One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation.

BACKGROUND: The CLASP IID (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical) trial is the first randomized controlled trial comparing the PASCAL system and the MitraClip system in prohibitive risk patients with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: The study sought to report primary and secondary endpoints and 1-year outcomes for the full cohort of the CLASP IID trial. METHODS: Prohibitive-risk patients with 3+/4+ DMR were randomized 2:1 (PASCAL:MitraClip). One-year assessments included secondary effectiveness endpoints (mitral regurgitation [MR] ≤2+ and MR ≤1+), and clinical, echocardiographic, functional, and quality-of-life outcomes. Primary safety (30-day composite major adverse events [MAE]) and effectiveness (6-month MR ≤2+) endpoints were assessed for the full cohort. RESULTS: Three hundred patients were randomized (PASCAL: n = 204; MitraClip: n = 96). At 1 year, differences in survival, freedom from heart failure hospitalization, and MAE were nonsignificant (P > 0.05 for all). Noninferiority of the PASCAL system compared with the MitraClip system persisted for the primary endpoints in the full cohort (For PASCAL vs MitraClip, the 30-day MAE rates were 4.6% vs 5.4% with a rate difference of -0.8% and 95% upper confidence bound of 4.6%. The 6-month MR≤2+ rates were 97.9% vs 95.7% with a rate difference of 2.2% and 95% lower confidence bound (LCB) of -2.5%, for, respectively). Noninferiority was met for the secondary effectiveness endpoints at 1 year (MR≤2+ rates for PASCAL vs MitraClip were 95.8% vs 93.8% with a rate difference of 2.1% and 95% LCB of -4.1%. The MR≤1+ rates were 77.1% vs 71.3% with a rate difference of 5.8% and 95% LCB of -5.3%, respectively). Significant improvements in functional classification and quality of life were sustained in both groups (P <0.05 for all vs baseline). CONCLUSIONS: The CLASP IID trial full cohort met primary and secondary noninferiority endpoints, and at 1 year, the PASCAL system demonstrated high survival, significant MR reduction, and sustained improvements in functional and quality-of-life outcomes. Results affirm the PASCAL system as a beneficial therapy for prohibitive-surgical-risk patients with significant symptomatic DMR.

Transcaval Versus Transaxillary TAVR in Contemporary Practice: A Propensity-Weighted Analysis.

OBJECTIVES: The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice. BACKGROUND: There are no systematic comparisons of transcaval and transaxillary TAVR access routes. METHODS: Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared. RESULTS: Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%). CONCLUSIONS: Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option.

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry.

OBJECTIVES: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. BACKGROUND: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. METHODS: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. RESULTS: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. CONCLUSIONS: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

The Fate of Transcaval Access Tracts: 12-Month Results of the Prospective NHLBI Transcaval Transcatheter Aortic Valve Replacement Study.

OBJECTIVES: The authors investigated 1-year outcomes after transcaval access and closure for transcatheter aortic valve replacement (TAVR), using commercially available nitinol cardiac occluders off-label. BACKGROUND: Transcaval access is a fully percutaneous nonfemoral artery route for TAVR. The intermediate-term fate of transcaval access tracts is not known. METHODS: The authors performed a prospective, multicenter, independently adjudicated trial of transcaval access, using Amplatzer nitinol cardiac occluders (Abbott Vascular, Minneapolis, Minnesota), among subjects without traditional transthoracic (transapical or transaortic) access options. One-year clinical follow-up included core laboratory analysis of serial abdominal computed tomography (CT). RESULTS: 100 subjects were enrolled. Twelve-month mortality was 29%. After discharge, there were no vascular complications of transcaval access. Among 83 evaluable CT scans after 12 months, 77 of fistulas (93%) were proven occluded, and only 1 was proven patent. Fistula patency was not associated with overall survival (p = 0.37), nor with heart failure admissions (15% if patent vs. 23% if occluded; p = 0.30). There were no cases of occluder fracture or migration or visceral injury. CONCLUSIONS: Results are reassuring 1 year after transcaval TAVR and closure using permeable nitinol occluders off-label. There were no late major vascular complications. CT demonstrated spontaneous closure of almost all fistulas. Results may be different in a lower-risk cohort, with increased operator experience, and using a dedicated transcaval closure device. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).

