Catheter-based closure of residual leaks after percutaneous occlusion of the left atrial appendage.

INTRODUCTION: The purpose of this study was to evaluate safety and efficacy of catheter-based occlusion of residual leaks after percutaneous closure of the left atrial appendage (LAA). METHODS: All cases of LAA closure at our center were reviewed to identify secondary interventions for residual leaks. Leaks with a width of more than 3 mm by transesophageal echocardiography (TEE) were considered relevant. In a case-specific approach, depending on the respective morphology of the defect, either an LAA occlusion device or an Amplatzer Vascular Plug was implanted under TEE and fluoroscopic guidance. RESULTS: Between June 2003 and December 2013, 12 patients underwent residual leak closure. All procedures were technically successful and without complications. In 10 cases (83%), complete sealing was confirmed at TEE follow-up. In 2 patients, minimal gaps (2-3 mm) persisted and anticoagulation was continued. None of the patients had strokes during the follow-up period. CONCLUSION: Percutaneous residual leak closure after attempted LAA occlusion can be done safely and with high procedural success rates. © 2015 Wiley Periodicals, Inc.

Left atrial appendage closure: First in man with the 4th generation WATCHMAN device.

OBJECTIVES: To evaluate the feasibility and safety of the fourth generation WATCHMAN device. BACKGROUND: The WATCHMAN left atrial appendage (LAA) closure device has been shown to be non-inferior to conventional oral anticoagulation with warfarin for stroke prevention in patients with non-valvular atrial fibrillation. A new (fourth) generation of the WATCHMAN device was designed to facilitate easier delivery and improve safety. METHODS: We conducted a prospective, non-randomized study of LAA closure with use of the 4(th) generation WATCHMAN device in 36 patients with non-valvular atrial fibrillation. Follow-up was performed at 45 days, 6 months and 12 months following implantation. RESULTS: The mean age of the population was 73 ± 6 years and 67% were male. The mean CHADS2 and CHA2 DS2-VASc Score were 2.5 and 4.5, respectively. The device was implanted successfully in 34/36 (94%). No serious hospital complications related to the device or procedure occurred. During 12 month follow-up, three ischemic strokes (8%), one hemorrhagic stroke (3%), one TIA (3%) and three deaths (9%) occurred. Device-associated thrombus formation was detected in one patient (3%) during six-month follow-up and was treated successfully with low molecular weight heparin. CONCLUSIONS: LAA closure with the 4(th) generation WATCHMAN device is feasible and safe. New technical features may contribute to a better performance of the occluder, particularly regarding the risk of pericardial effusions.

Predictors of blood pressure response: Obesity is associated with a less pronounced treatment response after renal denervation.

OBJECTIVES: The purpose of this study was to identify predictors of BP response. BACKGROUND: Catheter-based renal denervation (RDN) causes significant blood pressure (BP) reductions in a large number of patients with resistant hypertension. METHODS: One hundred one consecutive patients with resistant hypertension who underwent RDN with the Symplicity™ catheter were included in this retrospective study. Primary endpoint was the change in office systolic BP after 6 months. Uni- and multivariate logistic regression analyses were performed to detect baseline predictors of a significant BP response 6 months after RDN (age, gender, office and ambulatory BP, renal function, body mass index [BMI], diabetes mellitus, antihypertensive medication, number of ablations). RESULTS: The procedure was technically uneventful in all patients. Mean BP at baseline was 166.6/90.2 ± 22.5/16.4 mmHg and decreased by -14.7 (P < 0.0001)/-5.3 (P < 0.001) ± 22.8/14.1 mm Hg at 6-month follow-up. Similarly, paired analysis of 24-hr-ambulatory BP measurement (n = 71) showed a significant reduction of mean systolic BP by 6.8 ± 14.4 mm Hg (P < 0.0002). Upon univariate analyses, a higher baseline office systolic BP (P < 0.0001) and lower BMI (P = 0.014) were identified as significant predictors of the magnitude of BP response after 6 months. Importantly, on multivariate analysis, baseline office systolic BP (standardized ß = -0.46; r = -0.47; P < 0.0001) and BMI (standardized ß = 0.21; r = 0.95; P = 0.019) remained significant. CONCLUSION: Blood pressure reductions after RDN were more pronounced in patients with higher baseline blood pressure and lower BMI. These findings may have implications regarding patient selection for renal denervation. © 2015 Wiley Periodicals, Inc.

