Transcatheter Aortic Valve Implantation in Patients With Advanced Chronic Kidney Disease.

Advanced chronic kidney disease (CKD) is associated with poor outcomes in patients who underwent surgical aortic valve replacement, whereas its prognostic role in transcatheter aortic valve implantation (TAVI) remains unclear. This study aimed to investigate outcomes in patients with advanced CKD who underwent TAVI. A total of 1,904 consecutive patients who underwent balloon-expandable TAVI in 33 centers between 2007 and 2012 were enrolled in the Italian Transcatheter Balloon-Expandable Valve Implantation Registry. Advanced CKD was defined according to the estimated glomerular filtration rate: 15 to 29 ml/min/1.73 m2 stage 4 (S4), <15 ml/min/1.73 m2 stage 5 (S5). Edwards Sapien or Sapien-XT prosthesis were used. The primary end point was all-cause mortality during follow-up. Secondary end points were major adverse cardiac events at 30 days and at follow-up, defined with Valve Academic Research Consortium 2 criteria. A total of 421 patients were staged S5 (n = 74) or S4 (n = 347). S5 patients were younger and had more frequently porcelain aorta and a lower incidence of previous stroke. Periprocedural and 30-day outcomes were similar in S5 and S4 patients. During 670 (±466) days of follow-up, S5 patients had higher mortality rates (69% vs 39%, p <0.01) and cardiac death (19% vs 9%, p = 0.02) compared with S4 patients. Male gender (hazard ratio [HR] 1.6, 95% confidence interval [CI] 1.2 to 2.2), left ventricular ejection fraction <30% (HR 2.3, 95% CI 1.3 to 4), atrial fibrillation (HR 1.4, 95% CI 1.0 to 1.9), and S5 CKD (HR 1.5, 95% CI 1.0 to 2.1) were independent predictors of death. In conclusion, TAVI in predialytic or dialytic patients (i.e., S5) is independently associated with poor outcomes with more than double risk of death compared with patients with S4 renal function. Conversely, in severe CKD (i.e., S4) a rigorous risk stratification is required to avoid the risk of futility risk.

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.

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.

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.

An Unusual Left Ventricular Apical Mass.

Left ventricular apical masses constitute a rare finding. Imaging properties together with the clinical history of the patient usually allow an etiologic definition. We report a challenging case of an ambiguous left ventricular apical mass of uncertain nature till histological examination. Points of interest were singular clinical history and echocardiographic findings, although not conclusive in hypothesis generating. Furthermore to the best of our knowledge, this is one of the rare attempt to excise a deep left ventricular mass with a mini-invasive surgical approach.

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.

Circulatory support in elderly chronic heart failure patients using the CircuLite® Synergy® system.

OBJECTIVE: The Synergy(®) system, a miniature partial circulatory support device, is implanted with an off-pump, minimally invasive surgical approach. In our experience, implantation of this system is associated with fewer perioperative adverse events than current full support devices. This approach therefore offers the possibility of treating elderly chronic heart-failure patients who might not ordinarily be considered for long-term circulatory support. METHODS: A total of 54 patients (12 patients ≥ 70 years) were implanted with the Synergy system in an off-pump minithoracotomy procedure. Mean age (54 ± 10 vs 73 ± 3), body surface area (1.9 ± 0.2 vs 1.7 ± 0.1), blood urea nitrogen (BUN) (59 ± 33 vs 91 ± 38), estimated glomerular filtration rate (eGFR) (71 ± 23 vs 50 ± 38) and haemoglobin (12.6 ± 1.9 vs 11.3 ± 1.3) differed significantly between young and old. RESULTS: Older patients had longer mean durations of support (337 vs 188 days). On average, both groups showed similar improvements (changes from baseline) in haemodynamics (pulmonary capillary wedge pressure -9 ± 16 vs -10 ± 8 mmHg; CO +1.0 ± 0.7 vs 0.9 ± 1.0 l/min, periferical vascular resistance (PVR) -1.2 ± 1.5 vs = 0.8 ± 1.7 Wood) and 6 min walk (107 ± 120 vs 130 ± 121 m). Older patients showed less improvement in peak VO2 (0.5 ± 2.9 vs 1.9 ± 3.0 ml/kg/min). Major adverse events (old vs young) between groups included major bleeding (75 vs 38%), infection (25 vs 38%), renal dysfunction (0 vs 17%) and device-related stroke (8 vs 10%). Mortality rate was 20% for the young and 40% for the elderly. CONCLUSIONS: Older patients implanted with Synergy had smaller body sizes and worse renal function than younger patients. Both groups experienced similar haemodynamic benefits and functional improvements, though peak VO2 is less improved in the elderly. Risks of bleeding and renal dysfunction appear to be increased in the elderly, though still within acceptable ranges compared with other full support devices. Minimally invasive long-term circulatory support devices, like Synergy, offer a new treatment option to the elderly chronic heart-failure population.