Transcaval transcatheter aortic valve replacement: a visual case review.

Transcatheter aortic valve replacement (TAVR) has emerged as a viable, minimally-invasive and widely adopted approach for the treatment of severe symptomatic aortic stenosis in patients who are intermediate-risk or greater for surgical aortic valve replacement. Numerous studies have demonstrated favorable outcomes with TAVR in this population, particularly with transfemoral access TAVR. Transfemoral TAVR has been shown to be safer and associated less morbidity, shorter lengths of hospital stay and more rapid recovery as compared with traditional thoracic alternative-access TAVR (transapical or transaortic). Despite iterative advancements in transcatheter heart valve technology and delivery system, there remain a portion of patients with iliofemoral arterial vessel sizes that are too small for safe transfemoral TAVR. Paradoxically, these patients are generally higher risk and are thus less favorable candidates for open surgery or traditional alternative-access TAVR. With these considerations in mind, transcaval TAVR was developed as a fully percutaneous, non-surgical approach for aortic valve replacement in patients who are poor candidates for traditional alternative-access TAVR. In this manuscript we describe the principles on which transcaval TAVR was developed, the outcomes from the largest trial completed evaluating this technique as well as describing the technique used to perform this procedure in a case-based format.

Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation.

BACKGROUND: Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. OBJECTIVES: The authors performed a prospective, independently adjudicated, multicenter, single-arm trial of transcaval access for TAVR in patients who were ineligible for femoral artery access and had high or prohibitive risk of complications from transthoracic access. METHODS: A total of 100 patients underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing it into a pre-positioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core laboratory analyzed pre-discharge and 30-day abdominal computed tomograms. The Society of Thoracic Surgeons predicted risk of mortality was 9.6 ± 6.3%. RESULTS: Transcaval access was successful in 99 of 100 patients. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) occurred 98 of 99 patients; 1 subject had closure with a covered stent. Inpatient survival was 96%, and 30-day survival was 92%. Second Valve Academic Research Consortium (VARC-2) life-threatening bleeding and modified VARC-2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 days (range 2 to 6 days). There were no vascular complications after discharge. CONCLUSIONS: Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high-risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. (Transcaval Access for Transcatheter Aortic Valve Replacement in People With No Good Options for Aortic Access; NCT02280824).

Pulmonary vein isolation for the treatment of drug-refractory atrial fibrillation in adults with congenital heart disease.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia in adults with congenital heart disease (CHD). Long-term antiarrhythmic therapy (AAT) in these patients has significant shortcomings. The safety and efficacy of pulmonary vein antrum isolation (PVAI) for the treatment of AF in CHD is presently unknown. HYPOTHESIS: We hypothesized that PVAI for AF in patients with CHD is effective and safe. METHODS: We reviewed a prospective cohort of 4315 patients (age ≥ 18) undergoing PVAI for drug refractory AF at a single institution and identified 36 consecutive patients with CHD (single ventricle physiology, tetralogy of Fallot, coarctation of the aorta, ventricular septal defects, atrial septal defects (ASD) and cardiomyopathy resulting from anomalous origin of the left main coronary from the pulmonary artery). A second cohort of 355 consecutive patients with noncongenital structural heart disease (NSHD) (coronary artery disease, valvular heart disease, ejection fraction <50%, or prior noncongenital cardiac surgery) undergoing PVAI during the same time period was used as a control. Success was defined as freedom from AF starting two months after PVAI in the absence AAT until the end of follow-up. Partial success was defined as freedom from AF in the presence of AAT until the end of follow-up. Combined success was defined as the sum of success and partial success. We compared the outcomes with the use of propensity-score matching in the overall cohort. RESULTS: Patients with NSHD were older and had higher prevalence of hypertension (P < .01), diabetes (P < .01) and hyperlipidemia (P < .01). The most common CHD lesion was ASD (61%) and the most common NSHD lesion was valvular heart disease (57%). After one PVAI, success was achieved in 42% and 53% at 300 days in the CHD and NSHD groups respectively. Four-year success was achieved in 27% and 36% in the CHD and NSHD groups, respectively. There were no significant differences in the success rates between patients groups (P= .46), nor were there any differences in left atrial size or changes in ejection fraction after one or two PVAI in the respective groups. Complication rates between the CHD and NSHD groups were similar (15% vs. 11%, P= .42) except for a higher risk of vascular site complications in patients with CHD (8% vs. 1%, P < .05). CONCLUSION: PVAI is an attractive treatment modality in drug refractory AF in CHD, with combined success rates in excess of 60%. The maintenance of sinus rhythm after PVAI in CHD appears similar to that of NSHD and warrants prospective validation.

