The IrisFIT Patent Foramen Ovale Closure Device in Patients With History of Cryptogenic Embolization.

BACKGROUND: The aim of this study was to assess safety, efficacy, and clinical outcome of the IrisFIT PFO Closure System (Lifetech Scientific) for transcatheter closure of patent foramen ovale (PFO) in patients with a history of cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolization. PATIENTS AND METHODS: We report the results of 60 consecutive patients undergoing PFO closure with the IrisFIT occluder for secondary prevention of paradoxical embolization. All cases were analyzed for periprocedural and device-related adverse events up to 12 months after implantation. In addition, the patients were evaluated for complete defect closure with transesophageal echocardiography (TEE) after 1 month, 6 months, and (if indicated) 12 months. Mean patient age was 53 ± 14 years and 37 patients (62%) were males. All patients had a history of at least 1 cryptogenic stroke, TIA, or peripheral embolization. RESULTS: Technical success was achieved in all 60 procedures. The mean procedure time was 28 ± 11 minutes. There were no periprocedural or device-related complications up to 12 months after the implant. Successful defect closure at 6 months post device implantation was achieved in 56 cases (93.3%). Within 12 months of follow-up, 2 patients had recurrent TIAs, both with complete PFO sealing at the last TEE prior to the event. CONCLUSION: The IrisFIT PFO Closure System can be used safely and with high technical success for secondary prevention of cryptogenic stroke or peripheral embolization.

Acute Stroke Interventions Performed by Cardiologists: Initial Experience in a Single Center.

OBJECTIVES: The aim of this study was to evaluate the technical and clinical success of acute stroke interventions performed in our interventional cardiology center. BACKGROUND: Dedicated interventional stroke centers remain limited. Interventional cardiologists have established networks of catheterization laboratories and the necessary infrastructure to provide around the clock interventional therapy. These networks may also provide the currently lacking universal rapid access to prompt stroke intervention. METHODS: Between July 2012 and July 2018, 70 consecutive patients underwent acute stroke intervention for large-vessel occlusions. Seventeen patients (24%) had tandem or multiple vessel occlusions. The majority (n = 63, 90%) were admitted via our local stroke unit, and 7 (10%) patients were transferred from other regional referral centers. RESULTS: In 43 (61%) patients, systemic fibrinolytic therapy was started after baseline imaging. Mean time between symptom onset and arrival to the cath lab was 138 min; mean door-to-vascular access time was 64 min; mean time between cath lab activation and its operational readiness was 13 min. In all cases, access to supra-aortic vessels was achieved. Mean time between femoral arterial puncture and lesion crossing was 26 min. Stent implantation for extracranial stenosis or dissection was performed in 14 (20%) cases. Thrombectomy of intracranial occlusions was done with a stent retriever (n = 64, 91%) or an aspiration system (n = 14, 20%). In 20 (28%) cases, a combination of techniques was used. Recanalization was technically successful (Thrombolysis In Cerebral Infarction flow grade 2b or 3) in 65 (93%) patients. The 30-day mortality was 18% (n = 13). Favorable clinical outcome, defined as a modified Rankin Scale score of 0 to 2, was achieved in 61% at 3-month follow-up. CONCLUSIONS: Acute stroke interventions can be performed safely and with high technical and clinical success by experienced interventional cardiologists.

Outcomes of Veterans Undergoing TAVR Within Veterans Affairs Medical Centers: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program.

