Utility of conventional aortic root shot angiography for SAPIEN 3 prosthesis sizing in TAVI: feasibility and inter-reader variability.

Background: The gold-standard approach to prosthesis sizing before transcatheter aortic valve implantation (TAVI) is multislice computed tomography (MSCT). We aimed to investigate whether conventional aortic root angiography (CA) alone can reliably facilitate valve selection and to describe its inter-reader variability. Methods: Five TAVI specialists (3 interventional cardiologists and 2 cardiac surgeons) independently reviewed preprocedural CAs for 50 patients implanted with the Edwards SAPIEN 3 valve. Results: The prosthesis size selected based on visual CA appraisal matched that based on MSCT in 60% of cases (range: 50%-68%), with undersizing in 11% (4%-33%) and oversizing in 29% (10%-46%; p=0.187 for equality of the proportions test). Agreement between CA-based and MSCT-based valve selection was moderate (K=0.41; Kw=0.61). Reassessment of choice following awareness of the annulus long-axis diameter did not significantly improve this agreement (0.40 and 0.63, respectively), though more undersizing (14%) and less oversizing (25%) occurred. Correct valve selection was more common in interventional cardiologists than cardiac surgeons (66% vs 53%; p=0.0391), who made more oversizing errors. Conclusions: There is a modest agreement between CA-based and MSCT-based SAPIEN 3 selection. Although the former should not be performed routinely, it may be informative in settings where MSCT and transoesophageal echocardiography are unavailable.

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.

Standardized methodology for transfemoral transcatheter aortic valve replacement with the Edwards Sapien XT valve under fluoroscopy guidance.

OBJECTIVES: To provide a simplified, standardized methodology for a successful transfemoral transcatheter aortic valve replacement (TAVR) procedure with the Sapien XT valve in patients with severe aortic stenosis (AS). BACKGROUND: TAVR is currently reserved for patients with severe, symptomatic AS who are inoperable or at high operative risk. In many institutions, TAVR is performed under general anesthesia with intubation or with conscious sedation. In addition, many institutions still use transesophageal echo (TEE) during the procedure for aortic root angulations and positioning of the valve prior to implantation. Methods. We enrolled 100 consecutive patients (mean age, 80 ± 7 years; range, 50-94 years; female n=59) with severe symptomatic AS. Annulus measurements were based on computed tomography angiograms. All patients underwent fluoroscopy-guided transfemoral TAVR with little to no sedation and without simultaneous TEE. RESULTS: TAVR was predominantly performed with the use of local and central analgesics; only 36% of our cohort received conscious sedation. Procedural success of TAVR was 99%. Transthoracic echocardiography before discharge excluded aortic regurgitation (AR) >2 in all patients (AR >1; n=6). In-hospital stroke rate was 6%. The vessel closure system was successfully employed in 96%. Major vascular complication rate was 1%. The 30-day mortality was 2%. CONCLUSIONS: Fluoroscopy-guided TAVR with the use of just analgesics with or without conscious sedation is safe and effective, and this potentially enables a more time-effective and cost-effective procedure. This paper provides simplified, stepwise guidance on how to perform transfemoral TAVR with the Sapien XT valve.

Should patients with asymptomatic significant carotid stenosis undergo simultaneous carotid and cardiac surgery?

A best evidence topic in cardiovascular surgery was written according to a structured protocol. The question addressed was whether patients with severe asymptomatic carotid and coronary artery diseases should undergo simultaneous carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG). A total of 624 papers were found using the reported search, of which 20 represent the best evidence to answer the clinical question. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study results of these papers are tabulated. Previous cohort studies showed mixed results, while advocating for the necessity of a randomized controlled trial (RCT). A recent RCT showed that patients undergoing prophylactic or simultaneous CEA + CABG had lower rates of stroke (0%) compared with delayed CEA 1-3 months after CABG (7.7%), without significant perioperative mortality difference. This study included patients with unilateral severe (>70%) asymptomatic carotid stenosis requiring CABG. An earlier partly randomized trial also showed better outcomes for patients undergoing simultaneous procedures (P = 0.045). Interestingly, systematic reviews previously failed to show compelling evidence supporting prophylactic CEA. This could be partly due to the fact that these reviews collectively analyse different cohort qualities. Neurological studies have, however, shown reduced cognitive and phonetic quality and function in patients with unilateral and bilateral asymptomatic carotid artery stenosis. Twenty-one RCTs comparing lone carotid artery stenting (CAS) and CEA informed the American Heart Association guidelines, which declared CAS comparable with CEA for symptomatic and asymptomatic carotid stenosis (CS). However, the risk of death/stroke for CAS alone is double that for CEA alone in the acute phase following onset of symptoms, while CEA alone is associated with a doubled risk of myocardial infarction. There is, however, no significant difference for combined 30-day risk of death/stroke/myocardial infarction. Outcomes of hybrid or simultaneous CAS/CABG procedures show comparable results, albeit from rather small cohorts. While current evidence leans towards simultaneous CEA/CABG, the emergence of hybrid operating theatres in various institutions may allow larger cohorts with subsequent significant data on simultaneous CAS/CABG. A randomized controlled trial comparing both approaches would be crucial in informing future updates of existing guidelines.

