact, preoperative UDS impairment was frequent (27.5%) and improved in all the low surgical risk cases (limited dorsal myeloschisis, filar, transitional and dorsal lipomas). On the contrary, in CLchaos and TMC, early de-tethering was unable to revert preoperative UDS impairment, and radical surgery carried a high risk of new neuro-urological deterioration directly caused by the operation. In our experience, IOM had a protective role for motor functions, while it was less effective for the neuro-urological ones, probably due to the anesthesiology regimens applied. In conclusion, among the dysraphisms, CLchoas proved to be the worst enemy that often camouflages at MRI. Affording it without all possible IOM weapons carries a high risk to harm the patient.

Transcatheter Versus Surgical Aortic Valve Replacement: An Updated Systematic Review and Meta-Analysis With a Focus on Outcomes by Sex

Women at increased surgical risk have been shown to have better outcomes with transcatheter aortic valve implantation (TAVI) as compared to surgical valve replacement (SAVR). With the scope of TAVI moving into low-surgical risk patients, we aimed to update the current literature to include the new low-risk randomised controlled trial (RCT) data in investigating outcomes by sex. We systematically searched MEDLINE (Ovid), PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and reference lists for relevant RCTs comparing TAVI to SAVR published prior to 4 May 2020. Data extraction was performed by two independent authors and included trial design details, baseline characteristics and outcome data stratified by sex. Risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB 2) tool. Quantitative synthesis of pooled data was performed using Mantel-Haenszel fixed or random effects model. Q-statistic and the I2 test were used for assessment of heterogeneity. Our search yielded eight RCTs included in the final quantitative synthesis. The overall pooled cohort was 8,040, of whom 41.4% were female. Women had significantly lower rates of one-year all-cause mortality (12.2% vs 17.7%, pooled OR 0.59, 95% CI 0.40-0.86) and one-year composite endpoint (9.7% vs 12.4%, pooled OR 0.73, 95% CI 0.58-0.92) with TAVI as compared to SAVR. The selective mortality benefit with TAVI over SAVR in women did not persist to 5 years (pooled HR 1.01, 95% CI 0.87-1.17). At 30 days, women demonstrated lower rates of major bleeding and acute kidney injury following TAVI compared to SAVR. For men, these outcomes were similar regardless of type of intervention. Both sexes were at increased risk of major vascular complications with TAVI as compared to SAVR, however women demonstrated nearly double the odds of major vascular complication with TAVI compared to men. Our updated meta-analysis demonstrates that at one-year women undergoing TAVI have significantly lower mortality and better safety outcomes compared to those undergoing SAVR. These benefits are not seen in men. In the new low-risk era, these results are ever more important for guiding appropriate patient selection.

Surgical vs transfemoral aortic valve replacement in low-risk patients: An updated meta-analysis of trial and registry data.

Transfemoral aortic valve replacement (TAVR) has been studied extensively in patients with improving safety and efficacy in high to intermediate-risk patients with aortic stenosis. TAVR has been now approved for patients with low surgical risk. The purpose of this study is to integrate the evidence from randomized controlled trials (RCT) and large registry data comparing TAVR to surgical aortic valve repair (SAVR). Seven studies (three RCTs, one post hoc study of a RCT, and three registries) were included. Incidence rate ratios (IRR) of outcomes of interest (overall mortality, 30-day mortality, cardiovascular death, stroke, pacemaker implantation [PPMI], myocardial infarction, moderate-severe paravalvular leak [PVL], and re-intervention) were compared using a random-effects model. The pooled analysis included 24 819 patients (TAVR, 8227 and SAVR, 16 592). 2,952 (11.9%) patients were from RCTs and 21 867 (88.1%) were registry patients. Thirty-day mortality was lower in TAVR (logIRR, -0.43; 95% CI. -0.61 to -0.25; P < .001), whereas the rate of moderate-severe PVL (logIRR, 1.44; 95% CI, 0.58-2.3; P < .001) and PPMI (logIRR, 1.13; 95% CI, 1.02-1.24; P < .001) were higher. There were no significant differences in the rates of overall mortality, reintervention, cardiovascular death, myocardial infarction, or stroke between SAVR and TAVR. Early mortality is higher in SAVR while rates of PVL and PPMI are substantially higher in TAVR. There is no significant advantage with TAVR for overall survival, cardiovascular death, stroke, MI, and re-intervention rates.

