Transcaval Transcatheter Aortic Valve Replacement for Pure Aortic Regurgitation Using a Dedicated Self-Expanding Device.

Novel dedicated devices allow transcatheter treatment of pure aortic regurgitation (AR). The JenaValve Trilogy Heart Valve System was introduced as the first dedicated and on-label AR transcatheter aortic valve replacement system, implementing a locator-based and calcium-independent anchoring mechanism. Here, we present the first-in-human transcatheter aortic valve replacement for pure AR via a transcaval access in a patient with prohibitive alternative arterial accesses.

Improving the effectiveness of CPR during interventional procedures.

INTRODUCTION: The number of interventional procedures, such as transcatheter aortic valve replacements or thoracic endovascular aortic repairs, is on the rise. Intraprocedural cardiac arrest is a rare occurrence during high-risk procedures. Modern hybrid-operating tables may adversely affect chest compression quality due to their flexibility. To investigate this relationship, we analyzed the blood pressure generated during chest compressions at different degrees of table extension and assessed the effect of an additional stabilization bar to secure the table. METHODS: A CPR manikin was connected to online blood pressure monitoring on a hybrid operating table. Chest compressions were administered using a mechanical device (at 100 bpm and 80 bpm). Hemodynamic effects were evaluated at various degrees of table extension (0%, 50%, 100% table extension) and with the addition of a stabilization bar. RESULTS: A greater degree of table extension was associated with lower diastolic blood pressure. The addition of a stabilization bar alleviated this drop in diastolic blood pressure and enabled the generation of higher mean arterial pressures at 50% and 100% table extension during chest compressions. CONCLUSION: The flexibility of a hybrid operating table adversely impacts the hemodynamic effect of chest compressions. This effect may be mitigated by using a stabilization bar. These results may be relevant for providing further recommendations for CPR guidelines in hybrid OR settings.

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.

Factor Xa Inhibitors for Patients after Mechanical Heart Valve Replacement?

Patients with a mechanical heart valve need a lifelong anticoagulation due to the increased risk of valve thrombosis and thrombo-embolism. Currently, vitamin K antagonists (VKA) are the only approved class of oral anticoagulants, but relevant interactions and side effects lead to a large number of patients not achieving the optimal therapeutic target international normalized ration (INR). Therefore, steady measurements of the INR are imperative to ensure potent anticoagulation within a distinctive range. Direct oral anticoagulants (DOACs) with newer agents could serve as a possible alternative to VKAs in this patient cohort. DOACs are approved for several indications, e.g., atrial fibrillation (AF). They only have a minor interaction potential, which is why monitoring is not needed. Thereby, DOACs improve the livability of patients in need of chronical anticoagulation compared with VKAs. In contrast to dual platelet inhibition using aspirin in combination with an ADP receptor antagonist and the direct thrombin inhibitor dabigatran, the oral factor Xa inhibitors apixaban and rivaroxaban show promising results according to current evidence. In small-scale studies, factor Xa inhibitors were able to prevent thrombosis and thrombo-embolic events in patients with mechanical heart valves. Finally, DOACs seem to represent a feasible treatment option in patients with mechanical heart valves, but further studies are needed to evaluate clinical safety. In addition to the ongoing PROACT Xa trial with apixaban in patients after aortic On-X valve implantation, studies in an all-comer collective with rivaroxaban could be promising.

Outcomes and Characteristics of Patients with Intraprocedural Cardiopulmonary Resuscitation during TAVR.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become an established alternative to surgical aortic valve replacement (AVR) for higher risk patients. Periprocedural TAVR complications decreased with a growing expertise of implanters. Yet, TAVR can be accompanied by life-threatening adverse events such as intraprocedural cardiopulmonary resuscitation (CPR). This study retrospectively analyzed predictors and outcomes in a cohort of patients from a high-volume center undergoing periprocedural CPR during TAVR. METHODS: A total of 729 patients undergoing TAVR, including 59 with intraprocedural CPR, were analyzed with respect to peri- and postprocedural outcomes. RESULTS: Patients undergoing CPR showed a significantly lower left ventricular ejection fraction (LVEF) and lower baseline transvalvular mean and peak pressure gradients. The systolic blood pressure measured directly preoperatively was significantly lower in the CPR cohort. CPR patients were in a higher need for intraprocedural defibrillation, heart-lung circulatory support, and conversion to open heart surgery. Further, they showed a higher incidence of atrioventricular block grade III , valve malpositioning, and pericardial tamponade. The in-hospital mortality was significantly higher after intraprocedural CPR, accompanied by a higher incidence of disabling stroke, new pacemaker implantation, more red blood cell transfusion, and longer stay in intensive care unit. CONCLUSION: Impaired preoperative LVEF and instable hemodynamics before valve deployment are independent risk factors for CPR and are associated with compromised outcomes. Heart rhythm disturbances, malpositioning of the prosthesis, and pericardial tamponade are main causes of the high mortality of 17% reported in the CPR group. Nevertheless, mechanical circulatory support and conversion to open heart surgery reduce mortality rates of CPR patients.