Efficacy and safety of renal denervation in elderly patients with resistant hypertension.

BACKGROUND: Catheter-based renal sympathetic denervation (RD) causes significant blood pressure (BP) reductions in patients with resistant hypertension (rHTN). However, hypertensive elderly patients reportedly have a lower sympathetic tone than younger patients and a BP lowering effect of RD in this population has not yet been demonstrated. The purpose of this study was to assess the efficacy and safety of RD in elderly patients. METHODS: We reviewed all consecutive patients aged ≥ 75 years (mean: 78 years) with rHTN treated with RD. Twenty-four patients were included in this prospective study. Office and ambulatory BPs were assessed at baseline and 6-months follow-up. Primary endpoint was the change in office systolic BP at 6 months. RESULTS: Baseline mean office BP was 173/86 ± 21/13 mm Hg. Baseline 24-hr mean ambulatory BP, available in 22 patients, was 158/80 ± 20/13 mm Hg. Baseline creatinine was 1.0 ± 0.18 mg/dl and mean number of antihypertensive agents at baseline 4.3 ± 1.4. No device- or procedure-related adverse events occurred. At 6-months follow-up, the mean office BP decreased by 19/11 ± 29/16 mm Hg (P < 0.01 compared to baseline). Mean systolic 24 hr ambulatory BP, available in 17 patients, decreased by 9/5 ± 13/13 mm Hg. Antihypertensive medications could be reduced in nine patients. Furthermore, renal function was not impaired. CONCLUSION: According to our findings, a similar magnitude of BP reduction as reported in previous trials can be expected in elderly patients. Elderly patients with rHTN should not be excluded from renal denervation.

Transcatheter patch closure of an atrial septal defect of sinus venosus type using the immediate release patch.

Following promising preclinical studies, we report our first clinical experience with transcatheter closure of an atrial septal defect of sinus venosus type in a 65-year-old patient using the Immediate Release Patch.

Left atrial appendage closure using the Amulet device: an initial experience with the second generation amplatzer cardiac plug.

OBJECTIVES: Aim of this study was to demonstrate the feasibility, safety, and short-term outcome of left atrial appendage (LAA) closure with a new generation LAA closure device. BACKGROUND: The Amulet device (AGA, St Jude Medical, Minneapolis, MN) is a new generation of the amplatzer cardiac plug (ACP), specifically designed for LAA closure. This new version is designed to facilitate the implantation process and minimize procedural or device-related complications. METHODS: The device was implanted in 17 patients with nonvalvular atrial fibrillation (AF). Clinical data were obtained at baseline, during the procedure, at discharge, at 30 and 90 days. RESULTS: All devices were implanted successfully. Device sizes ranged from 20 mm to 31 mm. A 12 French (Fr) or 14 Fr delivery sheath was used depending on the selected device size. Full and partial recapture was performed in 1 case and 3 cases, respectively. There was 1 procedure-related pericardial effusion successfully managed with pericardiocentesis. There was no device embolization. The mean length of stay was 2.1 ± 0.3 days. At 90 days, there were no deaths, strokes, systemic thromboembolism, or bleeding complications. There was no device-related thrombus or pericardial effusion at 90-day TEE. In 2 of the 17 patients minimal peridevice flow (smaller than 2 mm) was present. CONCLUSIONS: The Amulet device, which has new novel features as compared with the first generation ACP, is a feasible option for LAA closure. From our initial experience, implantation of the Amulet is associated with high success rate and good short-term outcome.

"A bend in time": Shaping the sheath facilitates left atrial appendage closure.