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.

Postsurgical aortic false aneurysm: pathogenesis, clinical presentation and surgical strategy.

Postsurgical aortic false aneurysm occurs in less than 0.5% of all cardiac surgical cases and its management is a challenge in terms of preoperative evaluation and surgical approach. Although infections are well recognized as risk factors, technical aspects of a previous operation may have a role in pseudoaneurysm formation. The risk factors and clinical presentation of pseudoaneurysms and the surgical strategy are revisited in this article.

Left ventricular pseudoaneurysm following aortic valve prosthesis endocarditis.

A 63-year-old man underwent aortic valve replacement and an early reoperation for recurrent endocarditis. Sixteen months later he presented with persistent fever and a 64-slice computed tomography (CT) scan revealed a subannular left ventricular pseudoaneurysm. He underwent successful left ventricular outflow tract reconstruction and aortic valve prosthesis, partial root and ascending aorta replacement.

6 months of "temporary" support by Levitronix left ventricular assist device.

An otherwise healthy 47-year-old man presented to the emergency department in cardiogenic shock after suffering a massive myocardial infarction due to left main occlusion. He was initially supported by extracorporeal membrane oxygenation and subsequently was converted to paracorporeal support with a Levitronix left ventricular assist device. He experienced multiple postoperative complications including renal failure, respiratory failure, retroperitoneal hematoma requiring suspension of anticoagulation, and fungal bloodstream infection precluding transition to an implantable device. He was reconditioned and successfully underwent orthotopic heart transplant 183 days after presentation. A discussion of the relevant issues is included.

Bicuspidy does not affect reoperation risk following aortic valve reimplantation.

Aortic valve reimplantation has been shown to be a safe procedure. However, evidences of durability in bicuspid aortic valves (BAVs) are limited in the literature. Between 2002 and 2011, 132 patients (mean age 61 ± 12 years) underwent aortic valve reimplantation. In 24 patients (18%), aortic valve was bicuspid. Mean follow-up was 50 ± 26 months (range 1-102 months) and was 99% complete. In-hospital mortality was 0.8% (1 patient). Survival at 1 and 5 years was 99 and 94%, respectively. Overall freedom from aortic valve reoperation at 1 and 5 years was 96 and 90%, respectively, without significant difference between patients with bicuspid and tricuspid aortic valve. Freedom from aortic valve regurgitation >2+/4+, excluding patients reoperated, was at 1 and 5 years of 100 and 99%, respectively. Patients with valve cusp repair showed a higher rate of aortic valve reoperation; however, only postoperative aortic regurgitation >2+/4+ was significant risk factor for redo procedure at multivariate analysis. Aortic valve reimplantation in BAV without cusp repair provides excellent mid-term results. Further observations and longer follow-up are necessary to determine if BAV sparing, even in the presence of cusps alterations, could allow satisfying durability.

Aortic valve replacement for paraprosthetic leak after transcatheter implantation.

