Statin loading before coronary artery bypass grafting: a randomized trial.

AIMS: Evidence suggests that a high-dose statin loading before a percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. This study aimed to analyse the effects of such an additional statin therapy before surgical revascularization. METHODS AND RESULTS: This investigator-initiated, randomized, double-blind, and placebo-controlled trial was conducted from November 2012 to April 2019 at 14 centres in Germany. Adult patients (n = 2635) with a long-term statin treatment (≥30 days) who were scheduled for isolated coronary artery bypass grafting (CABG) were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 h prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occuring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. Non-statistically relevant differences were found in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.74-1.18; P = 0.562] or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR 0.88, 95% CI 0.69-1.12; P = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/ml, P = 0.333), and death at 12 months (3.1% vs. 2.9%; P = 0.825) were comparable between treatment arms. CONCLUSION: Additional statin loading before CABG failed to reduce the rate of MACCE occuring within 30 days of surgery.

Early-Term Results of Rapid-Deployment Aortic Valve Replacement versus Standard Bioprosthesis Implantation Combined with Coronary Artery Bypass Grafting.

OBJECTIVES: Aortic stenosis is highly prevalent among patients with concomitant coronary artery disease. Surgical aortic valve replacement with coronary artery bypass grafting is usually the treatment of choice for patients with severe aortic stenosis and significant coronary disease. The aim of this study was to evaluate the outcome and hemodynamic results of the implantation of rapid-deployment valves (Rapid-Deployment Edwards Intuity Valve System [RDAVR]) versus conventional sutured valves (CSAVR) in combined surgery. METHODS: Between January 2012 and January 2017, 120 patients underwent replacement via RDAVR and 133 patients underwent replacement using CSAVR with concomitant coronary bypass grafting. Clinical and echocardiographic data were compared. RESULTS: The mean age was 76 ± 7 for RDAVR patients and 74 ± 6 years for CSAVR patients (p = 0.054); 48% in the RDAVR group were female versus 17% in the CSAVR group (p <0.002). Other characteristics such as diabetes mellitus, body-mass index, chronic obstructive pulmonary disease, nicotine consumption, and extracardiac arteriopathy were similar. Coronary three-vessel disease was more common in the RDAVR group (42.5 vs. 27.8%, p = 0.017). Both mean EuroSCORE II (6.6 ± 5.4 vs. 4.3 ± 3.0, p = 0.001) and STS score (5.4 ± 4.4 vs. 3.4 ± 2.4, p = 0.001) were significantly higher in the RDAVR group. Mean cross-clamp time (82 ± 25 vs. 100 ± 30 minutes, p < 0.001) and cardiopulmonary bypass time (119 ± 38 vs. 147 ± 53 minutes, p < 0.001) were shorter with RDAVR. The mean number of bypass grafts, length of hospital and ICU stays, and mechanical ventilation time were not statistically significant different. Hospital mortality was 2.5% for RDAVR and 9.7% for CSAVR (p = 0.019). There was a similar rate of stroke (5.8 vs. 6.0%, p = 0.990) and postoperative delirium (14.1 vs. 15.8%, p = 0.728). Mean gradients were 8.2 ± 4.1 mm Hg in the RDAVR group vs. 11.3 ± 4.6 mm Hg in the CSAVR group (p = 0.001) at discharge. CONCLUSION: RDAVR combined with coronary artery bypass grafting (CABG) can be performed extremely safely. Cross-clamp and cardiopulmonary bypass times can be significantly reduced with rapid deployment aortic valve system in the scenario of combined CABG. RDAVR resulted in lower gradients than CSAVR in patients implanted with prostheses of the same size.