OBJECTIVES: The purpose of this study is to determine feasibility, safety, and effectiveness of the "shape-the-sheath" method in left atrial appendage closure. BACKGROUND: LAA occlusion is often a difficult procedure, due to not just the learning curve but also the three-dimensional variable nature of the left atrial appendage. Multiple sheaths have been created for various takeoffs. The purpose of this article is to show the feasibility of the "shape-the-sheath" method in left atrial appendage closure. METHODS: Ten consecutive patients undergoing LAA occlusion without the "shape-the-sheath" method were compared to 10 consecutive patients undergoing LAA occlusion with the "shape-the-sheath" method using the Amplatzer Cardiac Plug (ACP) system and the Amplatzer TorqVue 45×45 sheath. RESULTS: The "shape-the-sheath" method resulted in significant decreases in fluoroscopy time (7.2±3.0 min vs. 13.7±6.7 min, P<0.05), number of partial recaptures (0% vs. 50%, P<0.05), with a trend toward decrease in the number of complete recaptures (0 vs. 40%, P=0.09) compared to conventional sheath use. CONCLUSIONS: Shaping-the-sheath is a simple, elegant way to help conform delivery systems to better access the LAA and ensure stable position. Further experience with this procedure optimization step is warranted.

Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack.

BACKGROUND: Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device. METHODS: Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed. RESULTS: The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation. CONCLUSION: In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure.

Use of EchoNavigator, a novel echocardiography-fluoroscopy overlay system, for transseptal puncture and left atrial appendage occlusion.

Structural heart disease requires a coordinated effort to join echocardiographic and fluoroscopic data. Various methods have been used, including echocardiography, CT, and MRI. We report on the use of EchoNavigator (Philips Inc., Amsterdam, Netherlands), a novel echocardiographic-fluoroscopic fusion system. This new system allows real-time integration and marking of important structures that track on fluoroscopy even with movement of the C-arm. In this article, we describe potential uses for this system in respect to transseptal puncture and left atrial appendage closure.

Safety of transcatheter aortic valve implantation in a hospital with visiting on-site cardiac surgery.

OBJECTIVES: To describe the feasibility and safety of transcatheter aortic valve implantation (TAVI) with a visiting on-site cardiac surgery program for surgical back-up. BACKGROUND: Both European and American guidelines recommend institutional cardiac surgery back-up for TAVI. However, the conversion to cardiac surgery is very rare, many complications of TAVI can be managed by catheter techniques and a visiting team can also provide surgical stand-by. Therefore, the need for institutional cardiac surgery (by a surgeon who routinely performs conventional surgical valve replacement at the institution performing TAVI) has been questioned. METHODS: A retrospective review of consecutive TAVI cases with visiting on-site cardiac surgery was performed. Key demographic, echocardiographic, and procedural data were collected prospectively. RESULTS: A total of 97 patients (81.9 ± 6.3 years) with high-risk criteria (log Euroscore 21.6 ± 14.4, chronic renal failure 39.2%, severe systolic dysfunction 24.7%) underwent TAVI with visiting on-site cardiac surgery at our institution. Local anesthesia with or without conscious sedation was used in 94.8% of patients. Procedural technical success was 100%, with 2 episodes of tamponade (both treated with pericardiocentesis) and a 16.5% vascular complication rate (all treated conservatively or percutaneously). Thirty-day mortality was 3.1%, with 5.2% rate of stroke and 8.2% rate of major bleeding. There were no conversions to surgery. CONCLUSIONS: TAVI can be done safely in the setting of a hospital with visiting on-site cardiac surgery. This requires careful patient selection, experienced operators and surgeons in experienced centers with well-established criteria and processes of care. In this setting, it may be an option for hospitals without institutional cardiac surgery.

Devices in heart failure--the new revolution.

Heart failure is a growing epidemic, with more patients living longer and suffering from this disease. There is a growing segment of patients who have persistent symptoms despite pharmacologic therapy. In an era when transplants are rare, the need for devices and interventions that can assist ventricular function is paramount. This review goes through the devices used in heart failure, including left ventricular reconstruction, aortic counterpulsation, short-term mechanical circulatory support, long-term mechanical circulatory support, and right heart interventions.

Results of percutaneous closure of patent foramen ovale with the GORE(®) septal occluder.