The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis.

The economic value of transcatheter aortic valve replacement (TAVR) in low surgical risk patients with severe, symptomatic aortic stenosis is not known. Our objective was to determine the cost-effectiveness of balloon-expandable TAVR and self-expandable TAVR relative to surgical aortic valve replacement (SAVR) in low-risk patients. A fully probabilistic Markov cohort model was constructed to estimate differences in costs and effectiveness [quality-adjusted life years (QALYs)] over the patient's life-time time from the third-party payer's perspective. Clinical outcomes modelled were alive/well (no complications), permanent stroke, ≥moderate paravalvular leak, new pacemaker, rehospitalization, and death. A network meta-analysis of the PARTNER 3 and Evolut Low Risk trial was performed to compare balloon-expandable TAVR, self-expandable TAVR, and SAVR for the efficacy inputs. Incremental-cost effectiveness ratios (ICER) were calculated. The total life-time costs in the balloon-expandable TAVR, self-expandable-TAVR, and SAVR arms were $37 330 ± 4724, $39 660 ± 4862, and $34 583 ± 6731, respectively, and total life-time QALYs gained were 9.15 ± 3.23, 9.13 ± 3.23, and 9.05 ± 3.20, respectively. The ICERs for balloon-expandable TAVR and self-expandable TAVR against SAVR were $27 196/QALY and $59 641/QALY, respectively. Balloon-expandable TAVR was less costly and more effective than self-expandable TAVR. There was substantial uncertainty, with 53% and 58% of model iterations showing balloon-expandable TAVR to be the preferred option at willingness-to-pay thresholds of $50 000/QALY and $100 000/QALY, respectively. Compared with SAVR, TAVR, particularly with balloon-expandable prostheses may be a cost-effective option for patients with severe aortic stenosis at low surgical risk.

Myval Transcatheter Heart Valve System in the Treatment of Severe Symptomatic Aortic Stenosis

The transcatheter aortic valve replacement (TAVR) is an established treatment for patients with severe symptomatic aortic stenosis (AS) at prohibitive risk for surgery. It is an alternative treatment to surgical aortic valve replacement in patients with AS at intermediate- and high-surgical risk. Although regulatory authorities extend the indications of TAVR to treat patients at low-surgical risk, the limitations of earlier-generation transcatheter heart valve (THV) systems accelerate the development of improved newer generation of THV systems. Myval™ THV (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) is a newer-generation, balloon-expandable TAVR system with features that facilitate accurate positioning of the bioprosthetic valve and favorable procedural and clinical outcomes. This review summarizes existing preclinical and clinical data on Myval THV for the intervention of symptomatic native AS and lays out the plan for future research program.

Conduction disturbances in low-surgical-risk patients undergoing transcatheter aortic valve replacement with self-expandable or balloon-expandable valves.

