Transapical aortic valve replacement is a safe option in patients with poor left ventricular ejection fraction: results from the Italian Transcatheter Balloon-Expandable Registry (ITER).

OBJECTIVES: The most commonly used accesses for transcatheter aortic valve implantation (TAVI) are the transfemoral (TF-TAVI) and the transapical (TA-TAVI) ones. There are concerns about TA-TAVI use in patients with reduced left ventricular ejection fraction (LVEF). The aim of this retrospective multicentre study was to compare the outcomes of TA-TAVI and TF-TAVI in patients with poor LVEF. METHODS: Patients with LVEF ≤35% were included in the analysis. Data were obtained from the Italian Transcatheter Balloon-Expandable Registry (ITER), which enrolled patients undergoing TAVI with the Sapien bioprosthesis in 33 national centres. Patients were divided into 2 groups according to the access: TA or TF. A multivariable logistic regression analysis was performed in order to evaluate whether the type of approach (TA and TF) has an impact on outcomes. RESULTS: Between 2007 and 2012, 1882 patients were enrolled in the Registry. LVEF ≤35% was found in 208 (11.1%) patients. TA-TAVI and TF-TAVI were performed in 69 (33.2%) and 139 (66.8%) patients, respectively. Overall 30-day mortality was 11.6% and 7.9% in TA and TF patients, respectively (P = 0.45). Overall Kaplan-Meier survival was significantly higher in the TF-TAVI group (log rank: P = 0.003). Age [odds ratio (OR) 1.066, P = 0.016], creatinine (OR: 2.301, P < 0.001), preoperative permanent pacemaker (OR: 4.662, P = 0.035) and TA approach (OR: 2.577, P = 0.006) were identified as independent predictors of overall mortality at follow-up. However, the TA approach resulted an independent variable of mortality only 3 years after TAVI. CONCLUSIONS: TAVI yields good results in patients with depressed LVEF. Age, preoperative creatinine and preoperative pacemaker are independently associated with mortality. The TA access is associated with mortality only after 3 years of follow-up, thus probably reflecting a worse general clinical status of these patients.

Does pre-existing aortic regurgitation protect from death in patients who develop paravalvular leak after TAVI?

OBJECTIVE: The aim of this study was to investigate interactions among pre-procedural aortic regurgitation (AR), post-procedural paravalvular leak (PVL) and long-term clinical outcomes. METHODS AND RESULTS: We analyzed data prospectively collected in the Italian Transcatheter balloon-Expandable Registry (ITER) on aortic stenosis (AS) patients. The degree of pre-procedural AR and post-procedural PVL was stratified as: absent/trivial, mild, and moderate/severe. VARC definitions were applied to outcomes. Of 1708 patients, preoperatively, AR was absent/trivial in 40% of the patients, mild in 42%, and moderate in 18%. Postoperatively, PVL was moderate-severe in 5%, mild in 32% of patients, and absent/trivial in 63%. Clinical follow-up, median 821days (IQR 585.75), was performed in 99.7% of patients. PVL, but not preoperative AR, was a major predictor of adverse outcome (HR 1.33, CI 95% 0.9-2.05, p=0.012 for mild PVL, HR 1.36, CI 95% 0.9-2.05, p<0.001 for PVL≥moderate and OR 1.04, p=0.97 respectively). Patients with moderate-severe PVL and preoperative left ventricle (LV) dilatation (LVEDVi>75ml/m2) showed better survival than those without dilatation (HR 8.63, p=0.001). CONCLUSIONS: In patients with severe AS treated with balloon-expandable TAVI, the presence of PVL, but not pre-procedural AR, was a major predictor of adverse outcome. Preoperative LV dilatation seemed to offer some clinical advantages.

Impact of Cusp Repair on Reoperation Risk After the David Procedure.