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of the GORE(®) Septal Occluder (GSO) at 1-, 6-, and 12-month follow-up in patients with a clinical indication for patent foramen ovale (PFO) closure. BACKGROUND: Limited data are available regarding the safety and efficacy of the GSO for PFO closure. METHODS: Sixty consecutive patients with an embolic event, migraine, or risk of decompression sickness were enrolled. Transesophageal or transthoracic echocardiography and clinical follow-up were performed at 1, 6 and 12 months after implantation. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. RESULTS: Procedures were technically successful in 98.3% (59/60). In one case, the anterior interatrial septal rim proved too short to allow safe GSO implantation and, instead, a different occluder was implanted. One patient developed transient neurological symptoms during the procedure without evidence for a stroke by magnetic resonance imaging. At 6-month follow-up, the closure rate was 86.6% (52/60). The complete closure rate after 1 year was 93.3% (56/60). Stroke, thrombus formation and atrial fibrillation (AF)/flutter occurred in 1 (1.7%), 1 (1.7%), and 5 (8.3%) patients, respectively. CONCLUSION: PFO closure with the GSO is accompanied by a high technical success rate and closure rates similar to other currently used devices. The incidence of AF was higher than reported with most other devices. This may be a chance finding but warrants further investigation in larger trials.

Paravalvular leak closure after transcatheter aortic valve replacement with a self-expanding prosthesis.

INTRODUCTION: Paravalvular leak (PVL) after percutaneous transcatheter aortic valve replacement (TAVR) is associated with significant morbidity and mortality. Percutaneous PVL closure has been reported for balloon-expandable valves but not self-expandable valves. METHODS: We conducted a review of cases at our center where patients who received TAVR with self-expandable valves and went on to develop severe PVL underwent percutaneous closure. Baseline demographic, TAVR procedural, PVL procedural, and follow-up data were collected. RESULTS: A total of five patients with severe PVL after TAVR with a self-expanding valve underwent percutaneous PVL closure. Four of five patients had a trial of balloon postdilatation after valve deployment and had significant persistent PVL. In all five patients, PVL went from moderate-severe to mild-moderate PVL. There were no adverse events. CONCLUSION: Percutaneous PVL closure for severe PVL self-expanding valve for TAVR is a safe and efficacious procedure. Procedural technique involves transesophageal guidance, a high approach through the valve struts, deployment of an appropriate size device, and careful monitoring. This method may be part of the algorithm for severe PVL after TAVR.

Safety of percutaneous left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation.

OBJECTIVE: To evaluate the safety of percutaneous left atrial appendage (LAA) closure with the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (AF) who are not eligible for oral anticoagulation with warfarin. BACKGROUND: Anticoagulation is the treatment of choice for prevention of strokes in patients with AF, but some patients have contraindications to anticoagulation. METHODS: A total of 60 patients with a CHA2 DS2 -VASc score of at least 1 and contraindications to warfarin who underwent percutaneous LAA closure with the ACP were included. Stroke risk assessment was performed with the CHADS2 and CHA2 DS2 -VASc score and the bleeding risk was calculated with the HAS-BLED-score. Follow-up included office visits, telephone inquiries, and mail contact. RESULTS: Mean CHADS2 -, CHA2 DS2 -VASc-, and HAS-BLED scores were 2.6 (± 1.4), 4.3 (± 1.7), and 3.3 (± 1.0), respectively. Twenty-five percent had a history of previous bleeding without oral anticoagulation and 63.3% while receiving oral anticoagulation. In 36.7% other contraindications to warfarin were present. Procedural success was achieved in 95%. Mean follow-up time was 1.8 (1.0-2.8) years. The estimated annual stroke risk based on the CHADS2 -score was 5.8%. The estimated annual bleeding risk on warfarin based on the HAS-BLED score was 3.7%. During follow-up, the annual incidence of stroke was 0%. Major bleeding complications occurred in 1.9% annually. CONCLUSIONS: Percutaneous LAA closure with the ACP in patients with contraindications to oral anticoagulation is safe. The stroke and bleeding risk after percutaneous LAA closure is lower than predicted by conventional risk scores.

