Amplatzer left atrial appendage closure: Single versus combined procedures.

OBJECTIVES: This study compares procedural and late clinical outcomes of left atrial appendage closure (LAAC) with Amplatzer devices as a single versus a combined procedure with other structural or coronary interventions. BACKGROUND: Multiple cardiac conditions are frequent among elderly patients and invite simultaneous treatment to ensure a favorable patient outcomes. METHODS: 559 consecutive patients (73.3 ± 11.1 years) underwent LAAC with Amplatzer devices at two centres (Bern and Zurich university hospitals, Switzerland) either as a single procedure or combined with other interventions. The primary safety endpoint was a composite of major peri-procedural complications and major bleeding at follow-up, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. All event rates are reported per 100 patient-years. RESULTS: In 263 single and 296 combined procedures with percutaneous coronary interventions (47.6%), closure of an atrial septal defect (8.4%) or a patent foramen ovale (36.5%), transcatheter aortic valve implantation (10.1%), mitral clipping (4.1%), atrial fibrillation ablation (8.8%), or another procedure (3.0%) were analyzed. Device success (96.6% [single] vs. 99.0% [combined], p = .08) did not differ between the groups. After a mean follow-up of 2.6 ± 1.5 vs. 2.5 ± 1.5 years and a total of 1,422 patient-years, the primary efficacy (40/677, 5.9% [single] vs. 37/745, 5.0% [combined]; HR, 1.2, 95% CI, 0.8-1.9, p = .44), as well as the primary safety endpoint (25/677, 3.7% vs 28/745, 3.8%; HR, 1.0, 95% CI, 0.6-1.8, p = .89) were comparable. CONCLUSIONS: LAAC with Amplatzer devices combined with structural, coronary, and electrophysiological procedures offers procedural feasibility and safety, as well as long-term efficacy.

Impact of individual stroke risk on outcome after Amplatzer left atrial appendage closure in patients with atrial fibrillation.

OBJECTIVES: To investigate periprocedural and long-term outcome of left atrial appendage closure (LAAC) using Amplatzer occluders with respect to individual pre-procedural stroke risk. BACKGROUND: LAAC is a proven strategy for prevention from stroke and bleeding in patients with nonvalvular atrial fibrillation not amenable to oral anticoagulation. Whether individual pre-procedural stroke risk may affect procedural and long-term clinical outcome after LAAC is unclear. METHODS: Multicenter study of consecutive patients who underwent Amplatzer-LAAC. Using pre-procedural CHADS2 score, outcomes were compared between a low (0-2 points) and a high stroke risk group (3-6 points). RESULTS: Five hundred consecutive patients (73.9 ± 10.1 years) who underwent Amplatzer-LAAC. Two hundred and forty eight had preprocedural CHADS2 score ≤ 2 points (low-risk group) and the remaining 252 patients had 3-6 points (high-risk group). Periprocedural complication rates (6.0% vs. 5.6%, p = .85), procedural success (LAAC without major periprocedural or device-related complications or major para-device leaks: 89.4% vs. 87.9%, p = .74), and 30-day-mortality (2.4% vs. 2.6%, p = .77) were comparable. After 1,346 patient-years (PY), the long-term composite efficacy endpoint (stroke, systemic embolism, cardiovascular, and unexplained death) was reached in 23/653 (3.5/100 PY) versus 52/693 (7.5/100 PY); HR = 2.13; 95%-CI, 1.28-3.65, p = .002) with stroke rates 67% and 68% lower than anticipated by preprocedural CHADS2 score. Combined safety endpoint (major periprocedural complications and major, life-threatening or fatal bleedings) occurred in 22/653 (3.4/100 PY) versus 28/693 (4.0/100 PY); HR = 1.20; 95%-CI, 0.66-2.20, p = .52). CONCLUSIONS: Compared with patients at low risk of stroke, LAAC with Amplatzer devices is associated with similar safety and efficacy in high-risk patients in our study.

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure.

INTRODUCTION: The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN). METHODS: Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards. RESULTS: The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA2 DS2 -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable. CONCLUSION: In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

Long-term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure.

