What Dr In Sun City, Az Does Mitraclip Transcatheter Mitral Valve Repair

Transcatheter mitral valve replacement (MVR) has recently emerged every bit an exciting new frontier in the field of cardiac structural interventions. Although transcatheter aortic valve replacement (TAVR) is a well-established treatment option for patients with symptomatic severe calcific aortic stenosis, the experience with transcatheter MVR remains at an early stage. There take been of import challenges in the development of this engineering, including the complexity of the mitral valve anatomy involving a saddle oval shape, the subvalvular apparatus, the interaction with the left ventricular outflow tract (LVOT) and the aortic valve, as well as the large size of transcatheter MVR devices and large catheters for implantation. At this stage of development, all of these limit the delivery arroyo to transapical in most cases. The wide variety of mitral pathology, from stenosis to multiple mechanisms of regurgitation, likewise adds to the difficulties of valve blueprint. Furthermore, the patients being considered for transcatheter MVR are usually high take a chance with multiple comorbidities, including frailty, pulmonary hypertension, or astringent left ventricular systolic dysfunction, each of which negatively touch the overall clinical outcome. Despite these technical, anatomic, and clinical limitations, there has been meaning progress in the terminal couple of years.

Overview of Engineering science and Early Outcomes With Transcatheter MVR

The type of transcatheter heart valve that best suits a specific patient varies according to the underlying pathology to exist treated.

Transcatheter MVR in Failed Surgical Bioprostheses or Rings

Patients with failed surgical mitral bioprostheses or rings have been treated with the off-label use of standard aortic transcatheter centre valve devices. The pre-existing circular frame provided by a surgical bioprosthesis and some surgical rings can exist used every bit a landing zone and provide anchoring for a balloon expandable or newer aortic transcatheter middle valve devices. Therefore, aortic transcatheter eye valve engineering has been used for this purpose prior to development of dedicated transcatheter heart valve devices specifically designed for the mitral position. Transcatheter mitral valve-in-valve and valve-in-ring accept been successfully performed with aortic transcatheter heart valve in hundreds of patients worldwide. Most of the outcomes data reported come from case reports, case series, and the Bright (Valve In Valve International Database) Registry.^ane-v The most often used transcatheter center valves have been the Edwards SAPIEN family of valves (Edwards Lifesciences; Irvine, CA) (Effigy 1). The delivery approach in most patients has been transapical. Although the transseptal approach has been increasingly adopted, upmost access was used in 80% of cases in the VIVID registry.⁵ The composite endpoint of 30-twenty-four hours survival free from moderate or severe mitral regurgitation (MR) or clinically evident LVOT obstruction was observed in 88.viii% of 349 valve-in-valve and 71% of 88 valve-in-ring patients retrospectively evaluated in the VIVID registry. The MITRAL (Mitral Implantation of Transcatheter Valves) trial is a prospective Food and Drug Adminstration-canonical, physician-sponsored multicenter trial evaluating the safety and feasibility of transcatheter MVR with the Edwards SAPIEN three valve in three patient populations: native valves with severe mitral annular calcification (MAC), failed surgical rings, and failed surgical bioprosthesis.⁶ The transvenous transseptal arroyo is the commitment method of choice in this trial and is being successfully utilized. Enrollment is underway, and it is expected that this trial volition provide of import information about the safety and outcomes of transseptal transcatheter MVR. Table ane summarizes the transcatheter MVR clinical trials recruiting patients at the time of this review'southward publication. These trials are in feasibility stage at this fourth dimension and are not randomized.

