18 research outputs found
Aortic Stenosis and Heart Failure – Invasive Treatment and Prognosis
ABSTRACT
Background: Aortic stenosis (AS) is one the most common heart valve diseases. Symptomatic AS leads to death within a few years if left untreated. For decades, open heart surgery with surgical aortic valve replacement (SAVR) was the only definitive treatment option. Since the first transcatheter aortic valve replacement (TAVR) procedure in 2002, the annual overall procedure numbers have increased over the last decade.
Methods: The nationwide FinnValve registry was created to investigate the outcomes of TAVR and SAVR treatments in Finland from 2008 to 2017, herein with special interest in patients with heart failure.
Results: The FinnValve registry includes data from 6463 patients who underwent primary TAVR (2130 patients) or SAVR with bioprosthesis (4333 patients) for severe AS. Annual SAVR and TAVR numbers were 367 and 21 in 2008, 565 and 181 in 2013 and 335 and 622 in 2017 (p<0.0001). Since 2008, two-year survival improved from 71.4% to 83.9% for TAVR (p<0.001), and from 87.2% to 91.6% for SAVR (p=0.006). The prevalence of recent acute heart failure and left ventricular systolic dysfunction were 11.4% and 20.8% in the SAVR cohort and 11.3% and 27.7% in the TAVR cohort, respectively. Both acute heart failure and systolic dysfunction were associated with increased morbidity and mortality after TAVR and SAVR when compared to no heart failure. After acute heart failure, 3-year survival in the TAVR cohort were 66.6% and in the SAVR cohort 68.6%, respectively (p=0.166). In patients with left ventricular dysfunction 4-year survival after TAVR was 65.9% and 69.6% after SAVR (RMST ratio, 1.002, 95%CI 0.929–1.080, p=0.964).
Conclusions: TAVR has led to a more widespread use of invasive treatment for severe AS. Both acute heart failure and left ventricular dysfunction are associated with increased morbidity and mortality. TAVR is a valid alternative to SAVR in these patients. Intermediate survival is similar in heart failure patients
KEYWORDS: Aortic stenosis, heart failure, surgical aortic valve replacement, SAVR, transcatheter aortic valve replacement, TAVR.TIIVISTELMÄ
Tausta: Aorttaläppäahtauma on yleinen sydämen läppävika. Oireinen tauti johtaa hoitamattomana kuolemaan muutamassa vuodessa. Avosydänkirurginen keinoläppäleikkaus (surgical aortic valve replacement, SAVR) oli pitkään ainoa parantava hoitovaihtoehto. Vuodesta 2002 alkaen sen rinnalla vaihtoehtona on ollut katetriläppätoimenpide (transcatheter aortic valve replacement, TAVR). Tämän seurauksena aorttaläppätoimenpiteet ovat sittemmin lisääntynet nopeasti.
Metodit: Kansalliseen FinnValve-rekisteriin on kerätty TAVR- ja SAVRpotilaiden tiedot Suomessa vuosilta 2008–2017. Selvitimme hoidon ja ennusteen kehittymistä tänä aikana. Erityinen mielenkiinto kohdistui potilaisiin, joilla on sydämen vajaatoiminta.