OBJECTIVES: To compare long-term clinical outcomes after left atrial appendage closure with the Amplatzer Cardiac Plug (ACP) and Amulet. BACKGROUND: The Amulet was designed to improve clinical outcomes of first-generation ACP. METHODS: Three Amplatzer registries (Bern, Coburg, Zurich), with enrollment of patients from 2009 to 2018, were retrospectively analyzed. The primary safety endpoint was a composite of major peri-procedural complications and major bleedings, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. The net clinical benefit was a combination of all above-mentioned hazards. RESULTS: A total of consecutive 563 patients (344 ACP vs. 219 Amulet) with a mean follow-up of 2.9 ± 1.6 and 1.9 ± 0.9 years were included. Mean age (74.4 ± 9.9 [ACP] vs. 74.4 ± 9.1 [Amulet] years), stroke (CHA2 DS2 -VASc score 4.4 ± 1.6 vs. 4.6 ± 1.7), and bleeding risk (HAS-BLED score 3.2 ± 1.1 vs. 3.2 ± 0.9) were comparable. The primary endpoints of efficacy (72/998, 7.2% [ACP] vs. 43/417, 10.3% [Amulet]; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.44-1.02, p = .062), safety (40/998, 4.0% vs. 18/417, 4.3%; HR, 1.15; 95% CI, 0.53-2.51, p = .72), and the net clinical benefit (101/998, 10.1% vs. 55/417, 13.4%; HR, 0.73; 95% CI, 0.49-1.07, p = .11) were similar. CONCLUSION: In the long term, left atrial appendage closure with first and second-generation Amplatzer devices provided similar efficacy, safety, and net clinical benefit. Clinical outcomes may be rather determined by implantation technique and hemodynamics, but not by the design modifications of the Amulet.

Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC).

AIMS: This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC). METHODS AND RESULTS: Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66-1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29-1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55-1.12; P = 0.26) were similar for both groups. CONCLUSION: This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.

Propensity-matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman.

BACKGROUND: Optimal antithrombotic therapy following left atrial appendage closure (LAAC) with the Watchman occluder remains uncertain. This study retrospectively compared clinical outcomes of a 3-month dual antiplatelet therapy (DAPT group) and a protocol of anticoagulation plus aspirin for 45 days followed by DAPT for 6 months (ACT group) after LAAC with the Watchman device. METHODS: Of two Watchman registries (Coburg and Lichtenfels hospitals, Germany), 220 and 304 consecutive patients with successful LAAC were included. Patients in Coburg hospital received DAPT while they received ACT in Lichtenfels. After a 1:1 propensity score matching, 174 (DAPT) versus 174 (ACT) patients were compared by use of the primary efficacy endpoint of thromboembolic events and cardiovascular/unexplained death, the primary safety endpoint of nonprocedural related major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. RESULTS: The mean age 77.5 ± 7.2 (DAPT) versus 77.3 ± 7.1 (ACT) years, CHA2 DS2 -VASc score 4.6 ± 1.5 versus 4.7 ± 1.6, and HAS-BLED score 3.3 ± 0.8 versus 3.3 ± 0.8 were similar. After 12 months, the clinical efficacy (13/174, 7.4% [DAPT] vs 11/174, 6.3% [ACT]; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.38-1.86; P = .66) and safety (6/174, 3.4% vs 8/174, 4.5%; HR, 0.86; 95% CI, 0.29-2.56; P = .79) as well as the combined hazard endpoint (18/174, 10.3% vs 18/174, 10.3%; HR,1.01; 95% CI, 0.53-1.95; P = .97) were comparable. CONCLUSIONS: This study suggests comparable efficacy and safety of 3-month DAPT versus 6 weeks ACT plus aspirin following LAAC with the Watchman.

The effect of pegylated granulocyte colony-stimulating factor on collateral function and myocardial ischaemia in chronic coronary artery disease: A randomized controlled trial.