Outcomes in Patients with Left Bundle Branch Block after Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Increased rates of postoperative left bundle branch block (LBBB) and permanent pacemaker implantation (PPI) frequently occur after implantation of rapid deployment valves. The impact of LBBB on follow-up outcomes remains controversial. So far, no data regarding long-term outcomes exist. AIM: The aim of this study was to analyze the impact of LBBB on postoperative outcomes after rapid deployment aortic valve replacement (RDAVR). METHODS: A total of 620 consecutive patients without preexisting LBBB or PPI who underwent rapid deployment AVR between March 2012 and September 2019 were included. New-onset LBBB was defined as any new LBBB that persisted at hospital discharge. The median follow-up time for clinical data was 1.7 years post-RDAVR. RESULTS: At discharge, new-onset LBBB was seen in 109 patients (17.5%). There were no differences between the LBBB groups and no-LBBB groups regarding baseline characteristics. At a median follow-up of 1.7 years, no difference was found between LBBB groups and no-LBBB groups concerning all-cause mortality (12.8 vs. 11.7%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.74-1.53; p = 0.54). Nevertheless, new-onset LBBB was associated with significant higher pacemaker implantation rates at follow-up (10.1 vs. 6.3%; HR: 3.58; 95% CI: 1.89-6.81 p < 0.001). CONCLUSION: After a median follow-up of 1.7 years, new-onset LBBB was not associated with increased mortality. Nevertheless, higher pacemaker implantation rates were observed in patients with new-onset LBBB after RDAVR.

Urgent Endovascular Aortic Repair Requiring Coverage of the Left Subclavian Artery.

BACKGROUND: Evaluation of the optimal left subclavian artery (LSA) management during thoracic endovascular aortic repair (TEVAR) involving the distal aortic arch in an urgent setting. METHODS: A total of 52 patients with acute aortic syndromes underwent TEVAR (March 2017 to May 2021) requiring proximal landing in the distal aortic arch. Decision for partial or complete LSA ostial endograft coverage, with or without additional bypassing, was made depending upon the aortic pathology and vascular anatomy. We focused on the patency of the circle of Willis and the unilateral dominance of one carotid or a vertebral artery: 35% underwent complete (complete LSA group) and 17% partial LSA coverage (partial LSA group), whereas in 48% the LSA was reached only by the bare springs of the endograft (control group). A total of 22% of the complete LSA group underwent LSA bypass before TEVAR, whereas 11% underwent cerebrospinal fluid drainage. Endpoints were 30-day and 1-year mortality, stroke, spinal cord ischemia (SCI), and malperfusion. RESULTS: Technical success was achieved in 96%. The endograft length was 171 ± 34 (complete LSA group) versus 151 ± 22 (partial LSA group) versus 181 ± 52 mm (control group), covering 6 ± 2 versus 5 ± 1 versus 7 ± 2 intercostal arteries. The 30-day mortality, stroke and SCI rates did not differ. One patient with arm malperfusion underwent LSA bypass post-TEVAR. After 1 year, aortic interventions occurred in 6 (complete LSA group) versus 22 (partial LSA group) versus 13% (control group). One-year mortality (0 vs. 0 vs. 8%), stroke (6 vs. 0 vs. 4%), and SCI (0 vs. 0 vs. 4%) were similar between groups. CONCLUSION: With an adequate analysis of vascular anatomy, coverage of the LSA for TEVAR is safe and may offer results similar to TEVAR starting distal to the LSA.

Transcatheter Aortic Valve Implantation in Patients Who Cannot Undergo Transfemoral Access.

INTRODUCTION: Though transfemoral (TF) access has emerged as a gold standard access for patients with aortic stenosis who undergo transcatheter aortic valve implantation (TAVI), there has been no study that has characterized patients who cannot undergo TF access in detail. We aim to evaluate the contraindications for TF access, their incidence, classify them, and provide the outcomes of patients who failed to be TF candidates. METHODS: From 925 patients who underwent TAVI between February 2014 and May 2020 at our heart center, 130 patients failed to be TF candidates and underwent transapical-transcatheter aortic valve implantation (TA-TAVI). In this study, we included all those patients who failed to be TF candidates and underwent TA-TAVI using the third-generation balloon expandable valve (Edwards SAPIEN 3 valve [S3]) (116 patients; STS score 6.07 ± 4.4; age 79.4 ± 7). RESULTS: The incidence of patients unsuitable for TF access at our heart center was 14%. We classified this TAVI population into absolute contraindication for TF access n = 84 (72.5%) and increased interventional risk for TF access n = 32 (27.5%). After TA-TAVI of this specific population using S3, the in-hospital mortality and stroke were 1.7 and 1.7%, respectively. The vascular injury rate was 1.7%. We registered no paravalvular leakage ≥2. The pacemaker rate was 7.4%. The mean transvalvular pressure gradient was 8.7 mm Hg. CONCLUSION: The incidence of patients who cannot undergo TF access or who are at high interventional risk is considerably high. TA-TAVI, supported with sufficient interventional experience and appropriate valve system, represents an excellent alternative for patients with distinct vasculopathy.

