Case series of bail-out procedures with a balloon-expandable sheath after unsuccessful introduction of the NovaFlex device.

OBJECTIVE: Vascular complications remain the main problem of transcatheter aortic valve replacement, despite downsizing of delivery catheter diameter and judicious patient selection. In case of diffusely calcified and/or very tortuous access vessels, the SoloPath Balloon Expandable TransFemoral Introducer (Onset Medical Corporation, Irvine, CA USA), providing the smallest insertion profile of any sheath in its class, may enable exceptional trackability and offer the largest working diameter, thus helping to prevent feared vascular complications. We report the successful use of SoloPath sheath to face six cases of NovaFlex (Edwards Lifesciences Inc, Irvine, CA USA) sheath failed insertion due to vessel tortuosity and calcifications. METHODS: In six patients enrolled for transfemoral transcatheter Edwards SAPIEN XT replacement, resistance to NovaFlex sheath pushing was encountered, subsequent to the bending of the distal portion of the sheath due to vessel tortuosity and calcifications. Damaged Edwards sheaths were exchanged for a SoloPath sheath with a 21-French inner diameter. SoloPath Controlled Deployment Technology design provides the introducer, once expanded, with great radial and pillar resistance. RESULTS: The unexpanded SoloPath sheath-dilator combination tracked without resistance or kinking over a stiff guide wire through the iliofemoral axis and then was expanded. All transcatheter prostheses were successfully deployed within the native annulus, showing good hemodynamic function. CONCLUSIONS: We report six successful bail-out procedures with the SoloPath Balloon Expandable TransFemoral sheath after unsuccessful introduction of the NovaFlex device. If similar results are confirmed, use of the SoloPath during transcatheter aortic valve replacement may help prevent vascular complications and eliminate the need for other preoperative steps (eg, vascular stenting), therefore reducing procedural mortality, surgical expense, and patient recovery time.

Transcatheter vs. surgical aortic valve replacement: a retrospective analysis assessing clinical effectiveness and safety.

OBJECTIVE: To compare, in terms of clinical effectiveness and safety, patients who underwent transcatheter aortic valve implantation (TAVI) with those who underwent surgical aortic valve replacement (S-AVR) for the treatment of severe aortic stenosis during the same period. METHODS: One hundred and eighty-seven consecutive patients were included: 81 with S-AVR and 106 with TAVI. Primary and secondary outcomes were reported in accordance with published reporting guidelines for valve surgery. A propensity matching model was computed in the attempt to reduce confounding effects of covariates. RESULTS: Thirty-day mortality and morbidity, as well as follow-up events, did not differ between the two therapeutic options, except for ICU stay, in favor of TAVI, and occurrence of pleural effusions, in favor of S-AVR. TAVI accomplished significant mean aortic gradient reduction (better than S-AVR in the immediate postoperative and at least comparable at follow-up) and improvement in valve area and functional class (always higher than S-AVR). Although for the first year, survival was at least comparable between TAVI and S-AVR (both whole and matched groups); at later times, TAVI all-cause and noncardiac mortality was higher in the whole sample, as expected from age and comorbidities of TAVI patients. At later follow-up, in the matched subsamples, 1-year mortality rates were replicated, with a significantly higher incidence of cardiac deaths in S-AVR patients. CONCLUSION: TAVI morbidity and mortality registered in this series are lower than those estimated for conventional surgery in high-risk patients and compare to those associated with S-AVR in good surgical candidates.

Cumulative radiation exposure during thoracic endovascular aneurysm repair and subsequent follow-up.