OBJECTIVE: To test the effect of long-term pegfilgrastim on collateral function and myocardial ischaemia in patients with chronic stable coronary artery disease (CAD). METHODS: This was a prospective clinical trial with randomized 2:1 allocation to pegfilgrastim or placebo for 6 months. The primary study endpoint was collateral flow index (CFI) as obtained during a 1-minute ostial coronary artery balloon occlusion. CFI is the ratio of mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure (mm Hg/mm Hg). Secondary endpoints were signs of myocardial ischaemia determined during the same coronary occlusion, that is quantitative intracoronary (i.c.) ECG ST-segment shift (mV) and the occurrence of angina pectoris. Endpoints were obtained at baseline before and at follow-up after three subcutaneous study drug injections. RESULTS: Collateral flow index in the pegfilgrastim group changed from 0.096 ± 0.076 at baseline to 0.126 ± 0.070 at follow-up (P = 0.0039), while in the placebo group CFI changed from 0.157 ± 0.146 to 0.122 ± 0.043, respectively (P = 0.29); the CFI increment at follow-up was +0.030 ± 0.075 in the pegfilgrastim group and -0.034 ± 0.148 in the placebo group (P = 0.0172). In the pegfilgrastim group, i.c. ECG ST-segment shift changed from +1.23 ± 1.01 mV at baseline to +0.93 ± 0.97 mV at follow-up (P = 0.0049), and in the placebo group, it changed from +0.98 ± 1.02 mV to +1.43 ± 1.09 mV, respectively (P = 0.05). At follow-up, the fraction of patients free from angina pectoris during coronary occlusion had increased in the pegfilgrastim but not in the placebo group. CONCLUSION: Pegfilgrastim given over the course of 6 months improves collateral function in chronic stable CAD, which is reflected by reduced myocardial ischaemia during a controlled coronary occlusion.

Percutaneous left atrial appendage occlusion: Effect of device positioning on outcome.

OBJECTIVE: The study in patients with percutaneous left atrial appendage (LAA) occlusion investigates clinical outcomes according to the position of the Amplatzer Cardiac Plug (ACP) disc. BACKGROUND: The ACP consists of a disc and an anchoring lobe. The disc is meant to cover the ostium of the LAA, but frequently retracts partially or completely into the neck of the LAA. It is not known whether a retracted disc affects outcome. METHODS: Outcomes of 169 consecutive patients (age 73.1 ± 10.4 years; 76% male) with successful LAA closure were analyzed according to the position of the ACP disc: group A had complete coverage of the LAA ostium; in group B the disc prolapsed partially or completely into the LAA-neck. Transesophageal echocardiography was performed 1-6 months after ACP implantation. The safety endpoint was the composite of clinically significant pericardial effusion, device embolization, procedure-related stroke/transient ischemic attack (TIA), major bleeding, or device thrombus. The efficacy endpoint was the composite of death, neurological events (ischemic and hemorrhagic stroke, TIA), or systemic embolism during follow-up. RESULTS: Group A comprised 76 patients (age 73.0 ± 9.9 years; 74% male) and group B 93 patients (age 73.3 ± 10.9 years; 79% male). Mean CHA2 DS2 -Vasc score and HASBLED score were 4.2 ± 1.7 (group A 4.3 ± 1.6; group B 4.2 ± 1.8) and 2.9 ± 1.1 (group A 2.9 ± 1.0; group B 3.0 ± 1.2), respectively. Mean follow-up of the study population was 13.0 ± 10.4 months. Overall, the composite safety and efficacy endpoints occurred in 20 (12%) and 6 patients (4%), respectively. There was no significant difference between groups A and B in the occurrence of the safety endpoint (13% vs. 11%, P = 0.64), or the efficacy endpoint (4% vs. 3%, P = 1.0). CONCLUSIONS: No evidence for a difference in the occurrence of the safety and efficacy endpoint was found between patients with complete vs. incomplete ACP disc coverage of the LAA ostium. The risk of repositioning attempts in case of incomplete coverage does not seem to be warranted. Current findings need further confirmation in a larger scale clinical trial. © 2016 Wiley Periodicals, Inc.

