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Transcatheter aortic valve replacement in patients with severe aortic stenosis and active cancer: a systematic review and meta-analysis.

ABSTRACT: Background:Patients with severe aortic stenosis and concomitant active cancer (AC) are considered high-risk patients and usually are not allowed to undergo surgical valve replacement. Transcatheter aortic valve replacement (TAVR) may be an attractive option for them; however, little is known about the outcomes of TAVR in this subset of complex patients. Methods and results:In this meta-analysis, Medline, Cochrane Library and Scopus databases were searched (anytime up to April 2019) for studies evaluating the outcomes of TAVR in patients with or without AC. We assessed pooled estimates (with their 95% CIs) of the risk ratio (RR) for the all-cause mortality at the 30-day and 1-year follow-ups, a 4-point safety outcome (any bleeding, stroke, need for a pacemaker and acute kidney injury) and a 2-point efficacy outcome (device success and residual mean gradient (mean difference)). Three studies (5162 patients) were included. Of those patients, a total of 368 (7.1%) had AC. Apart from a significantly higher need for a postprocedural pacemaker (RR 1.29, 95%?CI 1.06 to 1.58, p=0.01), TAVR in patients with AC resulted in similar outcomes for safety and efficacy at the 30-day follow-up compared with those without AC. Patients with AC experienced similar rates of the all-cause mortality at the 30-day follow-up compared with those without (RR 0.92, 95%?CI 0.53 to 1.59, p=0.76); however, the all-cause mortality was significantly higher in patients with AC at the 1-year follow-up (RR 1.71, 95%?CI 1.26 to 2.33, p=0.0006). This mortality difference was independent of cancer stage (advanced or limited) at the 30-day follow-up but not at the 1-year follow-up; only patients with limited cancer stages showed similar all-cause mortality rates compared with those without cancer at the 1-year follow-up (RR 1.22, 95%?CI 0.79 to 1.91, p=0.37). Conclusion:TAVR in patients with AC is associated with similar 30-day and potentially worse 1-year outcomes compared with those in patients without AC. The 1-year all-cause mortality appears to be dependent on the cancer stage. Involving a specialised oncologist who usually considers cancer stage in the decision-making process and applying additional preoperative scores such as frailty indices might refine the risk assessment process among these patients. PROSPERO registration number:CRD42019120416.

SUBMITTER: Bendary A

PROVIDER: S-EPMC7066604 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Transcatheter aortic valve replacement in patients with severe aortic stenosis and active cancer: a systematic review and meta-analysis.

Bendary Ahmed A Ramzy Ahmed A Bendary Mohamed M Salem Mohamed M

Open heart 20200311 1

<h4>Background</h4>Patients with severe aortic stenosis and concomitant active cancer (AC) are considered high-risk patients and usually are not allowed to undergo surgical valve replacement. Transcatheter aortic valve replacement (TAVR) may be an attractive option for them; however, little is known about the outcomes of TAVR in this subset of complex patients.<h4>Methods and results</h4>In this meta-analysis, Medline, Cochrane Library and Scopus databases were searched (anytime up to April 2019 ...[more]

PMID: 32201582

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Project description:BackgroundStudies assessing outcomes of transcatheter aortic valve replacement (TAVR) in patients with severe aortic valve stenosis (AS) with hemodynamic subtypes have demonstrated mixed results with respect to outcomes and periprocedural complications. This study aimed to assess the outcomes of TAVR in patients across various hemodynamic subtypes of severe AS.MethodsPubMed, Embase, and Cochrane databases were searched through September 2023 to identify all observational studies comparing outcomes of TAVR in patients with paradoxical low flow low gradient (pLFLG), classic LFLG, and high gradient AS (HGAS). The primary outcome was major adverse cardiovascular events (MACE). The secondary outcomes were components of MACE (mortality, myocardial infarction [MI], stroke). A bivariate, influential, and frequentist network meta-analysis model was used to obtain the net odds ratio (OR) with a 95% CI.ResultsA total of 21 studies comprising 17,298 (8742 experimental and 8556 HGAS) patients were included in the quantitative analysis. TAVR was associated with a significant reduction in the mean aortic gradient, and an increase in the mean aortic valve area irrespective of the AS type. Compared with HGAS, TAVR in classic LFLG had a significantly higher (OR, 1.68; 95% CI, 1.04-2.72), while pLFLG (OR, 0.98; 95% CI, 0.72-1.35) had a statistically similar incidence of MACE at a median follow-up of 1-year. TAVR in LFLG also had a significantly higher need for surgery (OR, 3.57; 95% CI, 1.24-10.32), and a greater risk of periprocedural (OR, 2.00; 95% CI, 1.17-3.41), 1-month (OR, 1.69; 95% CI, 1.08-2.64), and 12-month (OR, 1.41; 95% CI, 1.05-1.88) mortality compared with HGAS. The incidence of MI, major bleeding, vascular complications, paravalvular leak, pacemaker implantation, and rehospitalizations was not significantly different between all other types of AS (HGAS vs LFLG, pLFLG).ConclusionsTAVR is an effective strategy in severe AS irrespective of the hemodynamic subtypes. Relatively, pLFLG did not have significantly different risk of periprocedural complications compared with HGAS, while classical LFLG AS had higher risk of MACE, primarily driven by the greater mortality risk.

