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Percutaneous versus Surgical Intervention for Severe Aortic Valve Stenosis: A Systematic Review.

ABSTRACT: Aortic stenosis is a disease that is increasing in prevalence and manifests as decreased cardiac output, which if left untreated can result in heart failure and ultimately death. It is primarily a disease of the elderly who often have multiple comorbidities. The advent of transcatheter aortic valve therapies has changed the way we treat these conditions. However, long-term results of these therapies remain uncertain. Recently, there has been an increasing number of studies examining the role of both surgical aortic valve replacement and transcatheter aortic valve replacement. We therefore performed a systematic review using Ovid MEDLINE, Ovid Embase, and the Cochrane Library. Two investigators searched papers published between January 1, 2007, and to date using the following terms: "aortic valve stenosis," "aortic valve operation," and "transcatheter aortic valve therapy." Both strategies in aortic stenosis treatment highlighted specific indications alongside the pitfalls such as structural valve degeneration and valve thrombosis which have a bearing on clinical outcomes. We propose some recommendations to help clinicians in the decision-making process as technological improvements make both surgical and transcatheter therapies viable options for patients with aortic stenosis. Finally, we assess the role of finite element analysis in patient selection for aortic valve replacement. THVT and AVR-S are both useful tools in the armamentarium against aortic stenosis. The decision between the two treatment strategies should be best guided by a strong robust evidence base, ideally with a long-term follow-up. This is best performed by the heart team with the patient as the center of the discussion.

SUBMITTER: Iervolino A

PROVIDER: S-EPMC8175165 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Objective To examine the effect of transcatheter aortic valve implantation (TAVI) versus surgical replacement of an aortic valve (SAVR) in patients with severe aortic stenosis at low and intermediate risk of perioperative death.Design Systematic review and meta-analysis DATA SOURCES: Medline, Embase, and Cochrane CENTRAL.Study selection Randomized trials of TAVI compared with SAVR in patients with a mean perioperative risk of death <8%.Review methods Two reviewers independently extracted data and assessed risk of bias for outcomes important to patients that were selected a priori by a parallel guideline committee, including patient advisors. We used the GRADE system was used to quantify absolute effects and quality of evidence.Results 4 trials with 3179 patients and a median follow-up of two years were included. Compared with SAVR, transfemoral TAVI was associated with reduced mortality (risk difference per 1000 patients: -30, 95% confidence interval -49 to -8, moderate certainty), stroke (-20, -37 to 1, moderate certainty), life threatening bleeding (-252, -293 to -190, high certainty), atrial fibrillation (-178, -150 to -203, moderate certainty), and acute kidney injury (-53, -39 to -62, high certainty) but increased short term aortic valve reintervention (7, 1 to 21, moderate certainty), permanent pacemaker insertion (134, 16 to 382, moderate certainty), and moderate or severe symptoms of heart failure (18, 5 to 34, moderate certainty). Compared with SAVR, transapical TAVI was associated higher mortality (57, -16 to 153, moderate certainty, P=0.015 for interaction between transfemoral versus transapical TAVI) and stroke (45, -2 to 125, moderate certainty, interaction P=0.012). No study reported long term follow-up, which is particularly important for structural valve deterioration.Conclusions Many patients, particularly those who have a shorter life expectancy or place a lower value on the risk of long term valve degeneration, are likely to perceive net benefit with transfemoral TAVI versus SAVR. SAVR, however, performs better than transapical TAVI, which is of interest to patients who are not candidates for transfemoral TAVI.Systematic review registration PROSPERO CRD42016042879.

Project description:Recently, two randomized trials, the PARTNER 3 and the Evolut Low Risk Trial, independently demonstrated that transcatheter aortic valve replacement (TAVR) is non-inferior to surgical aortic valve replacement (SAVR) for the treatment of severe aortic stenosis in patients at low surgical risk, paving the way to a progressive extension of clinical indications to TAVR. We designed a meta-analysis to compare TAVR versus SAVR in patients with severe aortic stenosis at low surgical risk. The study protocol was registered in PROSPERO (CRD42019131125). Randomized studies comparing one-year outcomes of TAVR or SAVR were searched for within Medline, Scholar and Scopus electronic databases. A total of three randomized studies were selected, including nearly 3000 patients. After one year, the risk of cardiovascular death was significantly lower with TAVR compared to SAVR (Risk Ratio (RR) = 0.56; 95% CI 0.33-0.95; p = 0.03). Conversely, no differences were observed between the groups for one-year all-cause mortality (RR = 0.67; 95% CI 0.42-1.07; p = 0.10). Among the secondary endpoints, patients undergoing TAVR have lower risk of new-onset of atrial fibrillation compared to SAVR (RR = 0.26; 95% CI 0.17-0.39; p < 0.00001), major bleeding (RR = 0.30; 95% CI 0.14-0.65; p < 0.002) and acute kidney injury stage II or III (RR = 0.28; 95% CI 0.14-0.58; p = 0.0005). Conversely, TAVR was associated to a higher risk of aortic regurgitation (RR = 3.96; 95% CI 1.31-11.99; p = 0.01) and permanent pacemaker implantation (RR = 3.47; 95% CI 1.33-9.07; p = 0.01) compared to SAVR. No differences were observed between the groups in the risks of stroke (RR= 0.71; 95% CI 0.41-1.25; p = 0.24), transient ischemic attack (TIA; RR = 0.98; 95% CI 0.53-1.83; p = 0.96), and MI (RR = 0.75; 95% CI 0.43-1.29; p = 0.29). In conclusion, the present meta-analysis, including three randomized studies and nearly 3000 patients with severe aortic stenosis at low surgical risk, shows that TAVR is associated with lower CV death compared to SAVR at one-year follow-up. Nevertheless, paravalvular aortic regurgitation and pacemaker implantation still represent two weak spots that should be solved.