Coronary artery disease severity and aortic stenosis: clinical outcomes according to SYNTAX score in patients undergoing transcatheter aortic valve implantation.

AIM: The aim of this study was to evaluate whether coronary artery disease (CAD) severity exerts a gradient of risk in patients with aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: A total of 445 patients with severe AS undergoing TAVI were included into a prospective registry between 2007 and 2012. The preoperative SYNTAX score (SS) was determined from baseline coronary angiograms. In case of revascularization prior to TAVI, residual SS (rSS) was also determined. Clinical outcomes were compared between patients without CAD (n = 158), patients with low SS (0-22, n = 207), and patients with high SS (SS > 22, n = 80). The pre-specified primary endpoint was the composite of cardiovascular death, stroke, or myocardial infarction (MI). At 1 year, CAD severity was associated with higher rates of the primary endpoint (no CAD: 12.5%, low SS: 16.1%, high SS: 29.6%; P = 0.016). This was driven by differences in cardiovascular mortality (no CAD: 8.6%, low SS: 13.6%, high SS: 20.4%; P = 0.029), whereas the risk of stroke (no CAD: 5.1%, low SS: 3.3%, high SS: 6.7%; P = 0.79) and MI (no CAD: 1.5%, low SS: 1.1%, high SS: 4.0%; P = 0.54) was similar across the three groups. Patients with high SS received less complete revascularization as indicated by a higher rSS (21.2 ± 12.0 vs. 4.0 ± 4.4, P < 0.001) compared with patients with low SS. High rSS tertile (> 14) was associated with higher rates of the primary endpoint at 1 year (no CAD:12.5%, low rSS: 16.5%, high rSS: 26.3%, P = 0.043). CONCLUSIONS: Severity of CAD appears to be associated with impaired clinical outcomes at 1 year after TAVI. Patients with SS > 22 receive less complete revascularization and have a higher risk of cardiovascular death, stroke, or MI than patients without CAD or low SS.

Amplatzer left atrial appendage occlusion through a patent foramen ovale.

OBJECTIVES: To assess feasibility and outcomes of left atrial appendage (LAA) closure when using a patent foramen ovale (PFO) for left atrial access. BACKGROUND: Because of the fear of entering the left atrium too high, using a PFO for left atrial access during LAA occlusion (LAAO) is generally discouraged. We report our single-center experience using a concomitant PFO for LAAO, thereby avoiding transseptal puncture. METHODS: LAAO was performed with local anesthesia and fluoroscopic guidance only (no echocardiography). The Amplatzer Cardiac Plug (ACP) was used in all patients. After LAAO, the PFO was closed at the same sitting, using an Amplatzer occluder through the ACP delivery sheath. Patients were discharged the same or the following day on dual antiplatelet therapy for 1-6 months, at which time a follow-up transesophageal echocardiogram (TEE) was performed. RESULTS: In 49 (96%) of 51 patients (35 males, age 70.9 ± 11.9 years), LAAO was successful using the PFO for left atrial access. In one patient, a long tunnel PFO precluded LAAO, which was performed via a more caudal transseptal puncture. In a second patient, a previously inserted ASD occluder precluded LAAO, which was abandoned because of pericardial bleeding. PFO closure was successful in all patients. Follow-up TEE was performed in 43 patients 138 ± 34 days after the procedure. It showed proper sitting of both devices in all patients. CONCLUSIONS: Using a PFO for LAAO had a high success rate and could be the default access in all patients with a PFO, potentially reducing procedural complications arising from transseptal puncture.

Paraincisional subcutaneous infusion of ropivacaine after open abdominal vascular surgery shows significant advantages.

