Midterm outcomes of transaortic and transapical TAVI in patients with unsuitable vascular anatomy for femoral access: A propensity score inverse probability weight study.

AIMS: Transaortic (TAo) and transapical (TA) implantation can be used in transcatheter aortic valve implantation (TAVI) when the transfemoral (TF) approach is precluded. We compare the safety and efficacy of these alternative techniques. METHODS: From October 2007 to February 2016, TAo and TA patients' data were collected. Propensity score inverse probability of treatment weight (IPTW) method was employed to minimize the impact of no-randomization bias. RESULTS: From our single-center non-TF-TAVI registry, 282 patients were included: 235 (83.3%) underwent TAo and 47 (16.7%) TA. Differences in baseline characteristics were statistically significant in age, sex, risk profile according to logistic-EuroSCORE, and previous cardiac surgery. No difference in hospital morbidity and mortality, but lower stroke-rate in TAo (1.27% vs. 8.5% p < .01) was observed. This was confirmed at logistic regression after IPTW adjustment (odds ratio [OR]: 0.16, 95% CI 0.03-0.71, p = .01), together with reduced risk of the paravalvular leak (PVL) (OR: 0.14, 95% confidence interval [CI]: 0.02-0.81, p = .02). Kaplan-Meier estimates did not demonstrate differences in long-term mortality among access routes (logrank test p = .13). At the IPTW-Cox regression model, long-term mortality was related to New York Heart Association III-IV (hazard ratio [HR]: 2.92, 95% CI: 1.15-7.40, p = .026), chronic renal failure (HR: 3.25; 95% CI: 1.02-10.32 p = .046), previous transient ischemic attack/stroke (HR: 2.29, 95% CI: 1.25-4.20 p = .007). Sapien-3 device resulted to be a protective factor, reducing long-term mortality (HR: 0.18, 95% CI 0.04- 0.90 p = .03). CONCLUSIONS: TAo is safe and feasible in case of contraindication to femoral approach demonstrating comparable midterm outcomes to TA, thus representing a central access alternative, to increase the overall safety of high-risk TAVI procedures.

Safety and effectiveness of a transaortic approach for TAVI: procedural and midterm outcomes of 265 consecutive patients in a single centre.

OBJECTIVES: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices. METHODS: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria. RESULTS: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class

Direct Comparison of Feasibility and Safety of Transfemoral Versus Transaortic Versus Transapical Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to compare outcomes among transfemoral (TF), transaortic (TAo), and transapical (TA) transcatheter aortic valve replacement (TAVR). BACKGROUND: Very few studies have investigated the differences among TF, TAo, and TA TAVR in terms of safety and feasibility. METHODS: Between January 2011 and December 2014, 467 consecutive cases of TF TAVR, 289 cases of TAo TAVR, and 42 cases of TA TAVR were analyzed. Baseline characteristics, procedural characteristics, and outcomes were compared between TF and TAo and between TAo and TA approaches. RESULTS: Balloon-expandable prostheses were used in 320 cases of TF TAVR (69%), 209 cases of TAo TAVR (72%), and all cases of TA TAVR. The remaining cases were performed using self-expandable prostheses. Patient age and Society of Thoracic Surgeons score were similar (83.8 years vs. 83.7 years vs. 81.3 years and 6.2% vs. 5.8% vs. 7.1%) among all groups. Although nonsignificant, a trend toward lower 30-day mortality (5% vs. 9%; p = 0.057) was observed with TF TAVR compared with TAo TAVR. Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.067) with TF TAVR compared with TAo TAVR. There was no significant difference in 30-day mortality between TAo and TA TAVR (9% vs. 14%; p = 0.283). Kaplan-Meier analysis revealed a trend toward a higher 1-year survival rate (log-rank p = 0.154) with TAo TAVR compared with TA TAVR. CONCLUSIONS: Although the 30-day mortality and 1-year survival rates were similar between TF and TAo TAVR patients, a trend in favor of the TF approach was observed. In addition, the TAo approach can be considered as an alternative to the TA approach when the TF approach seems unsuitable.

