Stroke outcomes following durable left ventricular assist device implant in patients bridged with micro-axial flow pump: Insights from a large registry.

BACKGROUND: Stroke after durable left ventricular assist device (d-LVAD) implantation portends high mortality. The incidence of ischemic and hemorrhagic stroke and the impact on stroke outcomes of temporary mechanical circulatory support (tMCS) management among patients requiring bridge to d-LVAD with micro-axial flow-pump (mAFP, Abiomed) is unsettled. METHODS: Consecutive patients, who underwent d-LVAD implantation after being bridged with mAFP at 19 institutions, were retrospectively included. The incidence of early ischemic and hemorrhagic stroke after d-LVAD implantation (<60 days) and association of pre-d-LVAD characteristics and peri-procedural management with a specific focus on tMCS strategies were studied. RESULTS: Among 341 patients, who underwent d-LVAD implantation after mAFP implantation (male gender 83.6%, age 58 [48-65] years, mAFP 5.0/5.5 72.4%), the early ischemic stroke incidence was 10.8% and early hemorrhagic stroke 2.9%. The tMCS characteristics (type of mAFP device and access, support duration, upgrade from intra-aortic balloon pump, ECMELLA, ECMELLA at d-LVAD implantation, hemolysis, and bleeding) were not associated with ischemic stroke after d-LVAD implant. Conversely, the device model (mAFP 2.5/CP vs. mAFP 5.0/5.5: HR 5.6, 95%CI 1.4-22.7, p = 0.015), hemolysis on mAFP support (HR 10.5, 95% CI 1.3-85.3, p = 0.028) and ECMELLA at d-LVAD implantation (HR 5.0, 95% CI 1.4-18.7, p = 0.016) were associated with increased risk of hemorrhagic stroke after d-LVAD implantation. Both early ischemic (HR 2.7, 95% CI 1.9-4.5, p < 0.001) and hemorrhagic (HR 3.43, 95% CI 1.49-7.88, p = 0.004) stroke were associated with increased 1-year mortality. CONCLUSIONS: Among patients undergoing d-LVAD implantation following mAFP support, tMCS characteristics do not impact ischemic stroke occurrence, while several factors are associated with hemorrhagic stroke suggesting a proactive treatment target to reduce this complication.

Benefits of "Best for Groin" Strategy Leading to a Transapical TAVI Dominance.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a recognized therapeutic option for high-risk and inoperable patients with aortic valve stenosis. The choice of access route is a matter of debate. We are presenting our 5-year experience of transapical TAVI dominance. PATIENTS: This single-center study includes 575 patients. Two groups were compared: transapical (TA) and transfemoral (TF) with 454 and 121 patients, respectively. Individual access route decision was made by our heart team following a clinical and computed tomography (CT) data based nonbiased strategy. The same team performed all procedures. The mean logistic EuroSCORE was significantly higher in the TA group, however, without difference in STS score. The number of patients with coronary artery disease, previous cardiac surgery, and low left ventricular ejection fraction was higher in the TA group. There were no significant differences in age and presence of other comorbidities. RESULTS: Procedural success in both TA and TF groups was high (97.9% and 97.6%). No patient died during the procedure. Patient survival (30 days: TF, 97.5% vs. TA, 95.7%; 1 year: TF, 94.6% vs. TA, 81.8%; 2 years: TF, 84.7% vs. TA, 76.7%; 3 years: TF, 59.9% vs. TA, 67.8%) and a low TF vascular complication rate (1.6%) are encouraging compared with other registry data. CONCLUSION: A "no competition" team approach strategy along with an experienced hybrid team leads to fewer vascular complications and better outcomes for both TA and TF TAVI patients.

More in, better out? Successful valve-in-valve procedure of an iatrogenic ventricular septal defect following transcatheter aortic valve replacement: a case report.