OBJECTIVES: Thoracic endovascular aneurysm repair (TEVAR) is an appealing alternative to the standard surgical approach, but requires rigorous radiological follow-up. The cumulative radiation exposure (RE) of patients undergoing TEVAR-including pre-operative workup, the procedure and subsequent follow-up computed tomography (CT) imaging-has not previously been investigated. METHODS: From August 2003 to February 2011, 48 patients underwent TEVAR at our institution. Mean age was 66 ± 11 years, with 10 patients (21%) aged <60 years. Forty-one (85%) patients were male; 7 (15%) had urgent/emergent operation; 21 (44%) had undergone previous aortic surgery. Mean aortic diameter was 7.3 ± 2.1 cm. Intra-operative screening time and RE were reviewed, and typical institutional thoracic CT scan RE was calculated (17.8 mSv). Life expectancy of an age- and sex-matched population was estimated to assess the cumulative RE from recurrent CT follow-up. RESULTS: The average screening time was 15.7 ± 11.4 min, with an RE of 11.3 ± 9 mSv. Obese patients had significantly higher RE during TEVAR (Pearson's coefficient = 0.388, P = 0.019). The RE dropped from 14.9 ± 9.4 mSv to 8.6 ± 7.9 mSv (P = 0.033) after a hybrid suite was established. Our institutional TEVAR protocol involves one pre-operative thoracoabdominal CT scan and three follow-up thoracic CT scans for the first year, with a yearly evaluation thereafter. The life expectancy of an age- and sex-matched population was 17 years. A patient adhering to our surveillance protocol would be subjected to an overall exposure of 89 mSv at 1 year and 161 mSv at 5 years, with a projected lifetime RE >350 mSv. CONCLUSIONS: A 2-year RE exceeding the threshold of 100 mSv with a life expectancy >15 years can be estimated to lead to a lifetime risk increase in radiation-induced leukaemia and solid-tumour cancer >2.7%. The risks of cumulative RE especially in younger and/or obese patients must be balanced with the expected morbidity and mortality reduction in TEVAR versus traditional open repair, and the anticipated benefits of recurrent radiographic imaging.

Transapical aortic valve implantation in high-risk patients with severe aortic valve stenosis.

BACKGROUND: Transapical aortic valve implantation (TA-TAVI) represents an alternative in patients with symptomatic severe aortic valve stenosis (SSAVS) who cannot be operated on or have a high surgical risk. The aim of this prospective multicenter observational study was to assess early and 2-year clinical and hemodynamic outcomes after TA-TAVI. METHODS: From May 2008 to September 2010, 179 patients with inoperable conditions or high-risk patients underwent TA-TAVI at 4 institutions. Indications for TA-TAVI were SSAVS and logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) greater than 20% or porcelain aorta in patients with severe aortoiliac disease. Patients underwent clinical and echocardiographic follow-up visits at hospital discharge, 3 and 6 months after TA-TAVI, and every 6 months thereafter. The impact of the learning curve for the centers and of intraoperative complications on patient outcomes was also evaluated. RESULTS: Mean age was 81 ± 6 years. Mean logistic EuroSCORE was 22% ± 12%. Transapical delivery was successful in all patients. Seventeen severe intraoperative complications occurred in 13 (7.3%) patients. Thirty-day mortality was 3.9% (7 patients). Mean follow-up was 9.2 ± 6.5 months. Late mortality occurred in 9 patients. Two-year survival was 88% ± 3%. An intraoperative severe complication was identified as the only significant independent predictor of 1-year mortality. A significant benefit was found when comparing 2-year survival of the second versus the first 50% patients at each center (93% ± 2% versus 84% ± 3 %; p = 0.046). A significant reduction of both mean and peak gradients from the preoperative to the postoperative period, which remained stable during follow-up, was found. CONCLUSIONS: TA-TAVI provides excellent early and 2-year results in terms of survival, valve-related adverse events, and hemodynamic performance. Survival after TA-TAVI is affected by the center learning curve and by the occurrence of an intraoperative complication.

Recurrent pericardial effusion after cardiac surgery: the use of colchicine after recalcitrant conventional therapy.

Pericardial effusion represents a common postoperative complication in cardiac surgery. Nonetheless, it can be resistant to conventional therapy leading to prolonged in-hospital stay and worsening of clinical conditions. Recent literature shows that colchicine therapy should be useful in the treatment of recurrent post surgical pericardial effusion. Hereby we report the case of a patient with postsurgical recurrent effusion treated with colchicine, and a review of literature concerning the use of this old drug.

Feasibility and accuracy of a comprehensive multidetector computed tomography acquisition for patients referred for balloon-expandable transcatheter aortic valve implantation.

