Publications by authors named "Mika Laine"

104 Publications

Transcatheter Replacement of Transcatheter Versus Surgically Implanted Aortic Valve Bioprostheses.

J Am Coll Cardiol 2021 Jan;77(1):1-14

Centres for Heart Valve and Cardiovascular Innovation, St. Paul's and Vancouver General Hospital, Vancouver, British Columbia, Canada. Electronic address:

Background: Surgical aortic valve replacement and transcatheter aortic valve replacement (TAVR) are now both used to treat aortic stenosis in patients in whom life expectancy may exceed valve durability. The choice of initial bioprosthesis should therefore consider the relative safety and efficacy of potential subsequent interventions.

Objectives: The aim of this study was to compare TAVR in failed transcatheter aortic valves (TAVs) versus surgical aortic valves (SAVs).

Methods: Data were collected on 434 TAV-in-TAV and 624 TAV-in-SAV consecutive procedures performed at centers participating in the Redo-TAVR international registry. Propensity score matching was applied, and 330 matched (165:165) patients were analyzed. Principal endpoints were procedural success, procedural safety, and mortality at 30 days and 1 year.

Results: For TAV-in-TAV versus TAV-in-SAV, procedural success was observed in 120 (72.7%) versus 103 (62.4%) patients (p = 0.045), driven by a numerically lower frequency of residual high valve gradient (p = 0.095), ectopic valve deployment (p = 0.081), coronary obstruction (p = 0.091), and conversion to open heart surgery (p = 0.082). Procedural safety was achieved in 116 (70.3%) versus 119 (72.1%) patients (p = 0.715). Mortality at 30 days was 5 (3%) after TAV-in-TAV and 7 (4.4%) after TAV-in-SAV (p = 0.570). At 1 year, mortality was 12 (11.9%) and 10 (10.2%), respectively (p = 0.633). Aortic valve area was larger (1.55 ± 0.5 cm vs. 1.37 ± 0.5 cm; p = 0.040), and the mean residual gradient was lower (12.6 ± 5.2 mm Hg vs. 14.9 ± 5.2 mm Hg; p = 0.011) after TAV-in-TAV. The rate of moderate or greater residual aortic regurgitation was similar, but mild aortic regurgitation was more frequent after TAV-in-TAV (p = 0.003).

Conclusions: In propensity score-matched cohorts of TAV-in-TAV versus TAV-in-SAV patients, TAV-in-TAV was associated with higher procedural success and similar procedural safety or mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.10.053DOI Listing
January 2021

Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants.

JACC Cardiovasc Interv 2021 Jan 23;14(2):135-144. Epub 2020 Dec 23.

Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland. Electronic address:

Objectives: This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation.

Background: A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.

Methods: Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.

Results: Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).

Conclusions: Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2020.09.062DOI Listing
January 2021

Dedicated plug based closure for large bore access -The MARVEL prospective registry.

Catheter Cardiovasc Interv 2020 Dec 21. Epub 2020 Dec 21.

Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands.

Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.

Background: The MANTA is a novel plug-based device for large bore arteriotomy closure.

Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.

Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.

Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29439DOI Listing
December 2020

Impact of COVID-19 pandemic and diabetes on mechanical reperfusion in patients with STEMI: insights from the ISACS STEMI COVID 19 Registry.

Cardiovasc Diabetol 2020 12 18;19(1):215. Epub 2020 Dec 18.

Division of Cardiology, Azienda Ospedaliero-Universitaria Maggiore della Carità, Università del Piemonte Orientale, Novara, Italy.

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19.

Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality.

Results: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73-0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78-0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients.

Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic.

Trial Registration Number: NCT04412655.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12933-020-01196-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747477PMC
December 2020

Impact of COVID-19 Pandemic on Mechanical Reperfusion for Patients With STEMI.

J Am Coll Cardiol 2020 11;76(20):2321-2330

Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Background: The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality.

Objectives: The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of "at-risk" patient cohorts for failure to present or delays to treatment.

Methods: This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020. Main outcomes are the incidences of PPCI, delayed treatment, and in-hospital mortality.

Results: A total of 6,609 patients underwent PPCI in 77 centers, located in 18 countries. In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio: 0.811; 95% confidence interval: 0.78 to 0.84; p < 0.0001). The heterogeneity among centers was not related to the incidence of death due to COVID-19. A significant interaction was observed for patients with arterial hypertension, who were less frequently admitted in 2020 than in 2019. Furthermore, the pandemic was associated with a significant increase in door-to-balloon and total ischemia times, which may have contributed to the higher mortality during the pandemic.