Table 1: Transcatheter MVR Clinical Trials

Trial Name	Device	Enrollment Criteria	Intended Enrollment
PRELUDE (Percutaneous Mitral Valve Replacement Evaluation Utilizing IDE Early on Feasibility Report)	Caisson transcatheter MVR arrangement (Caisson Interventional LLC; Maple Grove, MN)	xviii years and older Severe MR High chance for surgery	20
RELIEF (Reduction or Emptying of Mitral Regurgitation in Degenerative or Functional Mitral Regurgitation With the CardiaAQ-Edwards™ Transcatheter Mitral Valve)	CardiaAQ-Edwards™ Transcatheter Mitral Valve (Edwards Lifesciences; Irvine, CA)	xviii years and older New York Heart Association (NYHA) ≥II Moderate to severe/severe MR Prohibitive risk for open-heart surgery	200
Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation	CardiaAQ-Edwards™ Transcatheter Mitral Valve (Edwards Lifesciences; Irvine, CA)	eighteen years and older Clinically significant symptomatic MR Loftier risk for open-heart surgery	28
Early Feasibility Written report of the Neovasc Tiara™ Mitral Transcatheter Heart Valve With the Tiara™ Transapical Delivery System	Tiara™ valve and transapical delivery system transcatheter MVR (Neovasc Inc; Richmond, B.C. Canada)	xviii years and older NYHA ≥Three Loftier risk for open mitral valve surgery	30
TIARA-2 Tiara™ (Transcatheter Mitral Valve Replacement Study)	Tiara™ valve and transapical delivery arrangement transcatheter MVR (Neovasc Inc; Richmond, B.C. Canada)	18 years and older Severe MR High run a risk for open up mitral surgery	115
Evaluation of Safety and Functioning of the Twelve Transcatheter Mitral Valve Replacement System in Patients With Astringent, Symptomatic Mitral Regurgitation	Twelve transcatheter MVR (Twelve, Inc; Redwood City, CA)	18 years and older NYHA ≥2 Severe MR	10
Expanded Clinical Study of Tendyne Mitral Valve System	Tendyne™ Mitral Valve Arrangement (Tendyne Holdings, LLC, a subsidiary of Abbott Vascular, Roseville, MN)	18 years and older NYHA ≥2 Non suitable for traditional surgical treatment	110
MITRAL	Edwards SAPIEN XT and SAPIEN 3 transcatheter heart valve (Edwards Lifesciences; Irvine, CA)	22 years and older NYHA ≥Two Severe MAC Astringent mitral stenosis or severe MR with at to the lowest degree moderate mitral stenosis Extremely high adventure for standard mitral surgery	xxx
SITRAL (Surgical Implantation of Transcatheter Valve in Native Mitral Annular Calcification Report)	Edwards SAPIEN iii transcatheter heart valve (Edwards Lifesciences; Irvine, CA)	22 years and older Severe MAC with mitral stenosis or MR NYHA ≥Ii High-risk or inoperable	thirty
NHLBI DIR LAMPOON Written report (Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation)	Edwards SAPIEN three transcatheter middle valve (Edwards Lifesciences; Irvine, CA)	21 years and older Severe mitral valve failure later mitral annuloplasty repair or related to MAC High or prohibitive risk for surgical MVR Loftier or prohibitive risk of LVOT obstruction or transcatheter heart valve dysfunction from long/anterior mitral valve leaflet	60

Transcatheter MVR in Native Mitral Valves

Implantation of a transcatheter heart valve in a native mitral valve is significantly more than challenging than mitral valve-in-valve and valve-in-ring procedures where there is a scaffold the operator can utilize equally a landing zone to ballast the new prosthesis. A major problem for transcatheter MVR in native mitral valves is LVOT obstruction from protrusion of the device into the LVOT and/or displacement of the anterior mitral leaflet. During surgical MVR, the anterior mitral valve leaftlet is oft removed to mitigate LVOT obstruction. The type of transcatheter mitral valve design is pathology dependent. In patients with MR, novel self-expanding nitinol-framed valves with an anchoring organisation are being used and developed. In contrast, for severe calcific mitral stenosis, balloon expandable valves, primarily aortic transcatheter heart valve, are being used.

Mitral Regurgitation

Multiple transcatheter eye valve devices designed to treat MR are being adult. Most of them are in early phases of evaluation with mixed technical and clinical results. A few of them were acquired past larger companies and are already under evaluation in early feasibility clinical trials.

