Direct access valve replacement (DAVR) - are we entering a new era in cardiac surgery?

OBJECTIVE: This study validates the off-pump antegrade trans-ventricular route for ultrasound-guided direct access aortic valve replacement. Direct access aortic valve replacement using a transthoracic and valved stent-based approach offers numerous advantages over the remote access percutaneous approach and may one day provide an alternative treatment modality for aortic valve disease. METHODS: Valved stents were implanted off-pump in 17 pigs (72.10+/-8.4 kg) via the direct access transapical approach using a left-sided mini-thoracotomy and continuous ultrasonic and fluoroscopic guidance. Acute valved stent function was studied with intravascular and two-dimensional intracardiac ultrasound. The invasive valve gradient was assessed with pull-back pressure catheter. All valved stents were tested in vitro before insertion. Macroscopic analysis was performed at necropsy. RESULTS: In 11 of the 17 pigs, valved stents were delivered to the target site over the native aortic valve leaflets without interference of coronary blood flow and with good acute valve function. Three valved stents were deployed supra-annularly, two of those occluded the right coronary orifice and one the left coronary orifice, leading to fatal outcomes. Three valved stents dislodged into the left ventricle, one because of size-mismatch and two because of failure to unfold correctly. In 11 properly sized and deployed valved stents, two showed a moderate and one a severe paravalvular leak. CONCLUSIONS: Seventeen pigs underwent direct access valve replacement of the aortic valve with deployment of a valved stent into the native aorta. Eleven valves observed for an average 5-h period showed satisfactory, postimplantation valve function

Muscular counterpulsation: preliminary results of a non-invasive alternative to intra-aortic balloon pump

Objectives: IABP is the most widely used form of temporary cardiac assist and its benefits are well established. We designed an animal study to evaluate a device based on muscular counterpulsation (MCP) that should reproduce the same hemodynamic effects as IABP in a completely non-invasive way. Methods: Six calves, 60±4 kg, divided into 2 groups, in general anaesthesia, equipped with EKG, Swan-Ganz, pressure probe in the femoral artery and flow probe in the left carotid artery, received either IABP through right femoral artery, or muscle counterpulsation (MCP). MCP consists of electrically induced skeletal muscle contraction during early diastole, triggered by EKG and microprocessor controlled by a portable device. For each animal the following parameters were also considered: mean aortic pressure (mAoP), CO, CI, left ventricular stroke work index (LVSWI), systemic vascular resistance (SVR) and mean femoral artery flow (Faf). We did 3 sets of measurements: baseline (BL), after 20 (M20) and 40 (M40) min of cardiac assistance. These measurements have been repeated after 40 min of rest for 3 times. Results are expressed as mean±SD. Results: Baseline values: mAoP, 76.51±12 mmHg; mCVP, 11.5±3 mmHg; CO, 5±1 l/min per m2; LVSWI, 0.77±0.2KJ/m2; SVR, 1040±15dyns/cm−5; Faf, 75.5±10 ml/min. IABP group: mAoP, 81.1±6 mmHg; mCVP, 1±0.1 mmHg; CO, 4.5±0.7 l/min per m2; LVSWI, 0.69±0.2KJ/m2; SVR, 1424±8dyns/cm−5; Faf, 64.3±3 ml/min. MCP group: mAoP, 60.1±7 mmHg; mCVP, 23.6±2 mmHg; CO, 4.8±0.4 l/min per m2; LVSWI, 0.69±0.2KJ/m2; SVR, 608±25dyns/cm−5; Faf, 92.3±12 ml/min. Conclusions: MCP and IABP had the same effects on CO and LVSWI. Moreover, MCP reduced SVR and increased the peripheral circulation without requiring any vascular access nor anticoagulation therap

Late removal of retrievable caval filters.