Despite a considerable improvement in TAVR devices and procedures, together with a reduction in procedural complications, the rate of conduction disturbances (CD) remained stable over the years. Indeed, the CD rate is still significantly higher than in surgical aortic valve replacement, and represents one of the main limitations to the expansion of TAVR to younger low-risk patients. The aim of the present study was to assess the incidence and predictors of CD in low-risk patients undergoing TAVR. Among 637 patients without preexisting CD who underwent TAVR, 116 (18.2%) were considered at low surgical risk. Up to 25% of low-risk patients presented with persistent CD at discharge. The pacemaker implantation rate was similar in the low-risk group compared to the intermediate-/high-risk group (8.7% vs 10.6%, p = 0.55). Moreover, the rate of new persistent left bundle branch block (LBBB) following TAVR was also similar between both groups (18.1% vs 22.1%, p = 0.34). At 1-year follow-up, LBBB was persistent in 62.5% of patients and 3 of them required a pacemaker implantation. Depth of valve implantation, baseline QRS duration and mean aortic transvalvular gradient were identified as independent predictors of CD in low-risk patients. Patients at low surgical risk showed an equivalent CD rate than intermediate-/high-risk patients. The depth of valve implantation was the main predictor of CD in low-risk patients undergoing TAVR. Baseline QRS duration and mean aortic transvalvular gradient were also associated with increased CD.

Association between surgical risk and 30-day stroke after transcatheter versus surgical aortic valve replacement: a systematic review and meta-analysis.

Stroke is a feared complication of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). With this meta-analysis we aimed to evaluate the incidence of 30-day stroke with TAVR and SAVR focusing on its possible correlation with surgical risk. Major electronic databases were searched for studies published between January 2002 and October 2019 reporting the rates of 30-day stroke after TAVR and SAVR. Data were pooled using fixed- and random-effects models. The primary outcome of the study was stroke rate within 30-day from TAVR or SAVR. Results were stratified according to surgical risk score (high, intermediate and low). A total of 23 studies were identified (TAVR: 14,589 patients; SAVR: 11,681 patients). Regardless of the model used, in the overall population TAVR was associated with a significant reduction in the risk of stroke compared with SAVR (fixed effect: OR 0.78, 95% CI 0.66-0.92, p = .003; random-effects: OR 0.80, 95% CI 0.64-1.00, p = .045). Rates of 30-day stroke after TAVR and SAVR were not significantly different in the high- (OR 1.01, 95% CI 0.44-1.98, p = .105) and intermediate-risk groups (OR 0.92, 95% CI 0.63-1.36, p = .319), while low-risk patients had a lower rate of 30-day stroke after TAVR than SAVR (OR 0.65, 95% CI 0.50-0.83, p < .001). Meta-regression showed a significant association between surgical risk score and 30-day stroke rate (p = .007). TAVR is associated with a lower risk of 30-day stroke compared with SAVR, mainly as a result of the significant advantage observed in patients at low surgical risk.

Impact of Transcatheter Aortic Valve Durability on Life Expectancy in Low-Risk Patients With Severe Aortic Stenosis.

Recent clinical trial results showed that transcatheter aortic valve replacement (TAVR) is noninferior and may be superior to surgical aortic valve replacement (SAVR) for mortality, stroke, and rehospitalization. However, the impact of transcatheter valve durability remains uncertain. Discrete event simulation was used to model hypothetical scenarios of TAVR versus SAVR durability in which TAVR failure times were varied to determine the impact of TAVR valve durability on life expectancy in a cohort of low-risk patients similar to those in recent trials. Discrete event simulation modeling was used to estimate the tradeoff between a less invasive procedure with unknown valve durability (TAVR) and that of a more invasive procedure with known durability (SAVR). Standardized differences were calculated, and a difference >0.10 was considered clinically significant. In the base-case analysis, patients with structural valve deterioration requiring reoperation were assumed to undergo a valve-in-valve TAVR procedure. A sensitivity analysis was conducted to determine the impact of TAVR valve durability on life expectancy in younger age groups (40, 50, and 60 years). Our cohort consisted of patients with aortic stenosis at low surgical risk with a mean age of 73.4±5.9 years. In the base-case scenario, the standardized difference in life expectancy was <0.10 between TAVR and SAVR until transcatheter valve prosthesis failure time was 70% shorter than that of surgical prostheses. At a transcatheter valve failure time <30% compared with surgical valves, SAVR was the preferred option. In younger patients, life expectancy was reduced when TAVR durability was 30%, 40%, and 50% shorter than that of surgical valves in 40-, 50-, and 60-year-old patients, respectively. According to our simulation models, the durability of TAVR valves must be 70% shorter than that of surgical valves to result in reduced life expectancy in patients with demographics similar to those of recent trials. However, in younger patients, this threshold for TAVR valve durability was substantially higher. These findings suggest that durability concerns should not influence the initial treatment decision concerning TAVR versus SAVR in older low-risk patients on the basis of current evidence supporting TAVR valve durability. However, in younger low-risk patients, valve durability must be weighed against other patient factors such as life expectancy.

