Twenty years' experience of type B aortic dissections: a population-based national registry study from Finland.

OBJECTIVES: The objective of this study was to investigate the incidence, treatment and survival of Stanford type B aortic dissection (BTAD) during 20 years in the Finnish population. METHODS: Data collection was made from the Nationwide Care Register for Health Care, Finnish National Institute for Health and Welfare. All patients over 15 years of age with BTAD from 2000 to 2019 were included in the study. A data search of the Registry of Death Cause (Statistic Finland) was carried out to identify the date and cause of death. RESULTS: There were 1742 cases of BTAD during the study period. BTAD represented 45.6% of all aortic dissections leading to hospital admission. Incidence for BTAD was 1.62 per 100 000 inhabitants per year. The median survival was 12.7 years [95% confidence interval (CI) 9.63-14.7], 12.4 years (95% CI 10.5-14.4) and 8.6 years (95% CI 7.5-9.7) for patients treated with thoracic endovascular aortic repair (TEVAR), surgery and medical treatment (MT), respectively. Survival was significantly better after TEVAR and surgery, compared to MT only (P < 0.001). Age-adjusted survival was significantly better after TEVAR compared to patients treated with MT or surgery (hazard ratio 0.578, 95% CI 0.420-0.794, P < 0.001). Aortic-related death was the most common cause of death in all groups (41%). CONCLUSIONS: The incidence of BTAD seems to be similar in the Finnish population compared to other populational studies. Patients treated with TEVAR had significantly better survival compared to other patients. A high risk for late aortic-related death should be recognized in patients with BTAD.

Nondestructive Evaluation of Mechanical and Histological Properties of the Human Aorta With Near-Infrared Spectroscopy.

INTRODUCTION: Ascending aortic dilatation is a well-known risk factor for aortic rupture. Indications for aortic replacement in its dilatation concomitant to other open-heart surgery exist; however, cut-off values based solely on aortic diameter may fail to identify patients with weakened aortic tissue. We introduce near-infrared spectroscopy (NIRS) as a diagnostic tool to nondestructively evaluate the structural and compositional properties of the human ascending aorta during open-heart surgeries. During open-heart surgery, NIRS could provide information regarding tissue viability in situ and thus contribute to the decision of optimal surgical repair. MATERIALS AND METHODS: Samples were collected from patients with ascending aortic aneurysm (n = 23) undergoing elective aortic reconstruction surgery and from healthy subjects (n = 4). The samples were subjected to spectroscopic measurements, biomechanical testing, and histological analysis. The relationship between the near-infrared spectra and biomechanical and histological properties was investigated by adapting partial least squares regression. RESULTS: Moderate prediction performance was achieved with biomechanical properties (r = 0.681, normalized root-mean-square error of cross-validation = 17.9%) and histological properties (r = 0.602, normalized root-mean-square error of cross-validation = 22.2%). Especially the performance with parameters describing the aorta's ultimate strength, for example, failure strain (r = 0.658), and elasticity (phase difference, r = 0.875) were promising and could, therefore, provide quantitative information on the rupture sensitivity of the aorta. For the estimation of histological properties, the results with α-smooth muscle actin (r = 0.581), elastin density (r = 0.973), mucoid extracellular matrix accumulation(r = 0.708), and media thickness (r = 0.866) were promising. CONCLUSIONS: NIRS could be a potential technique for in situ evaluation of biomechanical and histological properties of human aorta and therefore useful in patient-specific treatment planning.

Transcatheter and surgical aortic valve replacement in patients with left ventricular dysfunction.

BACKGROUND: Patients with severe aortic stenosis and left ventricular systolic dysfunction have a poor prognosis, and this may result in inferior survival also after aortic valve replacement. The outcomes of transcatheter and surgical aortic valve replacement were investigated in this comparative analysis. METHODS: The retrospective nationwide FinnValve registry included data on patients who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis for severe aortic stenosis. Propensity score matching was performed to adjust the outcomes for baseline covariates of patients with reduced (≤ 50%) left ventricular ejection fraction. RESULTS: Within the unselected, consecutive 6463 patients included in the registry, the prevalence of reduced ejection fraction was 20.8% (876 patients) in the surgical cohort and 27.7% (452 patients) in the transcatheter cohort. Reduced left ventricular ejection fraction was associated with decreased survival (adjusted hazards ratio 1.215, 95%CI 1.067-1.385) after a mean follow-up of 3.6 years. Among 255 propensity score matched pairs, 30-day mortality was 3.1% after transcatheter and 7.8% after surgical intervention (p = 0.038). One-year and 4-year survival were 87.5% and 65.9% after transcatheter intervention and 83.9% and 69.6% after surgical intervention (restricted mean survival time ratio, 1.002, 95%CI 0.929-1.080, p = 0.964), respectively. CONCLUSIONS: Reduced left ventricular ejection fraction was associated with increased morbidity and mortality after surgical and transcatheter aortic valve replacement. Thirty-day mortality was higher after surgery, but intermediate-term survival was comparable to transcatheter intervention. Trial registration The FinnValve registry ClinicalTrials.gov Identifier: NCT03385915.