The CardiAQ-Edwards™ transcatheter mitral valve (Edwards Lifesciences; Irvine, CA), was the get-go transcatheter centre valve implanted percutaneously in a native mitral valve in humans.⁷ The start generation was made of porcine pericardium mounted on a cocky-expandable nitinol stent (Figure 1). The second generation of the CardiAQ can be delivered via transapical or transfemoral transseptal approach. Thirteen patients have been treated under compassionate use: one with the first generation and the remaining 12 with the second generation device. Technical success, defined as successful valve delivery, valve deployment, and delivery arrangement retrieval was accomplished in 92%. There were two procedure-related deaths: i due to interaction with preexisting mechanical aortic valve and i due to malpositioning secondary to sub-leaflet calcification.⁸ The RELIEF Study has been initiated (Table i).

The Medtronic Intrepid™ transcatheter heart valve (Medtronic; Minneapolis, MN) has a self-expandable nitinol outer stent, which provides fixation and sealing, and a circular inner stent, which houses a 27 mm tri-leaflet bovine pericardium valve with an effective orifice area of 2.4 cm² (Figure i). The valve is implanted via transapical access; a transseptal delivery arroyo is existence developed. 30-eight patients have been treated in a pilot study. The valve was successfully deployed in 35 patients, and there were 4 procedure-related deaths. MR severity was reduced to 1(+) in iii and 0 in 32 patients, resulting in improvement of symptoms of 1 or more functional course in 21 of 25 patients with clinical follow-up data bachelor.^nine A clinical trial has been initiated (Table 1).

The Tendyne™ Mitral Valve System (Tendyne Holdings, LLC, a subsidiary of Abbott Vascular, Roseville, MN) has a self-expanding nitinol double-frame design. The inner stent frame is circular and supports a tri-leaflet porcine pericardial valve with an constructive orifice surface area of three.2 cm². The outer stent frame has a D-shape to conform to the mitral valve annulus shape. The outer stent has a poly-terephthalate cuff for sealing in the annulus. Its anchoring mechanism is an upmost tether (Effigy ane). The valve is delivered via a transapical approach through a 34 Fr sheath. The outcomes of the first xxx patients treated in the global feasibility trial were recently published. The valve was successfully implanted in 28 patients (93.3%). Residual MR was grade 1 in ane patient and 0 in the remaining 27 patients. Despite a high-risk patient population with a Society of Thoracic Surgeons mortality hazard score of vii.3%, there were no cardiac deaths, strokes, or myocardial infarctions at thirty days. At that place was 1 not-cardiac death on post-operative day xiii due to hospital-caused pneumonia.¹⁰ The Expanded Clinical Study of Tendyne Mitral Valve Organisation is ongoing (Table 1).

Effigy 1

SAPIEN iii™ valve (A). Reprinted with permission from Edwards Lifesciences (Irvine, CA). CardiAQ-Edwards™ Transcatheter Mitral Valve (B). Reprinted with permission from Edwards Lifesciences (Irvine, CA). Medtronic Intrepid™ transcatheter middle valve (C) Reprinted with permission from Medtronic (Minneapolis, MN). Tendyne™ Mitral Valve System (D) Reprinted with Permission from Tendyne Holdings, LLC, a subsidiary of Abbott Vascular (Roseville, MN).