Transapical-transcatheter aortic valve implantation in patients without transvascular options: Modified transapical approach.

OBJECTIVES: Outcomes in patients with iliofemoral and concomitant iliofemoral-remote arteriopathies who cannot undergo transfemoral or other alternative transvascular approaches have not been studied so far. This study aimed to evaluate the early and midterm outcomes after transapical (TA)-transcatheter aortic valve implantation (TAVI) in patients with femoral and femoral-remote arteriopathies who cannot undergo transvascular approaches. METHODS: Multimorbid patients with severe aortic stenosis and distinct panarteriopathy underwent TA-TAVI treatment between January 2012 and January 2021 at the authors' institution. Second- and third-generation self- and balloon-expanding valves were used. For patients without arterial access, TA-TAVI was modified to the artery-no-touch technique. RESULTS: Seventy-two consecutive elderly patients (78.2 ± 6.9 years; 73% male) were included in the study. The Society of Thoracic Surgery-Predicted Risk of Mortality score was 7 ± 5%. No procedural deaths or conversion to conventional surgery was registered. The 30-day and midterm mortality rates were 5% and 28%, respectively. The median time of freedom from a composite of death and cardiocerebral adverse events was 34.3 months (95% confidence interval: 17.6-51.1). The rate of moderate/severe paravalvular leakage was 0%. The pacemaker rate was 11%. CONCLUSIONS: TA-TAVI is a safe method with low-rate procedural complications and shows good early and midterm outcomes in patients with extensive panarteriopathy for whom transfemoral and other alternative transvascular approaches are contraindicated or at high interventional risk. The modified artery-no-touch TA-TAVI method is safe and feasible for selected patients with no other possible arterial approach.

Long-term Follow up after Transfemoral Transcatheter Aortic Valve Implantation in Lower Risk Patients Using the Balloon-Expandable Bioprosthesis: Gender-Dependent Outcomes.

INTRODUCTION: Long-term data on gender-related outcomes after transfemoral transcatheter aortic valve implantation (TF-TAVI) using newer generations heart valves in lower-risk patients are sparse. We aimed to evaluate gender-dependent long-term outcomes after TF-TAVI in lower-risk patients using the third-generation balloon expandable bioprosthesis. METHODS: Data of 103 patients undergoing TF-TAVI using the third-generation balloon expandable bioprosthesis were analyzed. We conducted up to six years follow up and performed comparison on gender basis: men (45 patients; 82 ± 4.7 years; STS Score 3.7 ± 1.6%) vs. women (58 patients; 83.2 ± 4.5 years; STS Score 3.6 ± 1.8%). The mean follow-up time was 30 months. RESULTS: Cardiovascular risk factors at baseline were similar, without significant differences between men and women. The 30-day mortality was 4.4% in men vs. 3.4% in women (P = 0.745). The 30-day stroke was 4.4% in men vs. 1.7% in women (P = 0.582). The major vascular injury rate and the pacemaker rate was 2.3% vs. 10.7% (P = 0.134) and 19.5% vs. 18.9% (P = 1) in men vs. women, respectively. There was a significant difference of mean long-term survival: men, 42.1 months [95%CI: 33.154-51.101] vs. women, 57.3 months [95%CI: 50.618-64.159], P = 0.015. CONCLUSION: Although considerably more prone to procedural complications, women had a significantly long-term survival benefit after TF-TAVI in lower-risk patients despite similar baseline characteristics.

Single-Center Outcomes with Rapid Deployment Aortic Valve Replacement.