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 transfused 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 incidence 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.

Reversible myocardial ischaemia caused by ectopic left circumflex coronary artery: a case report.

Background: Coronary artery anomalies (CAAs) are congenital disorders associated with variable manifestations and pathophysiological mechanisms. Anomalies can be asymptomatic or cause chest pain, myocardial infarction, or even sudden cardiac death. Case summary: We describe a 34-year-old man with a history of a single episode of chest pain. An ectopic origin on the part of the left circumflex (LCX) coronary artery from the proximal right coronary artery (RCA) was evident upon coronary computed tomography angiography. A positron emission tomography perfusion study revealed a stress-induced perfusion defect in the anomalous LCX territory (infero-posterior wall). The patient experienced dyspnoea and ST-segment depression in electrocardiography, suggestive of myocardial ischaemia during the maximal bicycle ergometer stress test. No mechanical compression or stenosis was seen upon invasive coronary angiography. The left ventricular perfusion normalized after the initiation of beta-blocker medication. Discussion: Patients with CAAs especially benefit from a multimodality assessment of the vascular territories. In our case, the myocardial perfusion of the infero-posterior wall normalized after treatment with beta-blockers. This may be due to increased coronary vasodilation capacity and myocardial flow reserve, as well as reduced oxygen consumption. Beta-blockers may represent a viable option in low-symptomatic CAA patients with perfusion defect and no ostial stenosis or compression.

Decreasing complications of pectoralis major muscle flap reconstruction with two modalities of negative pressure wound therapy.

BACKGROUND AND OBJECTIVE: Deep sternal wound infection is a feared complication of open-heart surgery. Negative pressure wound therapy has gained an important role in the treatment of deep sternal wound infection. Incisional negative pressure wound therapy has been introduced as a method to prevent wound complications after sternotomy, and lately, after flap reconstructions in the treatment of deep sternal wound infection. We aimed to study if incisional negative pressure wound therapy with PICO™ had similar beneficial effect described earlier with competing commercial devices. METHODS: This study included 82 patients treated with pectoralis major muscle flap for deep sternal wound infection during the years 2006-2020. PICO group consisted of 24 patients treated with preoperative negative pressure wound therapy and postoperative incisional negative pressure wound therapy (PICO™). Two control groups included 48 patients with conventional treatment and 10 patients with preoperative negative pressure wound therapy only. RESULTS: In the PICO group, the complication rate declined from 50.0% to 33.30%, major complication rate from 29.2% to 12.5%, and need for an additional flap from 14.6.% to 4.2% when compared to conventional treatment. The length of hospital stay decreased as well. Preoperative negative pressure wound therapy alone was associated with moderate decline in the complication rates. In addition, we described the use of split pectoralis major muscle flap reconstruction in 57 patients. To our knowledge, this is the largest published patient series describing this method in the treatment of deep sternal wound infection. CONCLUSIONS: Incisional negative pressure wound therapy with PICO™ seems beneficial after flap reconstruction. Split pectoralis major muscle flap is a versatile reconstruction option suitable to be used as a workhorse in the treatment of deep sternal wound infection.

Does Incisional Negative Pressure Wound Therapy Prevent Sternal Wound Infections?

BACKGROUND: Incisional negative pressure wound therapy has been described as an effective method to prevent wound infections after open heart surgery in several publications. However, most studies have examined relatively small patient groups, only a few were randomized, and some have manufacturer-sponsorship. Most of the studies have utilized Prevena; there are only a few reports describing the PICO incisional negative pressure wound therapy system. METHODS: We conducted a prospective cohort study involving a propensity score-matched analysis to evaluate the effect of PICO incisional negative pressure wound therapy after coronary artery bypass grafting. A total of 180 high-risk patients with obesity or diabetes were included in the study group. The control group included 772 high-risk patients operated before the initiation of the study protocol. RESULTS: The rates of deep sternal wound infections in the PICO group and in the control group were 3.9 and 3.1%, respectively. The rates of superficial wound infections needing operative treatment were 3.1 and 0.8%, respectively. After propensity score matching with two groups of 174 patients, the incidence of both deep and superficial infections remained slightly elevated in the PICO group. None of the infections were due to technical difficulties or early interruption of the treatment. CONCLUSION: It seems that incisional negative pressure wound therapy with PICO is not effective in preventing wound infections after coronary artery bypass grafting. The main difference in this study compared with previous reports is the relatively low incidence of infections in our control group.