Ten-Year Long-Term Analysis of Mechanical and Biological Aortic Valve Replacement.

BACKGROUND: For patients undergoing aortic valve replacement (AVR), structural valve deterioration (SVD) of a bioprosthesis (BP) is substantially accelerated in younger patients and valve-in-valve implantation is not always a considerable option. The risk-benefit assessment between SVD versus the risk of bleeding and thromboembolic events in patients with a mechanical prosthesis (MP) resulted in an age limit shift irrespective of inconsistent results reported in literature. METHOD: This retrospective single-center study compared 10-year long-term outcomes in patients undergoing isolated AVR with MP or BP. The risk-adjusted comparison of patients undergoing isolated AVR (n = 121) was performed after 1:1 propensity score matching (PSM) for age, sex, endocarditis, and chronic renal impairment (caliper of 0.2) leading to 29 pairs. Short- and long-term outcomes with respect to reoperation, major bleeding, stroke, all-cause and cardiovascular mortality, and overall survival at 10 years were analyzed. RESULTS: After PSM, groups were comparable with respect to preoperative characteristics, including patients with a mean age of 65 ± 3 years (MP) and 66 ± 4 years (BP) and an incidence rate of 6.9% for infective endocarditis in both cohorts. Short-term outcomes (transient neurologic disorder = 0.0 vs. 6.9%; stroke = 0.0%; in-hospital mortality = 3.4%) and in-hospital stays were comparable between MP and BP. CONCLUSION: After isolated AVR with MP and BP, 10-year long-term outcomes were comparable in the reported single-center cohort. MP can still be implanted safely without a disadvantage as regards long-term survival.

Lymphangiosis carcinomatosa independently affects long-term survival of Non-Small Cell Lung Cancer patients.

OBJECTIVE: The significance of postoperatively diagnosed Lymphangiosis Carcinomatosa (L1) as an independent risk factor for long-term survival in Non-Small Cell Lung Cancer (NSCLC) remains controversial. We analyzed the effect of L1 on postoperative survival in stage I, II and III NSCLC-patients. METHODS: We investigated all consecutive patients with NSCLC between January 2012 and December 2019 who underwent an anatomical resection and radical lymphadenectomy at our institute. L1-were compared to L0-patients. All patients received adjuvant chemotherapy in accordance with European guidelines. 3- and 5- year survival rates and median-survival were assessed. To investigate whether L1 is an independent risk factor, we carried out a multivariate cox regression and a pair-match analysis looking at different properties such as TNM. RESULTS: A total of 641 patients (L0: 74%; L1: 26%) were analyzed. Baseline characteristics were comparable between groups. The mean age was 65.3 ± 10.2 years and 64.9 ± 9.4 years in the L0 and L1-groups respectively (p-value = 0.703). 58.5% of L0-patients were male (L1: 62.7%; p-value = 0.351). Overall survival in the L1-group was significantly shorter compared to the L0-group (L1: 42.3 ± 2.8; L0: 67.6 ± 2.1 months; p-value<0.0001). We confirmed this finding in a pair-matched analysis (L0: 73.9 ± 4.7 months; L1: 42.2 ± 4.2; p-value = 0.009). 3- and 5-year survival were significantly shorter for L1-patients (3-year: L0: 65.9%; L1: 35.9%; p-value<0.0001) (5-year: L0: 34.9%; L1: 7.5%; p-value<0.0001). CONCLUSION: L1 is an independent risk factor for long-term survival of patients with NSCLC. This cohort supports that the L0/L1 status should be included in pathological reports. We suggest to further include L0/L1-status in guideline recommendations for NSCLC patients.

Preoperative Statin Therapy for Atrial Fibrillation and Renal Failure after Cardiac Surgery.