OBJECTIVES: Rapid-deployment valves can reduce procedural times and may facilitate minimally invasive surgery. In our institution, more than 500 patients underwent rapid deployment aortic valve replacement (AVR). METHODS: A total of 510 patients underwent rapid deployment AVR between March 2012 and September 2017, of whom 270 patients underwent isolated AVR and 240 underwent AVR with concomitant procedures. The cumulative follow-up time was 1,444 patient-years, the median follow-up time 2.8 years, respectively RESULTS: An early all-cause mortality of 3.5% (n = 18) was seen with a cumulative survival of 91.9 ± 2.2% after 12 months. Mean cross-clamp times were 37 ± 19 minutes for isolated AVR and 93 ± 29 minutes for AVR with concomitant procedures. The rate of new pacemaker implantation was 7.8% (n = 40). No case of structural degeneration occurred in the follow-up. Three (0.6%) cases of endocarditis were registered. CONCLUSIONS: Rapid deployment AVR can be performed safely with low complication rates and good hemodynamic results. Therefore, the relevance in aortic valve surgery can be stressed.

Oversized versus Non-oversized Prosthesis: Midterm Outcomes after Transcatheter Aortic Valve Replacement Using SAPIEN 3 Valve.

BACKGROUND: A certain degree of prosthesis oversizing is recommended for the SAPIEN 3 (S3; Edwards Lifesciences Corp., Irvine, California, United States) to ensure device success. We aimed to investigate midterm outcomes in patients who received oversized (OS) S3 valve after transapical-transcatheter aortic valve replacement (TA-TAVR). METHODS: Out of 122 patients with aortic stenosis who underwent TA-TAVR using S3 at our institution, 42 received OS prosthesis. We used computed tomography (CT) derived effective diameter to assess oversizing. We defined oversizing if the labeled diameter of the selected valve for implantation was ≥2 mm bigger than the effective annulus diameter calculated by the annulus area. We conducted a midterm follow-up and compared the OS cohort with the non-OS (nOS) cohort. RESULTS: The study groups showed similar risk score and age (STS [Society of Thoracic Surgery] score: 5.4 ± 3; mean age: 80.7 ± 5.7). The 30-day mortality was 7.1% in OS versus 2.4% in nOS. The 30-day all-stroke was 2.4% in OS versus 0% in nOS. The 1- and 3-year all-cause mortality were 28.5 and 42.8% in OS versus 21.9 and 26.8% in nOS, respectively. Midterm freedom from death and from cardiocerebral events was similar in both groups. Moderate/severe paravalvular leakage occurred in 0% in OS versus 5.4% in nOS. The postdilation rate was 7.1% in OS versus 15.3% in nOS. The rate of new permanent pacemaker implantation (PPI) was 15.7% in OS versus 9.3% in nOS. The STS score was detected as an independent predictor of mortality. CONCLUSION: Oversizing reduces the risk of device failure and intraprocedural postdilation but increases the risk of PPI. Early and midterm morbidity and mortality after OS and nOS with S3 are comparable.

Transcatheter aortic valve replacement using the SAPIEN 3 valve versus surgical aortic valve replacement using the rapid deployment INTUITY valve: Midterm outcomes.

OBJECTIVES: Little data have been published on the midterm effect of transapical/transfemoral-transcatheter aortic valve replacement (TA-/TF-TAVR) using the Edwards SAPIEN 3 valve (S3). We aimed to compare the outcomes after TA-/TF-TAVR utilizing the S3 (TA-/TF-S3) valve with those after surgical aortic valve replacement utilizing the rapid deployment Edwards INTUITY valve (RD-SAVR). METHODS: Between March 2012 and April 2018, 122 patients with aortic stenosis underwent TA-S3, 77 patients underwent TF-S3 and 182 patients underwent RD-SAVR through partial sternotomy at our institution. We conducted clinical and echocardiographic midterm follow-ups. The primary outcomes of the study were the incidence of new pacemakers permanent pacemaker implantation (PPI), the occurrence of paravalvular leakage (PVL) and the hemodynamic performance of the valves. RESULTS: All study groups were at intermediate surgical risk. The 30-day all-cause mortality and stroke rates in the TA-S3, TF-S3, and RD-SAVR groups were 4.1% and 1.6%, 3.9% and 2.6%, and 3.8% and 2.2%, respectively. The RD-SAVR group had significantly smaller PVL and PPI rates than did the TA-/TF-S3 group (p < .0001). At the discharge, the one-year postprocedure mean gradients were 9 ± 5.1/10 ± 4.5 mmHg, 11 ± 4.1/12 ± 3.8 mmHg, and 10.1 ± 4.3/10.4 ± 2.6 mmHg in the TA-S3, TF-S3, and RD-SAVR groups, respectively. Midterm valve thrombosis, Re-TAVR/SVAR were low and similar among the study groups, whereas endocarditis was higher in the TAVR group. CONCLUSION: RD-SAVR was superior to TA-/TF-S3 in the PVL and PPI rates. We observed similar early outcomes and valve hemodynamics. The endocarditis was higher in the TAVR group.