Conclusions: The COVID-19 pandemic had significant impact on the treatment of patients with STEMI, with a 19% reduction in PPCI procedures, especially among patients suffering from hypertension, and a longer delay to treatment, which may have contributed to the increased mortality during the pandemic. (Primary Angioplasty for STEMI During COVID-19 Pandemic [ISACS-STEMI COVID-19] Registry; NCT04412655).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.09.546DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834750PMC
November 2020

Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve.

Clin Res Cardiol 2021 Mar 24;110(3):429-439. Epub 2020 Oct 24.

Heart Center, Turku University Hospital, and University of Turku, Turku, Finland.

Objectives: To compare the outcomes after surgical (SAVR) and transcatheter aortic valve replacement (TAVR) for severe stenosis of bicuspid aortic valve (BAV).

Methods: We evaluated the early and mid-term outcome of patients with stenotic BAV who underwent SAVR or TAVR for aortic stenosis from the nationwide FinnValve registry.

Results: The FinnValve registry included 6463 AS patients and 1023 (15.8%) of them had BAV. SAVR was performed in 920 patients and TAVR in 103 patients with BAV. In the overall series, device success after TAVR was comparable to SAVR (94.2% vs. 97.1%, p = 0.115). TAVR was associated with increased rate of mild-to-severe paravalvular regurgitation (PVR) (19.4% vs. 7.9%, p < 0.0001) and of moderate-to-severe PVR (2.9% vs. 0.7%, p = 0.053). When newer-generation TAVR devices were evaluated, mild-to-severe PVR (11.9% vs. 7.9%, p = 0.223) and moderate-to-severe PVR (0% vs. 0.7%, p = 1.000) were comparable to SAVR. Type 1 N-L and type 2 L-R/R-N were the BAV morphologies with higher incidence of mild-to-severe PVR (37.5% and 100%, adjusted for new-generation prostheses p = 0.025) compared to other types of BAVs. Among 75 propensity score-matched cohorts, 30-day mortality was 1.3% after TAVR and 5.3% after SAVR (p = 0.375), and 2-year mortality was 9.7% after TAVR and 18.7% after SAVR (p = 0.268) CONCLUSIONS: In patients with stenotic BAV, TAVR seems to achieve early and mid-term results comparable to SAVR. Type 1 N-L and type 2 L-R/R-N BAV morphologies had higher incidence of PVR. Larger studies evaluating different phenotypes of BAV are needed to confirm these findings.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00392-020-01761-3DOI Listing
March 2021

Impact of paravalvular regurgitation on the mid-term outcome after transcatheter and surgical aortic valve replacement.

Eur J Cardiothorac Surg 2020 12;58(6):1145-1152

Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.

Objectives: The aim of this study was to evaluate the incidence and prognostic impact of paravalvular regurgitation (PVR) on the outcome after transcatheter (TAVR) and surgical aortic valve replacement (SAVR) for aortic stenosis.

Methods: The nationwide FinnValve registry included data on 6463 consecutive patients who underwent TAVR (n = 2130) or SAVR (n = 4333) with a bioprosthesis for the treatment of aortic stenosis during 2008-2017. The impact of PVR at discharge after TAVR and SAVR on 4-year mortality was herein investigated.

Results: The rate of mild PVR was 21.7% after TAVR and 5.2% after SAVR. The rate of moderate-to-severe PVR was 3.7% after TAVR and 0.7% after SAVR. After TAVR, 4-year survival was 69.0% in patients with none-to-trace PVR, 54.2% with mild PVR [adjusted hazard ratio (HR) 1.64, 95% confidence interval (CI) 1.35-1.99] and 48.9% with moderate-to-severe PVR (adjusted HR 1.61, 95% CI 1.10-2.35). Freedom from PVR-related reinterventions was 100% for none-to-mild PVR and 95.2% for moderate-to-severe PVR. After SAVR, mild PVR (4-year survival 78.9%; adjusted HR 1.29, 95% CI 0.93-1.78) and moderate-to-severe PVR (4-year survival 67.8%; adjusted HR 1.36, 95% CI 0.72-2.58) were associated with worse 4-year survival compared to none-to-trace PVR (4-year survival 83.7%), but the difference did not reach statistical significance in multivariable analysis. Freedom from PVR-related reinterventions was 99.5% for none-to-trace PVR patients, 97.9% for mild PVR patients and 77.0% for moderate-to-severe PVR patients.

Conclusions: This multicentre study showed that both mild and moderate-to-severe PVR were independent predictors of worse survival after TAVR. Mild and moderate-to-severe PVR are not frequent after SAVR, but tend to decrease survival also in these patients.

Clinical Trial Registration Number: ClinicalTrials.gov Identifier: NCT03385915.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ejcts/ezaa254DOI Listing
December 2020

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry.

Catheter Cardiovasc Interv 2020 Sep 23. Epub 2020 Sep 23.

