Abstract: OBJECTIVES: To provide data on feasibility, safety and efficacy of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve implantation (TAVI). Background. There are no data on BAV use as a bridge to TAVI in patients at high risk of periprocedural complications. METHODS: Between June 2007 to May 2009, 83 consecutive patients with symptomatic severe aortic stenosis (48 female, 35 male) aged from 65 to 88 years (mean age 81 +/- 5 years) were treated with TAVI. Early hemodynamic and clinical outcomes of patients undergoing palliative BAV before TAVI (BAV Group, n = 43) were compared with those of patients who directly underwent TAVI (no-BAV Group, n = 40). RESULTS: Patients in the BAV group had worse baseline clinical characteristics than those in the no-BAV group, with higher rates of congestive heart failure, New York Heart Association (NYHA) functional class III or IV and a higher EuroSCORE. In the BAV group, significant changes were found after valvuloplasty with regard to NYHA functional class, mean pressure gradient and aortic valve area. Peak-to-peak transvalvular pressure gradient and left ventricular systolic pressure also decreased immediately after BAV. Before TAVI, no differences in either clinical status or hemodynamic data were observed between patients who underwent BAV and those who did not. CONCLUSIONS: Bridging to TAVI with BAV is a feasible and reasonably safe approach to offer temporary relief in selected high-risk patients with symptomatic severe aortic stenosis and a high chance of periprocedural complications.
Abstract: Transcatheter aortic valve implantation has been shown to be an effective and reproducible therapy for severe aortic valve stenosis. Device performance and short-term outcomes of well-deployed prostheses have been extensively investigated and discussed; however, these endpoints have not yet been reported in cases characterized by suboptimal expansion. We describe a case of CoreValve self-expanding prosthesis underexpansion, reporting data on prosthesis performance and short-term clinical outcome.
Abstract: BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub-optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. METHODS: Of 110 patients who underwent TAVI using the third generation 18-French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid-term follow up. RESULTS: Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under-expansion conditioning moderate to severe peri-valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri-valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm(2) (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). CONCLUSIONS: Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid-term clinical and echocardiographic results.
Abstract: Mitral regurgitation (MR) is the second most common heart valve disease worldwide and the current gold-standard treatment is surgical repair or replacement. Nevertheless, many patients do not undergo surgical intervention due to several comorbidities. Percutaneous "edge-to-edge" mitral valve repair using the MitraClip System is an emerging and effective option to this subset of patients. This device has been used to treat both functional and degenerative mitral valve regurgitation and has been compared to surgery in the Endovascular Valve Edge-to-Edge Repair Study II (EVEREST II) randomized trial. Although the field of percutaneous management of MR is at an early stage, it has been demonstrated that percutaneous approaches can reduce MR, suggesting there is a great deal of potential for clinical benefit to patients with MR.
Abstract: We report the first human case of percutaneous transcatheter mitral valve repair with the MitraClip system under conscious sedation in a patient with severe mitral regurgitation. The procedure was performed using the standard MitraClip technique, in the catheterization laboratory, with transesophageal echocardiographic and fluoroscopic guidance. Transesophageal echocardiography is the primary imaging modality of the MitraClip procedure, which usually necessitates general anesthesia to guarantee complete immobilization of the patient allowing precise delivery of the MitraClip device. We successfully performed the procedure under deep sedation, using remifentanil and local anesthesia in a patient who had serious contraindications to general anesthesia. The success of this procedure suggests that percutaneous transcatheter mitral repair with the MitraClip system can be safely realized using conscious sedation. Conscious sedation may represent a convenient alternative approach for selected patients who undergo this innovative procedure.