BACKGROUND: We assessed whether additional cusp repair during valve-sparing aortic root replacement affects the echocardiographic mid-term results; a subgroup analysis among patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV) was performed. METHODS: Between June 2002 and May 2015, 157 consecutive patients underwent valve-sparing aortic root replacement with the David technique. Thirty patients (19%) had BAV. In 19 patients (12%), cusp motion or anatomic abnormalities contributed in determining aortic regurgitation requiring an additional cusp repair. Mean follow-up was 7 ± 3.4 years. RESULTS: The cumulative 1-, 5-, and 12-year survival rates were 98%, 94%, and 90%, respectively. Fourteen patients (9%) required aortic valve replacement during follow-up. In 2 patients the underlying cause was bacterial endocarditis. Freedom from aortic valve reoperation was 96% at 1 year, 92% at 5 years, and 89% at 12 years. Reoperation rate was significantly higher (p < 0.001) in patients who received leaflet repair compared with patients who did not, with a freedom from reoperation at 8 years of 58% versus 94%. Among patients with BAV, those who did not require cusp repair had a freedom from reoperation at 8 years of 94%, with a significant difference compared with patients who received cusp repair (p = 0.04). Cusp repair did not affect reoperation risk in patients with tricuspid aortic valve. CONCLUSIONS: Adjunctive cusp repair seems to affect the mid-term reoperation risk in patients with BAV and not in patients with tricuspid aortic valve. We recommend caution in using this technique in case of asymmetric BAV requiring cusp repair.

Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).

OBJECTIVES: The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy. METHODS: The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality. RESULTS: Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ≤72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m2 (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively). CONCLUSIONS: TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.

Predictive ability of the CHADS2 and CHA2DS2-VASc scores for stroke after transcatheter aortic balloon-expandable valve implantation: an Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) sub-analysis.

OBJECTIVES: Stroke incidence after transcatheter aortic valve implantation (TAVI) still represents a concern. This multicentre study aimed at investigating the hypothesis that CHADS2 and CHA2DS2-VASc scores may be used to predict perioperative stroke after TAVI. METHODS: The Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER) is a multicentre, prospective registry of patients undergoing balloon-expandable TAVI using Edwards Sapien and Sapien XT prosthesis between 2007 and 2012. The primary end-point of this study was the 30-day stroke rate. Secondary safety end-points were all the major adverse events based on Valve Academic Research Consortium (VARC-2) criteria. RESULTS: One thousand nine hundred and four patients were enrolled in the registry. Mean age was 81.6 ± 6.2 years and 1147 (60.2%) patients were female; mean CHADS2 and CHA2DS2-VASc scores were 2.2 ± 0.8 and 4.4 ± 1.1, respectively. Fifty-four (2.8%) patients had a stroke within 30 days. At multivariable logistic regression analysis, CHA2DS2-VASc (OR: 1.35, 95% CI: 1.03-1.78; P = 0.031) and previous cardiac surgery (OR: 1.96, 95% CI: 1.06-3.6; P = 0.033) but not CHADS2 (OR: 1.05, 95% CI: 0.76-1.44; P = 0.77) were found to be independent predictors of in-hospital stroke. A CHA2DS2-VASc score ≥5 was strongly related to the occurrence of in-hospital stroke (OR: 2.51, 95% CI: 1.38-4.57; P= 0.001). However, CHA2DS2-VASc score showed only poor accuracy for in-hospital stroke with a trend for better accuracy when compared with CHADS2 score (area under the curve: 0.61, 95% CI: 0.59-0.63 vs 0.51; 95% CI: 0.49-0.54, respectively, P = 0.092). CONCLUSIONS: In TAVI patients, CHA2DS2-VASc provided a strong correlation for in-hospital stroke but with low accuracy. Dedicated scores to properly tailor procedures and preventive strategies are needed.

Outcome of open total arch replacement in the modern era.