Experiência inicial com acesso alternativo via tronco braquiocefálico para implante transcateter de válvula aórtica

ABSTRACT Transcatheter aortic valve replacement is indicated as an alternative to conventional surgical treatment for elderly patients with low, moderate, and high surgical risk, or as the best therapeutic strategy for patients considered inoperable. The transfemoral vascular access is the preferred route for replacement. However, in a small portion of the population, this access is not possible for anatomical reasons. Access through the brachiocephalic trunk may be an option in specific cases. Nevertheless, data on feasibility and safety of this [...]

Cochrane corner: transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk.

Aortic valve stenosis (AS) is a growing health problem worldwide, especially in elderly populations.1 Its severity is classified by a number of clinical and echocardiographic parameters into mild, moderate and severe AS. The latter, if left untreated, can be deleterious to the affected individuals’ quality of life and may ultimately be fatal.1 Clinical manifestations of severe AS include exertional dyspnoea, chest pain and syncope.1 Surgical aortic valve replacement (SAVR) has long been the classical treatment modality for severe, symptomatic AS. SAVR has been proven to alleviate symptoms and prolong survival, rendering it the standard of care.2 In the current era, with the rapidly evolving technology and growing momentum towards minimally invasive procedures, transcatheter aortic valve implantation (TAVI) has emerged as a viable, alternative treatment option.3 TAVI has demonstrated outcomes comparable to SAVR in patients who are deemed inoperable or at a high to intermediate surgical risk.2 Nonetheless, whether TAVI improves outcomes in patients who are deemed to have a low surgical risk remains a matter of debate. Accordingly, in our Cochrane review,4 we sought to assess the comparative outcomes of TAVI and SAVR for severe AS in people with low surgical risk. We conducted an exhaustive literature search for randomised controlled trials (RCTs) comparing TAVI and SAVR for severe AS in patients with low surgical risk. We included adults (≥18 years old) of both sexes. The low surgical risk was defined as a Society of Thoracic Surgery (STS) risk score or European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of <4%. We searched the following databases on 29 April 2019: Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Web of Science Core Collection, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform. We performed the search from inception to present with no …

Integration of the Intrinsic Surgical Risk With Patient Comorbidities and Severity of Congenital Cardiac Disease Does Not Improve Risk Stratification in Children Undergoing Noncardiac Surgery.