BACKGROUND: The aim of this study was to assess the accuracy of a comprehensive multidetector computed tomography (MDCT) evaluation of the aortic annulus (AoA), coronary artery disease (CAD), and peripheral vessels in patients referred for transcatheter aortic valve implantation (TAVI). METHODS: In 60 patients referred for TAVI, the following parameters were assessed with 64-slices MDCT and compared with transesophageal echocardiography (TEE), invasive coronary angiography (ICA), and peripheral angiography: AoA maximum diameter (Max-AoA-D(MDCT)), minimum diameter (Min-AoA-D(MDCT)), and area; lumen morphology index ([Max-AoA-D(MDCT)/Min-AoA-D(MDCT)]); length of the left, right, and non-coronary aortic leaflets; degree (grades 1-4) of aortic leaflet calcifications; distance between AoA and left main coronary ostium and between AoA and right coronary ostium CAD and peripheral vessel disease. RESULTS: The Max-AoA-D(MDCT) and Min-AoA-D(MDCT) were 25.1 ± 2.8 and 21.2 ± 2.2 mm, respectively, with high correlation versus AoA diameter measured with TEE (r = 0.82 and 0.86, respectively). The area of AoA, systolic and diastolic lumen morphology index were 410 ± 81.5 mm(2), 1.19 ± 0.1 and 1.22 ± 0.11, respectively. Aortic leaflet calcification score was 3.3 ± 0.5. The lengths of left, right, and non-coronary aortic leaflets were 14.2 ± 2.4, 13.7.1 ± 2.1, and 14.5 ± 2.6 mm, whereas distances between AoA and the left main coronary ostium and between AoA, and the right coronary ostium were 13.7 ± 2.9 and 15.8 ± 3.5 mm, respectively. Feasibility, negative predictive value, and accuracy for CAD detection versus ICA were 87%, 100% (CI 100-100), and 96% (95% CI 94-100), respectively. All patients (N = 17) who were ineligible for TAVI were correctly detected by MDCT. CONCLUSIONS: A comprehensive MDCT evaluation of patients referred for TAVI is feasible, provides more accurate assessment than TEE of AoA morphology, and may replace peripheral angiography in all patients and ICA in patients without significant CAD.

Conservative management of the pseudoaneurysms of ascending aortic graft: a case of spontaneous regression at follow-up.

Pseudoaneurysms of thoracic aorta represent life-threatening complications of cardiac surgery. We present a case report of a patient who underwent urgent aortic valvular replacement with a biological prosthesis and ascending aortic replacement with graft interposition and developed postoperative ascending aortic pseudoaneurysms. The pseudoaneurysms did not increase in the postoperative stay and a conservative management was chosen. At follow-up, the two pseudoaneurysms had completely regressed. The therapeutic steps for aortic pseudoaneurysms should be tailored to the patient and even conservative management could be effective if selected after an evaluation of the clinical status of the patient.

Endovascular treatment of abdominal aortic aneurysm after previous left pneumonectomy: a sound choice.

Surgical treatment of abdominal aortic aneurysm after previous pneumonectomy is a challenge because of the impaired respiratory function and increased surgical risks. Endovascular aneurysm repair in anatomically suited high-surgical-risk patients offers excellent short-term results and provides good protection from aneurysm-related death. In this article, we report a successful endovascular aneurysm repair of an infrarenal aortic aneurysm in a patient with past left pneumonectomy.

Tent-shape technique: another procedure to repair P2 of posterior leaflet of mitral valve.

In this report, we describe a new procedure to repair the prolapsing high mid-scallop of the mitral valve (MV) posterior leaflet (P2) with detailed consideration of the anatomy and physiology of the MV. A new artificial chord is implanted in the body of the P2 at the same height of non-prolapsing P1 and P3, and the remaining part of the prolapsing P2 is anchored to the artificial chord taking the shape of a tent.

Impact of left ventricular systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation for severe aortic stenosis.