Calcific Mitral Stenosis

Patients with severe calcific mitral stenosis who are not candidates for standard mitral valve surgery due to surgical run a risk have been treated successfully with transcatheter MVR with the compassionate utilise of aortic transcatheter heart valve devices. Virtually of these patients take been treated with airship expandable valves. Lately, newer aortic transcatheter center valve devices such as the LOTUS Edge valve (Boston Scientific; Marlborough, MA) and Direct Menstruation (Direct Flow Medical; Santa Rosa, CA) have been used successfully to care for patients with severe MAC. However, this experience is express to few instance reports at this time,^11,12 and the Direct Flow valve is no longer available. The TMVR in MAC Global Registry was created to collect outcomes data of similar procedures performed worldwide to better understand its safety and efficacy in a larger patient population. The outcomes of the first 64 patients were recently published. Transapical approach was used in 45.3% of the patients, transseptal in 40.6%, and transatrial in 14.1%. Technical success according to the Mitral Valve Academic Research Consortium criteria was achieved in 46 of the 64 patients (72%), primarily limited past the need for a second transcatheter heart valve in 11 (17.2%). At the end of the procedure, the mean MV gradient was 4 ± ii.ii mmHg, the MV orifice area was 2.2 ± 0.95 cm^two, and paravalvular regurgitation was mild or absent in all patients. Vi patients (9.3%) had severe LVOT obstruction with hemodynamic compromise afterwards valve deployment. The thirty-twenty-four hours bloodshed was 29.vii% (cardiovascular in 12.five% and non-cardiac in 17.2%).¹³ The outcomes improved as the experience increased with more patients treated. A subsequent analysis of 104 patients evaluated outcomes relative to experience, dividing patients in tertiles in chronological order according to date of process. Most of the complications occurred in the first 3rd of the patients. Technical success in the outset tertile was 62.five%, improved to 84.4% in the second third, and was lxxx% in the third tertile. Xxx-24-hour interval mortality was 37.5% in the first tertile and decreased to 21.nine% in the 2d tertile and to 15% in the last tertile. At xxx days, 29 of the 37 patients (78%) with 30-mean solar day clinical follow-up data were in NYHA class I or Two.¹⁴ The MITRAL trial is prospectively evaluating the rubber and feasibility of the Edwards SAPIEN XT and SAPIEN three in patients with astringent native mitral disease with severe MAC who are not candidates for standard surgical MVR. Enrollment started in February of 2022 and is currently ongoing at 10 participating sites.^half-dozen

How Are Patients Evaluated for Transcatheter Mitral Valve Repair or Replacement?

Patients with symptomatic astringent mitral valve disease who are not candidates for standard open mitral valve surgery may be candidates for transcatheter mitral valve repair or transcatheter MVR under a clinical trial. At this early stage of transcatheter MVR development, the rubber and efficacy of transcatheter MVR remains uncertain. In contrast, transcatheter mitral valve repair with MitraClip (Abbott; Abbott Park, IL) has proven to provide similar improvement of symptoms and survival compared with surgery despite higher rates of remainder MR.^xv Therefore, with limited transcatheter MVR data at the fourth dimension of this review's publication, transcatheter mitral valve repair with MitraClip should be the first option for patients who take favorable anatomy and see clinical indication per guidelines. The underlying pathology plays a part when deciding on transcatheter repair versus replacement because repair with MitraClip is canonical only for master MR in the United States. The role of transcatheter mitral valve repair in patients with secondary MR is being evaluated in the COAPT (Cardiovascular Outcomes Cess of the MitraClip Percutaneous Therapy for Eye Failure Patients With Functional Mitral Regurgitation) trial. Therefore, patients with secondary MR who take favorable anatomy for MitraClip should exist considered for participation in the COAPT trial. Patients with secondary MR who take unfavorable beefcake for mitral valve repair with MitraClip could be considered for participation in a transcatheter MVR clinical trial.

Once patients have been evaluated by a structural heart team and have been considered poor surgical candidates and poor candidates for transcatheter mitral valve repair, a cardiac computed tomography scan is obtained for careful evaluation of mitral valve annulus size, presence of MAC, modeling of the valve implant, and estimation of the adventure of transcatheter MVR-induced LVOT obstacle. Patients with severe calcific mitral stenosis or regurgitation with severe MAC should be considered for inclusion in the MITRAL trial or other trial when bachelor. Patients with MR without MAC can be considered for participation in any of the clinical trials evaluating transcatheter heart valve devices designed for the mitral position.

Side by side Steps

An of import next step for clinicians is to consider referring patients to transcatheter MVR clinical trials. There are no dedicated mitral devices nevertheless well-developed enough or approved for use in practice anywhere in the globe. The development of transcatheter MVR will be more difficult than TAVR and will succeed only if we support clinical trials.

Conclusions

Transcatheter MVR is evolving into an alternative for patients with astringent mitral valve disease who are poor candidates or take increased chance for conventional mitral valve surgery. This field is at an early stage, and progress will be significantly slower than the development of TAVR due to the complication of the mitral valve beefcake and pathology. We have learned of import lessons during this early experience. Important challenges exist with the currently bachelor engineering. Improved and less bulky valve designs and delivery methods may improve technical success. A amend understanding of the kind of anticoagulation needed for transcatheter MVR is but commencement to develop. Optimizing the patient-option process past using multimodality imaging tools to accurately measure the annulus size and evaluate the risk of LVOT obstruction is essential to minimize complications.