Early Results after Aortic Valve Replacement Using Last Generation Bioprosthetic Aortic Valve.

INTRODUCTION: Few data are available about the newest generation surgical bioprosthesis. We aimed to evaluate early clinical and hemodynamic outcomes after using the INSPIRIS RESILIA aortic valve (Edwards Lifesciences, Irvine, California, USA). METHODS: Between July 2018 and April 2021, 80 patients underwent aortic valve replacement receiving the INSPIRIS RESILIA aortic valve at our institution. Primary outcomes were the composite of early mortality, stroke, and myocardial infarction. Secondary outcomes were hemodynamic performances of the valve, paravalvular leakage, and new pacemaker implantation. RESULTS: The mean age of the study population was 60.6 ± 8.3 years. The mean Society of Thoracic Surgery-Predicted Risk of Mortality score was 2.9 ± 1.7%. In 43.7% of the patients, concomitant surgery was performed. The in-hospital mortality, all-stroke, and myocardial infarction rates were 2.5%, 1.2%, and 1.2%, respectively. No valve was explanted and no redo was performed. The mean postoperative trans-prosthetic gradient at discharge was 10.2 ± 4.1 mm Hg. There was no need for new pacemaker implantation. We registered only two cases with minimal (trace) paravalvular leakage. CONCLUSION: The use of the INSPIRIS RESILIA aortic valve in a young, low-risk population is safe and associated with very good early clinical and hemodynamic outcomes.

Intermediate Outcomes after Rapid Deployment Aortic Valve Replacement in Multiple Valve Surgery.

BACKGROUND: Multiple valve surgery is associated with significant higher operative risks. Reduced cross-clamp and cardiopulmonary bypass times in multiple valve surgery may potentially be beneficial as they can be considered independent risk factors for increased morbidity and mortality following cardiac surgery. We report first intermediate outcomes of the Edwards Intuity valve system (Edwards Lifesciences, Irvine, California, United States) in combined procedures METHODS: Fifty-eight patients underwent rapid deployment aortic valve replacement with concomitant mitral valve surgery between January 2014 and November 2017 in our institution. The valve was assessed echocardiographically after 12 months. The median follow-up was 1.7 years with a cumulative follow-up time of 115.3 patient years. RESULTS: The mean age was 73.5 ± 6.2 years and the mean logistic Euroscore was 11.6 ± 3.1%. Concomitant mitral valve repair was performed in 43 cases (74.1%), and mitral valve replacement in 15 cases (19.0%). The mean cross-clamp time was 93 ± 21 minutes along with a mean bypass time of 118 ± 24 minutes. All-cause mortality after 30 days was 8.6%. Overall actuarial survival at 1 year was 87.2 ± 4.5% and after 2 years 82.8 ± 5.3%, respectively. CONCLUSIONS: Rapid deployment aortic valve replacement in multiple valve surgery can be performed safely with good intermediate outcomes in elderly, high-risk patients.

Mid-Term Outcomes after Transapical and Transfemoral Transcatheter Aortic Valve Implantation for Aortic Stenosis and Porcelain Aorta with a Systematic Review of Transfemoral versus Transapical Approach.

