Percutaneous mitral repair with-mitraclip system, safety and efficacy; initial Egyptian experience

To evaluate the feasibility, efficacy, and safety of the MitraClip system in patients with severe MR. Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by use of the MitraClip device to secure the mitral leaflets. Methods: Five Patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines between March 2013 and May 2013 and underwent percutaneous mitral repair with MitraClip system . Patients were followed up for six months after procedure. The primary acute safety endpoint was freedom from major adverse events (MAEs) at 30 days, defined as the composite of death, myocardial infarction, non-elective cardiac surgery for adverse events, renal failure, transfusion of more than 2 units of blood, ventilation for more than 48 h, deep wound infection, septicemia. The primary efficacy endpoint is acute device success defined as clip implant with reduction of MR to equal or less than grade II, based on current guidelines. Results: A total of 5 patients were treated. No patients (0%) had a major adverse event,. Freedom from clip embolization was 100%. Partial clip detachment had not occurred in any patients (0%) patients. Overall, 4 of 5 (80%) patients achieved acute procedural success, and 3 (60%) were discharged with MR of ⩽1+. Conclusions: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to edge mitral valve repair is feasible and may be accomplished with favorable short-term safety and efficacy results

Catheter-based radiofrequency renal sympathetic denervation for resistant hypertension; initial Egyptian experience

Objectives: To evaluate the feasibility, efficacy, and safety of catheter-based radiofrequency renal sympathetic denervation for treatment of resistant hypertension. Background: In a subpopulation of patients with essential hypertension, therapeutic targets are not met, despite the use of multiple types of medication. In this paper we describe our first experience with a novel percutaneous treatment modality using renal artery radiofrequency (RF) ablation. Methods: Thirty patients with essential hypertension unresponsive to at least three types of antihypertensive medical therapy (baseline office systolic blood pressure ⩾160 mmHg) were selected between March and September 2012 and received percutaneous RF ablation. Patients were followed up for 6 months after treatment. The primary effectiveness endpoint was change in seated office-based measurement of systolic blood pressure at 6 months. Another thirty patients were taken as control. Results: A reduction of mean office blood pressure was seen from 170/102 ± 9/5 mmHg at baseline to 151/91 ± 8/6 mmHg at 6 months follow-up (p = 0.001). Also, we noted a significant decrease in plasma renin activity (3.66 ± 0.64 versus 3.37 ± 0.47 ng/mL/h; p = 0.003). No periprocedural complications, adverse events or change in renal function were noted during follow-up. Conclusion: Catheter-based renal denervation seems an attractive minimally invasive treatment option in patients with resistant hypertension, with a low risk of serious adverse events

Percutaneous

Objectives: To evaluate the feasibility, efficacy, and safety of the MitraClip system in patients with severe MR. Background: Mitral valve repair for mitral regurgitation (MR) has been performed by the use of a surgically created double orifice. Percutaneous repair based on this surgical approach has been developed by the use of a MitraClip device. Methods: Five patients with 3 to 4+ MR were selected in accordance with the American Heart Association/American College of Cardiology guidelines between March 2013 and May 2013 and underwent percutaneous mitral repair with the MitraClip system with 6 months follow up after the procedure. The primary acute safety endpoint was freedom from major adverse events (MAEs) at 30 days. The primary efficacy endpoint was acute procedural success defined as clip implant with the reduction of MR to equal or less than grade II, based on current guidelines. Results: No transseptal complications were reported (0%). There was no procedural mortality. No patients experienced MAE at 30 days. No cases of clip detachment or embolization were observed. Acute procedural success was achieved in all treated patients (100%). There was an improvement in the severity of MR in all patients as assessed acutely. Acute MR reduction by 3 grades was achieved in 2 patients and by 2 grades in 3 patients (reduction ⩾2 grades in 100%). Conclusions: Our initial results with the MitraClip device in a very small number of patients indicate that percutaneous edge-to-edge mitral valve repair is feasible and may be accomplished with favorable short-term safety and efficacy results

Bioresorbable Vascular Scaffold (ABSORB BVS); first report in Egyptian patients with 6 month angiographic/IVUS follow up