Tulokset: FinnValve-rekisteri käsittää 6 463 potilasta, joille on tehty vaikean aorttaläppäahtauman vuoksi joko primaarinen TAVR (2 130 potilasta) tai SAVR biologisella keinoläpällä (4 333 potilasta). Vuosina 2008, 2013 ja 2017 kirurginen läppätoimenpide tehtiin 367, 565 ja 335 potilaalle ja katetriläppätoimenpide 21, 181 ja 622 potilaalle (p < 0.0001). Tutkimusajanjakson aikana kahden vuoden elossaolo parani 71,4–83,9 % TAVR:n jälkeen (p < 0,001), ja 87,2–91,6 % SAVR:n jälkeen (p = 0,006). Akuutin sydämen vajaatoiminnan ja vasemman kammion systolisen vajaatoiminnan esiintyvyydet olivat 11,4 % ja 20,8 % SAVR-kohortissa ja 11,3 % sekä 27,7 % TAVR-kohortissa. Sekä akuutti että systolinen vajaatoiminta lisäävät sairastavuutta ja kuolleisuutta verrattuna normaaliin sydämen toimintaan. Akuuttiin vajaatoimintaan sairastuneiden potilaiden elossaolo 3 vuoden kohdalla oli 66,6 % TAVR:n ja 68,6 % SAVR:n jälkeen, p = 0,166. Vasemman kammion systolista vajaatoimintaa sairastavien potilaiden 4 vuoden elossaolo oli TAVR:n jälkeen 65,9 % ja 69,6 % SAVR:n jälkeen (RMST ratio, 1,002, 95 % CI 0,929–1,080, p = 0,964).
Päätelmät: TAVR:n käyttö on lisääntynyt nopeasti aorttaläppäahtauman hoitona. Sekä akuutti sydämen vajaatoiminta että vasemman kammion systolinen vajaatoiminta lisäävät aorttaläppäahtaumapotilaiden sairastavuutta ja kuolleisuutta. TAVR vaikuttaa olevan hyvä vaihtoehto SAVR:n rinnalla vajaatoimintapotilaille. Keskipitkän seuranta-ajan kuolleisuus on yhtä hyvä kummankin toimenpiteen jälkeen näillä potilailla.
AVAINSANAT: Aorttaläppäahtauma, sydämen vajaatoiminta, SAVR, TAVR
Perioperative Bleeding Requiring Blood Transfusions is Associated With Increased Risk of Stroke After Transcatheter and Surgical Aortic Valve Replacement
Objectives: The authors aimed to investigate the impact of severe bleeding and use of red blood cell (RBC) transfusion on the development of postoperative stroke after surgical (SAVR) and transcatheter aortic valve replacement (TAVR), taken from the FinnValve registry. Design: Nationwide, retrospective observational study. Setting: Five Finnish university hospitals participated in the registry. Participants: A total of 6,463 patients who underwent SAVR (n = 4,333) or TAVR (n = 2,130). Interventions: Patients who underwent TAVR or SAVR with a bioprosthesis with or without coronary revascularization. Measurements and Main Results: The incidence of postoperative stroke after SAVR was 3.8%. In multivariate analysis, the number of trans-fused RBC units (odds ratio [OR], 1.098; 95% confidence interval [CI], 1.064-1.133) was one of the independent predictors of postoperative stroke. The incidence of stroke increased, along with the severity of perioperative bleeding, according to the European Coronary Artery Bypass Grafting (E-CABG) bleeding grades were as follows: grade 0, 2.2% (reference group); grade 1, 3.4% (adjusted OR, 1.841; 95% CI, 1.105-3.066); grade 2, 5.5% (adjusted OR, 3.282; 95% CI, 1.948-5.529); and grade 3, 14.8% (adjusted OR, 7.103; 95% CI, 3.612-13.966). The inci-dence of postoperative stroke after TAVR was 2.5%. The number of transfused RBC units was an independent predictor of stroke after TAVR (adjusted OR, 1.155; 95% CI, 1.058-1.261). The incidence of postoperative stroke increased, along with the severity of perioperative bleeding, as stratified by the E-CABG bleeding grades: E-CABG grade 0, 1.7%; grade 1, 5.3% (adjusted OR, 1.270; 95% CI, 0.532-3.035); grade 2, 10.0% (adjusted OR, 2.898; 95% CI, 1.101-7.627); and grade 3, 30.0% (adjusted OR, 10.706; 95% CI, 2.389-47.987). Conclusions: Perioperative bleeding requiring RBC transfusion and/or reoperation for intrathoracic bleeding is associated with an increased risk of postoperative stroke after SAVR and TAVR. Patient blood management and meticulous preprocedural planning and operative technique aiming to avoid significant perioperative bleeding may reduce the risk of cerebrovascular complications. (C) 2022 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)Peer reviewe