The objective of this study is to estimate the surgical risk of noncardiac procedures on the incidence of 30-day mortality in children with congenital heart disease. Children with congenital heart disease undergoing noncardiac surgery from 2012 to 2016 and included in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Pediatric database were included in the derivation cohort, while the 2017 database was used as a validation cohort. Intrinsic surgical risk quartiles were built utilizing 30-day mortality rates for each Current Procedural Terminology code and relative value units to create 2 groups defined as low surgical risk (quartiles 1-3) and high surgical risk procedures (quartile 4). We used multivariable logistic regression to determine the predictors for 30-day mortality including patient comorbidities and intrinsic surgical risk. A partially external validation of the model was performed using the 2017 version of the database. We included 37,658 children with congenital heart disease undergoing noncardiac surgery with an incidence of overall 30-day mortality of 1.7% in the derivation cohort and 1.5% in the validation cohort (n = 13,129). Intrinsic surgical risk of procedures represented by Current Procedural Terminology procedural codes and relative value units risk quartiles was significantly associated with 30-day mortality (unadjusted P < .001). Predicted probability of 30-day mortality ranges from 0.2% (95% confidence interval [CI], 0.2-0.2) with no comorbidities to 39.6% (95% CI, 23.2-56.0) when all comorbidities were present among high surgical risk procedures and from 0.3% (95% CI, 0.3-0.3) to 54.8% (95% CI, 39.4-70.1) among low surgical risk procedures. An excellent discrimination was reported for the multivariable model with area under the curve (AUC) of 0.86 (95% CI, 0.85-0.88). High surgical risk was not associated with increased odds of 30-day mortality after adjustment for all other predictors (adjusted odds ratio [OR]: 0.75, 95% CI, 0.62-0.91). We also estimated the discriminative ability of a model that does not include the surgical risk (0.86 [95% CI, 0.84-0.88], with P value for the direct comparison of the AUC of the 2 models = 0.831). The multivariable model obtained from an external validation cohort reported an optimism corrected AUC of 0.88 (95% CI, 0.85-0.91). Our study demonstrates that integration of intrinsic surgical risk to comorbidities and severity of cardiac disease does not improve prediction of 30-day mortality in children undergoing noncardiac surgery. In children with congenital heart disease, patient comorbidities, and severity of the cardiac lesion are the predominant predictors of 30-day mortality.

Early Feminizing Genitoplasty in Girls with Congenital Adrenal Hyperplasia (CAH)—Analysis of Unified Surgical Management

Aim: To analyze a single-centre experience in feminizing genitoplasty in virilized girls with congenital adrenal hyperplasia (CAH). Methods: Review of medical records of all 46, XX CAH patients undergoing single stage feminizing genitoplasty between 2003 and 2018 was performed. Results: A total of 31 girls aged from 4 months to 10 years were included in the study. The majority (n = 26/31, 84%) were operated before 2 years of age (median 8 months). External virilization was rated as Prader 3 (n = 7/31), Prader 4 (n = 21/31) and Prader 5 (n = 3/31). The urethrovaginal confluence location was low in 19 and high in 12 girls with a percentage distribution similar in Prader 4 and 5 (p > 0.05) but significantly different in Prader 3 (p = 0.017). The follow-up ranged from 12 months to 15 years. All parents assessed the cosmetic result as satisfactory. Perioperative complications occurred in two patients and included rectal injury (n = 1/31) and prolonged bleeding (n = 1/31). Three patients developed late complications including labial atheromas (n = 2/31) and vaginal stricture requiring surgical dilatation (n = 1/31). Low confluence did not decrease the risk of complications. Conclusions: Early feminizing genitoplasty in girls with congenital adrenal hyperplasia, irrespective of virilization severity, gives satisfactory cosmetic results and is characterized by low and acceptable surgical risk. Nevertheless, the most important determinant of the effectiveness of such management would be future patients’ satisfaction.

A Global Vascular Guidelines–Based Bypass-Preferred Population and Their Surgical Risk Among CLTI Patients Treated With Endovascular Therapy in a Real-World Practice

Purpose: To determine in a chronic limb-threatening ischemia (CLTI) population who underwent endovascular therapy (EVT) how many patients would have been categorized as preferred for bypass surgery according to the Global Vascular Guidelines (GVG) and ascertain their surgical risk. Materials and Methods: The current study analyzed 1043 CLTI patients who presented WIfI (wound, ischemia, and foot infection) stage ≥2 and underwent EVT between April 2010 and December 2017. Of these, 176 were excluded for lack of angiographic or other data, leaving 867 CLTI patients (mean age 74±10 years; 523 men) for stratification according to the GVG into bypass-preferred, indeterminate, or EVT-preferred groups. The GVG recommend bypass as the first-line treatment when the wound is severe (WIfI stage ≥3) and lesions are complex (GLASS stage III). Surgical risk was estimated using the modified PREVENT III risk score. To further stratify the bypass-preferred population according to mortality risk, a survival decision tree was constructed using recursive partitioning. Results: The bypass-preferred group accounted for 55% [95% confidence interval (CI) 51% to 58%] of the overall population. The decision tree analysis extracted a low-mortality risk subgroup with a survival rate of 99% (95% CI 98% to 100%) at 1 month and 80% (95% CI 73% to 87%) at 2 years. According to the PREVENT III score, 34% (95% CI 27% to 42%) of the low mortality risk subgroup were classified as high surgical risk. Conclusion: A high proportion of patients undergoing EVT were considered bypass preferred based on the GVG, and the survival of these patients was not significantly different whether they were high or low surgical risk.