Exogenous surfactant attenuates lung injury from gastric-acid aspiration during ex vivo reconditioning in pigs.

BACKGROUND: Lung injury (LI) due to gastric-acid aspiration is associated with poor posttransplantation outcomes. We investigated the effects of ex vivo lung perfusion (EVLP) reconditioning and surfactant administration on LI due to gastric-acid aspiration. METHODS: Thirty piglets were allocated at random to five groups: the lungs were studied 24 hr after gastric juice-induced LI of the left lower lobe (LLL), LI followed by EVLP (4 hr), or LI followed by LLL surfactant lavage immediately before EVLP; sham animals were studied 24 hr after saline infusion alone or followed by EVLP. Gross anatomy, hemodynamics, and aerodynamics were evaluated; neutrophil and bacterial counts were determined in bronchoalveolar lavage (BAL) fluid and blood. LLLs were evaluated based on a semi-quantitative histologic score, apoptotic cell death (TUNEL), and inflammatory cytokine levels. RESULTS: The sham and sham-EVLP groups were not significantly different. Compared with sham, LI animals had irreversible atelectasis, higher lung infection rates (P<0.0001) and BAL neutrophil percentages (P<0.0001), lower PaO2 (P=0.0006), higher IL-1 (P=0.022) and IL-8 (P=0.006), higher apoptotic cell percentages (P=0.007), and worse histologic severity scores (P<0.0001). EVLP alone did not improve these findings. Adding surfactant before EVLP returned PaO2, pulmonary vascular resistance, and apoptotic-cell percentage to sham-EVLP values but only partially improved the histologic severity score. CONCLUSION: Local surfactant infusion immediately before EVLP improved the function of donor lungs injured by gastric juice aspiration. This strategy may hold promise for decreasing the shortage of donor lungs.

The transaortic approach for transcatheter aortic valve implantation: a valid alternative to the transapical access in patients with no peripheral vascular option. A single center experience.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) in patients with poor peripheral vessels still remains problematic, as the transapical approach is not always feasible and is sometimes associated with myocardial damage, bleeding, post-procedural chest pain and pleural effusion. In order to address these issues, we adopted the recently introduced transaortic (TAo) approach. The purpose of this study was to evaluate the efficacy and safety of the TAo-TAVI approach using both the Sapien XT and the CoreValve according to VARC criteria. METHODS: Of 492 patients (October 2006 to February 2012), TAo-TAVI was performed in 94 consecutive patients with unfavourable peripheral access between January 2011 and February 2012. Aortic root condition, valve anatomy and annulus size were carefully assessed by multidetector computed tomography (MDCT) for possible TAo-TAVI. The aorta was exposed through an inverted 'T' manubriotomy. After retrograde guidewire crossing of the aortic valve, sheath insertion allowed device positioning and deployment subsequent to balloon valvuloplasty. RESULTS: Mean age was 84.1 ± 5.4 years (67-96) and logistic EuroSCORE 17.6 ± 10.2%. The Sapien XT was used in 88.3% and the CoreValve in 11.7% of patients. Full sternotomy allowed concomitant complete off-pump revascularization (2-4 grafts) in 11 patients. Device success rate was 92.6%. Paravalvular leak ≥2/4 was observed in 7.4%. Conversion to open chest surgery was required in 5.3% (3 aortic dissections, 1 valve migration and 1 left main occlusion). Three cerebrovascular accidents (2 transient ischaemia and 1 delayed stroke) were noted. Transfusion ≥4 units was performed in 12 patients (12.8%). Intensive care unit (ICU) and total hospital stay were 4.9 ± 5.0 and 12.2 ± 6.2 days, respectively. Thirty-day mortality and combined safety endpoint were reported in 7.4 and 16.0%, respectively. CONCLUSIONS: The TAo approach for both Sapien XT and CoreValve implantation can be used with satisfactory clinical outcome and an acceptable risk. This access route could prove a valid alternative to the transapical approach.