OBJECTIVE: To shed light on contemporary results of open total aortic arch surgery, we undertook a systematic review to identify all reports on this procedure published in the last 10 years. METHODS: Extensive electronic literature search was undertaken to identify all published articles from 2004 to 2014 that provided results on total aortic arch replacement. According to inclusion and exclusion criteria, 21 relevant studies were selected and meta-analyzed to assess outcomes. RESULTS: The pooled estimate for operative mortality was 5.3%. Permanent and transient neurologic deficit occurred postoperatively at a pooled rate of 3.4% and 5.2%, respectively. Pooled rate of irreversible spinal cord injury was 0.6%, whereas renal failure occurred at a pooled rate of 4.1%. Prolonged intubation occurred at pooled rate of 15.4%. Among elective patients, pooled rate of mortality and permanent neurologic deficit was 2.9% and 2.2%, respectively, with a significant difference compared with urgent/emergency surgery cases. CONCLUSIONS: The main findings from this meta-analysis indicate that total aortic arch replacement can be performed with satisfactory mortality and morbidity. The pooled rates of mortality and permanent neurologic deficit among elective cases were surprisingly low, and these data have an even greater prominence when they are compared with outcomes of hybrid arch series. Under urgent/emergency surgery, early mortality and neurologic complications showed an about threefold higher rate. Moderate hypothermic circulatory arrest and early rewarming seem to provide proper renal protection, with an intermediate risk of prolonged intubation.

Iatrogenic left ventricular false aneurysm.

: We present a false aneurysm of ventricular left apex after mitral valve in valve prosthesis transapical implantation.

Hybrid Versus Conventional Treatment of Acute Type A Aortic Dissection.

BACKGROUND: To determine whether the hybrid approach to acute type A aortic dissection results in improved outcomes in terms of mortality, neurologic complications, need for distal aortic reintervention, and false lumen thrombosis compared with the conventional approach. METHODS: Data from comparative studies of hybrid versus conventional treatment of acute type A aortic dissection were combined through meta-analysis. Pooled odd ratios were calculated using random effects models. RESULTS: Seven comparative studies including 967 patients were identified; of these, 503 underwent conventional proximal aortic repair and 429 extensive distal aortic repair including a stented elephant trunk technique. Between the two groups there was no significant difference in operative mortality (p = 0.96), permanent neurologic deficit (p = 0.95), and late mortality (p = 0.59). Distal aortic repair showed a higher rate of false lumen thrombosis of the thoracic aorta (odd ratio 11.16; p < 0.001) and a reduced risk of distal reintervention (odd ratio 0.37; p = 0.01). In sub-group analysis, frozen elephant trunk procedure showed a lower rate of distal aortic reintervention and a higher rate of false lumen thrombosis than antegrade/retrograde stent deployment techniques (p = 0.008 and <0.001, respectively). CONCLUSIONS: Distal aortic repair may reduce the risk of distal reintervention and increase the rate of false lumen thrombosis without significant increase in operative mortality and permanent neurologic deficit; however, no benefit with respect to late mortality was found. The frozen elephant trunk may reduce the risk of distal aortic reintervention and may increase the false lumen thrombosis of the thoracic aorta in comparison with antegrade/retrograde stent deployment procedures.

A Hybrid Double Access for Transcatheter Mitral Valve-In-Valve Implantation.

We present a case of hybrid mitral valve-in valve implantation. The planned transapical approach failed due to the inability to cross the degenerated stenotic mitral bioprosthesis. An alternative strategy was performed: first, an anterograde crossing of mitral stenosis, and then, a guidewire externalization through the apex by using a snare. To our knowledge, this is the first described case of double approach mitral valve-in valve implantation.

Transapical transcatheter valve-in-valve replacement for deteriorated mitral valve bioprosthesis without radio-opaque indicators: the "invisible" mitral valve bioprosthesis.