Conversion to surgical aortic valve replacement (AVR) has been described as a complication following transcatheter aortic valve implantation. This complication occurs in up to 8% of cases and, to the best of our knowledge, preoperative data and surgical outcomes of such patients have not been properly evaluated. Mild paraprosthetic regurgitation is commonly observed after transcatheter aortic valve implantation and usually leads to a benign clinical course. Unequal distribution of valve calcifications is described as a potential mechanism. We report a case of a perioperative paraprosthetic regurgitation that underwent successful urgent surgical AVR and review the incidence and results of paraprosthetic leaks following transcatheter implantation.

Compliance of the Valsalva graft's pseudosinuses at midterm follow-up with cardiovascular magnetic resonance.

BACKGROUND: In previous studies, the Valsalva graft's compliance at the level of the Dacron pseudosinuses was found similar to that of normal sinuses shortly (2±1 months) after the operation. We sought to investigate with cardiac magnetic resonance the compliance of the Valsalva graft pseudosinuses at midterm follow-up. METHODS: Seven patients (group A) and 7 age-matched controls (group B) were studied with steady-state free precession and phase-contrast cardiac magnetic resonance for aortic root and ascending aorta evaluation. Blood pressure was measured during phase-contrast acquisition to derive the following mechanical properties of the vascular prosthesis: pulsatility, compliance, distensibility, and elastic modulus. RESULTS: Mean postoperative follow-up was 55±9.84 months. Mean age was 69.2±4.98 years in group A, and 65.7±7.16 years in group B. All the studied variables were coherent in showing a significant difference between the two groups, and between aortic root (skirt portion of the graft) and ascending aorta (tubular part of the graft) in group A. The presence of periaortic fibrosis did not show any correlation with the ascending aorta's mechanical properties. CONCLUSIONS: At midterm follow-up, the pseudosinuses compliance of the Valsalva graft is still appreciable and significantly greater than the tubular portion.

Reimplantation valve-sparing aortic root replacement with the Valsalva graft: what have we learnt after 100 cases?

OBJECTIVES: Reimplantation valve-sparing aortic root replacement has been increasingly performed with improving perioperative and mid-term results. The success of this operation primarily depends on preserving the highly sophisticated dynamic function of the aortic valve by recreating an anatomical three-dimensional configuration similar to the normal aortic root, thus minimizing the mechanical stress and strain on the cusps. Over the years several techniques have been proposed to reproduce the sinuses of Valsalva. We reviewed our experience with aortic valve reimplantation by means of a modified Dacron graft that incorporates sinuses of Valsalva, in a series of 100 consecutive patients. METHODS: During a 60-month period, 100 patients with aortic root aneurysm underwent aortic valve reimplantation using the Gelweave Valsalva prosthesis. There were 74 males and the mean age was 60+/-12 years (range 28-83 years). Five patients had the Marfan's syndrome, 15 had a bicuspid aortic valve. Cusp repair was performed in five patients. The mean follow-up time was 28.6 months (range 1-60). Transesophageal echocardiogram was performed at the end of each procedure to assess the aortic valve in terms of competence, dynamic motion and level of coaptation within the graft. RESULTS: There was one hospital death and two late deaths. Overall survival at 60 months was 91.7+/-5.1%. Five patients developed severe aortic incompetence (AI) during follow-up requiring aortic valve replacement (AVR). The 60 months freedom from re-operation due to AI was 90.9+/-4.4%. One patient had moderate AI at latest echocardiographic study. The 60 months freedom from AI>2+ was 91.6+/-7.9%. Cox regression identified cusp's repair as independent risk factor (P=0.001) for late reimplantation failure (AVR or AI>2+). There were no episodes of endocarditis and the majority of the patients (88%) were in New York Heart Association functional class I. CONCLUSIONS: The aortic valve reimplantation with the Gelweave Valsalva prosthesis provided satisfactory mid-term results. An accurate assessment of the level of coaptation of the aortic cusps in respect to the lower rim of the Dacron graft by means of intraoperative transesophageal echocardiogram at the end of each procedure is mandatory in order to avoid early reimplantation failure. Cusp's repair may play an important role in the development of late AI. However, long-term results are needed in order to define the durability of this technique.