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 3.52.2% vs. SAVR 3.52.8%, 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 4years 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.Conclusions p id=Par The 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 registration p id=Par ClinicalTrials.gov Identifier: NCT03385915.Peer reviewe
Ten-year experience with transcatheter and surgical aortic valve replacement in Finland
Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p <.001) and from 87.2% to 91.6% for SAVR (p = .006). During the study period, a significant reduction in moderate-to-severe paravalvular regurgitation was observed among TAVR patients and a reduction of the rate of acute kidney injury was observed among both SAVR and TAVR patients. Similarly, the rate of red blood cell transfusion and severe bleeding decreased significantly among SAVR and TAVR patients. Hospital stay declined from 10.4 +/- 8.4 to 3.7 +/- 3.4 days after TAVR (p <.001) and from 9.0 +/- 5.9 to 7.8 +/- 5.1 days after SAVR (p <.001). Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR.Peer reviewe
Transcatheter and Surgical Aortic Valve Replacement in Patients with Recent Acute Heart Failure
Background. Patients with severe aortic stenosis and heart failure have poor prognosis, and their outcomes may be suboptimal even after transcatheter (TAVR) and surgical aortic valve replacement (SAVR). Methods. This is an analysis of the nationwide FinnValve registry, which included patients who underwent primary TAVR or SAVR with a bioprothesis for aortic stenosis. We evaluated the outcome of patients with acute heart failure (AHF) within 60 days prior to TAVR or SAVR. Results. The prevalence of recent AHF was 11.4% (484 of 4241 patients) in the SAVR cohort and 11.3% (210 of 1855 patients) in the TAVR cohort. In the SAVR cohort, AHF was associated with lower 30-day survival (91.3% vs 97.0%; adjusted odds ratio 1.801, 95% confidence interval [CI] 1.125-2.882) and 5-year survival (64.0% vs 81.2%; adjusted hazard ratio 1.482, 95% CI 1.207-1.821). SAVR patients with AHF had higher risk of major bleeding, need of mechanical circulatory support, acute kidney injury, prolonged hospital stay, and composite end-point (30-day mortality, stroke and/or acute kidney injury). Patients with AHF had a trend toward lower 30-day survival (crude rates 95.2% vs 97.9%; adjusted odds ratio 2.028, 95% CI 0.908-4.529) as well as significantly lower 5-year survival (crude rates 45.3% vs 58.5%; adjusted hazard ratio 1.530, 95% CI 1.185-1.976) also after TAVR. AHF increased the risk of acute kidney injury, prolonged hospital stay, and composite end-point after TAVR. Conclusions. Recent AHF is associated with increased risk of mortality and morbidity after SAVR and TAVR. These findings suggest that aortic stenosis patients should be referred for invasive treatment before the development of clinically evident heart failure.Peer reviewe
Transcatheter and surgical aortic valve replacement in patients with left ventricular dysfunction
Peer reviewe
Blood Transfusion and Outcome After Transfemoral Transcatheter Aortic Valve Replacement
Objective: To investigate the prognostic impact of red blood cell (RBC) transfusion on the outcome after transfemoral transcatheter aortic valve replacement (TAVR). Design: Nationwide, retrospective multicenter study. Setting: Five University Hospitals. Participants: The nationwide FinnValve registry included data from 2,130 patients who underwent TAVR for aortic stenosis from 2008 to 2017. After excluding patients who underwent TAVR through nontransfemoral accesses, 1,818 patients were selected for this analysis. Intervention: TAVR with or without coronary revascularization. Measurements and Main Results: RBCs were transfused in 293 patients (16.1%). Time-trend analysis showed that the rates of RBC transfusion decreased significantly from 27.5% in 2012 to 10.0% in 2017 (p <0.0001). Among 281 propensity score matched pairs, RBC transfusion was associated with higher 30-day mortality (7.1% v 0%, p <0.0001), late mortality (at 5-year, 59.1% v 43.3%, p = 0.008), as well