Technique and outcome of ostial common carotid artery stenting: a single centre experience.

AIMS: Our aim was to report techniques and outcomes of our experience in percutaneous stenting of ostial common carotid artery lesions. METHODS AND RESULTS: We retrospectively reviewed patient medical records at our institution from January 2005 until April 2011 to determine baseline characteristics, procedural details and follow-up data of patients who underwent percutaneous stenting of ostial lesions of the common carotid artery. Our study included 17 patients of whom eight (47%) were male. Sixteen of the 17 (94.1%) procedures were performed in left common carotid arteries. In seven recent patients we used a standardised technique, which was characterised by crossing the lesion with a 0.014" wire, followed by insertion of an embolic protection device with a 300 cm long wire. In this technique, the stent mounted on a 0.035" balloon catheter was deployed on both wires instead of only on the embolic protection device wire. Mean follow-up was 17.6 months. During the follow-up, only one patient had a transient ischaemic attack, and none of them had either stroke, ischaemic retinal event, myocardial infarction or contrast nephropathy. Death was observed in five patients at the end of the study period. CONCLUSIONS: Stenting of ostial lesions of the common carotid artery appears safe and effective.

Subintimal guidewire tracking during successful percutaneous therapy for chronic coronary total occlusions: insights from an intravascular ultrasound analysis.

OBJECTIVES: We sought to determine the frequency of subintimal guidewire tracking during successful percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) and to better understand the procedural implications of this event. BACKGROUND: Successful PCI for chronic CTO is associated with improved outcomes in patients with ischemia. While subintimal guidewire tracking resulting in failure to cross is recognized as the major mode of failure for CTO PCI, the implications of subintimal guidewire tracking during successful CTO PCI are unknown. METHODS: Between March 2007 and October 2007, 26 consecutive patients, each with one de-novo CTO lesion successfully crossed with a guidewire were included in the analysis. Intravascular ultrasound (IVUS) was performed in each CTO vessel after guidewire crossing. Cases were classified as having definite subintimal wire tracking or no clear evidence of subintimal wire tracking based on analysis of IVUS images. RESULTS: Subintimal wire tracking occurred in 45% of cases. In cases where subintimal wire tracking was present, a previous attempt at CTO PCI was more common (42% vs. 7%, P ≤ 0.05). Subintimal wire tracking was also associated with significantly longer final mean stent length (71 vs. 50 mm), procedure time (122 vs. 69 min), fluoroscopy time (47 vs. 22 min), and contrast dose (300 vs. 199 mL, P ≤ 0.05 for all). There was one perforation in the subintimal group which was successfully treated with stent placement. CONCLUSIONS: Subintimal wire tracking occurs frequently during successful PCI for CTO and is associated with increased lesion and procedural complexity.

Anterior ST-segment elevation with right coronary artery occlusion: a unique case of isolated right ventricular infarction.

Anterior ST-segment elevation is the classic electrocardiographic feature of anterior left ventricular myocardial infarction due to occlusion of the left anterior descending artery. However, anterior ST-segment elevation has also been described in patients with right coronary artery occlusion, in whom concomitant inferior ST-segment elevation is also typically present. A case of proximal right coronary artery occlusion resulting in anterior ST-segment elevation without inferior ST-segment elevation is reported in this article. It is hypothesized that the inferior left ventricular wall was protected by left-to-right collaterals, as seen on coronary angiography, with resultant isolated right ventricular infarction upon proximal right coronary artery occlusion. In conclusion, this report presents a unique case of an isolated right ventricular infarction resulting in an electrocardiographic pattern mimicking anterior-wall left ventricular infarction.