OBJECTIVES: This study sought to describe clinical and procedural characteristics of veterans undergoing transcatheter aortic valve replacement (TAVR) within U.S. Department of Veterans Affairs (VA) centers and to examine their association with short- and long-term mortality, length of stay (LOS), and rehospitalization within 30 days. BACKGROUND: Veterans with severe aortic stenosis frequently undergo TAVR at VA medical centers. METHODS: Consecutive veterans undergoing TAVR between 2012 and 2017 were included. Patient and procedural characteristics were obtained from the VA Clinical Assessment, Reporting, and Tracking system. The primary outcomes were 30-day and 1-year survival, LOS >6 days, and rehospitalization within 30 days. Logistic regression and Cox proportional hazards analyses were performed to evaluate the associations between pre-procedural characteristics and LOS and rehospitalization. RESULTS: Nine hundred fifty-nine veterans underwent TAVR at 8 VA centers during the study period, 860 (90%) by transfemoral access, 50 (5%) transapical, 36 (3.8%) transaxillary, and 3 (0.3%) transaortic. Men predominated (939 of 959 [98%]), with an average age of 78.1 years. There were 28 deaths within 30 days (2.9%) and 134 at 1 year (14.0%). Median LOS was 5 days, and 141 veterans were rehospitalized within 30 days (14.7%). Nonfemoral access (odds ratio: 1.74; 95% confidence interval [CI]: 1.10 to 2.74), heart failure (odds ratio: 2.51; 95% CI: 1.83 to 3.44), and atrial fibrillation (odds ratio: 1.40; 95% CI: 1.01 to 1.95) were associated with increased LOS. Atrial fibrillation was associated with 30-day rehospitalization (hazard ratio: 1.79; 95% CI: 1.22 to 2.63). CONCLUSIONS: Veterans undergoing TAVR at VA centers are predominantly elderly men with significant comorbidities. Clinical outcomes of mortality and rehospitalization at 30 days and 1-year mortality compare favorably with benchmark outcome data outside the VA.

Correction to: Percutaneous Creation of a Central Iliac Arteriovenous Anastomosis for the Treatment of Arterial Hypertension.

In the March 2018 issue of Current Hypertension Reports, the second author's name Nathan A. Sobotka was inadvertently left out of the byline. Also, the author names were changed from initials to spelled out. The corrected author list is given above. The original article has been corrected.

Percutaneous Creation of a Central Iliac Arteriovenous Anastomosis for the Treatment of Arterial Hypertension.

PURPOSE OF REVIEW: Provision of a summary on the physiologic effects of arteriovenous fistula creation and description of previously published human data on the efficacy of a percutaneously implanted device creating an arteriovenous fistula. Though antihypertensive therapy is effective, some patient's blood pressure remains poorly controlled despite adherence to optimal medical therapy. Moreover, some patients are not compliant with recommended medical therapy due to side effects or personal decision. This has prompted exploration of alternative, device-based antihypertensive therapies including, among others, the percutaneous creation of an arteriovenous fistula. An arteriovenous fistula is accompanied by a number of favorable physiologic changes that may lower blood pressure. These physiologic changes, conduction of the procedure, and previously published human experience are summarized in this review article. RECENT FINDINGS: The results of a recently published trial comparing arteriovenous fistula creation and standard antihypertensive therapy versus standard antihypertensive therapy alone are summarized. Creation of an arteriovenous fistula is accompanied by a significant blood pressure reduction likely related to a reduction in total arterial resistance, perhaps blood volume reduction, inhibition of the baroreceptor reflex, and release of natriuretic peptides. These findings foster further interest in studying the impact of an arteriovenous fistula and arterial blood pressure. The design of a large randomized trial comparing arteriovenous fistula creation to sham control is outlined.

Initial Experience Using the Gore Embolic Filter in Carotid Interventions.

BACKGROUND: This is the first clinical report on experience in the use of the Gore embolic filter in carotid interventions. It was designed as a guidewire and embolic protection system in carotid, peripheral, and coronary interventions. The ability to capture debris is driven by the frame of the filter, which is designed to improve vessel wall apposition and allows a short landing zone. METHODS: We report the results of the first 20 consecutive patients undergoing carotid artery stenting using the Gore embolic filter in our institution. We analyzed technical success as well as the occurrence of transient ischemic attack (TIA), stroke, or death periprocedurally and through 30 days of follow-up. Mean patient age was 72 years and 12 patients (60%) were male. Seven patients were symptomatic and 4 patients suffered recurrent neurological events. RESULTS: Technical success was achieved in all procedures. In 1 patient, the retrieval catheter was caught between the proximal struts of the stent and required further retrieval maneuvers. Within 30 days of follow-up, 1 patient had a TIA. No stroke, death, or myocardial infarction occurred. CONCLUSION: This initial experience suggests that the Gore embolic filter device can be used safely for distal embolic protection during carotid stenting procedures with high technical success.