Department of Cardiology, Heart and Lung Center, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland.

Objectives: The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR).

Background: The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited.

Methods: A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of ≥mild PVL after the S3-Ultra and S3 implantation.

Results: Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 ± 6.7 years and mean aortic annulus area: 492.5 ± 91.2 mm ). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of ≥mild PVL (the total cohort: 7.2 vs. 22.3%, p < .001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = .03) for the S3-Ultra. The S3-Ultra system, especially 20-, 23-, and 26-mm valve, was associated with significantly lower risk of ≥mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%, p = .05) in patients with the S3-Ultra.

Conclusions: In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced ≥mild PVL, with comparable safety.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29281DOI Listing
September 2020

Lower ST-elevation myocardial infarction incidence during COVID-19 epidemic in Northern Europe.

Scand Cardiovasc J 2020 12 18;54(6):358-360. Epub 2020 Sep 18.

Research Unit of Internal Medicine, Medical Research Center Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland.

We compared the ST elevation myocardial infarction (STEMI) incidence during COVID-19 pandemic (March 2020) to January-February 2020 and to same time period in earlier years 2017-2019 in five Nordic-Baltic tertiary centers. During 2017-2019, there were no marked differences in STEMI incidence between January, February and March. During 2020, there was an average drop of 32% in STEMI incidence in March. The isolation measures may decrease the risk for respiratory virus infection and contribute to the lower STEMI incidence and that we might benefit from firmer suggestions on hand hygiene and social distancing during flu season at least among high-risk individuals.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/14017431.2020.1820563DOI Listing
December 2020

Subtype of atrial fibrillation and the outcome of transcatheter aortic valve replacement: The FinnValve Study.

PLoS One 2020 11;15(9):e0238953. Epub 2020 Sep 11.

Heart Center, Turku University Hospital and University of Turku, Turku, Finland.

Whether the subtype of atrial fibrillation affects outcomes after transcatheter aortic valve replacement for aortic stenosis is unclear. The nationwide FinnValve registry included 2130 patients who underwent primary after transcatheter aortic valve replacement for aortic stenosis during 2008-2017. Altogether, 281 (13.2%) patients had pre-existing paroxysmal atrial fibrillation, 651 (30.6%) had pre-existing non-paroxysmal atrial fibrillation and 160 (7.5%) were diagnosed with new-onset atrial fibrillation during the index hospitalization. The median follow-up was 2.4 (interquartile range: 1.6-3.8) years. Paroxysmal atrial fibrillation did not affect 30-day or overall mortality (p-values >0.05). Non-paroxysmal atrial fibrillation demonstrated an increased risk of overall mortality (hazard ratio: 1.61, 95% confidence interval: 1.35-1.92; p<0.001), but not 30-day mortality (p = 0.084). New-onset atrial fibrillation demonstrated significantly increased 30-day mortality (hazard ratio: 2.76, 95% confidence interval: 1.25-6.09; p = 0.010) and overall mortality (hazard ratio: 1.68, 95% confidence interval: 1.29-2.19; p<0.001). The incidence of early or late stroke did not differ between atrial fibrillation subtypes (p-values >0.05). In conclusion, non-paroxysmal atrial fibrillation and new-onset atrial fibrillation are associated with increased mortality after transcatheter aortic valve replacement for aortic stenosis, whereas paroxysmal atrial fibrillation has no effect on mortality. These findings suggest that non-paroxysmal atrial fibrillation rather than paroxysmal atrial fibrillation may be associated with structural cardiac damage which is of prognostic significance in patients with aortic stenosis undergoing transcatheter aortic valve replacement.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238953PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485765PMC
November 2020

Patient-Prosthesis Mismatch Mismatch Worsens Long-Term Survival: Insights From the FinnValve Registry.

Ann Thorac Surg 2020 Aug 15. Epub 2020 Aug 15.

Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.

Background: The impact of patient-prosthesis mismatch (PPM) on long-term outcome after surgical aortic valve replacement (SAVR) is controversial. We sought to investigate the incidence of PPM and its impact on survival and reinterventions in a Finnish nationwide cohort.

Methods: In the context of the nationwide FinnValve registry, we identified 4097 patients who underwent SAVR with a stented bioprosthesis with or without myocardial revascularization. The indexed effective orifice areas (EOAs) of surgical bioprostheses were calculated using literature-derived EOAs. PPM was graded as moderate (EOA 0.65-0.85 cm/m) or severe (EOA ≤0.65 cm/m).