BACKGROUND: We have aimed to analyze early and mid-term outcomes of patients undergoing transapical/transfemoral transcatheter aortic valve implantation (TA-/TF-TAVI) for aortic stenosis and porcelain aorta (PAo) in our institution. Additionally, we postulated that the TA approach may be associated with a more favorable neurological outcome than the TF approach; hence, a systematic literature review was conducted. METHODS: Between 2011 and 2017, 15 patients with PAo underwent TA-TAVI and 4 patients with PAo TF-TAVI at our institution. The assessment of PAo was done either intraoperatively after aborted sternotomy or via computed tomography for elective TAVI. We conducted mid-term follow-up. Furthermore, a systematic review was performed to compare the mortality and neurological outcomes of TF and TA-TAVI approaches. RESULTS: TA/TF-TAVIs were performed with 100% device success, without paravalvular leakage ≥ 2 and without procedural death. The 30-day mortality/stroke rates were 6.6%/0% in TA-TAVI and 0%/25% in TF-TAVI, respectively. The 6-month, 1-year, and 2-year survival rates were in TA/TF-TAVI 93%/75%, 82%/66.6%, and 50%/0%, respectively.The pooled results derived from the literature review were as follows: The prevalence of PAo in the TAVI population is 9.74%; the mean logistic EuroSCORE is 41.9% in TA-TAVI versus 16.2% in TF-TAVI; the mean 30-day mortality is 5.9% in TA-TAVI versus 6.3% in TF-TAVI, and the mean stroke is 0.8% in TA-TAVI versus 9% in TF-TAVI. CONCLUSION: TA-TAVI shows promising early and mid-term outcomes in patients with PAo. TF-TAVI performed in patients with PAo is likely to be associated with higher rates of stroke than TA-TAVI.

Two-stage weaning strategy using veno-veno-arterial perfusion for patients on extracorporeal membrane oxygenation following cardiogenic shock.

OBJECTIVES: Veno-arterial extracorporeal membrane oxygenation represents the last therapy option in refractory cardiogenic shock. Successful weaning becomes difficult if the myocardial function recovers but pulmonary impairment persists. We present our experience with a new weaning strategy, using a stepwise mode-switch from veno-arterial to veno-veno-arterial and veno-venous extracorporeal membrane oxygenation setting for patients with primary cardiogenic shock and subsequent respiratory failure. METHODS: From 81 patients treated with veno-arterial extracorporeal membrane oxygenation following acute cardiogenic shock between January 2014 and April 2018, eight patients with cardiac and pulmonary failure were identified to be treated using the following protocol: patients were put on veno-arterial extracorporeal membrane oxygenation, a second inflow cannula was inserted via the right jugular vein and cardiac weaning was performed via veno-veno-arterial support. Finally, patients were pulmonary weaned via veno-venous extracorporeal membrane oxygenation mode. RESULTS: In the mode-switch group, etiologies of cardiogenic shock were cardiac arrest (12.5%), myocardial infarction (12.5%) and post-cardiotomic heart failure (75%). Mean time between onset of cardiogenic shock and start of veno-arterial extracorporeal membrane oxygenation was 76 ± 117 min. At implantation, lactate and pH values were 9.5 ± 5.0 mmol/L and 7.2 ± 0.2. Total extracorporeal membrane oxygenation-time was 9.3 ± 4.7 days, with a mode-switch from veno-arterial to veno-veno-arterial after 3.9 ± 2.7 days. The weaning rate in the mode-switch group was 75% (vs. 41% in the entire cohort) and the 30-day survival was 50% (vs 32% in the cohort). 38% of the patients presented a favorable neurological outcome. CONCLUSION: Mode-switch from veno-arterial to veno-veno-arterial and weaning via veno-venous extracorporeal membrane oxygenation mode is feasible for combined cardiac and pulmonary failure, with promising results due to an optimized pre-pulmonary oxygenation.

Aortic Valve Replacement with the Labcor TLPB Supra™ Porcine Bioprosthesis: Intermediate Clinical and Echocardiographic Outcomes.