BACKGROUND: Performing cardiac surgery in patients with cardiovascular risk factors incorporates a steady risk for the development of postoperative complications. Perioperative statin intake was associated with an improvement of perioperative outcomes in these patients. However, the European Association for Cardio-Thoracic Surgery guidelines regarding the perioperative statin treatment were changed recently due to large studies reporting about relevant adverse effects related to statin therapy. METHODS: All relevant databases were searched including the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and the metaRegister of Controlled Trials. Various registries were screened (National Research Register, the ClinicalTrials.gov, and gray literature) with search on online conference indices of relevant scientific meetings. No language restrictions were applied. RESULTS: We identified 10 randomized controlled studies summarizing 3,468 participants undergoing various kinds of cardiac surgical procedures. All included studies presented with marked differences regarding study design. Pooled analysis indicated that statin pretreatment was associated with a formally reduced incidence of postoperative atrial fibrillation (AF) (odds ratio [OR] 0.63, 95% confidence interval [CI] 0.39-1.00; p = 0.05) but with an increased incidence of renal failure (OR 1.20, 95% CI 1.01-1.44; p = 0.04) compared with control. Substantial heterogeneity was observed among studies reporting about AF. CONCLUSION: Current but sparse evidence reveals that statin pretreatment is associated with a higher rate of postoperative renal failure compared with control therapy but is ineffective to substantially reduce postoperative AF. Given the relevant heterogeneity among included studies, statin pretreatment cannot be generally recommended.

Impact of device landing zone calcification patterns on paravalvular regurgitation after transcatheter aortic valve replacement with different next-generation devices.

OBJECTIVE: Residual paravalvular regurgitation (PVR) has been associated to adverse outcomes after transcatheter aortic valve replacement (TAVR). This study sought to evaluate the impact of device landing zone (DLZ) calcification on residual PVR after TAVR with different next-generation transcatheter heart valves. METHODS: 642 patients underwent TAVR with a SAPIEN 3 (S3; n=292), ACURATE neo (NEO; n=166), Evolut R (ER; n=132) or Lotus (n=52). Extent, location and asymmetry of DLZ calcification were assessed from contrast-enhanced CT imaging and correlated to PVR at discharge. RESULTS: PVR was ≥moderate in 0.7% of S3 patients, 9.6% of NEO patients, 9.8% of ER patients and 0% of Lotus patients (p<0.001), and these differences remained after matching for total DLZ calcium volume. The amount of DLZ calcium was significantly related to the degree of PVR in patients treated with S3 (p=0.045), NEO (p=0.004) and ER (p<0.001), but not in Lotus patients (p=0.698). The incidence of PVR ≥moderate increased significantly over the tertiles of DLZ calcium volume (p=0.046). On multivariable analysis, calcification of the aortic valve cusps, LVOT calcification and the use of self-expanding transcatheter aortic valve implantation (TAVI) prostheses emerged as predictors of PVR. CONCLUSIONS: The susceptibility to PVR depending on the amount of calcium was mainly observed in self-expanding TAVI prostheses. Thus, DLZ calcification is an important factor to be considered in prosthesis selection for each individual patient, keeping in mind the trade-off between PVR reduction, risk of new pacemaker implantation and unfavourable valve ha emodynamics.

Higher incidence of perivalvular abscess determines perioperative clinical outcome in patients undergoing surgery for prosthetic valve endocarditis.