Combined Mitral and Aortic Valve Surgery: 17-year Experience in a Single Center.

BACKGROUND AND OBJECTIVE: It is not uncommon that patients requiring valve surgery have several simultaneous valvular dysfunctions. Combined aortic and mitral valve surgery is the most common form of double-valve surgery. The aim of this study was to analyze and present the outcomes of simultaneous aortic and mitral valve surgery in a single center in a real-life setting. METHODS: The study population consisted of 150 patients operated in the Kuopio University Hospital from 2004 to 2020. All patients undergoing concomitant mitral and aortic valve surgery were included. Four groups were formed based on either the etiology or pathophysiology of the valvular dysfunction. The most common combination was mitral regurgitation with aortic regurgitation (n = 72, 48%), followed by mitral regurgitation with aortic stenosis (n = 37, 25%), endocarditis (n = 29, 19%), and mitral stenosis with aortic regurgitation or stenosis (n = 12, 8%). Concomitant coronary artery revascularization was performed in 37 (25%) patients and tricuspid valve repair in 26 (17%) patients. RESULTS: Operative mortality was 2% and 30-day mortality was 7%. Overall survival was 86%, 78%, and 61% in 3, 5, and 10 years, respectively. Patients with endocarditis were significantly more morbid, and more often than other patients had to undergo an emergency operation. There were no significant differences between the groups in terms of early and late survival. In the overall cohort, the EuroSCORE II value, increased pulmonary artery pressure, decreased glomerular filtration, and length of the operation displayed a negative correlation with survival. CONCLUSIONS: Despite the challenging nature of multivalvular heart disease, surgery is a safe method of treatment with good short- and long-term outcomes.

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 <60 mL/min/1.73 m2. 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.

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

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.

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

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 cm2/m2) or severe (EOA ≤0.65 cm2/m2). 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.

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

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.

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

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.

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

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.

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

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 .

Favorable outcome of cancer patients undergoing transcatheter aortic valve replacement.

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.

Trifecta Versus Perimount Magna Ease Aortic Valve Prostheses.

BACKGROUND: Recent surgical bovine pericardial prostheses are widely used despite limited data on their long-term durability. METHODS: This is a comparative analysis of the outcome of the Trifecta (Abbott, Abbott Park, IL) and Perimount Magna Ease (Edwards, Lifesciences Corp, Irvine, CA) bioprostheses from the FinnValve registry, a Finnish nationwide database including patients with aortic stenosis who underwent transcatheter or surgical aortic valve replacement with a bioprosthesis between 2008 and 2017. RESULTS: Overall 2216 patients (mean age, 74.1 ± 6.7 years; age <65 years, 8.9%; mean follow-up, 3.8 ± 2.1 years) received the Trifecta (851 patients) or the Perimount Magna Ease (1365 patients) bioprostheses. The rates of late mortality and prosthetic valve endocarditis were comparable in the study cohorts. At 7 years the Trifecta cohort had a significantly higher risk of repeat aortic valve replacement for structural valve failure (3.3% vs 0%; adjusted subdistribution hazard ratio, 2.224; 95% confidence interval, 1.044-4.737), repeat aortic valve replacement for any cause (3.6% vs 0.4%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013), and repeat aortic valve replacement and/or prosthetic valve endocarditis (4.1% vs 0.9%; adjusted subdistribution hazard ratio, 3.210; 95% confidence interval, 1.286-8.013) compared with the Perimount Magna Ease cohort. Among 772 propensity score-matched pairs, at 7 years the Trifecta cohort had a higher risk of repeat aortic valve replacement for structural valve failure (5.7% vs 0%, P = .009). CONCLUSIONS: The Trifecta aortic bioprosthesis is associated with a higher occurrence of repeat aortic valve replacement for structural valve failure compared with the Perimount Magna Ease bioprosthesis. Further comparative studies with echocardiographic data on structural valve deterioration and longer follow-up are needed to confirm these findings.

Impact of Major Vascular Complication Access Site Status on Mortality After Transfemoral Transcatheter Aortic Valve Replacement　- Results From the FinnValve Registry.

Background: The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR). Methods and Results: The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16-3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63-7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86-2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19-3.89). Conclusions: In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity.

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.

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.

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.