BACKGROUND: The Labcor TBLP Supra™ prosthesis is a second-generation tissue valve that has evolved from the Labcor TBLP™ prosthesis, first introduced in 1984. The Supra prosthesis is a triple-composite porcine valve, with no specific anticalcification treatment being used in its production other than standard tissue fixation with 0.4% glutaraldehyde. To date, more than 100,000 Supra valves have been implanted, mainly in South America. Despite this remarkably high number of implants, only marginal data exist concerning durability and safety issues. Hence, the study aim was to analyze short-term and intermediate outcomes relating to the clinical and hemodynamic performance of the Supra valve, as well as complication rates METHODS: A follow up study was initiated to evaluate outcomes and durability of the Labcor Supra prosthesis. Between September 2004 and October 2010, a total of 331 patients (mean age 75.8 ± 7.2 years; mean logistic EuroSCORE 8.5 ± 2.3%) underwent aortic valve replacement using the Supra porcine bioprosthesis. RESULTS: The 30-day mortality rate was 4.8% (n = 16). The overall actuarial five-year survival was 72.3 ± 4.9%, and eight-year survival was 60.4 ± 5.6%. Actuarial freedom from reoperation was 96.3 ± 2.4% after five years, and 92.5 ± 3.5% after eight years. Actuarial freedom from structural valve deterioration (SVD) was 99.7 ± 0.3% at five years, and 97.2 ± 0.8% at eight years; actuarial freedom from thromboembolism was 97.5 ± 1.0% and 95.7 ± 1.6% at these times. Actuarial freedom from event rates for endocarditis were 99.5 ± 0.3% and 96.8 ± 0.6%, and 96.1 ± 0.9% and 93.0 ± 1.4% for reoperation CONCLUSIONS: No evidence was found of increased rates of SVD. All parameters studied were comparable to those examined for other second-generation porcine prostheses. Further long-term follow up investigations are required however, for the final judgment of this prosthesis.

Risk factors for acute kidney injury following TA-TAVI or minimally invasive aortic valve replacement: which procedure is less kidney damaging in elderly patients?

BACKGROUND: Acute kidney injury (AKI) represents a major complication following aortic valve replacement in elderly patients. The aim of this study was to determine possible risk factors for AKI and to find the ideal strategy, minimally invasive valve replacement (MIS-AVR) or transapical valve implantation (TA-TAVI), regarding the postoperative renal outcome. METHODS: A total of 133 patients (age ≥ 75 years, 67 male) with severe aortic stenosis were included over 2 years: 42% were treated with MIS-AVR, 58% underwent TA-TAVI procedure. AKI was considered as a postprocedural 1.5× increase in creatinine or an increase of > 0.3 mg/dL/48 hours. Group differences were tested with chi-square or t-test. AKI risk assumption was analyzed in multiple multivariate logistic regression models. RESULTS: EuroSCORE II-related risk assumption was 8.7 ± 6.9 for TA-TAVI and 4.5 ± 5.7 for MIS-AVR (p < 0.001). The overall 30-day survival rate was 93%. Fifty-eight patients developed a risk for AKI and 13 developed a manifest renal injury/failure. Logistic regression analysis revealed a higher AKI risk for TA-TAVI (odds ratio, OR = 2.58; 95% confidence interval, CI = 1.18, 5.63; p = 0.017). EuroSCORE II (OR = 0.98; 95% CI = 0.92, 1.04; p = 0.433); preoperative creatinine (OR = 1.78; 95% CI = 0.67, 4.77; p = 0.249) and estimated glomerular filtration rate (OR = 1.00; 95% CI = 0.97, 1.02; p = 0.655) had no impact on AKI. A regression model adjusting for the variables age, gender, body mass index (BMI), diabetes, and procedure type revealed a higher AKI rate for male gender (OR = 2.41; 95% CI = 1.13, 5.11; p = 0.022). Operation time and radio-contrast media volume had no influence on the AKI-occurrence. There was no correlation between AKI and early mortality. CONCLUSION: A higher risk for AKI after TA-TAVI should be considered in the therapy decision, especially in elderly male patients because MIS-AVR still yields excellent results.

Annular rupture leading to fatal complications in an elderly patient with calcified aortic and mitral annulus undergoing transapical aortic valve implantation.

This case illustrates the awareness that must be taken of the high morphological risk due to the calcifications of both, the aortic and mitral annulus in elderly patients when performing transapical aortic valve implantation. In an 86-year-old, multimorbid woman (logistic EuroSCORE = 27%) with symptomatic aortic stenosis (annular diameter = 23.4 mm) and severe mitral annular calcification, the implantation of a 26-mm Edwards SAPIEN (Edwards Lifesciences, Irvine, California, United States) valve in aortic position was primary successful, with no paravalvular leakage, valve instability, or coronary malperfusion. Second, a persisting transmural bleeding led to hypovolemic shock, which could not be stabilized even after going on cardiopulmonary bypass, and the patient died in the operation room. The autopsy showed a subvalvular ventricular rupture due to a transmural perforation of the calcified fibrotic annulus during valvuloplasty.