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.

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.

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.

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.

Evaluation of proximal protection devices during carotid artery stenting as the first choice for embolic protection.

AIMS: To assess the use of proximal protection devices in consecutive patients as the preferred means of cerebral embolic protection for primary carotid stenting. METHODS AND RESULTS: This was a prospective single-centre study to evaluate the technical and clinical success of proximal protection devices as the first choice for embolic protection in symptomatic (≥50%) and asymptomatic (≥70%) carotid stenosis. Proximal protection devices were used for embolic protection in 124 consecutive patients. No patients were excluded for anatomical reasons. The GORE Flow Reversal System (W.L. Gore, Flagstaff, AZ, USA) was used in 92 patients, and the Mo.Ma Ultra device (Medtronic, Minneapolis, MN, USA) in 32 patients. Follow-up duration was 30 days. Mean age was 71±8 years. Seventy-five percent of patients were male (n=93). Twenty-six of 124 (21%) treated stenoses were symptomatic. Technical success was achieved in 122 of 124 cases (98%). Due to anatomical conditions, in two patients flow reversal could not be established. In both cases additional distal filter devices were used. Carotid stenting was successful in 124 lesions (100%). Ten patients (8.1%) had contraindications to flow reversal (three high-grade ostial stenoses of the external carotid artery, seven contralateral occlusions of the internal carotid artery) in none of whom complications occurred. There were no procedural neurologic events. Within 30 days of follow-up, one patient had an ischaemic stroke (on day 11). CONCLUSIONS: Proximal protection is a safe method as the first choice for embolic protection. It can be used with a high rate of technical success.

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.

Renal denervation.

Severe hypertension, resistant to conventional antihypertensive medications, is associated with major adverse cardiovascular and cerebrovascular events and renal insufficiency. Renal sympathetic nerve over-activity frequently accompanies essential hypertension. Catheter-based renal sympathetic denervation leads to a reduction in renal and overall sympathetic nerve activity and improvement in blood pressure in the setting of severe resistant hypertension. In the following, we review the role of the renal sympathetic nervous system in blood pressure control and recent clinical experience with renal denervation. Furthermore, potential beneficial effects on diabetes control, obstructive sleep apnea, atrial and ventricular arrhythmias are discussed.

Long-term results after carotid stent implantation.

BACKGROUND: Though carotid artery stenting (CS) has gained popularity as an alternative to carotid endarterectomy, studies examining long-term results are limited. METHODS: All consecutive patients who underwent unilateral CS between 7/1993 and 8/2005 with no or non-significant contralateral stenosis were included. Follow-up with duplex sonography and/or angiography and neurological assessment was performed at 6 and/or 12 months. Thereafter, annually, a questionnaire was sent to the patients and their referring physicians. RESULTS: Two-hundred and seventy-nine patients underwent CS. In 99% of procedures stent delivery was successful. The periprocedural major and minor stroke rates were 2.2%, respectively. The periprocedural major stroke or death rate was 2.9%. Median clinical follow-up was 49 ± 32 months (range: 30 days-12.1 years). Excluding perioperative (<30 days) events, the annual major and minor stroke rate was 1.3% and the annual ipsilateral major and minor stroke rate was 0.6%. In symptomatic and asymptomatic patients, the annual major and minor stroke rates were 2.2% and 0.8%, respectively, and the ipsilateral major and minor stroke rates were 1.1% and 0.3%, respectively. There was no significant difference between ipsilateral and contralateral major or minor strokes at long-term follow-up. At last sonographic follow-up (median 36 ± 32 months), restenosis rates for symptomatic and asymptomatic stenoses were 5% and 3%, respectively. CONCLUSION: The results of our study demonstrate very low long-term cerebral event rates after CS supporting the long-term safety of CS. Importantly, there was no significant difference in long-term ipsilateral versus contralateral cerebral events lending support to the hypothesis of plaque stabilization.