Mitral valve restoration using the No-React(R) MitroFix™: a novel concept.

BACKGROUND: Mitral Valve Repair (MVRP) has been shown to be significantly superior to Mitral Valve Replacement (MVR). Since the majority of repairs involve the Posterior Mitral Leaflet (PML) and not the Anterior Mitral Leaflet (AML), the monocuspidalisation of the Mitral Valve (MV) can be achieved with a bio-posterior leaflet that imitates a closed PML. This approach may have the benefit of restoring the competence of the MV without reducing its effective orifice area. METHODS: We have used a new concept and device, the MitroFixTM, to correct MV regurgitation due to pathology of the PML. The device comes with functional sizers both of which have identical shape and size. This allows the surgeon to pre-test the success of the restoration. From December 2006 to October 2011, 51 MitroFixTM devices were implanted at three institutions. RESULTS: The mean age of the patients (32 males and 19 females) was 67.7 years. 37 of them were in NYHA class III or IV and all patients suffered from severe mitral valve regurgitation (MR). 31 patients underwent combined surgery. Successful implantation of the MitroFix™ device was performed in 51/53 patients.Mean cross-clamp time was 63.6 min (range: 29-118 min). Six patients had additional reconstructive procedures of the AML (chordae transfer, neo-chordae, triangular resection). At discharge, 33 patients showed no MR in the TTE and 17 patients exhibited trivial (I) or moderate (II) MR. The mean gradient was 4.0 mmHg and mean EOA was 2.52cm^2 (range: 1.5-4.0cm2). All patients were classified as being in NYHA class I or II. CONCLUSION: The MitroFixTM Mitral Valve Restoration Device is a new concept that offers an effective treatment of MR. The restoration of the mitral valve with the MitroFix™ device offers the advantage of preserving the AML and providing good coaptation with a prosthetic PML. Importantly, this preliminary evaluation indicates a mean effective orifice area ( EOA ) of 2.5cm2 in MV receiving a MitroFix™ device, witch is higher than EOA resulting from MVR or MVRP. The present study has also shown that severe regurgitation due to ischemic/rheumatic MR, endocarditis and complex prolapse of the PML are clear candidates for correction with the MitroFix™. Larger studies and a longer follow up period are needed to validate these promising results.

HeartMate II left ventricular assist device; early European experience.

OBJECTIVE: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results. METHODS: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy). RESULTS: In 70% of patients, the HeartMate II was intended as a bridge to transplant therapy, in 30%, it was used as a destination therapy device. The perioperative mortality post implant was 20% in the bridge to transplant patients and 7% in the destination therapy arm. However, after 1 year a comparable survival was observed in both groups (69% destination therapy, 63% bridge to transplant). Main causes of death were multiple organ failure (n=12) and cerebrovascular accidents (n=5). All, but one cerebrovascular accident occurred in the first 9 days after surgery. Only one other death was reported thereafter and there was no mechanical failure of the device. CONCLUSIONS: Even in the early experience the HeartMate II was used as a chronic support device in a substantial number of patients in Europe. Although the total experience is still limited, the incidence of cerebrovascular accidents is very low and the survival beyond the perioperative period is excellent.

Brain natriuretic peptide--a reliable parameter for the effectiveness of cardiac resynchronization therapy after coronary artery bypass grafting.

OBJECTIVES: Brain natriuretic peptide (BNP) is a valuable marker in heart failure and its therapy, for example cardiac resynchronization therapy (CRT). So far, one finding which is indicative for CRT is dyssynchrony of ventricular contraction obtained by echocardiography. The aim of this study was to show that BNP is also a helpful marker to help decide whether CRT is useful for patients after CABG. METHODS: Forty-two patients with a poor ejection fraction (<35%) underwent elective CABG. Twenty-eight of them received permanent biventricular stimulation for seven days after surgery. Before and on the first, third, seventh and tenth day after surgical treatment, the following parameters were established: left ventricular function obtained by transthoracic echocardiography, myocardium-specific enzymes (such as CK and CKMB), ECG and BNP. RESULTS: There was a very good correlation between the preoperative ejection fraction and BNP (r2=0.98, P<0.005). Patients who had received CRT after CABG had BNP levels similar to preoperative data on postoperative day 7. This decrease of the BNP values in the CRT-group is in accord with an increased left ventricular function as obtained by echocardiography. The control group, which had not received CRT, showed significantly higher BNP levels. CONCLUSIONS: Therefore, we conclude that BNP is a good marker to evaluate CRT in patients undergoing CABG. An extraordinary rise of the BNP level should lead to early therapeutic consequences like CRT. The significantly lower BNP level of the patients with heart failure who received CRT indicates a better prognosis.