Abstract: AIMS: This study sought to evaluate the feasibility and early outcomes of a percutaneous edge-to-edge repair approach for mitral valve regurgitation with the MitraClip system (Evalve, Inc., Menlo Park, CA, USA). METHODS AND RESULTS PATIENTS: were selected for the procedure based on the consensus of a multidisciplinary team. The primary efficacy endpoint was acute device success defined as clip placement with reduction of mitral regurgitation to < or =2+. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of >2 units of blood, ventilation for >48 h, deep wound infection, septicaemia, and new onset of atrial fibrillation. Thirty-one patients (median age 71, male 81%) were treated between August 2008 and July 2009. Eighteen patients (58%) presented with functional disease and 13 patients (42%) presented with organic degenerative disease. A clip was successfully implanted in 19 patients (61%) and two clips in 12 patients (39%). The median device implantation time was 80 min. At 30 days, there was an intra-procedural cardiac tamponade and a non-cardiac death, resulting in a primary safety endpoint of 93.6% [95% confidence interval (CI) 77.2-98.9]. Acute device success was observed in 96.8% of patients (95% CI 81.5-99.8). Compared with baseline, left ventricular diameters, diastolic left ventricular volume, diastolic annular septal-lateral dimension, and mitral valve area significantly diminished at 30 days. CONCLUSION: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favourable short-term safety and efficacy results.
Abstract: Transcatheter valve implantation is developing into an effective and reproducible therapy for aortic valve stenosis. The origin of this technique was pursued in 1992 when Andersen demonstrated the feasibility of percutaneous implantation of catheter-based valve prosthesis. Since then a lot of technical and device advances have been made and to date, transcatheter aortic valve implantation has became a concrete alternative to surgical replacement. This paper aims to go over all the current devices, from the most widely used to the newest technology, focusing on device description, procedural issues, potential complications and clinical studies currently available in literature.
Abstract: AIMS: To assess the NYHA class and the quality of life (QoL) scores after percutaneous aortic valve implantation (PAVI) with the 18-Fr CoreValve prosthesis. METHODS AND RESULTS: From April 2007 until August 2008, 57 consecutive patients with aortic stenosis were evaluated for PAVI. Of these, 30 patients with successfully prosthesis implantation had more than 5-month follow-up. QoL assessment was realized with the SF-12v2 Health-Survey, a simple questionnaire designed for self-administration that provides easily interpretable scales for physical [physical component summary (PCS)] and mental [mental component summary (MCS)] health. The questionnaire was administered before and 5 months after PAVI. All 30 patients had a marked upgrading in haemodynamic and echocardiographic parameters (peak-to-peak gradient from 64 +/- 23 to 2 +/- 0.4; P < 0.001; aortic valve area index from 0.3 +/- 0.1 to 0.9 +/- 0.3; P < 0.001), with an improvement in New York Heart Association (NYHA) class at discharge and after 5 months. Mean pre-operative SF-12v2 scores showed a severe impairment of perceived quality of life compared with general Italian population >75 years, both for physical (PCS-baseline 28.5 vs. 37.9, P < 0.001) and mental scores (MCS-baseline 37.8 vs. 45.4, P < 0.001). After 5 months, a striking improvement in both scores (PCS 41.3-MCS 48.3; P < 0.001) was observed. CONCLUSION: Our preliminary results show a marked short-term improvement in functional status and physical and mental health in patients underwent PAVI.
Abstract: BACKGROUND: Percutaneous closure of patent foramen ovale (PFO) is routinely performed with nonbiological devices, characterized by a persistent low-grade inflammatory response. We report our experience about PFO closure with a bioabsorbable device, BioSTAR (NMT Inc, USA). METHODS: From September 2007 to September 2008, 14 patients with migraine (eight with aura) and cerebral magnetic resonance positive for silent ischemia and nine patients with prior cardiovascular accident (CVA) underwent closure of PFO using BioSTAR. One patient had heterozygosis for sickle-cell-anaemia. Nickel allergy was present in eight patients. Echocardiogram was performed at 24 hr, one and 6 months. At 6 and 12 months a contrast-transcranial-doppler (c-TCD) and a trans-oesophageal echocardiogram (TOE) were scheduled, respectively. RESULTS: BioSTAR was successfully implanted in 22 patients (96%). The mean procedural time and the mean fluoroscopy time were 22 +/- 6 and 4 +/- 2 minutes, respectively. The mean in-hospital stay was 3 +/- 0.5 days. After a mean follow-up of 7.8 +/- 3.5 months there was an hemorrhagic stroke related to double antiaggregation. No other CVA or allergic reactions were registered. There were two cases of atrial arrhythmia. Fifteen patients had not residual shunts at c-TCD, while in four patients we observed a trivial microbubbles passage. The TOE, achieved in nine patients without contrast, showed the device well positioned, with a low profile and without thrombus. CONCLUSIONS: In our experience PFO closure with BioSTAR is safe and efficacious in preventing recurrent CVA. Its use could be advantageous in patients with nickel allergy and haematological disorders. The potential benefits of this device need to be certified in a larger cohort of patients with a longer follow-up.