BACKGROUND: Cardiac surgery for prosthetic valve endocarditis (PVE) is associated with substantial mortality. We aimed to analyze 30-day and 1-year outcome in patients undergoing surgery for PVE and sought to identify preoperative risk factors for mortality with special regard to perivalvular infection. METHODS: We retrospectively analyzed data of 418 patients undergoing valve surgery for infective endocarditis between January 2009 and July 2018. After 1:1 propensity matching 158 patients (79 PVE/79 NVE) were analyzed with regard to postoperative 30-day and 1-year outcomes. Univariate and multivariable analyses were performed to identify potential risk factors for mortality. RESULTS: 315 patients (75.4%) underwent surgery for NVE and 103 (24.6%) for PVE. After propensity matching groups were comparable with regard to preoperative characteristics, clinical presentation and microbiological findings, except a higher incidence of perivalvular infection in patients with PVE (51.9%) compared to NVE (26.6%) (p = 0.001), longer cardiopulmonary bypass (166 [76-130] vs. 97 [71-125] min; p < 0.001) and crossclamp time (95 [71-125] vs. 68 [55-85] min; p < 0.001). Matched patients with PVE showed a 4-fold increased 30-day mortality (20.3%) in comparison with NVE patients (5.1%) (p = 0.004) and 2-fold increased 1-year mortality (PVE 29.1% vs. NVE 13.9%; p = 0.020). Multivariable analysis revealed perivalvular abscess, sepsis, preoperative AKI and PVE as independent risk factors for mortality. Patients with perivalvular abscess had a significantly higher 30-day mortality (17.7%) compared to patients without perivalvular abscess (8.0%) (p = 0.003) and a higher rate of perioperative complications (need for postoperative pacemaker implantation, postoperative cerebrovascular events, postoperative AKI). However, perivalvular abscess did not influence 1-year mortality (20.9% vs. 22.3%; p = 0.806), or long-term complications such as readmission rate or relapse of IE. CONCLUSIONS: Patients undergoing surgery for PVE had a significantly higher 30-day and 1-year mortality compared to NVE. After propensity-matching 30-day mortality was still 4-fold increased in PVE compared to NVE. Patients with perivalvular abscess showed a significantly higher 30-day mortality and perioperative complications, whereas perivalvular abscess seems to have no relevant impact on 1-year mortality, the rate of readmission or relapse of IE.

SAVR versus TAVI: What about the Hemodynamic Performance? An In Vivo and In Vitro Analysis.

BACKGROUND: Surgical aortic valve replacement (SAVR) is nowadays discussed whether it remains the gold standard of treatment. In the last decade, there has been a tremendous increase in transcatheter aortic valve implantation (TAVI) due to the growing expertise and excellent results of the catheter-based approach. We, therefore, retrospectively compared the rapid deployment valve (RDV), the Edwards Intuity valve (IEV), with the Edwards Sapien 3 (S3V) with regard to post-procedural hemodynamics. METHODS: A total of 246 patients treated with TAVI or SAVR between February 2009 and November 2015 were included. One-hundred twenty-five patients were analyzed in the SAVR group and compared with 121 patients undergoing TAVI. Transvalvular pressure gradients (PGs) and the incidence and extent of aortic regurgitation (AR) were compared post-procedurally by echocardiography for each valve size. In vitro hemodynamics were analyzed by placing both valves into an aortic silicone phantom connected to a pulsatile flow pump and measured using phase-contrast magnetic resonance imaging (4D flow MRI). RESULTS: Post-procedurally, mean transvalvular PGs for the 23 mm valves were 9 (7;11.5) versus 13 (9;18) (p < 0.001), whereas maximum PGs were 16.5 (14;22) versus 25.5 mm Hg (17.5;34) (p < 0.001) in IEV and S3V patients, respectively. The 21 mm IEV showed significantly lower transvalvular PGs compared with the 23 mm S3V: mean PGs: 11 (8;13) versus 13 (9;18) (p < 0.05); maximum PG: 19.5 (13;24) versus 25.5 (18;34) mm Hg (p < 0.05). Analysis revealed significantly lower post-procedural transvalvular PGs for larger valves sizes. With respect to AR, the incidence of AR was significantly lower in IEV group (p < 0.05). In vitro velocities and turbulent kinetic energy values showed similar results between both valves. CONCLUSION: Implanted RDVs presented a lower incidence of paravalvular regurgitation and were associated with significantly lower post-procedural transvalvular PGs, especially for small valve sizes. Our data might support the application of rapid deployment aortic valves in patients with small aortic annulus in the TAVI era.

"Vascular Outlining": Augmented Imaging for Transfemoral Access-A Preclinical Investigation.

BACKGROUND: Advanced visualization software tools have been used in clinics to improve the safety and accuracy of transcatheter procedure. Imaging techniques have greatly evolved during the era of transcatheter aortic valve implantation (TAVI). In a retrospective analysis, we investigated the feasibility of augmented fluoroscopy for iliofemoral access using a novel "Vascular Outlining" roadmapping technology. METHODS: The Vascular Outlining prototype device (Philips Healthcare) application was used with iliofemoral angiography of 10 patients undergoing transfemoral TAVI. The software processes any conventional angiographic sequences, extracting the static outline of vessels and projecting the two-dimensional vessel margins as a roadmap on live fluoroscopy. Post-processed results were clinically assessed to determine whether the technical performance of the tool is sufficient. RESULTS: Augmented imaging was possible in all investigated angiography sequences. The analysis of software-generated images showed accurate projection of the two-dimensional outline of the iliofemoral vessels as an overlay on the live fluoroscopy image in most cases. Overlay inaccuracy was only observed in cases with low contrast or patient movement. CONCLUSION: In static and contrasted angiography sequences, "Vascular Outlining" showed accurate image overlay. We identified that the quality of the vascular outline is dependent on the opacification of the contrast injection and the stability of the patient on the table. With further development. this application might increase the accuracy of femoral puncture and reduce the incidence of vascular complications. Clinical trials are needed to confirm these hypotheses.