Long-Term Outcomes After Transfemoral-Transcatheter Aortic Valve Implantation in Very Old Patients Using the Balloon-Expandable Bioprosthesis.

Transcatheter aortic valve implantation (TAVI) can be safely performed in old patients. Increasing longevity raises often the question whether TAVI can be still useful for patients beyond a certain age limit. Data on long-term outcomes of elderly patients after TAVI are sparse. We sought to assess the impact of very advanced age on long-term outcomes after transfemoral (TF)-TAVI. Data of 103 patients undergoing TF-TAVI with the balloon-expandable bioprosthesis between May/2014 and May/2019 were analyzed. We divided the cohort into two age groups: ≥85 years (group1: n = 37; 87.5 ± 2.6 years; STS-Score 3.9 ± 1.4) versus < 85 years (group2: n = 66; 80 ± 3.1 years; STS-Score 3.4 ± 1.8). We conducted up to 6 years clinical follow-up. Overall mortality at 30 days was 3.8% without significant differences between the two age groups. Incidence of major vascular injury (8.6 vs. 6.3%, p = .695) and stroke (2.8 vs. 3%, p = 1) was not significantly different between group 1 and 2, respectively. More than mild paravalvular leakage was found in 1 patient (group 1). The mean long-term survival probability was 51.3 months [95% CI: 42.234-60.430] in group 1 versus 49.5 months [95% CI: 42.155-56.972] in group2 (p = .921). Long-term outcomes of very old patients after TF-TAVI show a similar treatment benefit compared to the younger patients.

Surgical Resection of Very Small Multiple Papillary Fibroelastomas of the Aortic Valve.

Papillary fibroelastomas (PFEs) in multiple presentations on the aortic valve surface are extremely rare tumors that can cause sudden major cardio-cerebral adverse events. The treatment of these tumors varies from conservative care strategy to curative surgical resection. The bigger the tumor size, the bigger seems the tendency toward surgical treatment concepts. Here, we present the case of a completely healthy young woman who suffered sudden myocardial infarction and occlusion of the circumflex artery caused by very small multiple PFEs of the aortic valve. The patient underwent cardiac surgery for resection at our institution. The surgical approach appears to be recommended as a solitary reasonable treatment option once multiple PFEs have been detected.

Transapical-transcatheter aortic valve implantation using the Edwards SAPIEN 3 valve.

BACKGROUND: Scarcely any data has been published on the mid-term effect of transapical-transcatheter aortic valve implantation (TA-TAVI) using the Edwards SAPIEN 3 valve (S3; Edwards Lifesciences Corp., Irvine, CA, USA). We present mid-term clinical and echocardiographic outcomes after TA-TAVI utilizing S3. METHODS: Between 02/2014-06/2017, 122 elderly patients with severe aortic stenosis underwent TA-TAVI utilizing S3 at our institution. We conducted clinical and echocardiographic follow-up. The mean follow-up was 15 months. All end-point-related outcomes were adjudicated according to Valve Academic Research Consortium-2 definitions. RESULTS: The STS-score of the entire cohort was 6.26±4.6. More than one-third of the patients exhibited severe peripheral artery disease. The 30-d all-cause mortality, all-stroke rate, and myocardial infarction of the entire cohort were 4.1%, 1.6%, and 0.8% respectively. Median survival time of the entire cohort was 35 months. The cumulative mid-term myocardial infarction and stroke rate was 2.6% and 3.5%, respectively. The postoperative moderate/severe paravalvular leakage occurred in 1.6% of cases. At discharge, one-year and two-year postprocedure peak/mean gradients were 16.6±8.3/ 9±5.1 mmHg, 18±6.9/ 10±4.5 mmHg, and 22.2±5.4/ 12.8±4.6 mmHg, respectively. The rate of new pacemaker cases was 14.1%. Acute kidney injury network 2/3 appears, as an independent predictor of mortality. CONCLUSIONS: We observed very promising early and mid-term clinical outcomes with a high degree of device success and good hemodynamic performance after TA-TAVI using the S3 in the intermediate risk patient profile.