Objective: To evaluate the feasibility, efficacy, and safety of the ABSORB BVS (Bioresorbable Vascular Scaffold) for the treatment of de novo native coronary artery stenosis. Methods: Thirty patients with ischemic heart disease were selected between September 2012 and December 2012 and received ABSORB BVS for the treatment of de novo native significant coronary artery stenosis. Patients were followed up for six months after the procedure. In each patient, the treated segment and the periscaffold segments (5 mm proximal and distal to the scaffold edge) were analyzed by Quantitative coronary angiography (QCA) and phased-array intravascular ultrasound (IVUS) catheters in paired matched angiographic views after the procedure and at follow-up. The major clinical end point was ischemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization. Results: Overall the scaffold area remained unchanged. The angiographic late lumen loss amounted to 0.27 ± 0.32 mm with an IVUS relative decrease in minimal lumen area of 1.94% (p = 0.12), without significant changes in the mean lumen area. After 2 weeks, 1 patient presented with STEMI, control coronary angiography revealed a patent stent with thrombus distal to it that was treated with a metallic drug-eluting stent (Xience V). There were no cardiac deaths or ischemia-driven target lesion revascularizations. At six months the hierarchical ID-MACE was 3.3%. Conclusions: ABSORB BVS seems an attractive option for the treatment of significant de novo native coronary artery stenosis with low risk of serious adverse events

Safety and efficacy of transcatheter left atrial appendage closure using the Watchman device in Egyptian patients with nonvalvular atrial fibrillation

Background: Atrial fibrillation (AF) is considered the major cause of stroke in the elderly. Alternative therapies to the anticoagulant therapy are warranted, particularly in patients who are ineligible or at high risk of bleeding. The left atrial appendage (LAA) is a prominent source of thrombi in nonvalvular AF, accounting for 90% of thrombi. As a result, surgical and transcatheter techniques have been explored to reduce the risk of stroke in patients with AF by occluding the LAA. Objectives: To assess the safety and efficacy of LAA closure in patients with nonvalvular atrial fibrillation (AF) ineligible for warfarin therapy. Methods: A prospective study that evaluated LAA closure with the Watchman device (Boston Scientific, Natick, MA; group A) in fifteen patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ⩾75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ⩾1, who were considered ineligible for warfarin therapy. The primary efficacy endpoint was the combined events of ischemic/hemorrhagic stroke, systemic embolism and cardiovascular/unexplained death during a period of six months follow-up. Results: Successful closure of the LAA using the Watchman device was achieved in 15 patients (100%). The mean age was found to be 67.9 ± 9 years with 40% of them being males. No device or procedure related adverse events were detected. The mean CHADS2 score was 2.4 ± 0.8, while the mean CHA2DS2-VASC score was 4.4 ± 1.0. After a mean period of 8 ± 2 months of follow-up, no device dislodgement or device-related thrombi were documented. The all-cause stroke (ischemic and hemorrhagic) and systemic embolism were 0%. The device and procedure related mortality was found to be 0%. Only one patient died after 8 months of device implantation from pneumonia. Conclusion: LAA closure with the Watchman device can be safely performed, and may be a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation or with high risk of bleeding

Evaluation of the dislodgement force of splinted restorations with engaging conical abutments over multiple nonparallel implants (in-vitro study)

Abstract Background Splinted multiunit cement-retained restorations with screw access channels over engaging abutments are viable implant prosthetic options. However, information regarding the maximum degree of divergence between multiple implants is lacking. The purpose of this in vitro study was to determine the maximum degree of divergence between 2 adjacent implants with conical connections that allows insertion and removal of splinted restorations with engaging preparable abutments or titanium base abutments. Methods Two implants were aligned in a stone base, one straight and the other at an angle ranging from 0 to 20 degrees. The implants represented an implant system that had an internal conical connection and a hexed abutment engaging the base of the connection. Two straight preparable engaging cement retained abutments were screwed onto the implants and splinted together using acrylic resin. A total of 11 angles were tested, with 7 specimens for every angle. Evaluation of dislodging force was performed by pulling out the splinted abutments after unscrewing them. This was performed subjectively by 3 blinded investigators who applied a tactile pulling force. A scale of 0–10 was used to estimate the pulling force. Objectively the dislodging force was measured in Newtons using a universal testing machine. A statistical correlation was made between the subjective and objective dislodging force values using Spearman’s rank correlation coefficient. Results The mean subjective values increased gradually from 0 to 16 degrees. A sudden rise was noticed at 18 degrees (9.71 ± 0.23) and, at 20 degrees, the investigators were not able to remove the splinted abutments from the implants. The mean objective dislodgement force values increased gradually from 0 to16 degrees and abruptly from 16 degrees (13.57 ± 0.45 N) to 18 degrees (25.40 ± 0.66 N) and 20 degrees (35.22 ± 0.64). The correlation between the subjective and the objective evaluations assessed using the Spearman’s rank correlation coefficient was 0.98 indicating a statistically significant correlation (P < .001). As the objective dislodging force increased, the subjective dislodgement difficulty increased. Conclusions Splinting cement retained restorations with screw access channels on engaging abutments is possible when multiple implants with conical connections having an internal flare angle of 8 degrees are used, with implant divergence of up to 16 degrees

