Mini-invasive Balloon Aortic Valvuloplasty (SOFTLY-II)

Safety and Feasibility of Transradial Mini-invasive Balloon Aortic Valvuloplasty

The spreading of transcatheter aortic valve implantation has paradoxically increased the spectrum of indications for balloon aortic valvuloplasty. Balloon aortic valvuloplasty is currently used as destination therapy for patients excluded from transcatheter aortic valve implantation, as bridge to transcatheter aortic valve implantation or to surgical aortic valve replacement, or as a stratification tool for selected high-risk patients who cannot be immediate candidates for transcatheter aortic valve implantation. Moreover, it has been recently showed that transcatheter aortic valve implantation without balloon aortic valvuloplasty is encumbered by an increased risk of cerebral embolization. However, balloon aortic valvuloplasty has a complication rate comparable to transcatheter aortic valve implantation, mainly related to access site or temporary pacemaker implantation. Thus, a transradial mini-invasive approach with rapid pacing through the 0,035 inch left ventricular support wire could be extremely appealing.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Procedure: Transradial balloon aortic valvuloplasty; Procedure: Transradial balloon aortic valvuloplasty

Detailed Description

Consecutive patients with severe aortic stenosis with indication to aortic balloon valvuloplasty will be enrolled. An ad hoc informed consent for the procedure will be obtained from all patients.

This is a prospective observational study. The Investigators will include patients where aortic ballloon valvuloplasty is attempted by radial access and without temporary pacemaker implantation. The aim is to register and monitor the effectiveness and safety of this approach. Details regarding management of radial access and pacing with 0.035 wire can be found in the references reported below. The primary endpoint will be the 30-day occurence of minor and major vascular complications according VARC 2 classification. The safety endpoint will be the absence of intra- or periprocedural major complications in transradial balloon aortic valvuloplasty, namely balloon entrapment or compartment syndrome requiring surgical intervention.

The feasibility endpoint will be a procedural success rate ≥90%. The efficacy endpoint will be a reduction of the mean invasive gradient >30%. At baseline, Handgrip strength test will be performed and angiography of the instrumented arm will be performed at the beginning and at the end of the procedure. All patients will be prospectively followed-up for at least 30 days and all adverse events will be recorded. All patients will be assessed also for frailty according the clinical frailty scale (CFS). During the 30-day follow-up visit two independent blinded operators will evaluate radial artery patency by ultrasonography and perform handgrip strength test in in both arms in all patients.

• Study Type: Observational
• Enrollment (Actual): 361

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy
    • AOU di Ancona
  • Bologna, Italy
    • AOU di Bologna
  • Forlì, Italy
    • Ospedale Morgagni Pierantoni
  • Grosseto, Italy
    • Ospedale Misericordia
  • Lecce, Italy
    • Ospedale Vito Fazzi
  • Pescara, Italy
    • Ospedale Civile Santo Spirito
  • Ravenna, Italy
    • Ospedale Santa Maria delle Croci
  • Rimini, Italy
    • Ospedale degli Infermi
  • Salerno, Italy
    • Ospedale San Giovanni di Dio e Ruggi d'Aragona
  • Sassari, Italy
    • Ospedale di Sassari
  • Teramo, Italy
    • ASL di Teramo
  • Torino, Italy
    • Ospedale degli Infermi di Rivoli
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • University Hospital Of Ferrara
  • Lecce
    • Tricase, Lecce, Italy
      • Pia Fondazione Panico
  • Milano
    • Cinisello Balsamo, Milano, Italy
      • Ospedale Bassini
  • Torino
    • Orbassano, Torino, Italy
      • AOU San Luigi Gonzaga
  • Treviso
    • Conegliano, Treviso, Italy
      • Ospedale di Conegliano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with severe aortic stenosis with indication to balloon aortic valvuloplasty

Description

Inclusion Criteria:

• severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty

Exclusion Criteria:

• cardiogenic shock
• bilateral absence of radial pulse

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transradial balloon aortic valvuloplasty; Consecutive patients with severe aortic stenosis and receiving as first attempt balloon aortic valvuloplasty by transradial access.	Procedure: Transradial balloon aortic valvuloplasty; Mini-invasive balloon aortic valvuloplasty consisting in transradial access; Procedure: Transradial balloon aortic valvuloplasty; Rapid pacing using the 0.035-in. retrograde left ventricular support wire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular complications	Cumulative occurrence of major and minor bleeding complications according the VARC-2 classification	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transradial balloon aortic valvuloplasty major complications	Balloon entrapment, compartment syndrome requiring surgical intervention	1 month
Adverse events	Cumulative occurrence of death, stroke, coronary occlusion, coronary dissection, moderate-severe aortic regurgitation, severe hypotension requiring intervention, pericardiocentesis, definitive pace-maker implantation	1 month
Major vascular complications	Cumulative occurrence of major bleeding complications according the VARC-2	1 month
Minor vascular complications	Cumulative occurrence of minor bleeding complications according the VARC-2	1 month
Radial artery occlusion	Cumulative occurrence of radial artery occlusion	1 month
Radial artery occlusion	Cumulative occurrence of radial artery occlusion	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty assessment	Improvement from baseline to 1 month of the Clinical Frailty Scale. The Clinical Frailty Scale (CFS) ranges from 1 to 9, with higher values suggestive for poor prognosis	1 month
Physical performance assessment	Improvement from baseline to 1 month of grip strength	1 month
Essential Frailty Toolset	Improvement from baseline to 1 month of the value of the Essential Frailty Toolset scale. The Essential Frailty Toolset (EFT) ranges from 0 to 5, with higher values suggestive for poor prognosis	1 month

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Publications and helpful links

General Publications

• Tumscitz C, Pirani L, Tebaldi M, Campo G, Biscaglia S. Seven french radial artery access for PCI: a prospective single-center experience. Int J Cardiol. 2014 Oct 20;176(3):1074-5. doi: 10.1016/j.ijcard.2014.07.134. Epub 2014 Aug 2. No abstract available.
• Hilling-Smith R, Cockburn J, Dooley M, Parker J, Newton A, Hill A, Trivedi U, de Belder A, Hildick-Smith D. Rapid pacing using the 0.035-in. Retrograde left ventricular support wire in 208 cases of transcatheter aortic valve implantation and balloon aortic valvuloplasty. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):783-786. doi: 10.1002/ccd.26720. Epub 2016 Oct 11.
• Tumscitz C, Di Cesare A, Balducelli M, Piva T, Santarelli A, Saia F, Tarantino F, Preti G, Picchi A, Rolfo C, Attisano T, Colonna G, De Iaco G, Parodi G, Di Marco M, Cerrato E, Pierini S, Fileti L, Cavazza C, Dall'Ara G, Govoni B, Mantovani G, Serenelli M, Penzo C, Tebaldi M, Campo G, Biscaglia S. Safety, efficacy and impact on frailty of mini-invasive radial balloon aortic valvuloplasty. Heart. 2021 Jun;107(11):874-880. doi: 10.1136/heartjnl-2020-318548. Epub 2021 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2017
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): April 20, 2021

Study Registration Dates

• First Submitted: March 11, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 18072011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No