Results: The incidence of PPM was 46.0%. PPM was moderate in 38.8% (n = 1579) patients and severe in 7.2% (n = 297) patients. Time-trend analysis showed that the proportion of PPM decreased significantly from 74% in 2009 to 18% in 2017 (P < .01). Severe PPM was associated with increased 5-year all-cause mortality (adjusted hazard ratio [HR], 1.72; 95% confidence interval [CI], 1.07-2.76; P = .02). Severe PPM was not associated with an increased risk of repeat AVR (adjusted HR, 5.90; 95% CI, 0.95-36.5; P = .06). In a subanalysis of patients greater than or equal to 70 years of age, in comparison with no PPM, any PPM (adjusted HR, 1.23; 95% CI, 1.05-1.45; P = .01) and severe PPM (HR, 1.53; 95% CI, 1.17-2.00; P < 0.01) were associated with increased risk of 5-year mortality.

Conclusions: Severe PPM after SAVR had a negative impact on survival. This study demonstrated that the effects of PPM should not be overlooked in elderly undergoing SAVR.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.athoracsur.2020.06.026DOI Listing
August 2020

Early and late pace-maker implantation after transcatheter and surgical aortic valve replacement.

Catheter Cardiovasc Interv 2020 Aug 7. Epub 2020 Aug 7.

Heart Center, Turku University Hospital, and University of Turku, Turku, Finland.

Background: Conduction defects requiring permanent pacemaker (PPM) implantation are frequent complications occurring after surgical (SAVR) and transcatheter aortic valve replacement (TAVR).

Methods: Patients who underwent TAVR or SAVR with a bioprosthesis from the nationwide FinnValve registry were the subjects of this study. Patients with prior PPM, who received a sutureless prosthesis, or required cardiac resynchronization therapy or implantable cardioverter defibrillator were excluded from this analysis.

Results: Four thousand and ten patients underwent SAVR and 1,897 underwent TAVR. TAVR had an increased risk of PPM implantation at 30-day (10.1% vs. 3.5%, unadjusted OR 3.11, 95%CI 2.56-3.87) and 5-year (15.7% vs. 8.6%, unadjusted SHR, 2.12, 95%CI 1.81-2.48) compared to SAVR. PPM implantation within 30 days from the index procedure did not increase the risk of 5-year mortality after either SAVR or TAVR. Among 1,042 propensity score matched pairs, TAVR had an increased risk of PPM implantation at 30-day (9.9% vs. 4.7%, p < .0001) and 5-year (14.7% vs. 11.4%, p = .001), but late (>30 days) PPM implantation at 5-year (4.7% vs. 6.9% SHR 0.72, 95%CI 0.47-1.10) was comparable to SAVR. The types of prosthesis had an impact on 30-day PPM implantation after TAVR, but not on late (>30 days) PPM implantation.

Conclusions: Although the risk of 30-day PPM implantation is higher after TAVR compared to SAVR, late (>30 days) PPM implantation was comparable with these treatment methods. PPM implantation within 30 days did not affect late survival.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ccd.29177DOI Listing
August 2020

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis.

J Cardiothorac Surg 2020 Jun 29;15(1):157. Epub 2020 Jun 29.

Heart Center, Turku University Hospital, and Department of Surgery, University of Turku, Turku, Finland.

Background: There 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.

Methods: In 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.

Results: A 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 3.5 ± 2.2% vs. SAVR 3.5 ± 2.8%, 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 4 years 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: 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: ClinicalTrials.gov Identifier: NCT03385915 .
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13019-020-01203-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325109PMC
June 2020

Computed tomography coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE-HF 1C).

Eur Heart J Cardiovasc Imaging 2020 Jun 26. Epub 2020 Jun 26.

Department of Medicine (Cardiology), The University of Ottawa Heart Institute and University of Ottawa, 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada.

Aims: This randomized controlled trial sought to determine the financial impact of an initial diagnostic strategy of coronary computed tomography angiography (CCTA) in patients with heart failure (HF) of unknown aetiology. Invasive coronary angiography (ICA) is used to investigate HF patients. CCTA may be a non-invasive cost-effective alternative to ICA. This randomized controlled trial sought to determine the financial impact of an initial diagnostic strategy of coronary computed tomography angiography (CCTA) in patients with heart failure (HF) of unknown aetiology.

Methods And Results: This multicentre, international trial enrolled patients with HF of unknown aetiology. The primary outcome was the cost of CCTA vs. ICA strategies at 12 months. Clinical outcomes were also collected. An 'intention-to-diagnose' analysis was performed and a secondary 'as-tested' analysis was based on the modality received. Two hundred and forty-six patients were randomized (age = 57.8 ± 11.0 years, ejection fraction = 30.1 ± 10.1%). The severity of coronary artery disease was similar in both groups. In the 121 CCTA patients, 93 avoided ICA. Rates of downstream ischaemia and viability testing were similar for both arms. There were no significant differences in the composite clinical outcomes or quality of life measures. The cost of CCTA trended lower than ICA [CDN -$871 (confidence interval, CI -$4116 to $3028)]. Using an 'as-tested' analysis, CCTA was associated with a decrease in healthcare costs (CDN -$2932, 95% CI -$6248 to $746).