as increased risk of acute kidney injury (17.0% v 4.4%, p <0.0001), renal replacement therapy (3.6% v 0.4, p <0.0001) and prolonged hospital stay (mean, 8.5 v 4.7 days, p <0.0001) compared with patients who did not receive blood transfusion. In the overall series, the risk of adverse events increased significantly with the increasing amount of transfused RBC units and when operation for excessive bleeding was necessary. Consistently with these findings, postoperative hemoglobin drop and nadir level were associated with higher early and late mortality. Conclusions: Patients who received blood transfusion after TAVR had an increased risk of early and late adverse events. These adverse effects were particularly evident with increasing amount of RBC transfusion and operations for excessive bleeding. (C) 2019 Elsevier Inc. All rights reserved.Peer reviewe
Ten-year experience with transcatheter and surgical aortic valve replacement in Finland
Aim: We investigated the outcomes of transcatheter (TAVR) and surgical aortic valve replacement (SAVR) in Finland during the last decade. Methods: The nationwide FinnValve registry included data from 6463 patients who underwent TAVR or SAVR with a bioprosthesis for aortic stenosis from 2008 to 2017. Results: The annual number of treated patients increased three-fold during the study period. Thirty-day mortality declined from 4.8% to 1.2% for TAVR (p = .011) and from 4.1% to 1.8% for SAVR (p = .048). Two-year survival improved from 71.4% to 83.9% for TAVR (p Conclusions: In Finland, the introduction of TAVR has led to an increase in the invasive treatment of severe aortic stenosis, which was accompanied by improved early outcomes after both SAVR and TAVR.</p
Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk
IMPORTANCE Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. OBJECTIVE To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. DESIGN, SETTING, AND PARTICIPANTS This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. EXPOSURES Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. MAIN OUTCOMES AND MEASURES The primary outcomes were 30-day and 3-year survival. RESULTS Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P=.12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P=.45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. CONCLUSIONS AND RELEVANCE Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.Peer reviewe
Acute kidney injury following aortic valve replacement in patients without chronic kidney disease
Background: The data on acute kidney injury (AKI) in patients without chronic kidney disease (CKD) after transcatheter aortic valve replacement (TAVR) are limited. The study sought to compare the incidence of AKI and its impact on 5-year mortality after TAVR and surgical aortic valve replacement (SAVR) in patients without CKD. Methods: This registry included data from 6463 consecutive patients who underwent TAVR or SAVR. CKD was defined as estimated glomerular filtration rate Results: The study included 4555 consecutive patients (TAVR, n = 1215 and SAVR, n = 3340) without CKD. Propensity-score matching identified 542 pairs. Patients who underwent TAVR had a significantly lower incidence of AKI in comparison to those who underwent SAVR (unmatched 4.7% vs 16.4%, P <0.001, multivariable analysis: odds ratio, 0.29, 95% confidence interval [CI], 0.20-0.41; matched 5.9% vs 19.0%, P <0.001). Patients with AKI had significantly increased 5-year mortality compared with those without AKI (unmatched 36.0% vs 19.1%, log-rank P <0.001; matched 36.3% vs 24.0%, log-rank P <0.001). The adjusted hazard ratios for 5-year mortality were 1.58 (95% CI, 1.20-2.08) for AKI grade 1, 3.27 (95% CI, 2.09-5.06) for grade 2, and 4.82 (95% CI, 2.93-8.04) for grade 3. Conclusions: TAVR in patients without CKD was associated with a significantly less frequent incidence of AKI compared with SAVR. AKI significantly increased the risk of 5-year mortality after either TAVR or SAVR, and increasing severity of AKI was incrementally associated with 5-year mortality.Peer reviewe