Bioresorbable vascular scaffold (BVS) for the treatment of native coronary artery stenosis: one year

Background: The newer generation of Bioresorbable Vascular Scaffold ABSORB (BVS 1.1) showed better outcome in regard to scaffold area reduction as a result of improved scaffold design and enhanced polymer processing. Objective: To assess the safety and efficacy of treating significant native coronary artery stenosis using ABSORB BVS. Methods: Ninety-nine patients with de novo native significant coronary artery stenosis were selected between September 2012 and September 2014 and were treated using ABSORB BVS. For each patient, the target and the peri-scaffold segments (5 mm proximal and distal to the scaffold edge) were analyzed by Quantitative Coronary Angiography (QCA) and Intravascular Ultrasound (IVUS) immediately after the procedure and at one year of follow-up. The major clinical endpoint was ischemia-driven major adverse cardiac events (ID-MACE) defined as a composite of cardiac death, myocardial infarction or ischemia-driven target lesion revascularization (ID-TLR). Results: At one year, the overall scaffold area did not demonstrate any significant change. The angiographic insegment late lumen loss was estimated to be 0.11 ± 0.19 mm, while the IVUS assessment revealed a non-significant decrease in the minimal lumen area by 0.5% (p = 0.79), without significant change in the mean lumen area. There were no reported cardiac deaths. However, two cases of ID-TLR were recorded, one case with STEMI after two weeks due to thrombosis at the distal edge of the BVS and another case with restenosis after one year. Both were treated with metallic drug-eluting stents (Xience V). At one year the overall ID-MACE was found to be 2%. Conclusion: The performance of ABSORB BVS in the treatment of significant de novo native coronary artery stenosis makes it an attractive option with favorable early and late outcome

Transcarotid transcatheter aortic valve replacement

International audienceOBJECTIVES: The purpose of this study was to assess the feasibility and safety of transcarotid transcatheter aortic valve replacement (TAVR). BACKGROUND: Many candidates for TAVR have challenging vascular anatomy that precludes transfemoral access. Transcarotid arterial access may be an option for such patients. METHODS: The French Transcarotid TAVR Registry is a voluntary database that prospectively collected patient demographics, procedural characteristics, and clinical outcomes among patients undergoing transcarotid TAVR. Outcomes are reported according to the updated Valve Academic Research Consortium criteria. RESULTS: Among 96 patients undergoing transcarotid TAVR at 3 French sites (2009 to 2013), the mean age and Society of Thoracic Surgeons predicted risk of mortality were 79.4 +/- 9.2 years and 7.1 +/- 4.1%, respectively. Successful carotid artery access was achieved in all patients. The Medtronic CoreValve (Medtronic, Inc., Minneapolis, Minnesota) (n = 89; 92.7%) and Edwards SAPIEN valves (Edwards Lifesciences, Irvine, California) (n = 7; 7.3%) were used. Procedural complications included: valve embolization (3.1%), requirement for a second valve (3.1%), and tamponade (4.2%). There were no major bleeds or major vascular complications related to the access site. There were 3 (3.1%) procedural deaths and 6 (6.3%) deaths at 30 days. The 1-year mortality rate was 16.7%. There were 3 (3.1%) cases of Valve Academic Research Consortium-defined in-hospital stroke (n = 0) or transient ischemic attack (TIA) (n = 3). None of these patients achieved the criteria for stroke and none manifested new ischemic lesions on cerebral computed tomography or magnetic resonance imaging. At 30 days, a further 3 TIAs were observed, giving an overall stroke/TIA rate of 6.3%. CONCLUSIONS: Transcarotid vascular access for TAVR is feasible and is associated with encouraging short- and medium-term clinical outcomes. Prospective studies are required to ascertain if transcarotid TAVR yields equivalent results to other nonfemoral vascular access routes