No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the "no-touch" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment. The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration. RCT# NCT03501303.

Transcatheter versus surgical treatment for aortic stenosis: patient selection and early outcome.

OBJECTIVES: To describe short-term clinical and echocardiography outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). To explore patient selection criteria for treatment with TAVI. DESIGN: TAVI patients (n = 45) were matched to SAVR patients (n = 45) with respect to age within ± 10 years, sex and systolic left ventricular function. RESULTS: TAVI patients were older, 82 ± 8 versus 78 ± 5 years (p = 0.005) and they had higher logEuroSCORE, 16 ± 11% versus 8 ± 4% (p = 0.001). There were no significant differences in 30 days mortality, stroke and myocardial infarction. TAVI patients received less erythrocyte (53% vs. 78%, p = 0.03) and thrombocyte (7% vs. 27%, p = 0.02) transfusions. Postoperative atrial fibrillation was less common (18% vs. 60%, p = 0.001) in the TAVI group. Paravalvular regurgitation was more common in TAVI patients (87% vs. 0%, p = 0.001) and 27% had access site complications. Aortic transvalvular velocity was 2.3 ± 0.4 m/s versus 2.6 ± 0.5 m/s (p = 0.002) and mean valve pressure gradient was 12 ± 4 mmHg versus 15 ± 5 mmHg (p = 0.01) in the TAVI and SAVR groups, respectively. Twenty-nine (64%) of the TAVI patients had logEuroSCORE = 15%. CONCLUSIONS: Both TAVI and SAVR have good short term clinical outcome with excellent hemodynamic result. In clinical practice, factors other than high logEuroSCORE play an important role in patient selection for TAVI.

Evaluation of left ventricular diastolic function in patients operated for aortic stenosis.

BACKGROUND: Left ventricular diastolic dysfunction is common in patients with aortic valve stenosis (AS) and reportedly affects prognosis after surgical aortic valve replacement (SAVR). Here we investigated whether and how diastolic function (assessed following the most recent guidelines) was affected by SAVR, and whether preoperative diastolic function affected postoperative outcome. We also examined whether long-term mortality was associated with preoperative NT-proBNP and postoperative heart failure (PHF). METHODS: We performed a prospective observational study of 273 patients with AS who underwent AVR with or without concomitant coronary artery bypass surgery. Of these patients, 247 were eligible for assessment of left ventricular (LV) filling pressure. Preoperatively and at the 6-month postoperative follow-up, we measured N-terminal pro-B type natriuretic peptide (NT-proBNP) in serum and assessed diastolic function with Doppler echocardiography. PHF was diagnosed using prespecified criteria. Multivariable logistic regression was performed to explore variables associated with high LV filling pressure. Cox regression was performed to explore variables associated with mortality, accounting for timeto-event. RESULTS: At the time of surgery, 22% (n = 54) of patients had diastolic dysfunction expressed as high LV filling pressure. Of these 54 patients, 27 (50%) showed postoperative diastolic function improvement. Among the 193 patients with preoperative low LV filling pressure, 24 (12%) showed postoperative diastolic function deterioration. Increased long-term mortality was associated with PHF and high preoperative NT-proBNP, but not with preoperative or postoperative diastolic dysfunction. Cox regression revealed the following independent risk factors for long-term mortality: diabetes, renal dysfunction, preoperative NT-proBNP>960 ng/L, age, and male gender. CONCLUSIONS: Surgery for aortic stenosis improved diastolic function in patients with high LV filling pressure in 50% of the patients. Our results could not confirm the previously suggested role of diastolic dysfunction as a marker for poor long-term survival after SAVR. Our findings showed that both PHF and high preoperative NT-proBNP were associated with long-term mortality.

The combined impact of postoperative heart failure and EuroSCORE on long-term outcome after surgery for aortic stenosis.

BACKGROUND AND AIM OF THE STUDY: Although the EuroSCORE was developed for predicting operative mortality after cardiac surgery, it has also been shown to predict long-term mortality. It has been reported that postoperative heart failure (PHF) in association with surgery, albeit comparatively benign in the short term, has a profound impact on five-year survival after surgery for aortic stenosis (AS). The study aim was to determine the combined impact of EuroSCORE and PHF on long-term survival after isolated aortic valve replacement (AVR) for AS. METHODS: A total of 397 patients (48% females; average age 70 +/- 10 years) who underwent AVR for AS at the authors' institution between 1995 and 2000 was studied. The cohort was subdivided according to the additive EuroSCORE into a high-risk group (EuroSCORE >7) and a low-risk group (EuroSCORE < or = 7), and further analyzed in relation to PHF. RESULTS: The average follow up was 8.1 years (range: 5.2-11.2 years). Forty-five patients (11%) were treated for procedure-associated PHF. Patients with or without PHF and a high-risk EuroSCORE had crude five-year survivals of 57% and 64%, respectively (p = 0.6), whereas those with or without PHF but with a low-risk EuroSCORE had crude five-year survivals of 58% and 89%, respectively (p = 0.0003). CONCLUSION: Both PHF and a high EuroSCORE were associated with poor long-term survival. The role of PHF per se for the long-term prognosis was illustrated by the fact that the negative impact on long-term survival was almost as profound in patients of the low-risk group as of the high-risk group.