Left atrial appendage occlusion in octogenarians: short-term and 1-year follow-up.

OBJECTIVES: To determine the procedural safety, safety, and efficacy of left atrial appendage (LAA) occlusion in octogenarians. BACKGROUND: Elderly patients with atrial fibrillation (AF) often do not receive appropriate anticoagulation. LAA occlusion is an option for patients with AF and contraindications to anticoagulation. Not much is known about the procedural safety and clinical efficacy of LAA occlusion in the very elderly. METHODS: A retrospective review of LAA cases at our institution between 2002 and 2013 in patients 80 years of age or older was performed. Demographic, echocardiographic, procedural, and clinical follow-up data were collected. RESULTS: Seventy-five cases were attempted in patients 80 years of age or older (average age 83.4 ± 2.8 years, 53.3% males). Hypertension, coronary artery disease, and heart failure were present in 96, 41.3, and 36%, respectively. Mean CHADS2 and CHA2DS-VASc scores were 3.3 and 5.2. Devices used included the WATCHMAN, ACP, PLAATO, Lariat, and Coherex devices, which were attempted in 34.7, 36, 17.3, 5.3, and 5.3%, respectively. Overall procedural success, safety endpoint, and 1-year device efficacy was 90.1, 3.9, and 97.4%, respectively. CONCLUSION: LAA closure is a safe and efficacious method of stroke prevention in the very elderly with AF.

Predictors for prolonged hospital stay after transcatheter mitral valve repair with the MitraClip.

OBJECTIVE: The aim is to find predictors for a prolonged LOHS after MitraClip implantation. BACKGROUND: Due to its less invasive nature, average length of hospital stay (LOHS) after the MitraClip procedure is shorter compared to mitral valve surgery. However, some patients have a prolonged LOHS. METHODS: Records of consecutive patients who underwent MitraClip procedure were reviewed. A total of 41 consecutive patients with MitraClip implantation (76 ± 9 years, 59% men) were included. Median hospital stay was 7 days. Hospitalization lasting longer than 7 days was considered prolonged. RESULTS: Procedural success was achieved in 88% of the cases. In-hospital death occurred in 4 of 41 patients (10%). Patients with a prolonged hospital stay (46%) had a higher EuroSCORE I (22.7% [IQR 10.3-28.3] vs. 6.7% [IQR 3.5-18.3], P = 0.017), a higher STS mortality score (6.1%[(IQR 3.7-7.5] vs. 2.6% [IQR 1.4-4.8]; P = 0.043) and a higher STS long-length-of-stay score (18.9% [IQR 11.3-22.5] vs. 9.6% [IQR 6.2-16.1]; P = 0.039) as well as a lower estimated glomerular filtration rate (eGFR) (41 ml/min/1.73 m(2) [IQR 19-52] vs. 56 ml/min/1.73 m(2) [IQR 49-62]; P = 0.008) than those whose did not. In the multivariate model, lower eGFR was identified as predictor for a prolonged hospitalization. CONCLUSION: Lower pre-procedure eGFR is independently associated with a longer hospitalization.

Leaving no hole unclosed: left atrial appendage occlusion in patients having closure of patent foramen ovale or atrial septal defect.

OBJECTIVES: To report procedural outcome of sequential occlusion of the left atrial appendage (LAA) and an interatrial septal communication and discuss possible indications. BACKGROUND: There are some patients who may have indications for both closure of patent foramen ovale (PFO) or atrial septal defect (ASD), as well as closure of the LAA. The optimal procedural strategy is not known. METHODS: A retrospective review of LAA and PFO/ASD cases at our center was performed. Demographic, echocardiographic, and procedural data were recorded. RESULTS: Closure of LAA and then PFO/ASD (Group I: 11 patients), closure of both in the same setting (Group II: 3 patients), and closure of the PFO/ASD and then the LAA (Group III: 3 patients) was performed in a total of 17 patients. Average age was 63.5 ± 9.8 years. Most patients were hypertensive with prior cerebrovascular event in 52.9% of patients. Procedural success was 100%. Procedural adverse events were 2 episodes of tamponade (in Group I after first LAA procedure) treated with pericardiocentesis and 1 access-site hematoma (Group II) treated conservatively. CONCLUSIONS: Sequential (staged or during the same procedure) closure of the LAA and interatrial communications can be performed safely in a carefully selected patient population. This is also the first known report of LAA occlusion in patients with prior septal closure devices.