References

1. Cheung A, Webb JG, Barbanti M, et al. 5-year experience with transcatheter transapical mitral valve-in-valve implantation for bioprosthetic valve dysfunction. J Am Coll Cardiol 2022;61:1759-66.
2. Bouleti C, Fassa AA, Himbert D, et al. Transfemoral implantation of transcatheter centre valves after deterioration of mitral bioprosthesis or previous ring annuloplasty. JACC Cardiovasc Interv 2022;8:83-91.
3. Eleid MF, Cabalka AK, Williams MR, et al. Percutaneous Transvenous Transseptal Transcatheter Valve Implantation in Failed Bioprosthetic Mitral Valves, Band Annuloplasty, and Severe Mitral Annular Calcification. JACC Cardiovasc Interv 2016;ix:1161-74.
4. Dvir D, Webb J, Schäfer U, et al. TCT-797 Transcatheter Mitral Valve-in-Valve / Valve-in-Band Implantations For Degenerative Mail service Surgical Valves: Results From The Global Valve-in-Valve Registry. J Am Coll Cardiol 2022;60(Suppl B):B232.
5. Dvir D. Transcatheter Mitral Valve-in-Valve and Valve-in-Ring Implantations. Information presented at Transcatheter Cardiovascular Therapeutics 2022 2022.
6. Guerrero M. Mitral Implantation of TRAnscatheter vaLves (MITRAL) (ClinicalTrials website). 2022. Bachelor at: https://clinicaltrials.gov/ct2/show/NCT02370511. Accessed March 29, 2022.
7. Søndergaard L, De Capitalist O, Franzen OW, et al. Offset-in-Homo Case of Transfemoral CardiAQ Mitral Valve Implantation. Circ Cardiovasc Interv 2022;8:e002135.
8. Ussia G. CardiAQ-Edwards: Design and Clinical Trial Updates. Data presented at Transcatheter Cardiovascular Therapeutics 2022.
9. Reardon G. Transcatheter Mitral Valve Replacement with the Medtronic Intrepid Organisation. Data presented at the STS/AATS Tech-Con Meeting 2022.
10. Muller DW, Farivar RS, Jansz P, et al. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol 2022;69:381-91.
11. Mellert F, Sinning JM, Werner Due north, et al. Start-in-human being transapical mitral valve replacement using the Directly Flow Medical® aortic valve prosthesis. Eur Heart J 2022;36:2119.
12. Lim ZY, Boix R, Prendergast B, et al. Start reported case of transcatheter mitral valve implantation in mitral annular calcification with a fully repositionable and self-expanding valve. Circ Cardiovasc Interv 2022;8: e003031.
13. Guerrero M, Dvir D, Himbert D, et al. Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the Beginning Multicenter Global Registry. JACC Cardiovasc Interv 2022;9:1361-71.
14. Guerrero M. Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease with Severe Mitral Annular Cacification. Data presented at EuroPCR 2022.
15. Feldman T, Kar S, Elmariah S, et al. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST Two. J Am Coll Cardiol 2022;66:2844-54.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Pulmonary Hypertension and Venous Thromboembolism, Valvular Middle Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Pulmonary Hypertension, Interventions and Imaging, Interventions and Structural Heart Affliction, Mitral Regurgitation

Keywords: Aortic Valve, Aortic Valve Stenosis, Bioprosthesis, Comorbidity, Constriction, Pathologic, Heart Failure, Hemodynamics, Hypertension, Pulmonary, Mitral Valve, Mitral Valve Annuloplasty, Mitral Valve Stenosis, Mitral Valve Insufficiency, Myocardial Infarction, Pericardium, Stents, Stroke, Surgeons, Tomography, Transcatheter Aortic Valve Replacement

< Back to Listings

Source: https://www.acc.org/latest-in-cardiology/articles/2017/04/28/09/32/transcatheter-mitral-valve-replacement-therapies

Posted by: mercedesspreduche.blogspot.com

Share this post