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.

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.

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.

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 denervation in a patient with prior renal artery stenting.

This is a case report of a 69-year-old female with treatment-resistant severe arterial hypertension despite prior successful percutaneous intervention to both renal arteries for significant renal artery stenoses (stenting of the right and balloon angioplasty of the left renal artery). The office blood pressure was 221/108 mm Hg at baseline. Secondary hypertension was ruled out and catheter-based renal denervation performed (distal to the stent in the right renal artery and in the usual fashion in the left renal artery) without complications. The office blood pressure decreased at 1- and 3-month follow-up to 185/93 mm Hg and 182/95 mm Hg, respectively. This case illustrates the feasibility and potential efficacy of catheter-based renal denervation in patients with a renal artery stent, an important finding as persistent hypertension is common in patients despite successful renal artery stenting and currently available trials examining renal denervation have excluded patients with prior renal artery stents.

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.

Recurrent events after percutaneous closure of patent foramen ovale.

OBJECTIVES: To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events. BACKGROUND: It is well-known that cerebral or other embolic events may occur after PFO closure. METHODS: This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution. RESULTS: 1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8-3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years). CONCLUSION: The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts.

Safety and performance of the Spider™ patent foramen ovale occluder.

OBJECTIVES: The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic-coated double-disc patent foramen ovale (PFO) occluder. BACKGROUND: Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider™ PFO occluder was designed to minimize these risks. METHODS: The Spider™ PFO occluder is a self-expandable double-disc device with a ceramic coated nitinol wire mesh and an integrated expanded polytetrafluoroethylene (ePTFE) membrane on the right atrial side and ceramic coated nitinol anchors and ePTFE patch on the left atrial side. Study patient assessments were conducted at baseline, periprocedure, and discharge and at 1-, 6- and 12-month follow-up. RESULTS: Fifty-one patients (mean age 52 ± 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 ± 8.6 min. No periprocedural or in-hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1-month follow-up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1-month follow-up 63% (32/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6-month echo follow-up to date, 78% (39/50) had no residual shunt during Valsalva maneuver. CONCLUSION: Initial results with the novel Spider™ PFO occluder show that the device is safe and easy to use for percutaneous closure of PFO. The overall complication rate was low. The rate of AF needs further investigation.

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.

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.

Isolated tramadol overdose associated with Brugada ECG pattern.

Tramadol is a commonly prescribed synthetic opioid analgesic. In humans, electrocardiogram (ECG) changes consistent with sodium-channel blockade have not been described in overdoses with tramadol. We report a case of isolated tramadol overdose associated with a Brugada ECG pattern. A review of the literature reveals no previous human cases of tramadol overdose causing ECG changes consistent with sodium-channel blockade. However, in vitro blockade of sodium-channels has been demonstrated with high concentrations of tramadol. Tramadol overdose should be recognized as a cause for the manifestation of a Brugada ECG pattern in the setting of suicidal intoxication.

Ischemic cardiac complications following G-CSF.

Granulocyte-colony stimulating factor (G-CSF) is commonly used in bone marrow transplant donors to increase the number of circulating progenitor cells. G-CSF has also been studied following myocardial infarction, but concern has been raised about the risks of G-CSF administration in patients with coronary artery disease. We present two cases of ischemic cardiac complications that are likely to be related to administration of G-CSF and provide a contemporary overview of the literature on the cardiovascular risks of G-CSF.

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.

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.

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.