Abstract: BACKGROUND: Percutaneous aortic valve replacement (PAVR) is an emerging alternative for high-risk patients with severe aortic stenosis. The aim of this study was to report acute and short-term outcomes of PAVR with the 18 Fr CoreValve Revalving System. METHODS: From January 2007 to July 2008, 69 high-risk symptomatic patients with severe aortic stenosis were screened to assess their eligibility criteria for PAVR. All candidates were evaluated by a cardiac surgeon and a cardiologist. Thirty patients (13 men, 17 women, ages 82 +/- 5 years, range 73-88 years) met all the eligibility criteria and were enrolled in the study. RESULTS: Twenty-nine patients (97%) underwent successful valve implantation by a retrograde approach, with improvement in valve area (0.61 +/- 0.18 cm(2) to 1.49 +/- 0.39 cm(2); p < 0.001) and transvalvular gradient (58.1 +/- 17.6 mmHg to 9.2 +/- 4.0; p < 0.001). Paravalvular leakages were 1+ (n = 12) and 2+ (n = 2). Procedural success was achieved in 93% of patients, with 1 case of pericardial tamponade occurred during the first 48 hours after implantation. At 30-day mortality was 7%. The mean NYHA Functional Class declined from 2.72 +/- 0.59 to 1.31 +/- 0.47 (p < 0.001). No other major adverse events occurred at a mean follow up of 4.9 +/- 4.0 months (range 1-13 months). CONCLUSIONS: Our initial experience of PAVR in a cohort of older and high-risk surgical patients has been positive, with excellent acute and encouraging short-term results in terms of safety and efficacy.
Abstract: BACKGROUND: Percutaneous closure of the left atrial appendage (LAA) is a novel alternative for the treatment of patients with atrial fibrillation (AF) and with a high risk of stroke who are not eligible for long-term anticoagulation therapy. The aim of this study was to asses the safety, feasibility, and long-term efficacy of this procedure. METHODS: From July 2004 to June 2007, 20 patients (13 male, mean age 69 +/- 8 years) with non-valvular AF (NV-AF) underwent LAA percutaneous closure using the PLAATO system, implanted through a transeptal access. All patients had contraindications to anticoagulant therapy and were at high risk for cardioembolic stroke (mean CHADS(2) score 3 +/- 1.2). A trans-thoracic echocardiogram was performed at 1, 3, and every 6 months after the procedure, whereas a trans-oesophageal echocardiogram (TOE) was scheduled at 6 months. After 24 months, a phone interview was obtained. RESULTS: All procedures were successfully performed in 18 patients. In two patients, LAA closure was not feasible for the presence of a multilobed LAA. Two patients underwent percutaneous closure of patent foramen ovale in the same session. In one patient, the procedure was complicated by cardiac perforation with pericardial effusion, treated with pericardiocentesis. At a mean follow up of 40 +/- 10 months, no embolic events occurred. One patient died, after 36 months, for gastric cancer. TOE examination showed the complete exclusion of the LAA in all patients. CONCLUSIONS: Percutaneous closure of LAA is safe and efficacious to prevent stroke in patients with NV-AF at high risk for cardioembolic events, with contraindications to anticoagulant therapy.
Abstract: Percutaneous valvular replacement in aortic stenosis is an emerging alternative therapy for high-risk patients. Initial experience suggests that outcomes compare favorably with conventional valve surgery in selected patients with comorbidities such as advanced age. Although the current devices are approved for stenotic native valves, percutaneous approaches to treat degenerated aortic bioprostheses have been reported. Here we describe the case of an 85-year-old female with severe regurgitation of a stentless biological prosthesis treated using the third-generation of CoreValve Revalving System.