WITHDRAWN: Commentary: What pooling data tells us, or not, about using TAVR in the population at low surgical risk for mortality

WITHDRAWN: Commentary: What pooling data tells us, or not, about using TAVR in the population at low surgical risk for mortality

How does transcatheter aortic valve implantation compare with surgical aortic valve replacement for adults with severe aortic stenosis at low surgical risk?

How does transcatheter aortic valve implantation compare with surgical aortic valve replacement for adults with severe aortic stenosis at low surgical risk?

Perineural fat grafting in end-neuroma pain treatment: long-term outcomes

Peripheral painful end-neuromas decrease quality of life significantly. Drug-resistant painful neuromas often require surgical treatment, nevertheless there is no actual gold standard. We retrospectively analyzed 26 patients suffering from painful end-neuromas treated with neuroma excision followed by the perineural fat grafting (PFG). We evaluated the improvement in pain, disability, and quality of life on the long term.All patients were referred to our department between 2009 and 2017. “Visual analogue scale (VAS)”; “disability of the arm, shoulder, and hand (DASH)”; and “World Health Organization Quality of Life (WHOQOL) index” were systematically scored before each surgical intervention and re-evaluated after 24 months. The majority of neuromas were traumatic (n. 16; 62%) and involved the upper extremity (n. 21; 81%). Eight patients (31%) had already received a previous neuroma excision. After the neuroma excision followed by the PFG, pain decreased 4 points in the VAS scale on average (p < 0.001); disability improved 15 points in the DASH questionnaire (p < 0.001); the quality of life significantly improved in every WHOQOL index domain. Neuroma excision with PFG appeared equally effective both on patients with a primary or a relapsing neuroma. Neuromectomy with perineural fat grafting is a simple, accessible, and effective technique in end-neuroma pain treatment, owning a low surgical risk and minimal donor site morbidity. Level of evidence: Level III, therapeutic Study.

Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients

Transcatheter aortic valve replacement (TAVR) has revolutionised the treatment of severe aortic stenosis (AS), though its safety and efficacy in low-risk patients remains to be established. A systematic review of PubMed, Medline and EMBASE identified four randomised controlled trials (RCTs) in patients at low surgical risk comparing TAVR to surgical aortic valve replacement (SAVR). A meta-analysis was performed with a primary outcome of a composite of all-cause mortality and stroke at longest available follow-up. A total of four RCTs with 2,836 patients was included in the final analysis. 1,363 patients were randomised to SAVR and 1,473 to TAVR. The composite of all-cause mortality and stroke was significantly lower in patients undergoing TAVR compared with SAVR (OR 0.59, 95%CI 0.37-0.95, p=0.03) with low heterogeneity (I2=31%). The difference in the primary composite outcome was driven by a difference in mortality (OR 0.66, 95%CI 0.44-0.98, p=0.04; I2=0%) without significant differences in stroke (OR 0.75 95%CI 0.45-1.26, p=0.28; I2=37%). Weighted absolute risk difference (ARD) of the primary composite outcome also favoured TAVR (ARD -2.0% 95%CI -3.3 to -0.7%, p=0.002) with a number needed to treat (NNT) of 50 to prevent one death or stroke. Patients undergoing TAVR had a significantly higher risk of permanent pacemaker implantation (OR 3.9, 95%CI 1.8-8.4, p<0.001, I2=84%) and moderate or severe paravalvular leak (OR 5.0, 95%CI 1.6-15.7, p=0.01; I2=19%). In patients with severe AS at low surgical risk, the rate of the composite of death and stroke was significantly lower with TAVR than with SAVR. Longer term follow-up with a focus on the impact of permanent pacemaker (PPM) implantation, paravalvular leak (PVL) and structural valve deterioration is essential before the use of TAVR can be generalised to the broader population of patients with AS.