Mechanical antithrombotic intervention by LAA occlusion in atrial fibrillation.

Stroke in patients with atrial fibrillation (AF) is often associated with substantial morbidity and mortality. Oral anticoagulation remains the first-line approach to stroke prevention in such individuals; however, for a considerable proportion of patients, traditional treatment using warfarin is limited by a number of factors, such as the inconvenience of frequent therapeutic monitoring and the risk of haemorrhage. The development of new oral anticoagulants with improved efficacy and safety profiles has provided viable options for oral anticoagulation therapy in patients with nonvalvular (nonrheumatic AF). Nonetheless, in patients who have an increased risk of major haemorrhage, a nonpharmacological approach to antithrombotic therapy remains an attractive alternative. The left atrial appendage (LAA) has been found to be the source of >90% of thrombi in patients with nonvalvular AF; thus, prevention of thrombus formation via transcatheter mechanical LAA occlusion is a novel therapeutic target for stroke prevention in this patient population. In this Review, we present the rationale for LAA occlusion in patients with AF, the available occlusion devices and their clinical evidence to date. We also discuss the roles of various imaging techniques in device implantation and the management strategy for associated procedural complications.

Does the presence of accessory renal arteries affect the efficacy of renal denervation?

OBJECTIVES: This study sought to assess the efficacy of catheter-based renal sympathetic denervation in patients with accessory renal arteries and to compare the blood pressure (BP)-lowering effect with that observed in patients with bilateral single renal arteries after renal denervation. BACKGROUND: Catheter-based renal sympathetic denervation causes significant BP reductions in patients with resistant hypertension. METHODS: Seventy-four patients were included in this study. Patients were assigned to 2 main groups: a bilateral single renal arteries group I (n = 54) and an accessory renal arteries group II (n = 20). Group II consisted of 9 patients whose accessory renal arteries were all denervated (group IIa), and 11 patients whose accessory renal arteries were not, or only incompletely, denervated (group IIb). The primary endpoint was the change in office systolic BP after 6 months. RESULTS: The procedure was successful in all patients. Group I: mean BP at baseline was 166.2/89.4 ± 20.5/14.6 mm Hg and decreased by -16.6 (p < 0.001)/-6.7 (p = 0.016) ± 16.4/11 mm Hg at 6-month follow-up. Group II: mean BP at baseline was 164.2/89.1 ± 19.9/15.4 mm Hg and decreased by -6.2 (p = 0.19)/-0.2 (p = 0.5) ± 19.7/11.3 mm Hg at 6-month follow-up. Patients in group IIa had an office BP reduction of -8.8 (p = 0.2)/1.1 ± 17.9/10.8 mm Hg and patients in group IIb of -4.1 (p = 0.55)/-1.3 ± 20.8/11.6 mm Hg. Similarly, significant improvements in 24-h mean systolic BP were seen in group I (-8.3 ± 17.4 mm Hg, p < 0.01), whereas none were seen in group II (-3.7 ± 8.3 mm Hg, p = 0.38). CONCLUSIONS: BP reduction achieved after renal denervation in patients with accessory renal arteries is less pronounced than in patients with bilateral single renal arteries.

Retained catheter dilator in right ventricular outflow tract for 22 years.

We report the case of a 61-year-old male with a retained catheter dilator in the right ventricular outflow tract for over 22 years. The management of retained intravascular foreign objects in the myocardium is reviewed.

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.