Conclusion: In patients with HF of unknown aetiology, costs were not statistically different between the CCTA and ICA strategies.

Clinical Trials.gov: NCT01283659.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjci/jeaa109DOI Listing
June 2020

Acute Kidney Injury Following Aortic Valve Replacement in Patients Without Chronic Kidney Disease.

Can J Cardiol 2021 Jan 19;37(1):37-46. Epub 2020 Mar 19.

Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland. Electronic address:

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 <60 mL/min/1.73 m. AKI was defined according to the Kidney Disease Improving Global Outcomes criteria. For sensitivity analysis, propensity-score matching between TAVR and SAVR was performed.

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cjca.2020.03.015DOI Listing
January 2021

The value of myocardial perfusion imaging in screening coronary artery disease before kidney transplantation.

Clin Transplant 2020 08 22;34(8):e13894. Epub 2020 May 22.

Department of Cardiology, Heart and Lung Center, Helsinki University and Helsinki University Hospital, Helsinki, Finland.

The value of myocardial single-photon emission computed tomography (SPECT) in pre-transplant evaluation of kidney transplant recipients is controversial. We assessed whether myocardial SPECT predicts major adverse cardiac events (MACE) and determined whether SPECT findings affected transplant recipients' medical and invasive treatment. We analyzed 301 patients referred for myocardial SPECT before kidney transplantation and combined the results with information from patient files and the Transplantation Registry. During the median follow-up time of 96 months (IQR 70.75-118.25 months), the incidence of MACE was higher in patients (n = 37) with severely abnormal SPECT (>10% reversible perfusion defect) than in patients (n = 35) with mildly abnormal or normal SPECT (51.4%, 29.4%, and 27.0%, respectively, P = .011). Severely abnormal SPECT findings predicted long-term MACE in a univariable analysis but not after adjusting for other risk factors. Following SPECT, 29 patients (9.6%) underwent coronary angiography and 14 (4.6%) were revascularized. New antithrombotic or statin medication was prescribed to 7.3% of patients with ischemia in SPECT. Kidney transplantation patients are at high long-term risk of MACE even with normal preoperative myocardial SPECT. Abnormal SPECT did not predict MACE when adjusted for other risk factors. Minority of the patients underwent coronary revascularization or had changes in preventive medication before transplantation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/ctr.13894DOI Listing
August 2020

Acute coronary syndromes and acute heart failure: a diagnostic dilemma and high-risk combination. A statement from the Acute Heart Failure Committee of the Heart Failure Association of the European Society of Cardiology.

Eur J Heart Fail 2020 08 29;22(8):1298-1314. Epub 2020 Apr 29.

Department of Cardiology, Cumhuriyet University Faculty of Medicine, Sivas, Turkey.

Acute coronary syndrome is a precipitant of acute heart failure in a substantial proportion of cases, and the presence of both conditions is associated with a higher risk of short-term mortality compared to acute coronary syndrome alone. The diagnosis of acute coronary syndrome in the setting of acute heart failure can be challenging. Patients may present with atypical or absent chest pain, electrocardiograms can be confounded by pre-existing abnormalities, and cardiac biomarkers are frequently elevated in patients with chronic or acute heart failure, independently of acute coronary syndrome. It is important to distinguish transient or limited myocardial injury from primary myocardial infarction due to vascular events in patients presenting with acute heart failure. This paper outlines various clinical scenarios to help differentiate between these conditions and aims to provide clinicians with tools to aid in the recognition of acute coronary syndrome as a cause of acute heart failure. Interpretation of electrocardiogram and biomarker findings, and imaging techniques that may be helpful in the diagnostic work-up are described. Guidelines recommend an immediate invasive strategy for patients with acute heart failure and acute coronary syndrome, regardless of electrocardiographic or biomarker findings. Pharmacological management of patients with acute coronary syndrome and acute heart failure should follow guidelines for each of these syndromes, with priority given to time-sensitive therapies for both. Studies conducted specifically in patients with the combination of acute coronary syndrome and acute heart failure are needed to better define the management of these patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ejhf.1831DOI Listing
August 2020

Repeat Transcatheter Aortic Valve Replacement for Transcatheter Prosthesis Dysfunction.

J Am Coll Cardiol 2020 04;75(16):1882-1893

A.O.U. Policlinico Vittorio Emanuele, University of Catania, Catania, Italy. Electronic address: https://twitter.com/barbanti_marco.