BACKGROUND: This study aimed to evaluate the impact of baseline left ventricular (LV) systolic function on clinical and echocardiographic outcomes following transcatheter aortic valve implantation (TAVI). Survival of patients undergoing TAVI was also compared with that of a population undergoing surgical aortic valve replacement. METHODS: One hundred forty-seven consecutive patients (mean age=80±7 years) undergoing TAVI in 2 centers were included. Mean follow-up period was 9.1±5.1 months. RESULTS: At baseline, 34% of patients had impaired LV ejection fraction (LVEF) (<50%) and 66% had normal LVEF (≥50%). Procedural success was similar in these 2 groups (94% vs 97%, P=.41). All patients achieved improvement in transvalvular hemodynamics. At follow-up, patients with a baseline LVEF<50% showed marked LV reverse remodeling, with improvement of LVEF (from 37%±8% to 51%±11%). Early and late mortality rates were not different between the 2 groups, despite a higher rate of combined major adverse cardiovascular events (MACEs) in patients with a baseline LVEF<50%. The predictors of cumulative MACEs were baseline LVEF (HR=0.97, 95% CI=0.94-0.99) and preoperative frailty (HR=4.20, 95% CI=2.00-8.84). In addition, long-term survival of patients with impaired or normal LVEF was comparable with that of a matched population who underwent surgical aortic valve replacement. CONCLUSIONS: TAVI resulted in significant improvement in LV function and survival benefit in high-risk patients with severe aortic stenosis, regardless of baseline LVEF. Patients with a baseline LVEF<50% were at higher risk of combined MACEs.

Circulating microRNAs are new and sensitive biomarkers of myocardial infarction.

AIMS: Circulating microRNAs (miRNAs) may represent a novel class of biomarkers; therefore, we examined whether acute myocardial infarction (MI) modulates miRNAs plasma levels in humans and mice. METHODS AND RESULTS: Healthy donors (n = 17) and patients (n = 33) with acute ST-segment elevation MI (STEMI) were evaluated. In one cohort (n = 25), the first plasma sample was obtained 517 ± 309 min after the onset of MI symptoms and after coronary reperfusion with percutaneous coronary intervention (PCI); miR-1, -133a, -133b, and -499-5p were ~15- to 140-fold control, whereas miR-122 and -375 were ~87-90% lower than control; 5 days later, miR-1, -133a, -133b, -499-5p, and -375 were back to baseline, whereas miR-122 remained lower than control through Day 30. In additional patients (n = 8; four treated with thrombolysis and four with PCI), miRNAs and troponin I (TnI) were quantified simultaneously starting 156 ± 72 min after the onset of symptoms and at different times thereafter. Peak miR-1, -133a, and -133b expression and TnI level occurred at a similar time, whereas miR-499-5p exhibited a slower time course. In mice, miRNAs plasma levels and TnI were measured 15 min after coronary ligation and at different times thereafter. The behaviour of miR-1, -133a, -133b, and -499-5p was similar to STEMI patients; further, reciprocal changes in the expression levels of these miRNAs were found in cardiac tissue 3-6 h after coronary ligation. In contrast, miR-122 and -375 exhibited minor changes and no significant modulation. In mice with acute hind-limb ischaemia, there was no increase in the plasma level of the above miRNAs. CONCLUSION: Acute MI up-regulated miR-1, -133a, -133b, and -499-5p plasma levels, both in humans and mice, whereas miR-122 and -375 were lower than control only in STEMI patients. These miRNAs represent novel biomarkers of cardiac damage.

Left main coronary artery occlusion after percutaneous aortic valve implantation.

Left main coronary artery occlusion occurred immediately after transfemoral aortic valve implantation in an 87-year-old woman, which resulted in ventricular fibrillation and hemodynamic collapse. This life-threatening complication was promptly diagnosed with transesophageal echocardiography, which showed the disappearance of diastolic left main coronary artery jet flow and was confirmed with aortic root angiography. After prompt defibrillation, hemodynamic support was obtained with intra-aortic balloon pump and inotropic drugs. Functional recovery and survival were achieved with coronary stenting. This report highlights the importance of an integrated team approach of highly skilled specialists for these novel interventions.

Transcatheter aortic valve replacement: a dog bone-shaped balloon technique.

We report a new technique of the partially and sequentially gonflage of the transcatheter balloon valve, the so called dog bone shaped technique, which allowed us to approach the aortic root by inflating the valve balloon in two different times, stabilizing the heart and deplacing the valve.