In view of the high number of bioprosthetic valves implanted during the past 30 years, an increasing number of patients are coming to medical attention because of degenerated bioprostheses. Transcatheter aortic valve-in-valve implantation has been described as a less invasive alternative to re-operation to treat severe structural valve deterioration. As far as degenerated mitral valve bioprostheses are concerned, transcatheter transapical mitral valve-in-valve replacement (TMVR) has been less commonly performed, but may also become a viable alternative to re-do replacement surgery. We describe treatment of a degenerated bioprosthetic mitral valve, characterised by complete absence of any radio-opaque landmarks making the TMVR procedure very challenging.

Minimally invasive direct coronary artery bypass in the era of percutaneous coronary intervention.

AIM: Minimally invasive coronary artery bypass (MIDCAB) allows revascularization of the left anterior descending coronary (LAD) artery through a less traumatic surgical approach. However, the procedure is technically challenging and concern still exists, mainly based on graft patency. The purpose of this study is to critically evaluate short and long-term benefits of this surgical treatment. METHODS: Between June 1997 and July 2012, 306 patients underwent MIDCAB on LAD. The mean age was 62 ±â€Š10 years (range, 32-87 years) and 264 patients (86.3%) were men. Mean ejection fraction was 54%. Eighty-nine procedures (29.1%) were performed using a hybrid approach by means of MIDCAB and postoperative (60 patients, 67.4%) or preoperative (29 patients, 32.6%) percutaneous interventions on non-LAD vessels. A EuroScore more than 6 was found in 43 (14%) patients. The average follow-up time was 9.5 ±â€Š3.2 years and was 89% complete. RESULTS: Six patients (1.9%) required intraoperative conversion to sternotomy, whereas cardiopulmonary bypass institution after the sternotomy was necessary in one. Postoperative acute myocardial infarction occurring nine patients (2.9%), low output syndrome in four (1.3%). Postoperative mortality was 1.6% (n = 5), and perioperative stroke rate 0.6% (n = 2). Five and 10-year survival were 94.1 and 86.9%, respectively. Freedom from death due to cardiac events and major cardiac and cerebral events at 10 years was, respectively, 97.1 and 92.1%. CONCLUSIONS: The results confirm the favorable short and long-term results of the MIDCAB procedure. MIDCAB, in experienced centers, can represent an alternative treatment option for LAD disease.

Unusable radial artery for severe atherosclerosis in a young patient.

We report a young diabetic patient who was found to have an unusable radial artery (RA) for coronary bypass grafting because of severe and diffuse atherosclerosis. Techniques to diagnose RA conduits, which are not usable for coronary surgery, are reviewed.

Cusp repair during aortic valve-sparing operation: technical aspects and impact on results.

AIMS: Aortic valve-sparing operations are nowadays considered safe and reliable procedures in terms of mid-term and long-term results. Although surgical techniques regarding the modality of grafts' implantation have been properly addressed, the modality of cusp repair, when needed, is still open to debate. We sought to review the literature to try to shed light on when the cusp repair is required and how it should be performed. METHODS: We searched the PubMed database using the keywords aortic valve-sparing operation, aortic valve-sparing reimplantation, valve-sparing aortic root replacement, aortic valve repair, and aortic cusp repair. Only studies that included and described in detail the technique of cusp repairs in adjunct to aortic valve-sparing operation were considered. RESULTS: Bicuspid aortic valve more often requires correction when compared with tricuspid valve. The range of the techniques varies from the 'simple' free margin plication to the more complex triangular resection with patch repair. Results in the literature seem to be encouraging, showing that, in most of the cases, cusp repair does not affect valve competence in the mid-term and long-term. CONCLUSION: Correction of the cusp is a delicate balance between undercorrection that could lead to residual prolapse and overcorrection that could lead to cusp restriction. Although complex repair of the aortic valve in addition to root replacement provided satisfactory results, it should be reserved for experienced centers with a large volume of patients.

[CircuLite Synergy ventricular assist device: a new approach to end-stage congestive heart failure]. / Sistema di assistenza ventricolare CircuLite Synergy: un nuovo approccio all'insufficienza cardiaca terminale.