One-stage bilateral total hip arthroplasty versus unilateral total hip arthroplasty: A retrospective case-matched study

BackgroundOne-stage bilateral hip replacement has the advantage of involving a single anesthesia, single hospital admission and single rehabilitation program. The theoretic drawback is increased surgical risk. Few French series have been reported, and none with comparison versus unilateral arthroplasty. We therefore conducted a comparative case-control study between 1-stage bilateral (1B-THA) and unilateral total hip arthroplasty (U-THA), assessing (1) morbidity/mortality, (2) survival, and (3) functional scores and forgotten hip rates. HypothesisIn a selected ASA 1 or 2 population, 1B-THA shows complications rates and implant survival comparable to U-THA. Material and methodBetween 2004 and 2018, 327 patients were included: 109 with 1B-THA, 218 with U-THA. One 1B-THA patient was matched to 2 U-THA patients on age, gender, diagnosis, ASA score 1 or 2, and anterior or posterior approach. Minimum follow-up was 12 months. Complications were collected for all patients in both groups. Early (≤90 days) or late (>90 days) morbidity/mortality and implant survival were recorded for both groups. Secondary endpoints concerned blood-sparing strategy and blood loss, functional scores, and patient satisfaction. ResultsMortality was zero in both groups. There was no significant difference in complications rates (1B-THA 38.5%, U-THA 40.8%) (p=0.69), whether early (8.3% [9/109] and 7.8% [17/218] respectively [p=0.89]) or late (30.3% [33/109] and 33.0% [72/218] respectively [p=0.61]). Limb-length discrepancy was significantly less frequent in 1B-THA (5.5% [6/109] versus 13.3% [29/218] [p=0.03]). Forgotten hip rate was significantly more frequent in 1B-THA (86% [94/109] versus 70% [152/218] [p=0.01]). Five-year Kaplan-Meier implant survival was 97.2% (95% CI [91.9–99.1]) in 1B-THA and 96.6% (95% CI [93.0–98.4]) in U-THA (p=0.08). DiscussionOne-stage bilateral total hip arthroplasty gave acceptable results in disabling bilateral osteoarthritis of the hip with low surgical risk in selected patients (ASA 1 or 2). Mortality, complications and implant survival were unaffected, but the 1-stage bilateral procedure allowed better control of limb-length and provided a higher rate of forgotten hip. Level of evidenceIII, matched case-control study.

Current issues in transcatheter aortic valve replacement.

Aortic stenosis is the most common valvular disease worldwide. With transcatheter aortic valve replacement (TAVR) being increasingly expanded to lower-risk populations, several challenging issues remain to be solved. The present review aims at discussing modern approaches to such issues as well as the current status of TAVR. TAVR has undergone several developments in the recent years: an increased use of transfemoral access, the development of prostheses in order to adapt to challenging anatomies, improved delivery systems with repositioning features, and outer skirts aiming at reducing paravalvular leak. The indication of TAVR is increasingly being expanded to patients with lower surgical risk. The main clinical trials supporting such expansion are reviewed and the latest data on low-risk patients are discussed. A number of challenges need still to be addressed and are also reviewed in this paper: the need for updated international guidelines including the latest evidence; a reduction of main complications such as permanent pacemaker implantation, paravalvular leak, and stroke (and its potential prevention by using anti-embolic protection devices); the appropriate role of TAVR in patients with concomitant cardiac ischemic disease; and durability of bio-prosthetic implanted valves. Finally, the future perspectives for TAVR use and next device developments are discussed.