NT-proBNP and postoperative heart failure in surgery for aortic stenosis.

Objective: Postoperative heart failure (PHF) after aortic valve replacement (AVR) for aortic stenosis (AS) may initially appear mild and transient but has serious long-term consequences. Methods to assess PHF are not well documented. We studied the association between N-terminal pro-B-type natriuretic peptide (NT-proBNP) and PHF after AVR for AS. Methods: This is a prospective, observational, longitudinal study of 203 patients undergoing elective first-time AVR for AS. Plasma NT-proBNP was assessed at preoperative evaluation, the day before surgery, and the first (POD1) and third postoperative morning. A clinical endpoints committee, blinded to NT-proBNP results, used prespecified haemodynamic criteria to diagnose PHF. The mean follow-up was 8.6±1.1 years. Results: No patient with PHF (n=18) died within 30 days after surgery, but PHF was associated with poor long-term survival (HR 3.01, 95% CI 1.45 to 6.21, p=0.003). NT-proBNP was significantly higher in patients with PHF only on POD1 (6415 (3145-11 220) vs 2445 (1540-3855) ng/L, p<0.0001). NT-proBNP POD1 provided good discrimination of PHF (area under the curve=0.82, 95% CI 0.72 to 0.91, p<0.0001; best cut-off 5290 ng/L: sensitivity 63%, specificity 85%). NT-proBNP POD1 ≥5290 ng/L identified which patients with PHF carried a risk of poor long-term survival, and PHF with NT-proBNP POD1 ≥ 5290 ng/L emerged as a risk factor for long-term mortality in the multivariable Cox regression (HR 6.20, 95% CI 2.72 to 14.1, p<0.0001). Conclusions: The serious long-term consequences associated with PHF after AVR for AS were confirmed. NT-proBNP level on POD1 aids in the assessment of PHF and identifies patients at particular risk of poor long-term survival.

Rise and fall of NT-proBNP in aortic valve intervention.

Objectives: To describe the dynamics of N-terminal pro-B-type natriuretic peptide (NT-proBNP) from preoperative evaluation to 6-month follow-up in patients undergoing aortic valve intervention, and to evaluate NT-proBNP with regard to 1-year mortality. Methods: At preoperative evaluation, we prospectively included 462 patients accepted for aortic valve intervention. The median time to surgical aortic valve replacement (SAVR; n=336) or transcatheter aortic valve implantation (TAVI; n=126) was 4 months. NT-proBNP was measured at enrolment for preoperative evaluation, on the day of surgery, postoperatively on day 1, day 3 and at the 6-month follow-up. Subgroups of patients undergoing SAVR with aortic regurgitation and aortic stenosis with and without coronary artery bypass were also analysed. Results: NT-proBNP remained stable in all subgroups during the preoperative waiting period, but displayed a substantial transient early postoperative increase with a peak on day 3 except in the TAVI group, which peaked on day 1. At the 6-month follow-up, NT-proBNP had decreased to or below the preoperative level in all groups. In the SAVR group, NT-proBNP preoperatively and on postoperative days 1 and 3 revealed significant discriminatory power with regard to 1-year mortality (area under the curve (AUC)=0.79, P=0.0001; AUC=0.71, P=0.03; and AUC=0.79, P=0.002, respectively). This was not found in the TAVI group, which had higher levels of NT-proBNP both preoperatively and at the 6-month follow-up compared with the SAVR group. Conclusions: The dynamic profile of NT-proBNP differed between patients undergoing TAVI and SAVR. NT-proBNP in the perioperative course was associated with increased risk of 1-year mortality in SAVR but not in TAVI.

Impact of underlying heart disease per se on the utility of preoperative NT-proBNP in adult cardiac surgery.