BACKGROUND: The Synergy system, a miniature partial circulatory support device, is implanted by an off-pump, minimally invasive surgical approach. The system has been optimized to improve performance in an EU clinical trial for chronic ambulatory heart failure. This therefore offers the possibility of treating elderly chronic heart failure patients who might not usually be considered for long-term circulatory support. METHODS: From June 2007 to December 2012, 63 patients were implanted with the Synergy system (12 patients ≥70 years) using four different releases of the device. Briefly, the system draws blood through the inflow cannula from the left atrium into the micro-pump (placed in a right subclavicular pocket) and pumps it through an outflow graft to the right subclavian artery. In this paper, we present an intermediate analysis of the clinical trial as performed on April 30, 2013, leading to the placing of the CE mark. RESULTS: Mean duration of support is ongoing at 230 days (range 23-1387). Follow-up showed improved hemodynamic response, with additional improvements in 6-min walk distance (299 ± 144 to 420 ± 119 m) and Minnesota Living with Heart Failure Questionnaire (69.5 ± 20.4 to 49.2 ± 24.3). Older patients had longer mean durations of support (337 vs 188 days). On average, elderly and younger patients showed similar improvements in hemodynamics and 6-min walk distance (107 ± 120 vs 130 ± 121 m). Major adverse cardiac events included bleeding (n=4) with one bleeding related to renal failure resulting in death. CONCLUSIONS: Clinical use of the Synergy device was associated with a significant functional improvement. Very low adverse event rates were reported with the latest device release. Older patients had smaller body sizes and worse renal function than younger patients. Both groups experienced similar hemodynamic benefits and functional improvements. The risk of bleeding and renal dysfunction appears to be increased in the elderly, though still within acceptable ranges compared to other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option that might be available even for the elderly chronic heart failure population.

Analysis of postsurgical aortic false aneurysm in 27 patients.

Aortic false aneurysm is a rare complication after cardiac surgery. In recent years, improved results have been reported in regard to the surgical management of these high-risk lesions. We retrospectively examined 28 consecutive cases (in 27 patients) of postsurgical aortic false aneurysm diagnosed at our institution from May 1999 through December 2011. Twenty-four patients underwent reoperation. Cardiopulmonary bypass was instituted before sternotomy in 15 patients (63%). Isolated repair of the aortic false aneurysm was performed in 15 patients. Four patients (including one who had already undergone repeat false-aneurysm repair) declined surgery in favor of clinical monitoring. Eleven patients were asymptomatic at the time of diagnosis. In the other 16, the main cause was infection in 7, and previous operation for acute aortic dissection in 9. The in-hospital mortality rate was 16.6% (4 patients, 3 of whom had infective false aneurysms). Relevant postoperative sequelae were noted in 7 patients (29%). The cumulative 1-year and 5-year survival rates were 83% and 62%, respectively. The 4 patients who did not undergo reoperation were alive at a median interval of 23 months (range, 9-37 mo). Two underwent imaging evaluations; in one, computed tomography revealed an 8-mm increase of the false aneurysm's maximal diameter at 34 months. Aortic false aneurysm can develop silently. Surgical procedures should be proposed even to asymptomatic patients because of the unpredictable evolution of the condition. Radical aortic-graft replacement should be chosen rather than simple repair, because recurrent false aneurysm is possible.

Mitral and aortic valve prosthetic endocarditis after percutaneous closure of mitral paravalvular leak.

A 67-year-old man presented to our hospital with massive mitral and aortic valve prosthetic endocarditis 2 months after transcatheter percutaneous closure of a mitral paravalvular leak with an Amplatzer duct occluder device (AGA Medical Corp, Plymouth MN). He underwent successful reoperation for valve prosthesis replacement and reconstruction of the anterior fibrous trigone. Although transcatheter treatment of periprosthetic valve defects has been shown to be feasible, follow-up data are still limited. This procedure should be reserved only for patients who are not eligible for open surgical procedures and those with small periprosthetic defects.