Incidental detection of a giant ductus arteriosus aneurysm by low-dose multidetector computed tomography in an asymptomatic adult.

Aneurysm of the ductus arteriosus is a very rare congenital lesion in adults that can be associated with thromboembolism, rupture, and death. Its detection in a silent clinical phase is very important for planning appropriate treatment and avoiding potentially fatal complications. We report a case of a patent ductus arteriosus aneurysm of very large size (65.5 mm) that was incidentally discovered with low-dose (3.2 mSv) multidetector computed tomography in an asymptomatic 67-year-old man. The presence of coronary disease was also ruled out with this non-invasive imaging modality. Further evaluation with echocardiography and selective angiography confirmed the diagnosis. At surgery, the aneurysm was successfully resected via a left posterolateral thoracotomy.

Aortic dissection complicating intraaortic balloon pumping: percutaneous management of delayed spinal cord ischemia.

Iatrogenic acute type B dissection is a rare complication of intraaortic balloon pumping. Delayed visceral and spinal cord malperfusion can occur for distal progression of the dissection or relative hypotension. Cerebrospinal fluid drainage and percutaneous balloon fenestration provide a safe and effective method for managing ischemic complications.

Regenerative therapy in peripheral artery disease.

Patients with peripheral artery disease (PAD) and critical limb ischemia are the main candidates for limb amputations and have a poor life expectancy. Frequently, these patients are not eligible for either surgical or percutaneous interventions aimed at mechanical revascularization. Therefore, new strategies need to be identified to offer these patients a viable therapeutic option. Gene and cell therapy hold great promise for the treatment of peripheral vascular diseases because, in animal models, local delivery of growth factors and endothelial progenitor cells result in new blood vessel formation and regeneration of ischemic tissues. In this article, are reviewed phase I and phase II gene, and cell therapy clinical trials in patients with PAD.

An occasional diagnosis of myasthenia gravis--a focus on thymus during cardiac surgery: a case report.

BACKGROUND: Myasthenia gravis, an uncommon autoimmune syndrome, is commonly associated with thymus abnormalities. Thymomatous myasthenia gravis is considered to have worst prognosis and thymectomy can reverse symptoms if precociously performed. CASE REPORT: We describe a case of a patient who underwent mitral valve repair and was found to have an occasional thymomatous mass during the surgery. A total thymectomy was performed concomitantly to the mitral valve repair. CONCLUSION: The diagnosis of thymomatous myasthenia gravis was confirmed postoperatively. Following the surgery this patient was strictly monitored and at 1-year follow-up a complete stable remission had been successfully achieved.

Transcatheter aortic valve implantation in the operating room: early experience.

OBJECTIVE: Aortic stenosis is the most common valvular heart disease in the Western world and the proportion of patients unsuitable for conventional surgery is increasing as a result of aging and comorbidities. We report our early experience with transcatheter aortic valve implantation in high-risk patients with severe symptomatic aortic stenosis. METHODS: Transcatheter Edwards-SAPIEN valve implantation was attempted in 22 patients (80 +/- 5 years) in whom surgical risk was deemed excessive because of older age, poor left ventricular function, comorbidities, or all. A retrograde transarterial approach was used in 15 cases. In seven cases, valve implantation was performed by transapical approach because of aortic or iliac artery tortuosity, or both, and stenosis. All procedures were performed without cardiopulmonary bypass. Rapid ventricular pacing was used to reduce cardiac output while delivering balloon-expandable prosthesis. RESULTS: One patient died because of aortic dissection during early catheterization maneuvers. In the remaining patients, procedural success was achieved in all cases. Successful valve replacement was associated with an increase in transthoracic echocardiographic valve area from 0.65 +/- 0.14 to 2.2 +/- 0.4 cm2 and significant improvement in clinical condition. During the course of this experience, we encountered three (13.6%) cases of vascular complications related to transcatheter aortic valve implantation procedures. CONCLUSION: The present study confirms the excellent hemodynamic performances of the transcatheter-implanted aortic prosthesis, with both transarterial and transapical approaches, in inoperable candidates with end-stage aortic stenosis. With progressive improvement in patient selection, techniques, equipment, and operator endovascular skills, vascular complications can decline further.