BACKGROUND: Opiates are widely used for postoperative pain relief. Unfortunately, their side effects such as inhibited gastrointestinal motility and respiratory depression may compromise or delay postoperative recovery after laparotomy. We used paraincisional subcutaneous catheters (PSCs) and applied 0.25% ropivacaine infusion to improve pain relief and decrease postoperative morphine consumption in patients after open surgery for aortic aneurysm. METHODS: A retrospective single-center study including 58 patients treated by open surgery for aortic aneurysm between October 2006 and June 2012. Overall, 28 patients (control group) received standard postoperative pain management including opiates, and 30 patients (PSC group) were treated with paraincisional continuous local analgesia with 0.25% ropivacaine administrated via bilateral subcutaneous catheters along with additional ad libitum opiates administration, at first intravenously and then orally. RESULTS: Patients characteristics as well as perioperative and postoperative outcomes were comparable between the groups during the first 5 days after surgery. Patients of the PSC group received significantly less morphine, although the patients in both groups reported a similar pain intensity. Neither wound-healing disorder nor catheter-associated subcutaneous infection was reported. High serum concentration of ropivacaine was detected in 2 patients (6%) with end-stage renal disease, who developed temporary neurologic symptoms. Length of intensive care unit (ICU) stay was significantly shorter in the PSC group (2 [0-23] vs. 4.5 [0-32] ICU days). CONCLUSIONS: This is the first report about PSCs for analgesia after laparotomy. This case/control study shows that continuous paraincisional subcutaneous infusion of 0.25% ropivacaine after open surgery for aortic aneurysm repair is a feasible method of postoperative analgesia. This technique allows sustained pain relief with significant reduction of opiate requirement and faster recovery after surgery. Prospective randomized controlled trial is necessary for the assessment of safety and efficacy of this method.

Clinical outcomes of patients with estimated low or intermediate surgical risk undergoing transcatheter aortic valve implantation.

AIMS: Transcatheter aortic valve implantation (TAVI) is an established treatment alternative to surgical aortic valve replacement in high-risk and inoperable patients and outcomes among patients with estimated low or intermediate risk remain to be determined. The aim of this study was to assess clinical outcomes among patients with estimated low or intermediate surgical risk undergoing TAVI. METHODS AND RESULTS: Between August 2007 and October 2011, 389 consecutive patients underwent TAVI and were categorized according to the Society of Thoracic Surgeons (STS) score into low (STS < 3%; n = 41, 10.5%), intermediate (STS ≥3% and ≤8%, n = 254, 65.3%), and high-risk (STS > 8%; n = 94, 24.2%) groups for the purpose of this study. Significant differences were found between the groups (low risk vs. intermediate risk vs. high risk) for age (78.2 ± 6.7 vs. 82.7 ± 5.7 vs. 83.7 ± 4.9, P < 0.001), body mass index (28.1 ± 6.1 vs. 26.5 ± 4.9 vs. 24.4 ± 4.6, P < 0.001), chronic renal failure (34 vs. 67 vs. 90%, P < 0.001), all-cause mortality at 30 days (2.4 vs. 3.9 vs. 14.9%, P = 0.001), and all-cause mortality at 1 year (10.1 vs. 16.1 vs. 34.5%, P = 0.0003). No differences were observed with regards to cerebrovascular accidents and myocardial infarction during 1-year follow-up. CONCLUSION: In contemporary practice, TAVI is not limited to inoperable or STS-defined high-risk patients and should be guided by the decision of an interdisciplinary Heart Team. Compared with patients at calculated high risk, well-selected patients with STS-defined intermediate or low risk appear to have favourable clinical outcomes.

Amplatzer left atrial appendage occlusion: single center 10-year experience.