BACKGROUND: A rare, but serious, complication following transcatheter aortic valve replacement (TAVR) is the occurrence of an iatrogenic ventricular septal defect (VSD). CASE SUMMARY: We describe a case of an 80-year-old female who was referred with severe aortic stenosis for TAVR. Following thorough evaluation, the heart team consensus was to proceed with implantation via a transapical approach of an ACURATE neo M 25 mm valve (Boston Scientific, Natick, MA, USA). The valve was deployed harnessing transoesophageal echocardiographic (TOE) guidance under rapid pacing with post-dilation. Directly afterwards a very high VSD close to the aortic annulus was detected. As the patient was haemodynamically stable, the procedure was ended. The next day another TOE revealed a shunt volume (left-to-right ventricle) between 50% and 60%. Because the defect was partly located between the stent struts of the ACURATE valve decision was made to fix this leakage with implantation of a further valve and we chose an EVOLUT Pro 29 mm (Medtronic Inc., Minneapolis, MN, USA). The valve-in-valve was implanted 2-3 mm below the lower edge of the first valve, more towards the left ventricular outflow tract (LVOT) with excellent result: VSD was reduced to a very small residual shunt without any hemodynamic relevance. Figure 3(A) Fluoroscopic image after transapical transcatheter aortic valve replacement (ACURATE neo M); (B) transoesophageal echocardiography following transapical transcatheter aortic valve replacement showing a severe ventricular septal defect; (C) angiography after valve-in-valve implantation. The implantation depth of the second valve (EVOLUT Pro 29 mm) was slightly deeper in the left ventricular outflow tract; and (D) transoesophageal echocardiography after the valve-in-valve procedure showing a small residual shunt. (1) Stentstruts, (2) tricuspid valve, and (3) leakage (ventricular septal defect). *Pulmonary artery catheter, #Pleural drain.Figure 4Left ventricular angiogram after valve-in-valve implantation showing a very small residual contrast shunt from the left-to-right ventricle (encircled). *Pulmonary artery catheter, # Pleural drain. DISCUSSION: We suggest that an iatrogenic VSD located near the annulus may be treated percutaneously in a bail-out situation with implantation of a second valve that should be implanted slightly more into the LVOT to cover the VSD.

Clinical value of the 20% logistic EuroSCORE cut-off for selecting TAVI candidates: a single-centre cohort study analysis.

Background: A logistic European System for Cardiac Operative Risk Evaluation (logEuroSCORE) ≥20% is frequently recognised as a finite criteria for transcatheter aortic valve implantation (TAVI) reimbursement, despite guideline modifications to reflect the appropriacy of TAVI in selected lower-risk patients. The aim was to evaluate the clinical value of this threshold cut-off in TAVI patients and to identify factors associated with mortality in those below this threshold. Methods: We analysed data from a single-centre, German, observational, TAVI-patient registry, gathered between 2008 and 2016. Patients were stratified by logEuroSCORE (≥ or <20%) for comparisons. Logistic regression was performed to identify predictors of mortality at 1 year, with this analysis used to generate a calculated ('real') risk value for each patient. Results: 1679 patients (logEuroSCORE <20%: n=789; logEuroSCORE ≥20%: n=890) were included. LogEuroSCORE <20% patients were significantly younger (80.1 vs 81.6 years; p<0.001) and less comorbid than logEuroSCORE ≥20% patients, with a higher rate of transfemoral TAVI (35.6% vs 26.1%; p<0.001) and predilation (70.0% vs 63.3%; p=0.004). Patients with a logEuroSCORE <20% experienced more vascular complications (3.4% vs 1.5%; p=0.010). One-year survival was 88.3% in the logEuroSCORE <20% and 81.8% in the logEuroSCORE ≥20% group (p=0.005), with the calculated mortality risk falling within 2% of the logEuroSCORE in just 12.9% of patients. In the logEuroSCORE <20% group, only coronary artery disease was significantly predictive of 1-year mortality (OR 2.408; 95% CI 1.361 to 4.262; p=0.003). Conclusions: At our institution, patients with a logEuroSCORE <20% selected for TAVI have excellent outcomes. The decision not to reimburse TAVI in such patients may be viewed as inappropriate.