Project description:AimsAortic stenosis (AS) and cardiac amyloidosis (CA) are typical diseases of the elderly. Up to 16% of older adults with severe AS referred to transcatheter aortic valve replacement (TAVR) have a concomitant diagnosis of CA. CA-AS population suffers from reduced functional capacity and worse prognosis than AS patients. As the prognostic impact of TAVR in patients with CA-AS has been historically questioned and in light of recently published evidence, we aim to provide a comprehensive synthesis of the efficacy and safety of TAVR in CA-AS patients.Methods and resultsWe performed a systematic review and meta-analysis of studies: (i) evaluating mortality with TAVR as compared with medical therapy in CA-AS patients and (ii) reporting complications and clinical outcomes of TAVR in CA-AS patients as compared with patients with AS alone. A total of seven observational studies were identified: four reported mortality with TAVR, and four reported complications and clinical outcomes after TAVR of patients with CA-AS compared with AS alone patients. In patients with CA-AS, the risk of mortality was lower with TAVR (n = 44) as compared with medical therapy (n = 36) [odds ratio (OR) 0.23, 95% confidence interval (CI) 0.07-0.73, I2 = 0%, P = 0.001, number needed to treat = 3]. The safety profile of TAVR seems to be similar in patients with CA-AS (n = 75) as compared with those with AS alone (n = 536), with comparable risks of stroke, vascular complications, life-threatening bleeding, acute kidney injury, and 30 day mortality, although CA-AS was associated with a trend towards an increased risk of permanent pacemaker implantation (OR 1.76, 95% CI 0.91-4.09, I2 = 0%, P = 0.085). CA is associated with a numerically higher rate of long-term mortality and rehospitalizations following TAVR in patients with CA-AS as compared with those with AS alone.ConclusionsTAVR is an effective and safe procedure in CA-AS patients, with a substantial survival benefit as compared with medical therapy, and a safety profile comparable with patients with AS alone except for a trend towards higher risk of permanent pacemaker implantation.

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:BackgroundTo compare functional and health related quality of life outcomes post-transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients with critical aortic stenosis (AS) across low to high-risk surgical candidates. These patient-centred factors will be compared between both groups in the short to medium term time frames and will aid in shared decision making between patients and healthcare workers.Materials and methodsWe conducted a systematic review and meta-analysis of randomised controlled trials which compared TAVI with SAVR and reported on quality of life (QoL) and functional scores. The scores used were the Kansas City Cardiomyopathy Questionnaire (KCCQ), Euroqol-5DL (EQ5DL), the short form-36/12 (SF-36/12) and the NYHA.ResultsWe identified eight trials with a total of 8898 participants. Both groups showed improvements from baseline at one month. At one month there was a statistically significant difference in standardised mean difference (SMD) in favour of TAVI for EQ5DL (SMD 0.37, 95% CI 0.26,0.49), KCCQ (SMD 0.53,95% CI 0.48, 0.58), SF physical summary (SMD 0.55, 95% CI 0.31 - 0.78) and SF mental summary (SMD 0.34, 95% CI 0.27 - 0.40). At one year there was no statistically significant difference between any of these QoL metrics. For NYHA, no significant difference in odds ratio of class III/IV was observed at one month between TAVI and SAVR (OR 0.94, 95% CI 0.83, 1.07), however, TAVI was associated with reduced odds ratio of NYHA class I/II at one year (OR 0.87, 95% CI 0.78, 0.98).ConclusionBoth groups were associated with improvements in QoL and functional outcomes with TAVI reporting more significant improvements in QoL at one-month post-procedures. No significant improvements between groups were seen at one year. This is the largest meta-analysis comparing post-operative health-related quality of life outcomes post SAVR and TAVI and has major implications in shared decision making for the treatment of aortic stenosis.

Dataset Information

Transcatheter aortic valve replacement in patients with severe aortic stenosis and active cancer: a systematic review and meta-analysis.

Publications

Transcatheter aortic valve replacement in patients with severe aortic stenosis and active cancer: a systematic review and meta-analysis.

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