The advent of retrievable caval filters was a game changer in the sense, that the previously irreversible act of implanting a medical device into the main venous blood stream of the body requiring careful evaluation of the pros and cons prior to execution suddenly became a "reversible" procedure where potential hazards in the late future of the patient lost most of their weight at the time of decision making. This review was designed to assess the rate of success with late retrieval of so called retrievable caval filters in order to get some indication about reasonable implant duration with respect to relatively "easy" implant removal with conventional means, i.e., catheters, hooks and lassos. A PubMed search (www.pubmed.gov) was performed with the search term "cava filter retrieval after 30 days clinical", and 20 reports between 1994 and 2013 dealing with late retrieval of caval filters were identified, covering approximately 7,000 devices with 600 removed filters. The maximal duration of implant reported is 2,599 days and the maximal implant duration of removed filters is also 2,599 days. The maximal duration reported with standard retrieval techniques, i.e., catheter, hook and/or lasso, is 475 days, whereas for the retrievals after this period more sophisticated techniques including lasers, etc. were required. The maximal implant duration for series with 100% retrieval accounts for 84 days, which is equivalent to 12 weeks or almost 3 months. We conclude that retrievable caval filters often become permanent despite the initial decision of temporary use. However, such "forgotten" retrievable devices can still be removed with a great chance of success up to three months after implantation. Conventional percutaneous removal techniques may be sufficient up to sixteen months after implantation whereas more sophisticated catheter techniques have been shown to be successful up to 83 months or more than seven years of implant duration. Tilting, migrating, or misplaced devices should be removed early on, and replaced if indicated with a device which is both, efficient and retrievable

Atrial assist device, a new alternative to lifelong anticoagulation?

OBJECTIVE: Atrial fibrillation is a very common heart arrhythmia, associated with a five-fold increase in the risk of embolic strokes. Treatment strategies encompass palliative drugs or surgical procedures all of which can restore sinus rhythm. Unfortunately, atria often fail to recover their mechanical function and patients therefore require lifelong anticoagulation therapy. A motorless volume displacing device (Atripump) based on artificial muscle technology, positioned on the external surface of atrium could avoid the need of oral anticoagulation and its haemorrhagic complications. An animal study was conducted in order to assess the haemodynamic effects that such a pump could provide. METHODS: Atripump is a dome-shape siliconecoated nitinol actuator sewn on the external surface of the atrium. It is driven by a pacemaker-like control unit. Five non-anticoagulated sheep were selected for this experiment. The right atrium was surgically exposed, the device sutured and connected. Haemodynamic parameters and intracardiac ultrasound (ICUS) data were recorded in each animal and under three conditions; baseline; atrial fibrillation (AF); atripump assisted AF (aaAF). RESULTS: In two animals, after 20 min of AF, small thrombi appeared in the right atrial appendix and were washed out once the pump was turned on. Assistance also enhanced atrial ejection fraction. 31% baseline; 5% during AF; 20% under aaAF. Right atrial systolic surfaces (cm2) were; 5.2 +/- 0.3 baseline; 6.2 +/- 0.1 AF; 5.4 +/- 0.3 aaAF. CONCLUSION: This compact and reliable pump seems to restore the atrial "kick" and prevents embolic events. It could avoid long-term anticoagulation therapy and open new hopes in the care of end-stage heart failure

Effects of PDE-5 Inhibition on the Cardiopulmonary System After 2 or 4 Weeks of Chronic Hypoxia.

In pulmonary hypertension (PH), hypoxia represents both an outcome and a cause of exacerbation. We addressed the question whether hypoxia adaptation might affect the mechanisms underlying PH alleviation through phosphodiesterase-5 (PDE5) inhibition. Eight-week-old male Sprague-Dawley rats were divided into two groups depending on treatment (placebo or sildenafil, a drug inhibiting PDE5) and were exposed to hypoxia (10% O <sub>2</sub> ) for 0 (t0, n = 9/10), 2 (t2, n = 5/5) or 4 (t4, n = 5/5) weeks. The rats were treated (0.3 mL i.p.) with either saline or sildenafil (1.4 mg/Kg per day). Two-week hypoxia changed the body weight (- 31% vs. - 27%, respectively, P = NS), blood hemoglobin (+ 25% vs. + 27%, P = NS) and nitrates+nitrites (+ 175% vs. + 261%, P = 0.007), right ventricle fibrosis (+ 814% vs. + 317%, P < 0.0001), right ventricle hypertrophy (+ 84% vs. + 49%, P = 0.007) and systolic pressure (+ 108% vs. + 41%, P = 0.001), pulmonary vessel density (+ 61% vs. + 46%, P = NS), and the frequency of small (< 50 µm wall thickness) vessels (+ 35% vs. + 13%, P = 0.0001). Most of these changes were maintained for 4-week hypoxia, except blood hemoglobin and right ventricle hypertrophy that continued increasing (+ 52% vs. + 42%, P = NS; and + 104% vs. + 83%, P = 0.04). To further assess these observations, small vessel frequency was found to be linearly related with the right ventricle-developed pressure independent of hypoxia duration. Thus, although hypoxia adaptation is not yet accomplished after 4 weeks, PH alleviation by PDE5 inhibition might nevertheless provide an efficient strategy for the management of this disease