Successful catheter-based valve-in-valve implantation for a regurgitant stentless bioprosthesis.

Catheter-based transapical aortic valve implantation (TA-AVI) in patients with severe stenosis of the aortic valve and with a high operative risk is a new procedure which is becoming established in clinical practice. Aortic regurgitation is not yet a recognized indication for TA-AVI, and to date valve-in-valve (V-in-V) implantation in patients with incompetent stentless bioprostheses has not been attempted. The case is reported of a successful TA-AVI in a regurgitant, uncalcified stentless Medtronic Freestyle bioprosthesis. The position and hemodynamic function of the apically implanted valve were excellent, and the patient's current state of health is good.

Balloon-expandable transapical transcatheter aortic valve implantation with or without predilation of the aortic valve: results of a multicentre registry.

OBJECTIVES: To assess safety and efficacy of transapical transcatheter aortic valve implantation (TA-TAVI) in the absence of predilation using balloon aortic valvuloplasty (BAV). Predilation of the stenosed valve using BAV is a routine step in TA-TAVI; however, evidence supporting its clinical value is lacking, and several studies have linked it with higher complication rates. METHODS: A prospective, two-armed, multicentre registry (EASE-IT TA) to gather data on patients undergoing TA-TAVI with or without BAV, using the Edwards SAPIEN 3 valve was designed. The primary evaluation criterion was a composite of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, acute kidney injury and pacemaker implantation [per Valve Academic Research Consortium-2 (VARC-2)] within 30 days after TAVI. RESULTS: A total of 198 subjects underwent TA-TAVI, 61 with and 137 without BAV. Patient characteristics were comparable at baseline (mean ± SD: age 80.3 ± 5.7 years; logistic EuroSCORE 20.2 ± 12.6). Similar reductions in peak and mean transvalvular gradients were observed post-procedurally. There was a significant reduction of fluoroscopy time without BAV (4.7 vs 7.9 min; P = 0.039) and significantly decreased odds of catecholamine administration (17.5% vs 32.8%; P = 0.017). A decreased odds of the primary evaluation criterion in patients without BAV after 30 days (adjusted odds ratio 0.71; 95% confidence interval 0.34-1.82) and the same composite end-point after 6 months (adjusted odds ratio 0.74; 95% confidence interval 0.37-1.47) were not significant even after multivariable adjustment. CONCLUSIONS: TA-TAVI without BAV appears to be at least equal to its conventional counterpart in terms of efficacy and may offer advantages in terms of safety. Thus, there appears to be little justification for maintaining the BAV step in TA-TAVI for many patients.

Transapical transcatheter aortic valve implantation in patients with a low ejection fraction.

OBJECTIVES: It may be expected that patients with left ventricular dysfunction may be at greater risk of complications after transcatheter aortic valve implantation (TAVI) via transapical (TA) access compared with via transfemoral (TF) access. There is a lack of data comparing the outcomes of TAVI using TA and TF access in patients with a reduced left ventricular ejection fraction (EF). METHODS: This is a retrospective analysis of data from a high-volume heart centre in Germany. TAVI access route assignment was based on a 'best for TF' approach, where only patients who met a strict set of criteria underwent TF-TAVI, with the remainder receiving TA-TAVI. For this analysis, patients were included if they had a pre-TAVI EF of ≤ 40%. Early mortality and late (1-year) mortality were compared through multivariate logistic regression. RESULTS: A total of 342 patients in the registry had an EF of ≤ 40%, of which 74.9% underwent TA-TAVI and 25.1% underwent TF-TAVI. Higher proportions of the TA group presented with certain comorbidities, and their logistic EuroSCORE and Society of Thoracic Surgeons (STS) risk scores were higher than in the TF group. At 1 year, TA access was associated with greater mortality in the univariate analysis (odd ratio 2.43; 95% confidence interval 1.04-5.69). However, after multivariate adjustment, no significant differences were found in either 30-day or 1-year mortality rates. CONCLUSIONS: The data suggest that, for patients with a reduced EF, TA-TAVI is not associated with a poorer outcome compared with TF-TAVI. Therefore, TA access should not be discounted based on the presence of left ventricular dysfunction alone.