Background: Transcatheter aortic valve replacement (TAVR) use is increasing in patients with longer life expectancy, yet robust data on the durability of transcatheter heart valves (THVs) are limited. Redo-TAVR may play a key strategy in treating patients in whom THVs fail.

Objectives: The authors sought to examine outcomes following redo-TAVR.

Methods: The Redo-TAVR registry collected data on consecutive patients who underwent redo-TAVR at 37 centers. Patients were classified as probable TAVR failure or probable THV failure if they presented within or beyond 1 year of their index TAVR, respectively.

Results: Among 63,876 TAVR procedures, 212 consecutive redo-TAVR procedures were identified (0.33%): 74 within and 138 beyond 1 year of the initial procedure. For these 2 groups, TAVR-to-redo-TAVR time was 68 (38 to 154) days and 5 (3 to 6) years. The indication for redo-TAVR was THV stenosis in 12 (16.2%) and 51 (37.0%) (p = 0.002) and regurgitation or combined stenosis-regurgitation in 62 (83.8%) and 86 (62.3%) (p = 0.028), respectively. Device success using VARC-2 criteria was achieved in 180 patients (85.1%); most failures were attributable to high residual gradients (14.1%) or regurgitation (8.9%). At 30-day and 1-year follow-up, residual gradients were 12.6 ± 7.5 mm Hg and 12.9 ± 9.0 mm Hg; valve area 1.63 ± 0.61 cm and 1.51 ± 0.57 cm; and regurgitation ≤mild in 91% and 91%, respectively. Peri-procedural complication rates were low (3 stroke [1.4%], 7 valve malposition [3.3%], 2 coronary obstruction [0.9%], 20 new permanent pacemaker [9.6%], no mortality), and symptomatic improvement was substantial. Survival at 30 days was 94.6% and 98.5% (p = 0.101) and 83.6% and 88.3% (p = 0.335) at 1 year for patients presenting with early and late valve dysfunction, respectively.

Conclusions: Redo-TAVR is a relatively safe and effective option for selected patients with valve dysfunction after TAVR. These results are important for applicability of TAVR in patients with long life expectancy in whom THV durability may be a concern.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2020.02.051DOI Listing
April 2020

Favorable outcome of cancer patients undergoing transcatheter aortic valve replacement.

Int J Cardiol 2020 09 18;315:86-89. Epub 2020 Mar 18.

Heart Center, Kuopio University Hospital, Kuopio, Finland.

Aim: The aim of this study was to assess the outcome of transcatheter aortic valve replacement (TAVR) in patients with cancer.

Methods: This is a retrospective study from the nationwide FinnValve registry on 2130 consecutive patients who underwent TAVR for severe AS from January 2008 to October 2017.

Results: In this cohort, 417 patients (19.6%) had history of cancer and 113 (5.3%) had an active malignancy at the time of TAVR. Patients with any malignancy had similar late mortality than patients without any malignancy (at 7 years, 65.1% vs. 59.3%, adjusted HR 1.105, 95%CI 0.892-1.369). At 7 years, cancer-related mortality was 22.5% among patients with preoperative cancer, and 11.0% in those without preoperative cancer (p < 0.0001). Among cancer patients, 18 died of the same disease (at 7 years, mortality 12.5%). Active malignancy was not associated with increased risk of all-cause mortality (adjusted HR 1.100, 95%CI 0.757-1.599). However, patients with blood malignancies had a significantly increased risk of mortality (at 4-year, 53.5% vs. 35.4%, adjusted HR 2.029, 95%CI 1.328-3.098).

Conclusions: This analysis showed that, when properly selected by the heart team and oncologists, most cancer patients undergoing TAVR can achieve a good survival and eventually die of other diseases. Blood malignancies seem to carry a poor prognosis in these patients.

Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT03385915; https://clinicaltrials.gov/ct2/show/NCT03385915.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijcard.2020.03.038DOI Listing
September 2020

Ultrasound-Navigated Manta Deployment After Removal of Extracorporeal Membrane Oxygenation Cannula.

Ann Thorac Surg 2020 10 5;110(4):e307-e309. Epub 2020 Mar 5.

Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland.

The case provided suggests that an ultrasound-navigated Manta device works well in closing percutaneously the peripheral arterial extracorporeal membrane oxygenation cannulation site. Ultrasonography use during extracorporeal membrane oxygenation decannulation can further diminish the possible device-related technical failures (toggle or collagen protrusion through the vessel wall, toggle stacking into calcifications, or delivery failure of the collagen pad) leading to bleeding and vascular complications. Further studies are needed on this topic.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.athoracsur.2020.01.064DOI Listing
October 2020

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Open Heart 2020 19;7(1):e000947. Epub 2020 Jan 19.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.

Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.

Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.

Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.

Trial Registration Number: NCT01496638.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/openhrt-2018-000947DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999681PMC
June 2020

OUTSMART HF: A Randomized Controlled Trial of Routine Versus Selective Cardiac Magnetic Resonance for Patients With Nonischemic Heart Failure (IMAGE-HF 1B).

Circulation 2020 03 8;141(10):818-827. Epub 2020 Jan 8.

University of Ottawa Heart Institute (F.E., L.M., B.J.W.C., R.K., A.D., C.D., L.G., K-L.C.), University of Ottawa, Ontario, Canada.

Background: Cardiac magnetic resonance (CMR) is a recommended imaging test for patients with heart failure (HF); however, there is a lack of evidence showing incremental benefit over transthoracic echocardiography. Our primary hypothesis was that routine use of CMR will yield more specific diagnoses in nonischemic HF. Our secondary hypothesis was that routine use of CMR will improve patient outcomes.

Methods: Patients with nonischemic HF were randomized to routine versus selective CMR. Patients in the routine strategy underwent echocardiography and CMR, whereas those assigned to selective use underwent echocardiography with or without CMR according to the clinical presentation. HF causes was classified from the imaging data as well as by the treating physician at 3 months (primary outcome). Clinical events were collected for 12 months.

Results: A total of 500 patients (344 male) with mean age 59±13 years were randomized. The routine and selective CMR strategies had similar rates of specific HF causes at 3 months clinical follow-up (44% versus 50%, respectively; =0.22). At image interpretation, rates of specific HF causes were also not different between routine and selective CMR (34% versus 30%, respectively; =0.34). However, 24% of patients in the selective group underwent a nonprotocol CMR. Patients with specific HF causes had more clinical events than those with nonspecific caused on the basis of imaging classification (19% versus 12%, respectively; =0.02), but not on clinical assessment (15% versus 14%, respectively; =0.49).

Conclusions: In patients with nonischemic HF, routine CMR does not yield more specific HF causes on clinical assessment. Patients with specific HF causes from imaging had worse outcomes, whereas HF causes defined clinically did not. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01281384.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.119.043964DOI Listing
March 2020

Comparison of Survival of Transfemoral Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement for Aortic Stenosis in Low-Risk Patients Without Coronary Artery Disease.

Am J Cardiol 2020 02 19;125(4):589-596. Epub 2019 Nov 19.

Heart Center, Turku University Hospital and Department of Surgery, University of Turku, Turku, Finland; Department of Surgery, Oulu University Hospital and Research Unit of Surgery, Anesthesia and Intensive Care, Faculty of Medicine, University of Oulu, Oulu, Finland. Electronic address:

Increasing data support transcatheter aortic valve implantation (TAVI) as a valid option over surgical aortic valve replacement (SAVR) in the treatment for severe aortic stenosis (AS) also in patients with low operative risk. However, limited data exist on the outcome of TAVI and SAVR in low-risk patients without coronary artery disease (CAD). The FinnValve registry included data on 6463 patients who underwent TAVI or SAVR with bioprosthesis between 2008 and 2017. Herein, we evaluated the outcome of low operative risk as defined by STS-PROM score <3% and absence of CAD, previous stroke and other relevant co-morbidities. Only patients who underwent TAVI with third-generation prostheses and SAVR with Perimount Magna Ease or Trifecta prostheses were included in this analysis. The primary endpoints were 30-day and 3-year all-cause mortality. Overall, 1,006 patients (175 TAVI patients and 831 SAVR patients) met the inclusion criteria of this analysis. Propensity score matching resulted in 140 pairs with similar baseline characteristics. Among these matched pairs, 30-day mortality was 2.1% in both TAVI and SAVR cohorts (p = 1.00) and 3-year mortality was 17.0% after TAVI and 14.6% after SAVR (p = 0.805). Lower rates of bleeding and atrial fibrillation, and shorter hospital stay were observed after TAVI. The need of new permanent pacemaker implantation and the incidence of early stroke did not differ between groups. In conclusion, TAVI using third-generation prostheses achieved similar early and mid-term survival compared with SAVR in low-risk patients without CAD.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjcard.2019.11.002DOI Listing
February 2020

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.

EuroIntervention 2020 Feb;15(14):1240-1247

Cardiology unit, Cardio-Thoracic-Vascular Department, University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.

Aims: The aim of this study was to evaluate 30-day safety and efficacy outcomes of transcatheter aortic valve implantation (TAVI) performed with the SAPIEN 3 Ultra system.