Single center experience with patients on veno arterial ECMO due to postcardiotomy right ventricular failure.

OBJECTIVES: Right ventricular (RV) failure is associated with poor outcome and increased mortality in cardiac surgery. Aim of our study was to analyze the outcome of veno arterial extracorporeal membrane oxygenation (va ECMO) therapy in patients with isolated RV failure in postcardiotomy cardiogenic shock (PCS) and to evaluate risk factors associated with 30-day-mortality. METHODS: Between August 2006 until August 2016, 64 consecutive patients with va ECMO therapy due to fulminant RV failure in PCS were identified and included in this retrospective observation. Further, outcome data and a comparison of va ECMO survivors and nonsurvivors was conducted. RESULTS: The mean age of the patient cohort was 63 ± 14 years. Patients were treated with va ECMO for 79 ± 61 hours. Twenty-eight patients (44%) were successfully weaned off ECMO support. Overall 30-day-mortality was 88% (56/64). Hemoglobin concentration before ECMO implantation, maximum rise of muscle-brain type creatine kinase during ECMO therapy, as well as lactic acid concentration 24 hours after initiation of va ECMO therapy were predictive for 30-day mortality. CONCLUSION: ECMO therapy in RV failure due to PCS is shown to be associated with an excessive mortality. Regarding our data, va ECMO might only be an appropriate short-term mechanical assist device separating patients form cardiopulmonary bypass with an acceptable weaning rate. Particularly, in case of failed hemodynamic recovery of the right heart on va ECMO, direct RV bypass systems might function as a bailout option. Additionally, cardiac enzymes and lactic acid might provide valuable information in meeting therapy-related decisions.

Characteristics and outcomes of patients with right-sided endocarditis undergoing cardiac surgery.

BACKGROUND: There has been an increasing incidence of right-sided infective endocarditis (RSIE) due to the global rise of intravenous drug use (IVDU) and an increasing number of implantable cardiac electronic devices and central venous catheters. Our aim was to investigate differences in the clinical presentation, microbiological findings and prognosis of patients undergoing surgery for RSIE compared to left-sided infective endocarditis (LSIE). METHODS: Relevant clinical data of all 432 consecutive patients undergoing valve surgery for infective endocarditis (IE) at our institution between January 2009 and December 2018 were retrospectively analyzed. Acquired data included patients' demographic and preoperative comorbidities, manifestation of IE according to the recently modified Duke Criteria, perioperative data and relevant clinical outcomes. RESULTS: A total of 403 patients (93.3%) underwent surgery for LSIE and twenty-nine patients (6.7%) for RSIE. Eleven patients with RSIE (37.9%) showed a concomitant left-sided infection. Compared to LSIE, RSIE patients were significantly younger [47.5 (40.4-69.3) vs. 65.1 (53.7-74.6); P=0.008] and presented with less comorbidities such as hypertension (41.4% vs. 65.3%; P=0.010) and coronary artery disease (6.9% vs. 29.0%; P=0.010). Rates of IVDU (34.5% vs. 4.5%; P<0.001), human immunodeficiency virus (HIV) (10.3% vs. 1.7%; P=0.023) and hepatitis C virus (HCV) infection (24.1% vs. 5.2%; P=0.001) were greater in RSIE. The proportion of Staphylococcus aureus IE was significantly higher in RSIE compared to LSIE (37.9% vs. 21.1%; P=0.035). 30-day mortality was 6.9% after surgery for RSIE compared to 14.6% after operation for LSIE (P=0.372). CONCLUSIONS: Patients undergoing surgery for RSIE compared to LSIE presented with a higher rate of pulmonary septic emboli, more Staphylococcus aureus infections and larger vegetations. Larger multicenter prospective trials are needed to provide more reliable data on the clinical profile of these patients, in order to determine optimal surgical management.