OBJECTIVES: To report a 10-year single center experience with Amplatzer devices for left atrial appendage (LAA) occlusion. BACKGROUND: Intermediate-term outcome data following LAA occlusion are scarce. METHODS: Short- and intermediate-term outcomes of patients who underwent LAA occlusion were assessed. All procedures were performed under local aesthesia without transesophageal echocardiography. Patients were discharged on acetylsalicylic acid and clopidogrel for 1-6 months. RESULTS: LAA occlusion was attempted in 152 patients (105 males, age 72 ± 10 years, CHA2 DS2 -Vasc-score 3.4 ± 1.7, HAS-BLED-score 2.4 ± 1.2). Nondedicated devices were used in 32 patients (21%, ND group) and dedicated Amplatzer Cardiac Plugs were used in 120 patients (79%, ACP group). A patent foramen ovale or atrial septal defect was used for left atrial access and closed at the end of LAA occlusion in 40 patients. The short-term safety endpoints (procedural complications, bleeds) occurred in 15 (9.8%) and the efficacy endpoints (death, stroke, systemic embolization) in 0 patients. Device embolization occurred more frequently in the ND as compared to the ACP group (5 patients or 12% vs. 2 patients or 2%). Mean intermediate-term follow up of the study population was 32 months (range 1-120). Late deaths occurred in 15 patients (5 cardiovascular, 7 noncardiac, 3 unexplained). Neurologic events occurred in 2, peripheral embolism in 1, and major bleeding in 4 patients. The composite efficacy and safety endpoint occurred in 7% and 12% of patients. CONCLUSION: LAA closure may be a good alternative to oral anticoagulation. This hypothesis needs to be tested in a randomized clinical trial to ensure that all potential biases of this observational study are accounted for.

Chimney and periscope grafts observed over 2 years after their use to revascularize 169 renovisceral branches in 77 patients with complex aortic aneurysms.

PURPOSE: To evaluate the performance of periscope and/or chimney grafts (CPGs) in the endovascular treatment of pararenal or thoracoabdominal aneurysms using off-the-shelf devices. METHODS: Between February 2002 and August 2012, 77 consecutive patients (62 men; mean age 73±9 years) suffering from pararenal aortic (n=55), thoracoabdominal (n=16), or arch to visceral artery aneurysms (n=6) were treated with aortic stent-graft implantation requiring chimney and/or periscope grafts to maintain side branch perfusion. CPGs were planned in advance and were not used as bailout. A standardized follow-up protocol including computed tomographic angiography, laboratory testing, and clinical examination was performed at 6 weeks; 3, 6, and 12 months; and annually thereafter. RESULTS: Technical success was achieved in 76 (99%) patients; 1 branch stent-graft became dislocated from a renal artery, which could not be re-accessed. Overall, 169 target vessels (121 renal arteries, 30 superior mesenteric arteries, 17 celiac trunks, and 1 inferior mesenteric artery) were addressed with the chimney graft configuration in 111 and the periscope graft configuration in 58. In total, 228 devices were used for the CPGs: 213 Viabahn stent-grafts and 15 bare metal stents. Over a mean 25±16 months (range 1-121), 9 patients died of unrelated causes. Nearly all (95%) of the patients demonstrated a decreased or stable aneurysm size on imaging; there was a mean 13% shrinkage in aneurysm diameter. Twenty patients had primary type I/III endoleaks at discharge; in follow-up, only 3 of these were still present (no secondary or recurrent endoleaks were noted). Additional endovascular maneuvers were required for CPG-related complications in 13 patients from intervention throughout follow-up. Overall, 4 CPGs occluded (98% target vessel patency); no stent-graft migration was observed. Renal function remained stable in all patients. CONCLUSION: In this series, the use of CPGs has proven to be a feasible, safe, and effective way to treat thoracoabdominal and pararenal aneurysms with maintenance of blood flow to the renovisceral arteries. Nearly all of the aneurysms showed no increase in diameter over a >2-year mean follow-up, which supports the midterm adequacy of the CPG technique as a method to effectively revascularize branch vessels with few endoleaks or branch occlusions.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.

Microvascular response to metabolic and pressure challenge in the human coronary circulation.