Project description:Objective To determine the frequency of survival, stroke, atrial fibrillation, structural valve deterioration, and length of hospital stay after surgical replacement of an aortic valve (SAVR) with a bioprosthetic valve in patients with severe symptomatic aortic stenosis.Design Systematic review and meta-analysis of observational studies.Data sources Medline, Embase, PubMed (non-Medline records only), Cochrane Database of Systematic Reviews, and Cochrane CENTRAL from 2002 to June 2016.Study selection Eligible observational studies followed patients after SAVR with a bioprosthetic valve for at least two years.Methods Reviewers, independently and in duplicate, evaluated study eligibility, extracted data, and assessed risk of bias for patient important outcomes. We used the GRADE system to quantify absolute effects and quality of evidence. Published survival curves provided data for survival and freedom from structural valve deterioration, and random effect models provided the framework for estimates of pooled incidence rates of stroke, atrial fibrillation, and length of hospital stay.Results In patients undergoing SAVR with a bioprosthetic valve, median survival was 16 years in those aged 65 or less, 12 years in those aged 65 to 75, seven years in those aged 75 to 85, and six years in those aged more than 85. The incidence rate of stroke was 0.25 per 100 patient years (95% confidence interval 0.06 to 0.54) and atrial fibrillation 2.90 per 100 patient years (1.78 to 4.79). Post-SAVR, freedom from structural valve deterioration was 94.0% at 10 years, 81.7% at 15 years, and 52% at 20 years, and mean length of hospital stay was 12 days (95% confidence interval 9 to 15).Conclusion Patients with severe symptomatic aortic stenosis undergoing SAVR with a bioprosthetic valve can expect only slightly lower survival than those without aortic stenosis, and a low incidence of stroke and, up to 10 years, of structural valve deterioration. The rate of deterioration increases rapidly after 10 years, and particularly after 15 years.

Project description:Symptomatic aortic stenosis has a poor prognosis. Many patients are considered inoperable or at high surgical risk for surgical aortic valve replacement (SAVR), reflecting their age, comorbidities and frailty. The clinical effectiveness and safety of TAVI have not been reviewed systematically for these high levels of surgical risk. This systematic review compares mortality and other important clinical outcomes up to 5 years post treatment following TAVI or other treatment in these risk groups.A systematic review protocol was registered on the PROSPERO database (CRD42016048396). The Cochrane Library, Centre for Reviews and Dissemination Databases, MEDLINE, EMBASE, and ZETOC were searched from January 2002 to August 2016. Clinical trials or matched studies comparing TAVI with other treatments for AS in patients surgically inoperable or operable at a high risk were included. Data extraction and quality assessment were conducted by two reviewers. Data were pooled using random-effects meta-analysis. The main outcomes were all-cause mortality, efficacy and major complications.Three good quality randomised controlled trials (RCTs) were included. Patients' mean age ranged from 83-85 years, around half were female and New York Heart Association (NYHA) functional class III or IV ranged from 83.8% to 94.2% with frequent comorbidities. In 358 surgically inoperable patients from one RCT, TAVI was superior to medical therapy for all-cause mortality at 1 year (hazard ratio (HR) 0.58, 95% confidence interval (CI) 0.36-0.92), 2 years (HR 0.50, 95% CI 0.39-0.65), 3 years (HR 0.53, 95% CI 0.41to 0.68) and 5 years (HR 0.50, 95% CI 0.39-0.65), and NYHA class III or IV at 2 years (TAVI 16.8% (16/95), medical therapy 57.5% (23/40), p<0.001), quality of life and re-hospitalisation. TAVI had higher risks of major bleeding up to 1 year, of stroke up to 3 years (at one year 11.2% versus 5.5%, p = .06; HR at 2 years 2.79, 95% CI 1.25-6.22; HR at 3 years 2.81; 95% CI 1.26-6.26) and of major vascular complication at 3 years (HR 8.27, 95% CI 2.92-23.44). Using the GRADE tool, this evidence was considered to be of moderate quality. In a meta-analysis including 1,494 high risk surgically operable patients from two non-inferiority RCTs TAVI showed no significant differences from SAVR in all-cause mortality at two years (HR 1.03, 95% CI 0.82-1.29) and up to 5 years (HR 0.83, 95% CI 0.83-1.12). There were no statistically significant differences in major vascular complications and myocardial infarction at any time point, discrepant results for major bleeding on variable definitions and no differences in stroke rate at any time point. Using the GRADE tool, this evidence was considered of low quality.Symptomatic aortic stenosis can be lethal without intervention but surgical resection is contraindicated for some patients and high risk for others. We found that all-cause mortality up to 5 years of follow-up did not differ significantly between TAVI and SAVR in patients surgically operable at a high risk, but favoured TAVI over medical therapy in patients surgically inoperable. TAVI is a viable life-extending treatment option in these surgical high risk groups.

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Percutaneous versus Surgical Intervention for Severe Aortic Valve Stenosis: A Systematic Review.

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