Change in mitral annular size and geometry after MitraClip® implantation in patients with functional and degenerative mitral regurgitation.

BACKGROUND: MitraClip® therapy is an alternative to conventional surgery. The aim was to characterize the mitral annular geometry pre- and postrepair with the MitraClip® taking into account the regurgitation mechanism. METHODS: We retrospectively collected pre- and postprocedural transesophageal echocardiography data in 46 patients. Patients were categorized as having isolated degenerative (DMR, n = 18), isolated functional (FMR, n = 9) or a combination of both functional and degenerative mitral regurgitation (MMR, n = 19). RESULTS: A significant reduction in septolateral (SL) diameters in all patients occurred. Noteworthy, in those with DMR, there was no significant change in intercommissural (IC) diameters whereas in those with FMR and MMR, it increased significantly in systole (FMR: +2.8 ± 3.4 mm, P = 0.03, MMR: +2.1 ± 2.6 mm, P = 0.002). In DMR, a significant reduction in mitral annular areas post-procedure was observed (-1.8 ± 2.3 cm(2), P = 0.001 in diast., -0.8 ± 1.0 cm(2), P = 0.004 in syst.). In patients with FMR and MMR, though the SL diameter decreased, this occurred at the expense of an increase in IC diameter causing a change in annular shape but leaving the annular area unchanged. Nevertheless, a comparable reduction in regurgitant severity (DMR: P = <0.001; FMR: P = 0.003; MMR: P = <0.001) and improvement in functional class occurred regardless of regurgitant mechanism. CONCLUSIONS: Though changes in mitral annular geometry after MitraClip® repair differ depending on regurgitant mechanism, this does not appear to have an impact on residual regurgitation or clinical status in the short-term.

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.

Renal sympathetic denervation as second-line therapy in mild resistant hypertension: a pilot study.

BACKGROUND: Catheter-based renal sympathetic denervation (CRD) is associated with significant blood pressure (BP) reductions in patients with severe therapy-resistant hypertension (office systolic BP ≥ 160 mm Hg or ≥ 150 mm Hg in diabetic patients). Effects of renal denervation on BP in patients with milder forms of therapy-resistant hypertension have not been examined. We sought to investigate the feasibility, safety, and effectiveness of CRD in patients with longstanding mild hypertension despite treatment with ≥ 3 antihypertensive drugs. METHODS: Consecutive patients with office systolic BPs of 140-160 mm Hg despite ≥ 3 antihypertensive medications treated with CRD were included in this prospective study. Procedural safety and adverse events during follow-up were assessed. Clinical evaluations were performed at baseline, 3, and 6 months to determine changes in office systolic BPs, 24-hr ambulatory BPs, and medication doses. RESULTS: Twenty patients (mean age 60.6 ± 10.8 years; 45% female) treated with an average of 5.4 ± 1.5 antihypertensive drugs were treated with CRD. The procedure was successful in all patients. There were no procedure- or device-related complications. BP at baseline was 148.4/83.0 ± 6.6/11.0 mm Hg and decreased by 5.7/0.6 ± 20.0/8.3 mm Hg (P = 0.2) and 13.1/5.0 ± 13.6/8.3 mm Hg (P < 0.01) at 3 and 6 months, respectively. Comparing baseline and 6-month follow-up, mean ambulatory 24 hr-BP was reduced by 11.3/4.1 ± 8.6/7.3 mm Hg (P < 0.01). Four patients were able to reduce antihypertensive medications prior to their 3-month visit. CONCLUSION: As in patients with severe treatment-resistant hypertension, CRD is a safe and effective treatment for patients with milder drug-resistant hypertension.