Nina Wunderlich

Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial.

BACKGROUND Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of catheter-based renal denervation for reduction of blood pressure in patients with treatment-resistant hypertension. METHODS In this multicentre, prospective, randomised trial, patients who had a baseline systolic blood pressure of 160 mm Hg or more (≥150 mm Hg for patients with type 2 diabetes), despite taking three or more antihypertensive drugs, were randomly allocated in a one-to-one ratio to undergo renal denervation with previous treatment or to maintain previous treatment alone (control group) at 24 participating centres. Randomisation was done with sealed envelopes. Data analysers were not masked to treatment assignment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Primary analysis included all patients remaining in follow-up at 6 months. This trial is registered with ClinicalTrials.gov, number NCT00888433. FINDINGS 106 (56%) of 190 patients screened for eligibility were randomly allocated to renal denervation (n=52) or control (n=54) groups between June 9, 2009, and Jan 15, 2010. 49 (94%) of 52 patients who underwent renal denervation and 51 (94%) of 54 controls were assessed for the primary endpoint at 6 months. Office-based blood pressure measurements in the renal denervation group reduced by 32/12 mm Hg (SD 23/11, baseline of 178/96 mm Hg, p<0·0001), whereas they did not differ from baseline in the control group (change of 1/0 mm Hg [21/10], baseline of 178/97 mm Hg, p=0·77 systolic and p=0·83 diastolic). Between-group differences in blood pressure at 6 months were 33/11 mm Hg (p<0·0001). At 6 months, 41 (84%) of 49 patients who underwent renal denervation had a reduction in systolic blood pressure of 10 mm Hg or more, compared with 18 (35%) of 51 controls (p<0·0001). We noted no serious procedure-related or device-related complications and occurrence of adverse events did not differ between groups; one patient who had renal denervation had possible progression of an underlying atherosclerotic lesion, but required no treatment. INTERPRETATION Catheter-based renal denervation can safely be used to substantially reduce blood pressure in treatment-resistant hypertensive patients. FUNDING Ardian.

Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder).

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3+/-1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder.

Long-term results of a randomized trial comparing three different devices for percutaneous closure of a patent foramen ovale

AIMS Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices. METHODS AND RESULTS Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death). CONCLUSION Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.

New onset atrial fibrillation after patent foramen ovale closure.

Objectives: In this study, we evaluated the incidence of new onset atrial fibrillation (symptomatic or detected by routine ECG) after patent foramen ovale (PFO‐) closure. Background: Although atrial fibrillation is known to occur in some patients following patent foramen ovale closure, the incidence and the risk associated with each device is not well known. Methods: We evaluated 1,349 consecutive patients who underwent PFO closure with an approved device and examined the incidence and risk factors associated with the development of atrial fibrillation. The patients had a mean age of 50 years and underwent PFO closure for cerebrovascular accident in 696 (51.6%), transient ischemic attack in 610 (45.2%), paradoxical embolism in 22 (1.6%), decompression sickness in 13 (0.9%), and other reasons including migraine headaches in 6 (0.4%) of cases. Results: Over a mean follow‐up period of 38.1 ± 28 months, 53 (3.9%) patients developed new onset atrial fibrillation, which is higher compared with an age‐matched population. Of these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6 months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty (56.6%) patients developed chronic atrial fibrillation. On multivariate analysis, advanced age and use of the STARFlex device predicted atrial fibrillation. Conclusions: The number of patients in whom atrial fibrillation was detected was relatively low. It is often a self‐limited complication of PFO closure that may occur more frequently in elderly patients and those treated with the STARFlex device.

Percutaneous left ventricular partitioning in patients with chronic heart failure and a prior anterior myocardial infarction: Results of the PercutAneous Ventricular RestorAtion in Chronic Heart failUre PaTiEnts Trial

OBJECTIVES The aim of this study was to assess the feasibility, safety, and preliminary efficacy of a novel percutaneous left ventricular partitioning device (VPD) in patients with chronic heart failure (HF) and a prior anterior myocardial infarction. BACKGROUND Anterior myocardial infarction is frequently followed by left ventricular remodeling, HF, and increased long-term morbidity and mortality. METHODS Thirty-nine patients were enrolled in a multinational, nonrandomized, longitudinal investigation. The primary end point was an assessment of safety, defined as the successful delivery and deployment of the VPD and absence of device-related major adverse cardiac events over 6 months. Secondary (exploratory) efficacy end points included changes in hemodynamics and functional status and were assessed serially throughout the study. RESULTS Ventricular partitioning device placement was not attempted in 5 (13%) of 39 subjects. The device was safely and successfully implanted in 31 (91%) of the remaining 34 patients or 79% of all enrolled patients. The 6-month rate of device-related major adverse cardiac event occurred in 5 (13%) of 39 enrolled subjects and 5 (15%) of 34 treated subjects, with 1 additional event occurring between 6 and 12 months. For patients discharged with the device to 12 months (n = 28), New York Heart Association class (2.5 ± 0.6 to 1.3 ± 0.6, P < .001) and quality-of-life scores (38.6 ± 6.1 to 28.4 ± 4.4, P < .002) improved significantly; however, the 6-minute hall walk distance (358.5 ± 20.4 m to 374.7 ± 25.6 m, P nonsignificant) only trended toward improvement. CONCLUSIONS The left VPD appears to be relatively safe and potentially effective in the treatment for patients with HF and a prior anterior myocardial infarction. However, these limited results suggest the need for further evaluation in a larger randomized controlled trial.