Transcatheter aortic valve implantation at a high-volume center: the Bad Rothenfelde experience.

INTRODUCTION: The "transfemoral (TF) first" approach to access route selection in transcatheter aortic valve implantation (TAVI) is popular; however, the risk of major vascular complications is substantial. The "best for TF" approach identifies only the patients with ideal anatomy for TF-TAVI, potentially minimizing complications. AIM: To characterize the outcomes of patients undergoing TAVI at a large-volume site that employs this approach. MATERIAL AND METHODS: Patients who underwent TAVI at the Bad Rothenfelde Heart Centre between 2008 and 2016 were consecutively enrolled. Findings were compared to those from large, multicenter registries. RESULTS: Of the 1,644 patients enrolled, 1,140 underwent TA- and 504 TF-TAVI. Comorbidities were more frequent in TA patients, who also had higher risk scores (EuroSCORE: 25.5% vs. 21.2%; STS score: 11.0% vs. 7.5%; p < 0.001 for both). Rates of conversion to open surgery, major vascular complications and intra-procedural mortality did not differ between groups. At 30 days, mortality rates were higher in the TA group (3.9% vs. 1.9%, p = 0.036). Stroke/transient ischemic attack and permanent pacemaker implantation rates did not differ significantly between groups (2.0% and 9.1% overall, respectively). Compared to multicenter registries, trends in mortality and complication rates were similar, though magnitudes were lower in the present study. In contrast with the present study, major vascular complication rates in multicenter registries are significantly higher for TF compared to TA patients. CONCLUSIONS: At this high-volume center, the use of a "best for TF" approach to TAVI resulted in low mortality and complication rates.

Transcatheter aortic valve implantation using the ACURATE TA™ system: 1-year outcomes and comparison of 500 patients from the SAVI registries.

OBJECTIVES: The ACURATE TA TM system is a self-expanding transcatheter heart valve system designed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials. The SAVI-1 and SAVI-2 registries aimed to assess whether these promising outcomes can be translated into all-comers clinical routine. METHODS: From November 2011 to 2012 (SAVI-1), and November 2013 to 2014 (SAVI-2), a total of 500 patients were enrolled in the prospective, all-comers, multicentre, multinational SAVI registries. Patients were treated according to the standard of care at their respective hospitals. We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2. RESULTS: Patients were 80.8 ± 6.1 years old, the mean logistic EuroSCORE-I was 23.4 ± 14.3%. Valves were deployed under rapid pacing in 71.3% of the procedures in SAVI-1, and in 3.6% in SAVI-2. There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2. Overall mortality at 30 days and 1 year was 6.8% and 19.9%, the stroke rate was 2.2% and 3.7%, respectively; 10.2% of patients had received a permanent pacemaker, and no transcatheter valve-related complications after discharge were observed. Paravalvular leakage ≥2+ was reported in 1.9% of the patients at the early follow-up, and in 2.6% at the 1-year follow-up. CONCLUSIONS: The SAVI-registries have confirmed that transapical implantation using the ACURATE TA TM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year; outcomes were similar between SAVI-1 and -2.

Epicardial ablation of ventricular tachycardia using pericardioscopy through submammary minimal thoracotomy.

The subxiphoid access became the standard technique for epicardial ablation of ventricular tachycardia. However, it may prove difficult in certain situations. Here, we report an alternative method of epicardial and endocardial ablation performed via submammary minimal thoracotomy guided by pericardioscopy. Two male patients with structural heart disease and incessant ventricular tachycardia were successfully ablated using this technique. The described technique can be considered as an alternative to the standard technique. Moreover, it permits real-time visualization of cardiac vessels and fat tissue, and is safe in terms of damage to the phrenic nerve or potential bleeding complications.