OBJECTIVE: The primary aim was to investigate the role of underlying heart disease on preoperative NT-proBNP levels in patients admitted for adult cardiac surgery, after adjusting for the known confounders age, gender, obesity and renal function. The second aim was to investigate the predictive value of preoperative NT-proBNP with regard to severe postoperative heart failure (SPHF) and postoperative mortality. METHODS: A retrospective cohort study based on preoperative NT-proBNP measurements in an unselected cohort including all patients undergoing first time surgery for coronary artery disease (CAD; n = 2226), aortic stenosis (AS; n = 406) or mitral regurgitation (MR; n = 346) from April 2010 to August 2016 in the southeast region of Sweden (n = 2978). Concomitant procedures were not included, with the exception of Maze or tricuspid valve procedures. RESULTS: Preoperative NT-proBNP was 1.67 times (p<0.0001) and 1.41 times (p<0.0001) higher in patients with AS or MR respectively, than in patients with CAD after adjusting for confounders. NT-proBNP demonstrated significant discrimination with regard to SPHF in CAD (AUC = 0.79, 95%CI 0.73-0.85, p<0.0001), MR (AUC = 0.80, 95%CI 0.72-0.87, p<0.0001) and AS (AUC = 0.66, 95%CI 0.51-0.81, p = 0.047). In CAD patients NT-proBNP demonstrated significant discrimination with regard to postoperative 30-day or in-hospital mortality (AUC = 0.78; 95%CI 0.71-0.85, p<0.0001). The number of deaths was too few in the AS and MR group to permit analysis. Elevated NT-proBNP emerged as an independent risk factor for SPHF, and postoperative mortality in CAD. CONCLUSIONS: Patients with AS or MR have higher preoperative NT-proBNP than CAD patients even after adjusting for confounders. The predictive value of NT-proBNP with regard to SPHF was confirmed in CAD and MR patients but was less convincing in AS patients.

Evaluation of the Valve Academic Research Consortium-2 Criteria for Myocardial Infarction in Transcatheter Aortic Valve Implantation: A Prospective Observational Study.

OBJECTIVE: To evaluate the relevance of the individual components of the Valve Academic Research Consortium (VARC)-2 criteria for periprocedural myocardial infarction (MI) in transcatheter aortic valve implantation (TAVI). The association between biomarkers and adverse procedural outcome has been established. However, the additive prognostic importance of signs and symptoms are more uncertain. METHODS: A total of 125 consecutive TAVI patients were prospectively included in this study. Biomarkers for MI were analyzed and signs and symptoms according to VARC-2 criteria were collected from clinical records. RESULTS: The criteria of elevated biomarkers and of signs or symptoms were found in 27 (22%) and 32 (26%) of the patients, respectively. According to VARC-2 definition, 12 (10%) had MI. VARC-2 definition of MI, Troponin T (TnT) > 600 ng/L, and presence of signs or symptoms correlated with 6 months mortality, prolonged ICU stay, elevation of N-terminal prohormone brain natriuretic peptide, and renal impairment. No signs or symptoms were found in 7 (44%) of the patients who fulfilled the criterion of elevated TnT > 600 ng/L. In the group with positive TnT criterion, there were no significant differences between those with and without signs or symptoms in respect to levels of TnT (1014 [585-1720] ng/L versus 704 [515-905] ng/L, p = 0.17) or creatine kinase-MB (36 [25-52] µg/L versus 29 [25-39] µg/L, p = 0.32). In the multivariate Cox regression analysis, TnT > 600 ng/L was the only significant independent variable associated with 6-months postprocedural mortality. CONCLUSIONS: Myocardial injury in TAVI, measured with biomarkers, correlates well with adverse procedural outcome. In this study it is also the strongest predictor for early postprocedural mortality. The additional requirement of signs or symptoms for the diagnosis of MI results in omission of a considerable number of clinically significant MI.

A multimodal approach for reducing wound infections after sternotomy.

As previous efforts failed to reduce infection rates after cardiac surgery at our institution, we developed a concept based on adjustment of surgical technique. This concept was then evaluated in clinical practice. We modified our surgical technique towards: minimizing contamination, avoidance of devitalizing tissue, and securing a rigid fixation of the caudal part of sternum. After a pilot series sequential series was compared before and after introduction of the modified technique in a case-series design. All surgical site infections were recorded at discharge, after 6 weeks and by the attending cardiologist at 2 and 6 months. In the pilot series 9/136 patients developed sternal wound infections (SWI) compared with 15/89 patients in the control group (P=0.015). In the larger study population we found a significant drop in the total number of SWIs (72/772 vs 124/772, P<0.0001). Although not statistically significant a 32% reduction in deep SWIs was observed. No reduction in infections at harvest sites for graft material was seen. The preliminary results from the pilot study appear reproducible and we were able to reduce the incidence of SWIs significantly, using this simple modified surgical technique.