In vivo observations of microcirculatory behavior during autoregulation and adaptation to varying myocardial oxygen demand are scarce in the human coronary system. This study assessed microvascular reactions to controlled metabolic and pressure provocation [bicycle exercise and external counterpulsation (ECP)]. In 20 healthy subjects, quantitative myocardial contrast echocardiography and arterial applanation tonometry were performed during increasing ECP levels, as well as before and during bicycle exercise. Myocardial blood flow (MBF; ml·min(-1)·g(-1)), the relative blood volume (rBV; ml/ml), the coronary vascular resistance index (CVRI; dyn·s·cm(-5)/g), the pressure-work index (PWI), and the pressure-rate product (mmHg/min) were assessed. MBF remained unchanged during ECP (1.08 ± 0.44 at baseline to 0.92 ± 0.38 at high-level ECP). Bicycle exercise led to an increase in MBF from 1.03 ± 0.39 to 3.42 ± 1.11 (P < 0.001). The rBV remained unchanged during ECP, whereas it increased under exercise from 0.13 ± 0.033 to 0.22 ± 0.07 (P < 0.001). The CVRI showed a marked increase under ECP from 7.40 ± 3.38 to 11.05 ± 5.43 and significantly dropped under exercise from 7.40 ± 2.78 to 2.21 ± 0.87 (both P < 0.001). There was a significant correlation between PWI and MBF in the pooled exercise data (slope: +0.162). During ECP, the relationship remained similar (slope: +0.153). Whereas physical exercise decreases coronary vascular resistance and induces considerable functional capillary recruitment, diastolic pressure transients up to 140 mmHg trigger arteriolar vasoconstriction, keeping MBF and functional capillary density constant. Demand-supply matching was maintained over the entire ECP pressure range.

Determinants of preformed collateral vessels in the human heart without coronary artery disease.

BACKGROUND: Coronary collaterals protect myocardium jeopardized by coronary artery disease (CAD). Promotion of collateral circulation is desirable before myocardial damage occurs. Therefore, determinants of collateral preformation in patients without CAD should be elucidated. METHODS: In 106 patients undergoing coronary angiography who were free of coronary stenoses, a total of 39 clinical test variables were collected. The coronary collateral flow index (CFI) was measured. Stepwise multiple linear regression analysis was performed after choosing a restricted number of candidates emerging from univariate testing. Separate multiple regression analyses were performed in patients with and without beta-blocker therapy. RESULTS: Nine parameters were found to be possible determinants of CFI by univariate analysis: arterial hypertension (aHT), dyslipidemia, statins, diuretics, age, height, heart rate (HR), pulse pressure amplitude, and left ventricular end-diastolic pressure (LVEDP). After multiple regression analysis, a low HR, absence of aHT, and elevated LVEDP were significantly related to CFI (F = 5.31, p = 0.002, adjusted r(2) = 0.12). In patients without beta-blockers, a low HR and absence of aHT were independent predictors of CFI (F = 8.03, p < 0.001, n = 50, adjusted r(2) = 0.30). CONCLUSIONS: A low HR and absence of aHT are both related to collateral preformation in humans. We suppose that bradycardia favors fluid shear stress in coronary arteries, thus triggering collateral growth.

An indicator of sudden cardiac death during brief coronary occlusion: electrocardiogram QT time and the role of collaterals.

AIMS: The coronary collateral circulation has a beneficial role regarding all-cause and cardiac mortality. Hitherto, the underlying mechanism has not been clarified. The aim of this prospective study was to assess the effect of the coronary collateral circulation on electrocardiogram (ECG) QTc time change during short-term myocardial ischaemia. METHODS AND RESULTS: A total of 150 patients (mean age 63 +/- 11 years, 38 women) were prospectively included in this study. An ECG was recorded at baseline and during a standardized 1 min coronary balloon occlusion. QT interval was measured before, during, and after balloon occlusion and was corrected for heart rate (QTc). Simultaneously obtained collateral flow index (CFI), expressing collateral flow relative to normal anterograde flow, was determined based on intracoronary pressure measurements. During occlusion of the left anterior descending coronary artery mean QTc interval increased from 422 +/- 33 to 439 +/- 36 ms (P < 0.001), left circumflex occlusion led to an increase from 414 +/- 32 to 427 +/- 27 ms (P < 0.001). QTc was not influenced by occlusion of the right coronary artery (RCA) (417 +/- 35 and 415 +/- 34 ms, respectively; P = 0.863). QTc change during occlusion of the left coronary artery was inversely correlated with CFI (R(2) = 0.122, P = 0.0002). CONCLUSION: Myocardial ischaemia leads to QT prolongation during a controlled 1 min occlusion of the left, but not the RCA. QT prolongation is inversely related to collateral function indicating a protective mechanism of human coronary collaterals against cardiac death.