Methods And Results: The S3U registry is a physician-led, post-approval, multicentre, observational registry of transfemoral TAVI with the SAPIEN 3 Ultra. New features include an improved sealing skirt, a 14 Fr expandable sheath and a new delivery catheter. Overall, 139 consecutive patients at nine participating centres were enrolled. Mean age was 81.4±8.3 years, average STS score 3.8±2.4%. The vast majority (97.2%) underwent TAVI with local anaesthesia (28.8%) or conscious sedation (68.3%). Balloon predilatation was performed in 30 patients (21.6%), post-dilatation in three (2.2%). In-hospital, there were no cases of death, stroke, or conversion to open heart surgery. Major vascular complications occurred in three patients (2.2%), as well as major or life-threatening bleedings in three patients (2.2%). There were two moderate (1.4%) and no moderate/severe paravalvular leaks. Median length of stay after TAVI was three days (IQR 3-5 days). At 30 days, there were no deaths, MI, or strokes, and the incidence of new permanent pacemaker implantation was 4.4%.

Conclusions: This first multicentre international experience of transfemoral TAVI with the SAPIEN 3 Ultra transcatheter heart valve shows good in-hospital and 30-day clinical outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJ-D-19-00541DOI Listing
February 2020

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.

JACC Cardiovasc Interv 2019 10;12(20):2035-2046

Hammersmith Hospital, Imperial College London, London, United Kingdom.

Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies.

Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes.

Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization.

Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919).

Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2019.06.035DOI Listing
October 2019

Peripheral Administration of IL-13 Induces Anti-inflammatory Microglial/Macrophage Responses and Provides Neuroprotection in Ischemic Stroke.

Neurotherapeutics 2019 10;16(4):1304-1319

A.I.Virtanen Institute for Molecular Sciences, University of Eastern Finland, Kuopio, Finland.

Neuroinflammation is strongly induced by cerebral ischemia. The early phase after the onset of ischemic stroke is characterized by acute neuronal injury, microglial activation, and subsequent infiltration of blood-derived inflammatory cells, including macrophages. Therefore, modulation of the microglial/macrophage responses has increasingly gained interest as a potential therapeutic approach for the ischemic stroke. In our study, we investigated the effects of peripherally administered interleukin 13 (IL-13) in a mouse model of permanent middle cerebral artery occlusion (pMCAo). Systemic administration of IL-13 immediately after the ischemic insult significantly reduced the lesion volume, alleviated the infiltration of CD45 leukocytes, and promoted the microglia/macrophage alternative activation within the ischemic region, as determined by arginase 1 (Arg1) immunoreactivity at 3 days post-ischemia (dpi). Moreover, IL-13 enhanced the expression of M2a alternative activation markers Arg1 and Ym1 in the peri-ischemic (PI) area, as well as increased plasma IL-6 and IL-10 levels at 3 dpi. Furthermore, IL-13 treatment ameliorated gait disturbances at day 7 and 14 and sensorimotor deficits at day 14 post-ischemia, as analyzed by the CatWalk gait analysis system and adhesive removal test, respectively. Finally, IL-13 treatment decreased neuronal cell death in a coculture model of neuroinflammation with RAW 264.7 macrophages. Taken together, delivery of IL-13 enhances microglial/macrophage anti-inflammatory responses in vivo and in vitro, decreases ischemia-induced brain cell death, and improves sensory and motor functions in the pMCAo mouse model of cerebral ischemia.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13311-019-00761-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6985054PMC
October 2019

Blood Transfusion and Outcome After Transfemoral Transcatheter Aortic Valve Replacement.

J Cardiothorac Vasc Anesth 2019 Nov 1;33(11):2949-2959. Epub 2019 Jul 1.

Heart Center, Kuopio University Hospital, Kuopio, Finland; Heart Center, Turku University Hospital and Department of Surgery, University of Turku, Turku, Finland. Electronic address:

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1053/j.jvca.2019.06.038DOI Listing
November 2019

Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Cardiol 2019 09;4(9):857-864

Hammersmith Hospital, Imperial College London, London, England.

Importance: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated.

Objective: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial.

Design, Setting, And Participants: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.

Interventions: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.

Main Outcomes And Measures: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups.

Results: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25).

Conclusions And Relevance: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.

Trial Registration: ClinicalTrials.gov identifier: NCT02053038.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamacardio.2019.2298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6646975PMC
September 2019

Transcatheter and Surgical Aortic Valve Replacement in Patients With Recent Acute Heart Failure.

Ann Thorac Surg 2020 01 6;109(1):110-117. Epub 2019 Jul 6.

Heart Center, Turku University Hospital and Department of Surgery, University of Turku, Turku, Finland; Department of Surgery, Oulu University Hospital and University of Oulu, Oulu, Finland. Electronic address:

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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.athoracsur.2019.05.044DOI Listing
January 2020