Simultaneous transfemoral transcatheter mitral and tricuspid valve edge-to-edge repair (using MitraClip system) completed by atrial septal defect occlusion in a surgically inoperable patient. First-in-human report.

Transcatheter transfemoral mitral valve repair using the MitraClip system (Abbott Vascular, USA) is used in high-risk or inoperable patients with severe mitral regurgitation. We report the first-in-human simultaneous transfemoral clipping of the mitral and tricuspid valve completed by occlusion of an atrial septal defect (ASD). The procedure was performed in an 84-year-old patient in October 2015. After effective reduction of mitral and tricuspid regurgitations using the MitraClip system a PFO Occluder (St. Jude Medical, USA) was implanted. Transfemoral simultaneous mitral and tricuspid valve repair using the MitraClip system with ASD occlusion seems to be an effective therapy for high-risk or inoperable patients.

First registry results from the newly approved ACURATE TA™ TAVI system†.

OBJECTIVES: The novel ACURATE TA™ transcatheter aortic valve (Symetis, Ecublens, Switzerland) is composed of a self-expanding nitinol stent covered by an anti-paravalvular leak skirt designed for transapical implantation. Since Conformite Europeenne (CE)-mark approval, the first 250 patients implanted with the newly approved device have been included in this post-market, multicentre registry. METHODS: The registry was conducted at 17 sites in Germany, Italy, Switzerland and Argentina to treat 250 high-risk elderly patients. This all-comers population presented preoperatively with a mean aortic gradient of 43.2 ± 17.4 mmHg, mean age of 80.9 ± 6.3 years, mean society of thoracic surgeons risk score of 8.0 ± 5.9% and mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 22.3 ± 12.7%. The majority of patients (93%) were in New York Heart Association (NYHA) class III/IV. All patients were treated within a multidisciplinary Heart Team. RESULTS: The procedural success rate was 98% (n = 245) with two valve-in-valve procedures and three conversions to conventional surgery. The 30-day mortality rate was 6.8%. Postimplant echocardiography revealed a relevant paravalvular leak (moderate 2+) in 2.3% of patients, with all other patients demonstrating either none/trace or a 1+ leak. The 30-day stroke rate was 2.8% and the mean transvalvular gradient was 12.4 ± 5.8 mmHg. A new pacemaker implantation was required in 10.0% of patients and 85% of patients returning for the follow-up presented in NYHA class I/II. CONCLUSIONS: The short-term result of the registry shows a safety and efficacy profile comparable, if not improved in some aspects, with previously approved transcatheter aortic valve implantation devices. These 'real-world' data highlight an excellent functional outcome, especially in regard to a low rate of relevant paravalvular leak.

Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

OBJECTIVES: This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. BACKGROUND: Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. METHODS: Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. RESULTS: Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. CONCLUSIONS: Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.

Transapical angiography in a patient with severe aortic stenosis undergoing transapical transcatheter aortic valve implantation.

Transapical transcatheter aortic valve implantation (TA-TAVI) is the method of choice in patients with severe stenosis of the aortic valve, high operative risk, and an adverse peripheral vasculature. The procedure is generally guided by peripheral arterial access angiography. We report on a 71-year-old patient in whom, because of the absence of an alternative peripheral arterial access route, TA-TAVI was supported by the apical insertion of the angiography catheter. This approach was effective and safe, and proper valve deployment was feasible without unexpected procedural complications.

Reversal of flow in the mammary artery to treat subclavian steal syndrome in conjunction with coronary bypass surgery.

Occasionally patients with multi-vessel disease present with coronary stenoses and subclavian steal syndrome. A novel surgical approach for the treatment of these vascular problems is described. The in situ left internal mammary artery was used to create an aortosubclavian shunt, thus restoring antegrade vertebral flow and vein grafts were used for coronary revascularization.