Transcatheter Closure of Patent Foramen Ovale Without an Implant: Initial Clinical Experience

Background— Currently available catheter techniques for closure of a patent foramen ovale (PFO) rely on the placement of an implantable closure device. The objective of the Paradigm I study was to evaluate the safety and feasibility of transcatheter closure of PFO using radiofrequency energy without an implanted device in patients with cryptogenic stroke or transient ischemic attack. Methods and Results— Thirty patients were enrolled (15 females; mean age 48 years). Mean PFO size was 8.5±2.7 mm. Technical success (ie, successful application of radiofrequency energy) was achieved in 27 patients. The remaining 3 patients received an implantable closure device. All 30 patients were free from serious procedure-related adverse events. No recurrent strokes, deaths, or perforations occurred as a result of the procedure. The mean follow-up was 6 months, and 13 (43%) of the 30 patients experienced PFO closure after the first procedure. Nine of the patients whose PFOs remained patent after the first procedure elected to receive a second procedure using radiofrequency. The PFO was closed for 6 of those patients after the second procedure, which resulted in a secondary closure rate of 63%. Conclusions— This study demonstrates that transcatheter closure of an intracardiac defect without a permanent implant is technically feasible. Achievement of improved primary closure rates through technique and device modifications will warrant randomized clinical comparison to permanently implanted devices.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis.

The use of imaging in new transcatheter interventions: an EACVI review paper

Transcatheter therapies for the treatment of valve heart diseases have expanded dramatically over the last years. The new developments and improvements in devices and techniques, along with the increasing expertise of operators, have turned the catheter-based approaches for valvular disease into an established treatment option. Various imaging techniques are used during these procedures, but echocardiography plays an essential role during patient selection, intra-procedural monitoring, and post-procedure follow-up. The echocardiographic assessment of patients undergoing transcatheter interventions places demands on echocardiographers that differ from those of the routine evaluation of patients with valve disease, and there is a need for specific expertise for those working in the cath lab. In the context of the current rapid developments and growing use of transcatheter valve therapies, this document intends to update the previous recommendations and address new advancements in imaging, particularly for those involved in any stage of the treatment of patients with valvular heart diseases.

Percutaneous mitral valve repair with the MitraClip® system under deep sedation and local anaesthesia.

AIMS For appropriately selected patients with severe mitral regurgitation, percutaneous mitral valve repair with the MitraClip® system is a promising alternative to open chest surgery. The procedure requires transoesophageal echocardiographic guidance and is performed under general anaesthesia. However, many patients undergoing percutaneous repair are at high risk for complications related to anaesthesia. We report our initial experience in the use of the MitraClip® system under deep sedation and local anaesthesia in five consecutive cases. METHODS AND RESULTS Five patients (two male, three female), median age 79 years (range 71 to 88 years), four with moderate to severe mitral regurgitation suitable for percutaneous repair, underwent the MitraClip® procedure under local anaesthesia and deep sedation. All procedures were completed without general anaesthesia. All patients received 2 mg of midazolam, and propofol was administered according to response during the course of the procedure with 20-60 mg required per case. The median duration of the procedures was 88 (74 to 193) minutes, and the median duration of procedural TEE was 64 (59 to 193) minutes. Four of five procedures were carried out successfully. Three patients required one clip and one patient required two clips. In one patient, the clip was eventually withdrawn and not implanted because it did not lead to an adequate reduction of mitral insufficiency. CONCLUSIONS The implantation of a MitraClip® is feasible under local anaesthesia and sedation. In patients at high risk for complications related to general anaesthesia, percutaneous mitral valve repair under local anaesthesia may be a viable alternative.

Complications of Carotid Stenting During Live Transmissions

OBJECTIVES We sought to examine the acute and subacute results of carotid stenting performed during live transmissions. BACKGROUND Teaching courses focusing on live demonstrations of carotid interventions have been the key educational facility for physicians interested in learning state-of-the-art interventional techniques of carotid stenosis treatment. However, starting with the very first live demonstration of interventional procedures, there has been an ongoing discussion whether patients treated during live transmissions are at higher risk. METHODS Between March 1, 2001, and June 30, 2008, 186 high-grade lesions of the internal carotid artery in 186 patients have been treated by stent implantation during live transmissions to 22 interventional conferences at 3 high-volume centers. Technical success was defined as the ability to perform carotid stent implantation. The combined end point of death, major stroke, minor stroke, or myocardial infarction was defined as primary end point. RESULTS The procedure was technically successful in 185 of 186 (99.5%) interventions. Seventeen patients had 1 of the following acute in-hospital complications: major stroke in 2 (1.1%), minor stroke in 3 (1.6%), transient ischemic attack in 11 (5.9%), and amaurosis of the ipsilateral eye due to an occlusion of the retinal artery in 1 (0.5%). None of the patients died, and no myocardial infarctions occurred. The composite primary end point occurred in 6 (3.2%) patients. CONCLUSIONS In this consecutive series of carotid stent cases performed by expert operators during live demonstration courses, the procedural and 30-day clinical outcomes were similar to the results appearing in the contemporary published data.